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Karin, your speculations make perfect sense. I don’t think Leo would sell to Aspire at such low prices unless it’s absolutely necessary.
Today’s rally further proves (to me) that Aspire is the #1 selling pressure. It’s no coincidence the SP bounced back ~100% after May 9, the last day Leo sold to Aspire. I believe the SP will continue to go up as some investors are buying in anticipation to P results.
New investors, the statement “37% of today's volume was short sales" wasn’t in the source file. The most recent short interest is < 1% of the OS and the most recent failure-to-deliver (naked short) # is a measly 23,188 shares. IMHO interpreting short volume as actual short sales is incorrect. This is what FINRA, the exact same source which you used to post the #, said.
"Thank you for contacting FINRA’s Office of the Ombudsman. Regarding your question, it would be incorrect to assume that short sales comprise 32% of the total volume on that trading day for IPIX. FINRA publishes the daily short sale volume pursuant to an SEC mandate; however, there are various trading anomalies that result in the reported short sale volume often being exaggerated. Thus, the true total short sales volume may be significantly lower than the volume that is reported. Third parties sometimes ignore this and try to claim the ratio is valid to further their own objectives."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135537542
MMs mark shares short temporarily to execute trades and they are almost always covered in the same day, therefore the actual short % is much lower than the # suggests. If the short volume indicates actual naked shorting, would the criminals be stupid enough to leave incriminating evidence in the FINRA file?
You can also check out these two posts for some detailed explanations.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133263103
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=132584168
Here are the official short interest and failure-to-deliver data.
Settlement Date: 4/13/2018
Current Short: 1,131,509
Previous Short: 1,105,305
Change: 26,204 (2.37%)
Average Daily Volume: 302,523
Days to Cover: 3.74
http://otce.finra.org/ESI
0.77% of the outstanding shares were short interest.
“In a “naked” short sale, the seller does not borrow or arrange to borrow the securities in time to make delivery to the buyer within the standard two-day settlement period. As a result, the seller fails to deliver securities to the buyer when delivery is due (known as a ”failure to deliver” or “fail”).”
https://www.sec.gov/investor/pubs/regsho.htm
According to the SEC, only 23,188 shares (0.016% of the OS) were failure-to-deliver as of April 13.
20180413|45782D100|IPIX|23188|INNOVATION PHARMACEU|0.51
https://www.sec.gov/data/foiadocsfailsdatahtm
BP's interests in the Big Three
“The Company is engaged in discussions and negotiations regarding the out-licensing of its mid-stage, first-in-class clinical assets to global and/or specialty pharmaceutical companies who have expressed an interest in one or more assets in our pipeline.”
https://www.sec.gov/Archives/edgar/data/1355250/000147793218002302/ipix_10q.htm
“The Confidential Disclosure Agreement (CDA) count toward partnering with global and specialty pharmaceutical companies interested in the Company’s first-in-class drug candidates is nearing 20, with additional Agreements in review."
http://www.ipharminc.com/press-release/2018/1/29/innovation-pharmaceuticals-brilacidin-franchise-anchored-in-three-clinical-indications-oral-mucositis-inflammatory-bowel-disease-and-serious-skin-infections-expands-into-dermatologic-diseases
“These recent data, taken in aggregate, are what various actively engaged pharmaceutical companies have desired from us for some time—and they are what triggered a newfound flurry of inbound partnership discussions at the San Francisco conferences,”
http://www.ipharminc.com/press-release/2018/1/16/innovation-pharmaceuticals-presents-at-2018-biotech-conference-oral-mucositis-drug-candidate-garners-exceptional-interest-after-successful-phase-2-trial
"To advance our pipeline in an expeditious manner, this year we placed an emphasis on partnering—actively engaging global and regional pharmaceutical companies interested in licensing our novel drug candidates. These efforts have led to highly productive, mature (late-phase, ongoing) discussions, with multiple pharmaceutical companies, which we hope will bear fruit in the coming year." - CEO Letter to Shareholders
"We had said that confidential disclosure agreements have been signed with several pharmas interested in our drug candidates; to some, they're interested in one compound. Others have requested information on a combination of Brilacidin and Kevetrin and Prurisol."
https://seekingalpha.com/article/4080068-innovation-pharmaceuticals-ipix-ceo-leo-ehrlich-q3-2017-results-earnings-call-transcript
B-Dermatitis
"To further these efforts, the Company is in negotiations with a leading drug formulator to develop topical formulation(s) of Brilacidin for these three dermatology indications, starting in 1H2018. The goal of the negotiations is to reach terms on a strategic partnership for addressing these markets."
http://www.ipharminc.com/press-release/2018/1/29/innovation-pharmaceuticals-brilacidin-franchise-anchored-in-three-clinical-indications-oral-mucositis-inflammatory-bowel-disease-and-serious-skin-infections-expands-into-dermatologic-diseases
B-OM
“Given the notable interest from global and specialty pharmaceutical companies that we have received following recent Brilacidin-OM data releases, we continue to carefully assess all of our potential alliance opportunities—toward cementing the best pathway forward,” said Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals.”
http://www.ipharminc.com/press-release/2018/5/9/innovation-pharmaceuticals-concludes-data-analysis-of-its-phase-2-clinical-trial-for-severe-oral-mucositis-in-head-and-neck-cancer-positioning-to-fill-a-substantial-void-in-supportive-cancer-care
“Formal collaboration with pharmaceutical companies that have expressed an interest in partnering Brilacidin-OM may well assist further with expediting the drug candidate’s development timetable. Some of these partnering conversations have matured to the point of potentially structuring mutually beneficial licensing agreements, pending the final Phase 2 study results.”
http://www.ipharminc.com/press-release/2017/11/16/innovation-pharmaceuticals-offers-perspectives-on-brilacidin-as-a-potential-preventative-treatment-for-oral-mucositis-in-head-and-neck-cancer-patients
B-UP
"We've actively engaged with multiple large pharmas, who have expressed an interest in Brilacidin inflammatory bowel disease. The pharma industry is quite interested in pursuing novel IBD therapies one of the more active therapeutic areas when it comes to dealmaking."
https://seekingalpha.com/article/4080068-innovation-pharmaceuticals-ipix-ceo-leo-ehrlich-q3-2017-results-earnings-call-transcript
Prurisol
"We have entered into multiple non-disclosure agreements with large pharmaceutical companies that enable us to continue ongoing discussions regarding potential partnering should the trial results support such a relationship."
https://www.sec.gov/Archives/edgar/data/1355250/000147793217004400/ipix_10k.htm
Kevetrin
"The Company is adhering to a value-building strategy born from discussions with larger pharmaceutical companies interested in Kevetrin, one of the world’s most advanced p53 drug candidates. Securing the right development partner for Kevetrin remains an important objective."
http://www.ipharminc.com/press-release/2018/2/8/innovation-pharmaceuticals-concludes-successful-phase-2a-trial-of-kevetrin-for-ovarian-cancer-intra-tumor-modulation-of-p53-observed
"What we and potential partners are extremely interested in is learning via tumor biopsies if Kevetrin is reaching its target and modulating pathways within the tumor that can deliver a clinically meaningful benefit; this would be a significant development in the p53/oncology dynamic,"
http://www.ipharminc.com/press-release/2017/9/14/innovation-pharmaceuticals-opens-new-clinical-site-for-novel-p53-drug-candidate-in-phase-2-ovarian-cancer-trial-1
Document - Getting Ready for a BioPharma Partnering Deal
IPIX Milestones, Clinical Trials, Recent Articles, Corporate Overview, Patents
Potential Milestones (Q2)
1. Prurisol - Topline Data (Phase 2b)
2. B-OM - Breakthrough Therapy Designation
Past Milestones
Kevetrin
- Positive primary endpoint (Phase 2a)
http://www.ipharminc.com/press-release/2018/2/8/innovation-pharmaceuticals-concludes-successful-phase-2a-trial-of-kevetrin-for-ovarian-cancer-intra-tumor-modulation-of-p53-observed
- Highly encouraging preliminary data (Phase 2a)
http://www.ipharminc.com/press-release/2017/12/27/innovation-pharmaceuticals-obtains-direct-evidence-of-molecular-pathways-modulation-in-tumors-from-first-patients-in-kevetrin-ph2a-ovarian-cancer-trial
- Positive primary endpoint and p21 data (Phase 1)
http://www.ipharminc.com/press-release/2016/11/12/assay-results-from-cellceutix-phase-1-clinical-trial-of-kevetrin-for-cancer-show-increased-p21-expression-in-675-of-evaluable-patients
- Orphan drug designation for ovarian cancer
http://www.ipharminc.com/press-release/2016/11/16/cellceutixs-kevetrin-receives-fda-orphan-drug-designation-for-the-treatment-of-ovarian-cancer
- Orphan drug designation for pancreatic cancer
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-receives-fda-orphan-drug-designation-for-kevetrin-for-the-treatment-of-pancreatic-cancer
- Orphan drug designation for retinoblastoma
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-receives-fda-orphan-drug-designmation-for-kevetrin-for-the-treatment-of-retinoblastoma
- Rare pediatric disease designation for retinoblastoma
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-receives-rare-pediatric-disease-designation-from-fda-for-kevetrin-for-the-treatment-of-retinoblastoma
Brilacidin
- B-OM positive secondary endpoint (Phase 2)
http://www.ipharminc.com/press-release/2018/1/3/innovation-pharmaceuticals-brilacidin-meets-key-secondary-endpoint-in-phase-2-trial-delays-onset-of-severe-oral-mucositis-som
- B-OM positive top-line data (Phase 2)
http://www.ipharminc.com/press-release/2017/12/11/innovation-pharmaceuticals-reports-positive-topline-results-from-phase-2-placebo-controlled-trial-of-brilacidin-for-the-prevention-of-oral-mucositis-in-head-and-neck-cancer-patients
- B-UP positive top-line data (Phase 2 POC)
http://www.ipharminc.com/press-release/2017/7/13/innovation-pharmaceuticals-phase-2-poc-trial-for-inflammatory-bowel-disease-achieves-induction-of-remission-in-a-majority-of-patients-treated-with-brilacidin
- B-ABSSSI positive top-line data (Phase 2b)
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-announces-positive-top-line-data-from-phase-2b-absssi-trial-single-dose-brilacidin-comparable-to-7-days-of-daptomycin
- QIDP designation for B-ABSSSI
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-antibiotic-brilacidin-receives-qidp-designation-from-fda
- Fast track designation for B-OM
http://www.ipharminc.com/press-release/2016/11/16/fda-grants-fast-track-designation-to-cellceutixs-brilacidin-om-for-oral-mucositis
- MTA extension for prophylactic testing in implanted devices
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-completes-lab-testing-of-brilacidin-for-planned-phase-3-trial-for-acute-bacterial-skin-and-skin-structure-infections
- Formulation stable at room temperature
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-announces-breakthrough-in-the-formulation-of-novel-antibiotic-brlaicidin-plans-studies-to-treat-diabetic-foot-ulcers
- American Society for Microbiology journal publication
http://aac.asm.org/content/early/2014/06/11/AAC.02955-14#corresp-1
Prurisol
- Positive top-line data (Phase 2a)
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-phase-2-trial-of-prurisol-for-mild-to-moderate-psoriasis-meets-primary-endpoint
- Positive primary endpoint (Phase 1)
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-anti-psoriasis-drug-prurisol-meets-primary-endpoint-of-clinical-trial
- 505(b)(2) pathway
http://www.ipharminc.com/press-release/2016/11/17/cellceutix-informed-by-fda-that-505b2-approval-would-be-an-acceptable-approach-for-its-psoriasis-drug
Clinical Trials
1. K-OC (Phase 2a, Completed)
https://clinicaltrials.gov/ct2/show/NCT03042702?term=cellceutix&rank=1
2. P (Phase 1, Completed)
https://clinicaltrials.gov/ct2/show/NCT02101216?term=cellceutix&rank=2
3. B-OM (Phase 2, Completed)
https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3
4. P (Phase 2a, Completed)
https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=4
5. P (Phase 2b, Completed)
https://clinicaltrials.gov/ct2/show/NCT02949388?term=cellceutix&rank=5
6. B-ABSSSI (Phase 2b, Completed)
https://clinicaltrials.gov/ct2/show/NCT02052388?term=cellceutix&rank=6
7. K (Phase 1, Completed)
https://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=7
8. B-UP (Phase 2 POC, Completed)
http://www.ipharminc.com/press-release/2016/11/10/cellceutix-receives-update-on-first-patient-enrollment-in-phase-2-proof-of-concept-study-of-brilacidin-for-ulcerative-proctitis
Pipeline
Recent Articles
- Taking a Page from Merck’s Gardasil and Glaxo’s Requip, These Small Companies Look to Cement Riches for Shareholders in New Category of Oral Mucositis
http://www.baystreet.ca/articles/stockstowatch/38594/Taking-a-Page-from-Mercks-Gardasil-and-Glaxos-Requip-These-Small-Companies-Look-to-Cement-Riches-for-Shareholders-in-New-Category-of-Oral-Mucositis
- A Billion Dollar Market Just Waiting for a New Oral Mucositis Drug: Five Companies That Want It
http://www.baystreet.ca/stockstowatch/2658/A-Billion-Dollar-Market-Just-Waiting-for-a-New-Oral-Mucositis-Drug-Five-Companies-That-Want-It
- Innovation Pharmaceuticals Stock May Be A Triple-Crown Winner With Brilacidin By Year End
https://seekingalpha.com/article/4088788-innovation-pharmaceuticals-stock-may-triple-crown-winner-brilacidin-year-end
- 2017 Q3 Conference Call Transcript
https://seekingalpha.com/article/4080068-innovation-pharmaceuticals-ipix-ceo-leo-ehrlich-q3-2017-results-earnings-call-transcript
- 2017 Q1 Conference Call Transcript
http://seekingalpha.com/article/4023682-cellceutix-corporation-ctix-ceo-leo-ehrlich-q1-2017-results-earnings-call-transcript
- Interview with New Cellceutix President Dr A Bertolino
http://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino
- Cellceutix Pipeline Continues to Hit Milestone After Milestone
https://www.streetwisereports.com/pub/na/cellceutix-pipeline-continues-to-hit-milestone-after-milestone
- A Small-Cap Biotech with Big Ideas for Acute Infections and Cancers: Cellceutix's Leo Ehrlich and Dr. Daniel Jorgensen
http://www.thelifesciencesreport.com/pub/na/a-small-cap-biotech-with-big-ideas-for-acute-infections-and-cancers-cellceutixs-leo-ehrlich-and-dr-daniel-jorgensen
Corporate Overview
- April 2018
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5acbbec2562fa79982ad5e22/1523302089564/2018+Apr+IPIX+Corporate+Overview.pdf
- 2018 Biotech Showcase
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5a4e50e39140b721186d1a6f/1515081962344/2018Jan+IPIX+Corporate+Overview.pdf
- BioCentury NewsMakers Conference
https://static1.squarespace.com/static/5715352e20c647639137f992/t/59b2f34946c3c498ebfe112e/1504899917915/IPIX+Company+Presentation+BioCentury+NewsMakers+Conference++8Sep2017.pdf
- Drug Discovery and Therapy World Congress
https://static1.squarespace.com/static/5715352e20c647639137f992/t/596cac7df14aa1a6e7118ed8/1500294274057/IPI+DDTWC+Brilacidin+presentation+%28final-u%29+13Jul2017.pdf
Patents
- Kevetrin
https://www.google.com/patents/US8338454
- Brilacidin
https://www.sec.gov/Archives/edgar/data/1355250/000147793214002418/ctix_ex1037.htm
https://www.google.com/patents/US20160243117
https://www.google.com/patents/EP2709619A2
- Prurisol
https://www.google.com/patents/WO2013103601A1
MP Advisors Report
https://drive.google.com/file/d/0Bz15O4eaX-asWVpoclB2WUhENFk/view
Abbreviations
K – Kevetrin
B – Brilacidin
P – Prurisol
OC – ovarian cancer
ABSSSI – acute bacterial skin and skin structure infections
OM – oral mucositis
UP – ulcerative proctitis
QIDP – qualified infectious disease product
I’m just trying to follow what’s trending here. Ready for more?
You are welcome, Karin. My expectation is the same.
B-UP Due Diligence
IBD Development Update (10/24/2017)
"Oral formulation plans are underway to deliver Brilacidin more widely throughout the GI tract so as to enable treatment of more extensive forms of IBD—Crohn’s Disease and Ulcerative Colitis. A meeting with the Food and Drug Administration (FDA) is being requested to help inform appropriate next steps for our Brilacidin-IBD program, such as the size and scope of subsequent clinical trials. Finally, the Company plans to continue exploration of Brilacidin’s various mechanisms of action, including its anti-inflammatory and anti-bacterial properties, as well as its immunomodulatory and wound healing capabilities—all of which likely have a role in Brilacidin’s ability to treat IBD."
http://www.ipharminc.com/press-release/2017/10/24/innovation-pharmaceuticals-provides-development-update-on-brilacidin-for-inflammatory-bowel-disease
Positive Trial Result (7/13/2017)
Rate of Clinical Remission (% of patients achieving)
- 60% Cohort A (3 of 5 patients)
- 67% Cohort B (4 of 6 patients)
- 75% Cohort C (3 of 4 patients)
(i) #Endoscopy subscore ≤ 1 (% of patients achieving)
- 80% Cohort A (4 of 5 patients)
- 67% Cohort B (4 of 6 patients)
- 75% Cohort C (3 of 4 patients)
(ii) Rectal Bleeding subscore of 0 (% of patients achieving)
- 80% Cohort A (4 of 5 patients)
- 100% Cohort B (6 of 6 patients)
- 100% Cohort C (4 of 4 patients)
(iii) Stool Frequency subscore, improvement or no change from baseline (% of patients achieving)
- 100% Cohort A (5 of 5 patients)
- 100% Cohort B (6 of 6 patients)
- 100% Cohort C (4 of 4 patients)
Endoscopic Image (Cohort B, 100 mg)
http://www.ipharminc.com/press-release/2017/7/13/innovation-pharmaceuticals-phase-2-poc-trial-for-inflammatory-bowel-disease-achieves-induction-of-remission-in-a-majority-of-patients-treated-with-brilacidin
Patient Treatment Update (6/26/2017)
"With the study treatments now completed, Brilacidin has consistently shown strong signs of efficacy while exhibiting a good safety profile even as dosing increased, supporting its potential as a novel, non-corticosteroid, non-biologic anti-inflammatory drug candidate in treating IBD. Innovation Pharmaceuticals’ formulation development plans for Brilacidin include foam and/or gel for the treatment of UP/UPS, and pills for oral dosing for the treatment of Ulcerative Colitis and Crohn’s Disease."
http://www.ipharminc.com/press-release/2017/6/24/innovation-pharmaceuticals-completes-treatments-in-phase-2-poc-trial-for-induction-of-remission-in-inflammatory-bowel-disease-topline-results-with-endoscopic-response-to-be-presented-july-13-2017
Third Cohort Update (5/18/2017)
“What is perhaps most remarkable about this trial is that Brilacidin was administered to patients in water as a retention enema,” said Leo Ehrlich, Chief Executive Officer at Cellceutix. “The logical next step is transitioning to a foam and gel/lotion formulation, with planning already underway, which would greatly facilitate Brilacidin’s adhesion to the mucosal lining of the gastrointestinal tract and may lead to even greater efficacy. Brilacidin for UP/UPS is well-positioned to become first-in-class.”
http://www.ipharminc.com/press-release/2017/5/15/cellceutix-completes-patient-enrollment-of-final-cohort-in-phase-2-trial-of-brilacidin-for-inflammatory-bowel-disease-topline-results-anticipated-in-july
Investor & Shareholder Update (4/20/2017)
https://www.youtube.com/watch?v=kzFu-jItfMw&t=474s
First & Second Cohort Top-line Data (3/21/2017)
Primary Efficacy Endpoint of Clinical Remission (accounting for Stool Frequency, Rectal Bleeding and Endoscopy Findings subscores)—50 percent of patients in Cohort A (3 of 6) and 50 percent of patients in Cohort B (3 of 6) met this endpoint; all 6 of the remaining patients in Cohorts A and B met 2 of the 3 criteria (Partial Response).
Full MMDAI (accounting for Stool Frequency, Rectal Bleeding, Physician’s Global Assessment and Endoscopy Findings subscores)—notable improvements observed in 10 of 11 patients (one patient declined endoscopy at end of treatment):
- 100 percent reduction in 2 patients in Cohort A and 2 patients in Cohort B
- 50-75 percent reduction in 2 patients in Cohort A and 4 patients in Cohort B
- 20 percent reduction in 1 patient in Cohort A
Partial MMDAI (accounting for Stool Frequency, Rectal Bleeding and Physician’s Global Assessment subscores)—notable improvements observed in 11 of 12 patients:
- 100 percent reduction in 3 patients in Cohort A and 3 patients in Cohort B
- 50-83 percent reduction in 2 patients in Cohort A and 3 patients in Cohort B
- 0 percent reduction in 1 patient in Cohort A
Patient Quality of Life (as assessed by the Short Inflammatory Bowel Disease Questionnaire, SIBDQ)—notable improvements in all 12 patients; 50 percent of patients in Cohort A (3 of 6) and 80 percent of patients in Cohort B (5 of 6) reported significant improvements of 15 points to more than 50 points higher on the 70-point SIBDQ scale.
Other Clinically Meaningful Observations
- Endoscopy subscore of ≤ 1 met in 7 of 11 patients (1 patient declined final endoscopy).
- PGA subscore improved for 10 of 12 patients.
- Rectal Bleeding subscore improved for all 12 patients.
- Stool Frequency subscore demonstrated improvement by study end for all patients who were abnormal at study start.
http://www.ipharminc.com/press-release/2017/3/19/cellceutix-releases-favorable-topline-findings-as-part-of-interim-analysis-of-phase-2-drug-candidate-brilacidin-for-the-treatment-of-inflammatory-bowel-disease
Second Cohort Update (3/8/2017)
All 12 patients experienced a beneficial response, as measured by the Modified Mayo Disease Activity Index (MMDAI).
- At Day 42, the Primary Efficacy Endpoint of Clinical Remission (accounting for Stool Frequency, Rectal Bleeding, and Endoscopy sub-scores) was met in half (n=6) of all patients (3 of 6 in Cohort A; 3 of 6 in Cohort B).
- Among the remaining patients (n=6) in Cohorts A and B not meeting all three criteria for Clinical Remission, two of the three criteria were achieved by all of these patients (defined as a Partial Response).
Patient Quality-of-Life, as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was improved in all 12 patients after six weeks of daily Brilacidin treatment. Specifically, over 40 percent of patients reported significant improvements, ranging approximately from 20 points to more than 50 points higher on the 70-point SIBDQ scale.
http://www.ipharminc.com/press-release/2017/3/8/cellceutix-releases-preliminary-efficacy-and-safety-data-in-interim-analysis-of-first-two-cohorts-in-phase-2-trial-of-brilacidin-for-the-induction-of-remission-of-mild-to-moderate-ulcerative-colitis
Second Cohort Update (1/23/2017)
"Site investigators report enthusiastic feedback from patients currently receiving treatment in the second cohort with Brilacidin at 100 mg daily (by retention enema) for six weeks —comments included how the treatment already has greatly improved or eliminated their symptomatic complaints, daily functioning and overall quality of life. There is significant interest by new patients wishing to participate in the third (final) cohort once enrollment opens."
http://www.ipharminc.com/press-release/2017/1/22/cellceutixs-brilacidin-demonstrates-promise-in-treating-ulcerative-colitis-supported-by-endoscopic-assessment-patient-reported-outcomes
First & Second Cohort Update (12/7/2016)
"Review of safety data from the first cohort revealed that Brilacidin, administered for 6 weeks as a retention enema, at 50 mg once daily, appeared well-tolerated, with no measurable systemic absorption detected. This drug profile, at the lowest dose, allowed the approval of dose escalation to the second cohort (100 mg, once daily). Clinically meaningful improvements in symptoms of UP/UPS were also demonstrated in the first cohort, as measured by physician assessments and patient reported outcomes, further supported with endoscopic evaluation of disease activity."
http://www.ipharminc.com/press-release/2016/12/6/cellceutix-phase-2-trial-dose-escalates-in-2nd-cohort-for-brilacidin-as-a-novel-anti-inflammatory-drug-candidate-for-ulcerative-colitis
First Cohort Update (10/10/2016)
At Day 42, on the Partial MMDAI (accounting for Stool Frequency, Rectal Bleeding, and Physician’s Global Assessment scores), 2 of 4 patients achieved full response (100% reduction) and the other 2 patients had notable improvement (50% reduction).
At Day 42, on the MMDAI (equivalent to Partial MMDAI + Endoscopy score; completed by 3 of 4 patients), 1 of 3 patients achieved full response (100% reduction) and 2 of 3 patients had notable improvement (50% reduction). One patient who had demonstrated a full response on the Partial MMDAI (as defined in first bullet point) did not consent to the final endoscopy, so their data cannot be included in these initial results.
Patient quality of life, as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was improved after 6-weeks of treatment with Brilacidin.
Brilacidin was generally well-tolerated and patients maintained stable normal vital signs during treatment.
http://www.ipharminc.com/press-release/2016/10/27/cellceutix-phase-2-trial-initial-data-shows-potential-of-brilacidin-as-a-novel-anti-inflammatory-drug-candidate-for-induction-of-remission-of-mild-to-moderate-ulcerative-colitis
First Patient Update (07/18/2016)
"Cellceutix has been advised that the first patient in Cohort A remains on study. The clinical site administering Brilacidin to this patient has informed the Company, “Both the patient and the site staff have been amazed how the study drug works as all the symptoms decreased significantly within the 1st week of treatment.” "
http://www.ipharminc.com/press-release/2016/11/10/cellceutix-receives-update-on-first-patient-enrollment-in-phase-2-proof-of-concept-study-of-brilacidin-for-ulcerative-proctitis
About Ulcerative Proctitis
Ulcerative proctitis (UP), a limited type of ulcerative colitis (UC), is a mucosal inflammatory disease of unknown cause involving only the rectum. When it involves both the rectum and the distal colon, it is called Ulcerative Proctosigmoiditis (UPS). It is characterized by inflammation, redness, and ulcerations of the mucosa. The course of the disease is variable and ranges from complete resolution to easily maintained remission to chronic relapses or refractory disease. Diagnosis can occur at any point in life, with approximately 30-50 percent of patients developing more extensive UC. There is currently no cure. According to estimates provided by GlobalData, the worldwide UC market, which includes products for UP/UPS, is expected to increase at a compound annual growth rate of 4.7 percent, from $4.2 billion in 2012 to approximately $6.6 billion by 2022.
http://www.ipharminc.com/press-release/2016/11/10/cellceutix-starts-phase-2-trial-of-brilacidin-as-a-novel-therapy-for-ulcerative-proctitis
Trial Design
The primary objective of the P-o-C trial is to assess the frequency of clinical and endoscopic remission with Brilacidin administered per rectum in subjects with active UP or UPS after 6 weeks of treatment. Secondary objectives include evaluation of safety and tolerability of Brilacidin when administered per rectum, evaluation of clinical remission at Week 2 and Week 4, assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum, assessment of the efficiency of Brilacidin by biomarker evaluation of biopsy samples for interleukin (IL)-6 and IL-1beta, and estimation of statistical power for subsequent trial(s) in UP and UPS.
The P-o-C trial will include 18 patients divided evenly into three cohorts. Cohort A is receiving 50 milligrams (mg) of Brilacidin once daily for 42 days. Dosing will be increased to 100mg and 200mg once daily for 42 days for Cohort B and Cohort C, respectively. Endoscopic evaluation of the rectum and mucosa up to 40 cm from the anal verge will be performed at screening and at the end of treatment/Day 42 (± 3 days). Per protocol, a safety committee will review safety and retention data (clinical laboratory findings, vital signs and adverse events) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment in the subsequent cohort.
http://www.ipharminc.com/press-release/2016/11/10/cellceutix-receives-update-on-first-patient-enrollment-in-phase-2-proof-of-concept-study-of-brilacidin-for-ulcerative-proctitis
Q1 2017 Conference Call
During September we received initial comments on the first patient enrolled in our Phase 2 trial of Brilacidin for the inflammatory bowel disease, IBD, ulcerative proctitis or ulcerative proctosigmoiditis which detailed a significant decrease in symptoms within one week of Brilacidin activity. Early in the current quarter we followed that up with even better news of clinically meaningful improvements in the first four patients of the first cohort who completed the trial at the lowest dosing level. Yes, the lowest grossing level. Dr. Bertolino will provide some more color on the results. But the key is the fact that Brilacidin concentrations in the patient's plasma at all timeframes were basically undetectable. This is incredibly important in the safety profile that is being built for the FDA. We believe that a highly effective new drug with minimal systemic exposure will have competitive advantages to capture market share in a market for IBD medicine, the vision gain forecast to client to $9.3 billion in 2019.
Unidentified Analyst
Brilacidin seems to have very broad potential across a number of indications. Can you comment on why you chose to start with inflammatory bowel disease and ulcerative proctitis? Can you expand on the critical path for these indications and what other indications would you consider pursuing?
Leo Ehrlich
There is currently a significant medical need for effective treatment of inflammatory bowel disease. We look for massive markets with unmet needs, so IBD certainly qualified. The simplest way for us to do a proof-of-concept evaluation was to first explore ulcerative proctitis, ulcerative proctosigmoiditis. We have certainly been encouraged by preliminary results if it holds true that we can achieve significant clinical benefits with localized treatment and no significant systemic drug levels. We also anticipate potential for use in expanding IBD indications and in a number of dermatological diseases.
Unidentified Analyst
Dr. Bertolino, can you explain more about what is known of the science underlying the anti-inflammatory actions of Brilacidin?
Arthur P. Bertolino
Brilacidin is an immunomodulatory and anti-inflammatory agent. It inhibits the production of a number of key molecular targets, TNF-alpha, IL- 1 beta, MCP-1, MMP-9 and IL-6. Recent encouraging results in ulcerative proctitis, ulcerative proctosigmoiditis reassure us that the science is meaningful.
http://seekingalpha.com/article/4023682-cellceutix-corporation-ctix-ceo-leo-ehrlich-q1-2017-results-earnings-call-transcript
Interim Data
"A: Let me first touch on the ulcerative proctitis (UP) and oral mucositis (OM) trials. The UP trial is progressing smoothly and barring any unforeseen complications, we think that we will have some interim results sometime next quarter. This is a proof-of-concept study, which I believe can have a significant impact on the value of the Brilacidin franchise by serving as a gateway to other gastrointestinal diseases and conditions.”
http://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino#alt2
Modified Mayo Disease Activity Index (MMDAI)
Clinical improvement was defined as a greater than or equal to 3 point improvement from baseline in the total MMDAI score and a greater than or equal to 1 point improvement from baseline in the rectal bleeding subscale of the MMDAI. Secondary efficacy end points included the proportion of patients in clinical remission, defined as a score of 0 for rectal bleeding and a combined score of less than or equal to 2 for bowel frequency and physician's assessment using the MMDAI subscales.
https://www.ncbi.nlm.nih.gov/pubmed/19491859
Ulcerative Proctitis
Abstract
Ulcerative proctitis is an idiopathic mucosal inflammatory disease involving only the rectum and is therefore an anatomically limited form of ulcerative colitis. Diagnosis is made based on clinical presentation, endoscopic appearance, and histopathology. Additionally, other etiologies of proctitis are excluded. The course of the disease is variable ranging from complete resolution to easily maintained remission to frequent relapses or refractory disease. Extension of inflammatory changes involving the proximal colon occurs in some cases. Rectal 5-aminosalicylic acid (5-ASA) or steroids are the initial treatments of choice with oral 5-ASA, sulfasalazine, or steroids used for treatment failures or patients unable to tolerate rectally administered drugs. Immunomodulators like azathioprine and 6-mercaptopurine have been used successfully in small groups of patients who have not responded to 5-ASA or steroids. Oral or rectal 5-ASA products maintain remission but long-term steroid use should be avoided. Rare cases may require surgical therapy.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780078/
Foam Preparations
Abstract
Patients with ulcerative colitis uniformly have disease involving the distal colon. When patients have disease limited to the left colon or symptoms suggestive of active rectal inflammation, guidelines recommend topical rectal therapies as first-line agents either as monotherapy or in conjunction with oral products. Rectal delivery modalities offer the advantage of delivering high local concentrations of active medication to the site of maximal inflammation with minimization of systemic side effects. Methods of rectal administration include suppositories, liquid enemas and foams. Suppositories are limited to the treatment of rectal disease, and patients often have difficulty retaining the liquid enema secondary to its high volume and consistency. Rectal foams reliability extend to the descending and sigmoid colon with application. Foams are further characterized by increased viscosity, lower volumes, finer dispersion on the colonic mucosa, and increased adhesiveness to the colonic mucosa compared with liquid enemas. Additionally, rectal foam agents demonstrate equal efficacy to their liquid enema counterparts yet consistently yield better patient tolerance, lower incidence of side effects, and increased patient acceptability. Currently available agents include 5-aminosalicylic acid and corticosteroids, both first and newer generation. This review focuses on clinical trials assessing efficacy, tolerability, and patient preferences for these agents as well as describing the currently available rectal foam products.
http://www.ncbi.nlm.nih.gov/pubmed/21235478
Placebo Response Rate
Experience with foam preparations has demonstrated better retention and adherence, as well as more uniform distribution of medication in the distal colon and rectum, as compared with enemas and suppositories.
Analysis of the individual trials showed that 38.3% and 44% of patients in the budesonide arm achieved remission at 6 weeks as compared with 25.8% and 22.4% of the placebo groups (P=0.0324 and P<0.0001, respectively). Combined results showed a remission rate of 41.2% with budesonide foam and 24% with placebo (P<0.0001).
http://www.medpagetoday.com/meetingcoverage/acg/42311
Current and Future Therapies
Ulcerative Colitis and Crohn’s Disease
UC is a gastrointestinal (GI) disease that is localized to the large intestine, or colon, where inflammation can affect either the entire organ or a portion of it. Approximately 1.86 billion patients have been diagnosed with UC globally, with 1.54 billion patients currently receiving treatment. Traditional therapies have yielded $4.18 billion in annual sales around the world, a figure expected to increase to $6.85 billion by 2022 with the approval of various pipeline drugs.
CD can affect any part of the GI tract, but most commonly involves both the large and small intestines. Although CD is more severe than UC, the global prevalence is much lower, with only 1.3 million patients diagnosed and 0.8 million who currently receive treatment. Still, traditional therapies have resulted in an impressive $3.17 billion in global market sales, which is predicted to increase to $4.20 billion by 2022.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4123809/
Mesalamine in the Treatment and Maintenance of Remission of Ulcerative Colitis
Abstract
Ulcerative colitis (UC) is a chronic disease of the GI tract that is characterized by mucosal inflammation in the colon. Mesalamine (mesalazine) is a 5-aminosalicylic acid compound that is the first-line treatment for patients with mild-to-moderate UC. There are multiple formulations of mesalamine available, primarily differentiated by their means of delivering active mesalamine to the colon. Mesalamine has been demonstrated in randomized controlled trials to induce both clinical response and remission, and maintain clinical remission, in these patients. It has few serious adverse effects and is generally well tolerated by patients. The main areas of uncertainty with use of mesalamine in patients with UC center on the optimal dose for induction of response, how to maintain patient adherence and the role of mesalamine in cancer chemoprophylaxis. Generic forms of mesalamine have yet to be approved by regulatory bodies in the USA.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3314328/
Potential Market
The global ulcerative colitis (UC) market value will increase steadily over the coming years, growing from almost $4.2 billion in 2012 to approximately $6.6 billion by 2022, at a Compound Annual Growth Rate (CAGR) of 4.7%, according to a new report from research and consulting firm GlobalData.
Johnson & Johnson (J&J) has been continually dominating the UC market due to the success of Remicade. However, Remicade’s patent is set to expire between 2015 and 2018, which will knock J&J’s sales down from approximately $2 billion in 2012 to $1.5 billion by 2022, according to GlobalData.
Another key player in the UC industry, AbbVie’s Humira, will also lose its patent during the forecast period, with sales slipping from $1.2 billion in 2012 to $569 million by 2022.
https://healthcare.globaldata.com/media-center/press-releases/pharmaceuticals/global-ulcerative-colitis-market-simponi-and-entyvio-launches-to-boost-growth-by-2022-says-globaldata
http://www.prnewswire.com/news-releases/anti-inflammatory-therapeutics-market-is-expected-to-reach-1061-billion-globally-by-2020---allied-market-research-528652061.html
Recent IBD Deals
1. Janssen, Theravance ink GI pact worth up to $1B
“Janssen and Theravance Biopharma are teaming up to develop a JAK inhibitor for inflammatory bowel disease. Theravance will pick up $100 million up front, with the potential to earn another $900 million in milestone payments and royalties.”
“Under the agreement, Theravance will conduct a phase 2 study of the candidate, TD-1473, in Crohn’s disease, as well as a phase 2b/3 induction and maintenance study in ulcerative colitis, both slated to start this year. If all goes well, Janssen may pull the trigger on an exclusive license agreement for the program and take the lead on developing the drug in Crohn’s, according to a statement.”
“If the drug is approved, Janssen will be responsible for ex-U.S. marketing, with Theravance receiving tiered royalties, while the pair has the option of co-commercializing within the U.S. They will also split profits in the U.S., as well as development costs, with Janssen picking up 67% of the tab.”
https://www.fiercebiotech.com/biotech/janssen-theravance-ink-gi-pact-worth-up-to-1b
2. Johnson & Johnson commits $990M to land Protagonist’s oral Crohn’s drug (preclinical)
"Johnson & Johnson has landed rights to Protagonist Therapeutics’ preclinical Crohn’s disease asset PTG-200. The deal gives J&J a stake in an oral interleukin-23 (IL-23) receptor antagonist in return for $50 million upfront and up to $940 million in milestones."
"The asset is due to enter the clinic this year. Protagonist will run and fund the trial with J&J taking over—and covering 80% of the costs—once it advances to phase 2. Beyond this, a series of major paydays await Protagonist. J&J will pay Protagonist $125 million if it moves the drug into phase 2b and a further $200 million if it sticks with the asset after getting a look at data from the trial. The rest of the cash is tied to regulatory and sales milestones."
http://www.fiercebiotech.com/biotech/j-j-commits-990m-to-land-protagonist-s-oral-crohn-s-drug
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=138464059
UP Presentation
2017 Drug Discovery and Therapy World Congress
https://static1.squarespace.com/static/5715352e20c647639137f992/t/596cac7df14aa1a6e7118ed8/1500294274057/IPI+DDTWC+Brilacidin+presentation+%28final-u%29+13Jul2017.pdf
UP Blog
10/24/2017 - Deficient Defensins and Missing Mucins in the Pathogenesis of Inflammatory Bowel Disease
http://www.ipharminc.com/new-blog/2017/10/24/deficient-defensins-and-missing-mucins-in-the-pathogenesis-of-inflammatory-bowel-disease
7/13/2017 - Ulcerative Proctitis / Ulcerative Proctosigmoiditis — Opportunity for Newer Therapies Like Brilacidin to Emerge
http://www.ipharminc.com/new-blog/2017/7/13/ulcerative-proctitisulcerative-proctosigmoiditissubstantial-opportunity-exists-for-newer-therapies-like-brilacidin-to-emerge
7/6/2017 - Growing Interest in Novel Treatments for Inflammatory Bowel Disease
http://www.ipharminc.com/new-blog/2017/7/3/growing-interest-in-novel-non-biologic-treatments-for-inflammatory-bowel-disease
6/2/2017 - Dr. Francis A. Farraye on the Use of Endoscopy in Inflammatory Bowel Disease (IBD)
http://www.ipharminc.com/new-blog/2017/6/2/dr-francis-farraye-on-the-use-of-endoscopy-in-ibd
4/6/2017 - IBD Inpatient Costs Skyrocketing
http://www.ipharminc.com/new-blog/2017/2/2/ibd-inpatient-costs-skyrocketing-1
2/17/2017 - Endoscopic Remission in the Treatment of Ulcerative Colitis
http://www.ipharminc.com/new-blog/2017/2/2/endoscopic-remission-in-the-treatment-of-ulcerative-colitis
Dr. Francis A. Farraye – Scientific Advisor, Gastroenterology
Dr. Francis A. Farraye serves as Professor of Medicine, Clinical Director, Section of Gastroenterology and Co-Director, Center for Digestive Disorders, at Boston University School of Medicine. Dr. Farraye is a Fellow of the American College of Physicians, American Society of Gastrointestinal Endoscopy, American Gastroenterological Association and the American College of Gastroenterology. Across his professional career, he has published over 350 original manuscripts, abstracts and book chapters, with particular clinical interest in inflammatory bowel disease and colorectal cancer. Dr. Farraye has been named Humanitarian of the Year by the New England Chapter of the Chrohn’s & Colitis Foundation of America. Dr. Farraye received a MD from Albert Einstein College of Medicine in New York and a MSc (Epidemiology) from Harvard University.
http://www.cellceutix.com/senior-management-1/
Books
Questions & Answers About Ulcerative Colitis
https://books.google.com/books?id=45iIz7k14pwC&printsec=frontcover&dq=ulcerative+colitis+farraye&hl=en&sa=X&ved=0ahUKEwi5lJHKndHPAhVHQSYKHTgBCCwQ6AEINDAA#v=onepage&q=ulcerative%20colitis%20farraye&f=false
Curbside Consultations in IBD: 49 Clinical Questions
https://books.google.com/books?id=JQaR2Sk2Ek4C&printsec=frontcover&dq=curbside+consultation&hl=en&sa=X&ved=0ahUKEwiruMDTnNHPAhXIVyYKHd68A3gQ6AEIHjAA#v=onepage&q=curbside%20consultation&f=false
Presentations
Health Maintenance for your IBD Patient (Slide 104)
http://www.galamericas.org/dallas/library/PPTS/June2014/Inflammatory_Bowel_Disease.pdf
The role of chromoendoscopy in ulcerative colitis patients: Should we incorporate the SCENIC recommendations? (Slide 10)
http://advancesinibd.com/archive/2015/presentations/Friday/Clinical/Session-IVA/1030_Challenges%20in%20IBD_Med.pdf
Publications
https://www.researchgate.net/profile/Francis_Farraye/publications
YouTube
How can we best determine endoscopic severity in ulcerative colitis and Crohn's disease
https://www.youtube.com/watch?v=mdR7UCm33xg&t=23s
Diagnosis and Management of Colorectal Neoplasia in Inflammatory Bowel Disease
https://www.youtube.com/watch?v=kV5-9qwetmc
B-OM Due Diligence
Lastest Update
5/9/2018 - Innovation Pharmaceuticals Concludes Data Analysis of its Phase 2 Clinical Trial for Severe Oral Mucositis in Head and Neck Cancer; Positioning to Fill a Substantial Void in Supportive Cancer Care
“Given the notable interest from global and specialty pharmaceutical companies that we have received following recent Brilacidin-OM data releases, we continue to carefully assess all of our potential alliance opportunities—toward cementing the best pathway forward,” said Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals. “The expedient advancement of Brilacidin-OM into later clinical development is a priority, as is the broader expansion of the complete Brilacidin Franchise.”
http://www.ipharminc.com/press-release/2018/5/9/innovation-pharmaceuticals-concludes-data-analysis-of-its-phase-2-clinical-trial-for-severe-oral-mucositis-in-head-and-neck-cancer-positioning-to-fill-a-substantial-void-in-supportive-cancer-care
4/23/2018 - Innovation Pharmaceuticals Signs Drug Supply Contract with Evonik to Bulk Produce Commercial-Grade Brilacidin
"Securing a commercial-grade drug supply of Brilacidin with a leading Contract Development and Manufacturing Organization (CDMO), such as Evonik, is an important and necessary step that will enable Innovation Pharmaceuticals to more rapidly advance the Brilacidin Franchise, toward getting much-needed treatments to patients."
http://www.ipharminc.com/press-release/2018/4/23/innovation-pharmaceuticals-signs-drug-supply-contract-with-evonik-to-bulk-produce-commercial-grade-brilacidin
4/16/2018 - Innovation Pharmaceuticals Data from Phase 2 Brilacidin Oral Mucositis (OM) Trial in Head and Neck Cancer Show Notable Reductions in Median Duration of Severe OM and in Number of Unplanned Visits/Hospital Admissions Due to OM
· Median Duration of Severe Oral Mucositis (SOM) Reduced to Less Than One Day
· No Unplanned Office Visits, Emergency Department Visits, and/or Hospital Admissions Due to OM in Brilacidin-OM Arm vs. Four in Placebo Arm
· Data Align with Previously Reported 80.3% Risk Reduction in Incidence of Severe OM in Per Protocol Population Receiving Aggressive Chemotherapy Regimen Compared to Placebo
http://www.ipharminc.com/press-release/2018/4/16/innovation-pharmaceuticals-data-from-phase-2-brilacidin-oral-mucositis-om-trial-in-head-and-neck-cancer-show-notable-reductions-in-median-duration-of-severe-om-and-in-number-of-unplanned-visit
4/9/2018 - Innovation Pharmaceuticals Phase 2 Oral Mucositis Trial Additional Data Show Brilacidin-OM Demonstrated A Significant Reduction in the Incidence of Severe Oral Mucositis in Patients with Head and Neck Cancer (HNC) Receiving Aggressive Chemotherapy Regimen
“For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249).”
http://www.ipharminc.com/press-release/2018/4/9/innovation-pharmaceuticals-phase-2-oral-mucositis-trial-additional-data-show-brilacidin-om-demonstrated-a-significant-reduction-in-the-incidence-of-severe-oral-mucositis
3/15/2018 - Innovation Pharmaceuticals Views Brilacidin-OM as Clearly Differentiated Compared to Limited Competition for Preventing Severe Oral Mucositis
“The Company is currently focused on completing the Clinical Study Report for its Phase 2 clinical trial (see NCT02324335) evaluating Brilacidin’s ability to safely prevent and attenuate SOM in HNC patients receiving chemoradiation and compiling a Briefing Package for discussion with the FDA.”
http://www.ipharminc.com/press-release/2018/3/15/innovation-pharmaceuticals-views-brilacidin-om-as-clearly-differentiated-compared-to-limited-competition-for-preventing-severe-oral-mucositis
1/29/2018 - Innovation Pharmaceuticals Brilacidin Franchise Anchored in Three Clinical Indications — Oral Mucositis, Inflammatory Bowel Disease and Serious Skin Infections; Expands into Dermatologic Diseases
"A leading international drug manufacturer has been engaged with to bulk produce commercial-quality Brilacidin, aimed at lowering patient drug cost and anticipating future drug needs in preparation for expedient market introduction. This critical step also proactively facilitates future patient and insurance reimbursement adoption through favorable cost savings;"
http://www.ipharminc.com/press-release/2018/1/29/innovation-pharmaceuticals-brilacidin-franchise-anchored-in-three-clinical-indications-oral-mucositis-inflammatory-bowel-disease-and-serious-skin-infections-expands-into-dermatologic-diseases
1/3/2018 - Innovation Pharmaceuticals Brilacidin Meets Key Secondary Endpoint in Phase 2 Trial, Delays Onset of Severe Oral Mucositis (SOM)
"Onset of Severe Oral Mucositis: Based on Kaplan-Meier curves, Brilacidin-OM oral rinse showed a clear separation from placebo in delaying the onset of SOM—particularly the period from approximately 28-42 days, after the initiation of treatment, during which the incidence of SOM rose strikingly in the placebo group while not in the group being treated with Brilacidin."
http://www.ipharminc.com/press-release/2018/1/3/innovation-pharmaceuticals-brilacidin-meets-key-secondary-endpoint-in-phase-2-trial-delays-onset-of-severe-oral-mucositis-som
Kaplan-Meier Curves
12/18/2017 - Innovation Pharmaceuticals Brilacidin Oral Mucositis Program Moving Forward Based Upon Positive Anchoring Phase 2 Results and Increased Brilacidin Franchise Value
"Towards commercial planning, the Company has begun exploring potential unit dose drug product packaging in the form of a sachet. Sachets, which people are very familiar with and use on an almost daily basis (e.g., sugar packets, artificial sweeteners) increasingly are being developed as a novel means of patient-friendly, drug delivery. Manufacturing plans for drug substance appropriate for late phase testing and eventual market introduction are also underway."
http://www.ipharminc.com/press-release/2017/12/18/innovation-pharmaceuticals-brilacidin-oral-mucositis-program-moving-forward-based-upon-positive-anchoring-phase-2-results-and-increased-brilacidin-franchise-value
12/12/2017 - Innovation Pharmaceuticals Granted European Patent for Brilacidin in the Prevention of Oral Mucositis
"The European patent supplements other Brilacidin-OM patents that have been granted in the United States, Asia (Japan, Taiwan, China), Oceania (Australia) and South Africa. All currently issued patents have an expiration date of 2032. Additional Brilacidin-OM patent applications are pending in other key markets including Russia and South Korea."
http://www.ipharminc.com/press-release/2017/12/12/innovation-pharmaceuticals-granted-european-patent-for-brilacidin-in-the-prevention-of-oral-mucositis
12/11/2017 - Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients
Summary of Topline Results from the Placebo-Controlled Phase 2 Trial
· Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.
· Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
· Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.
· Trial results support continued and expedited development of Brilacidin-OM.
http://www.ipharminc.com/press-release/2017/12/11/innovation-pharmaceuticals-reports-positive-topline-results-from-phase-2-placebo-controlled-trial-of-brilacidin-for-the-prevention-of-oral-mucositis-in-head-and-neck-cancer-patients
11/16/2017 - Innovation Pharmaceuticals Offers Perspectives on Brilacidin as a Potential Preventative Treatment for Oral Mucositis in Head and Neck Cancer Patients
"Formal collaboration with pharmaceutical companies that have expressed an interest in partnering Brilacidin-OM may well assist further with expediting the drug candidate’s development timetable. Some of these partnering conversations have matured to the point of potentially structuring mutually beneficial licensing agreements, pending the final Phase 2 study results."
http://www.ipharminc.com/press-release/2017/11/16/innovation-pharmaceuticals-offers-perspectives-on-brilacidin-as-a-potential-preventative-treatment-for-oral-mucositis-in-head-and-neck-cancer-patients
10/26/2017 - Innovation Pharmaceuticals Aims to Develop First Drug for Approval in Prevention of Oral Mucositis in Head and Neck Cancer Patients as Phase 2 Clinical Trial of Brilacidin Completes
"The Company has begun the process of closing trial study sites and is now aggregating patient data for top-line analysis, to be reported this quarter."
http://www.ipharminc.com/press-release/2017/10/25/jk5qd8ltvc4ed00ekrbqwbej1vz0x1
10/18/2017 - Innovation Pharmaceuticals to Complete Phase 2 Trial of Brilacidin for Oral Mucositis in Cancer Patients
"After the final patient post-treatment follow-up is conducted next week, the Company will focus on the process of concluding the study, including closing clinical sites and aggregating and analyzing data."
http://www.ipharminc.com/press-release/2017/10/18/innovation-pharmaceuticals-to-complete-phase-2-trial-of-brilacidin-for-oral-mucositis-in-cancer-patients
10/2/2017 - Final Patient Completes Treatment in Innovation Pharmaceuticals Phase 2 Trial of Brilacidin for Preventing Oral Mucositis in Cancer Patients
"... today announces that the last patient has completed study treatment in the Company’s Phase 2 clinical trial of Brilacidin for the prevention and treatment of severe Oral Mucositis (OM) in patients undergoing chemoradiation for Head and Neck Cancer."
http://www.ipharminc.com/press-release/2017/10/2/final-patient-completes-treatment-in-innovation-pharmaceuticals-phase-2-trial-of-brilacidin-for-oral-mucositis
8/7/2017 - Innovation Pharmaceuticals Completes Patient Enrollment in Phase 2 Study of Brilacidin for the Prevention of Severe Oral Mucositis
"... today announces that it has completed patient enrollment for its ongoing Phase 2 clinical study of Brilacidin for the prevention of Severe Oral Mucositis (OM). A total of 61 patients have been enrolled, with topline results anticipated in 4Q2017."
http://www.ipharminc.com/press-release/2017/8/6/innovation-pharmaceuticals-completes-patient-enrollment-in-phase-2-study-of-brilacidin-for-the-prevention-of-severe-oral-mucositis
3/27/2017 - Cellceutix Reports Very Encouraging Interim Analysis of Phase 2 Drug Candidate Brilacidin for Severe Oral Mucositis (OM) in Head and Neck Cancer Patients; High Potential for Preventative Treatment
"Study showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent)"
Primary Efficacy Results: Incidence of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): 2 of 9 patients (22.2 percent)
• Control Arm (Placebo): 7 of 10 patients (70 percent)
Secondary Efficacy Results: Duration of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): Mean 10.5 days (Range 3 to 18 days; 2 patients)
• Control Arm (Placebo): Mean 14 days (Range 3 to 39 days; 7 patients)
http://www.ipharminc.com/press-release/2017/3/27/cellceutix-reports-very-encouraging-interim-analysis-of-phase-2-drug-candidate-brilacidin-for-severe-oral-mucositis-om-in-head-and-neck-cancer-patients-high-potential-for-preventative-treatment
Fast Track
11/25/2015 - FDA Grants Fast Track Designation to Cellceutix’s Brilacidin-OM for Oral Mucositis
"The FDA established the Fast Track Designation process to facilitate the development, and expedite the review of, drugs that have the potential to treat serious and life threatening conditions and fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to the FDA and could qualify for other programs to expedite development, including priority review and accelerated approval."
http://www.ipharminc.com/press-release/2016/11/16/fda-grants-fast-track-designation-to-cellceutixs-brilacidin-om-for-oral-mucositis
Study Design
CTIX-BRI-205 is a Phase 2 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Brilacidin as an oral rinse in preventing and controlling OM in patients receiving chemoradiation therapy for Head and Neck Cancer. The study is anticipated to enroll approximately 60 patients in the United States, 30 each to Brilacidin treatment or to placebo (water). Brilacidin (45 mg/15 ml oral rinse—“swish and spit”) is administered 3 times daily across 7 weeks (49 days). Pharmacokinetics of Brilacidin are to be evaluated if there is measurable systemic exposure (from drug concentrations in plasma).
The Brilacidin OM trial uses a World Health Organization (WHO) OM Grading Scale, a common measurement tool in assessing the presence and severity of OM, as defined below.
WHO Scale for OM
• Grade 0 = None
• Grade 1 = Erythema and Mouth Pain Soreness; no Ulceration/Pseudomembrane formation
• Grade 2 = Ulceration/Pseudomembrane formation; solid diet
• Grade 3 = Ulceration/Pseudomembrane formation; liquid diet
• Grade 4 = Ulceration/Pseudomembrane formation; not able to tolerate a solid or liquid diet (except enough liquid for medication)
About Oral Mucositis
Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation commonly manifesting in the treatment of Head and Neck Cancer. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak or eat (requiring the insertion of a feeding tube) and are more susceptible to bacterial infections, with severe cases leading to hospitalization and increased treatment costs of up to $25,000. Affecting over 500,000 people in the United States, there currently are no approved medications for the prevention of OM in this population, with only limited palliative care options available. Worldwide, the potential market for OM is expected to exceed $1 billion in the next few years.
For more information on the CTIX-BRI-205 Phase 2 study, please visit:
https://clinicaltrials.gov/ct2/show/NCT02324335
OM Market
"Head and Neck Cancer (HNC) patients -- comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source: GLOBOCAN) -- are at greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM during the course of their chemo/radiotherapy.
Estimates vary as to the market size (in dollars) of an effective OM treatment, for HNC-only patients, across major markets (U.S., Europe and Japan), ranging between $500 million and $1.5 billion on an annual basis (sources: GlobalData; Redington Inc., pdf). One company in the OM space projects the worldwide OM market opportunity to be as high as $2.6 billion annually."
http://www.ipharminc.com/new-blog/2017/10/17/the-market-opportunity-in-oral-mucositis
Potential Competitors
Taking a Page from Merck’s Gardasil and Glaxo’s Requip, These Small Companies Look to Cement Riches for Shareholders in New Category of Oral Mucositis
http://www.baystreet.ca/articles/stockstowatch/38594/Taking-a-Page-from-Mercks-Gardasil-and-Glaxos-Requip-These-Small-Companies-Look-to-Cement-Riches-for-Shareholders-in-New-Category-of-Oral-Mucositis
A Billion Dollar Market Just Waiting for a New Oral Mucositis Drug: Five Companies That Want It
http://www.baystreet.ca/stockstowatch/2658/A-Billion-Dollar-Market-Just-Waiting-for-a-New-Oral-Mucositis-Drug-Five-Companies-That-Want-It
Some of the players operating for the oral mucositis are
- Izun Pharmaceutical Ltd (US)
- Shoreline Pharmaceuticals Inc. (USA)
- Himalaya (India)
- AMAG Pharmaceuticals Inc. (USA)
- Kinnear Pharmaceuticals (US)
- Celleutix Corporation(USA)
- Soligenix Inc. (US)
- Oragenics (US)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135072984
Amgen Kepivance (IV)
"In addition to a lower incidence of severe oral mucositis, patients receiving palifermin had almost one week less severe mucositis compared to those receiving placebo (10.4 days vs 3.7 days). Furthermore, palifermin-treated patients reported 60 percent less soreness of the mouth and throat, required lower doses of painkillers and less total parenteral nutrition use (11 percent versus 40 percent with placebo)."
http://www.amgen.com/media/news-releases/2003/06/phase-3-data-suggest-palifermin-significantly-reduces-the-duration-and-incidence-of-oral-mucositis-in-cancer-patients/
"The cost for Kepivance intravenous powder for injection 6.25 mg is around $14,401 for a supply of 6 powder for injection, depending on the pharmacy you visit."
https://www.drugs.com/price-guide/kepivance
Soligenix SGX942 (IV)
"n the 1.5 mg/kg treatment group, the median duration of severe oral mucositis was decreased by 50%, from 18 days to 9 days (p=0.099), meeting the prospectively defined statistical threshold of p<0.1 in the study protocol. Further, patients receiving the most aggressive CRT in this dose group had even more striking reductions in their median duration of severe oral mucositis of 67%, from 30 days to 10 days (p=0.040)."
http://www.soligenix.com/news/soligenix-announces-positive-preliminary-results-from-its-phase-2-clinical-trial-of-sgx942-for-the-treatment-of-oral-mucositis-in-head-and-neck-cancer-patients/
Validive (applies to gum)
"The incidence of SOM (primary endpoint) was reduced by 26.3% (40% relative to placebo) in OPC patients treated with Validive (100 µg) (p=0.09)"
http://monopartherapeutics.com/phase_II
"Onxeo Grants Exclusive Worldwide License of Validive® developed for the treatment of oral severe mucositis to Monopar Therapeutics"
https://www.onxeo.com/onxeo-grants-exclusive-worldwide-license-validive-developed-treatment-oral-severe-mucositis-monopar-therapeutics/
Izun IZN-6N4 (oral rinse)
"Not only did patients treated with IZN-6N4 have less mouth and throat pain and soreness than controls, but importantly, they were also more able to maintain their weights throughout the course of radiotherapy. The data supports that the best efficacy of IZN-6N4 was related to its initiation of use at the start of chemoradiation."
http://www.businesswire.com/news/home/20171011005127/en/Izun-Pharmaceuticals-Announces-Positive-Results-Phase-2
Oragenics AG013 (oral rinse)
"Data from the Phase 1B trial published in the journal Cancer showed AG013 was safe, well tolerated, and demonstrated preliminary efficacy with a 35% reduction in the duration of ulcerative OM compared to placebo."
https://www.oragenics.com/news-media/press-releases/detail/37/oragenics-announces-positive-results-from-confirmatory
OM Presentation
January 2018 Corporate Overview
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5a4e50e39140b721186d1a6f/1515081962344/2018Jan+IPIX+Corporate+Overview.pdf
2017 Drug Discovery and Therapy World Congress
https://static1.squarespace.com/static/5715352e20c647639137f992/t/596cac7df14aa1a6e7118ed8/1500294274057/IPI+DDTWC+Brilacidin+presentation+%28final-u%29+13Jul2017.pdf
25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2015)
https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f83821b631be3d85bc071/1480557442978/ECCMID-2015-OM-poster.pdf
OM Blog
5/4/2018 - Brilacidin-OM in the News: Oral Mucositis Market Untapped—Framed as “Blue Sky” Opportunity
http://www.ipharminc.com/new-blog/2018/5/4/brilacidin-om-in-the-news-oral-mucositis-market-untappedframed-as-blue-sky-opportunity
12/11/2017 - Brilacidin-OM Called a “Top Contender” in Oral Mucositis Market
http://www.ipharminc.com/new-blog/2017/12/11/brilacidin-om-called-a-top-contender-in-oral-mucositis-market
10/17/2017 - The Market Opportunity in Oral Mucositis
http://www.ipharminc.com/new-blog/2017/10/17/the-market-opportunity-in-oral-mucositis
8/7/2017 - Brilacidin for the Prevention of Severe Oral Mucositis
http://www.ipharminc.com/new-blog/2017/8/7/brilacidin-for-oral-mucositis
5/19/2017 - On the Unmet Medical Need in Oral Mucositis: Brilacidin as a Potential First-in-Class Preventative Treatment
http://www.ipharminc.com/new-blog/2017/5/17/on-the-unmet-need-in-oral-mucositis-and-brilacidin-as-a-promising-one-of-a-kind-treatment
Stephen Sonis, MD
Scientific Advisor, Oral Mucositis
Dr. Sonis is one of the world’s foremost experts in the research and clinical treatment of cancer-related oral mucosal toxicities. He currently holds appointments at the Harvard School of Dental Medicine as Professor of Oral Medicine (part-time), and is a Senior Surgeon at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital. Dr. Sonis also is a Founder and Chief Scientific Officer of Biomodels, LLC, a preclinical contract research organization. Widely respected by his professional peers, he is the author of over 250 original publications, reviews and chapters, 11 books, and 5 patents, serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology. Dr. Sonis is a graduate of Tufts University and Harvard University and completed his post-doctoral education at Oxford University.
http://www.ipharminc.com/senior-management-1/
Cellceutix Corporation Welcomes Dr. Stephen T. Sonis to its Scientific Advisory Board
http://www.ipharminc.com/press-release-2/2016/9/19/cellceutix-corporation-welcomes-dr-stephan-t-sonis-to-its-sceintific-advisory-board
Stephen T. Sonis, DMD, DMSc, on Radiotherapy-Induced Oral Complications
https://vimeo.com/182309692
IPIX Clinical Trial Summaries
B-OM (Phase 2)
Kaplan-Meier Curves
"Onset of Severe Oral Mucositis: Based on Kaplan-Meier curves, Brilacidin-OM oral rinse showed a clear separation from placebo in delaying the onset of SOM—particularly the period from approximately 28-42 days, after the initiation of treatment, during which the incidence of SOM rose strikingly in the placebo group while not in the group being treated with Brilacidin."
http://www.ipharminc.com/press-release/2018/1/3/innovation-pharmaceuticals-brilacidin-meets-key-secondary-endpoint-in-phase-2-trial-delays-onset-of-severe-oral-mucositis-som
Topline Results
· Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.
· Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
· Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.
· Trial results support continued and expedited development of Brilacidin-OM.
http://www.ipharminc.com/press-release/2017/12/11/innovation-pharmaceuticals-reports-positive-topline-results-from-phase-2-placebo-controlled-trial-of-brilacidin-for-the-prevention-of-oral-mucositis-in-head-and-neck-cancer-patients
Subgroup Analysis
“For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249).”
http://www.ipharminc.com/press-release/2018/4/9/innovation-pharmaceuticals-phase-2-oral-mucositis-trial-additional-data-show-brilacidin-om-demonstrated-a-significant-reduction-in-the-incidence-of-severe-oral-mucositis
B-UP (Phase 2 POC)
Before and after endoscopic images (Cohort B, 100 mg)
Topline Results
Rate of Clinical Remission (% of patients achieving)
- 60% Cohort A (3 of 5 patients)
- 67% Cohort B (4 of 6 patients)
- 75% Cohort C (3 of 4 patients)
(i) #Endoscopy subscore ≤ 1 (% of patients achieving)
- 80% Cohort A (4 of 5 patients)
- 67% Cohort B (4 of 6 patients)
- 75% Cohort C (3 of 4 patients)
(ii) Rectal Bleeding subscore of 0 (% of patients achieving)
- 80% Cohort A (4 of 5 patients)
- 100% Cohort B (6 of 6 patients)
- 100% Cohort C (4 of 4 patients)
(iii) Stool Frequency subscore, improvement or no change from baseline (% of patients achieving)
- 100% Cohort A (5 of 5 patients)
- 100% Cohort B (6 of 6 patients)
- 100% Cohort C (4 of 4 patients)
http://www.ipharminc.com/press-release/2017/7/13/innovation-pharmaceuticals-phase-2-poc-trial-for-inflammatory-bowel-disease-achieves-induction-of-remission-in-a-majority-of-patients-treated-with-brilacidin
B-ABSSSI (Phase 2b)
Topline Results
"In treated patients assessed at 48-72 hours, 47/51 (92.2%), 46/48 (95.8%), 51/52 (98.1%), and 45/48 (93.8%) achieved clinical success in the Brilacidin 0.6 mg/kg single-dose group, Brilacidin 0.8 mg/kg single-dose group, Brilacidin 1.2 mg/kg 3-day group, and daptomycin 7-day group, respectively."
"On December 22nd 2014, Cellceutix also reported positive results in the Microbiological Intent-to-Treat (MITT) population. This is an important population that includes patients with baseline cultures positive for common ABSSSI pathogens, such as Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA). In this population, Clinical Success rates at 48-72 hours were again very high (above 90% across all treatment groups) and again very similar (with overlapping 95% confidence intervals)."
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-releases-confidence-interval-statistics-showing-clinical-success-rates-for-brilacidin-in-treatment-of-absssi
Prurisol (Phase 2a)
Topline Results (200 mg)
"Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 (“moderate”) as compared to those with a baseline score of 2 (“mild”). Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower."
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-phase-2-trial-of-prurisol-for-mild-to-moderate-psoriasis-meets-primary-endpoint
"Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites."
"Additional preliminary data analyses of secondary endpoints show patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point improvement (using the IGA scoring system) at a higher rate than that of patients in the placebo arm. This is another clear indication of the drug’s efficacy."
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-provides-additional-insight-into-successful-phase-2-trial-for-treating-psoriasis
K-OC (Phase 2a)
P53 Modulation
"Modulation of the p53 protein was observed in response to administration of Kevetrin. Pathways analyses also point to concomitant cell cycle modulation at the level of gene expression. Importantly, these data are the first to directly support, in ovarian cancer patient tumors, Kevetrin’s ability to affect p53 and associated molecular pathways—a central gene signaling network involved in regulating cell growth and the cell cycle, helping to prevent cancer."
"In more detail, preliminary analyses used Western Blots to assess relative levels of key proteins extracted from tumor biopsies before and after a series of nine Kevetrin infusions administered over three weeks. The level of phospho-p53, the activated form of the protein, in addition to the noted p53 modulation, was also seen to change in response to Kevetrin administration. These findings confirm in patient tumors Kevetrin-induced anti-cancer effects similar to those demonstrated (pdf) preclinically in ovarian cancer cell-lines. These new data reinforce prior clinical data, from the earlier concluded Phase 1 study of Kevetrin in advanced solid tumors (see NCT01664000), in which observations of p21 expression in peripheral blood monocytes supported p53 involvement in Kevetrin’s mechanism of action."
http://www.ipharminc.com/press-release/2017/12/27/innovation-pharmaceuticals-obtains-direct-evidence-of-molecular-pathways-modulation-in-tumors-from-first-patients-in-kevetrin-ph2a-ovarian-cancer-trial
I agree with your take in the 10-Q. Now let’s focus on the PR. In the second bullet point,
Successful trials -> CDAs -> Partnerships -> Stock goes up.
Watch and learn.
You predicted less than 30 cents today, so you were only off by 41%.
If you still don’t get my point, I’ll tell you today’s Mega Millions winning #s tomorrow because I don’t have your 20/20 hindsight vision.
I believe I’ve answered your question. Even if I haven’t, you should get used to it because I don’t report to you.
I’ll starting asking questions instead of answering them. Question #1, do you think the short and distort tactic was and still is being used in IPIX?
New investors, the statement “48% of today's volume was short sales" wasn’t in the source file. The most recent short interest is < 1% of the OS and the most recent failure-to-deliver (naked short) # is a measly 23,188 shares. IMHO interpreting short volume as actual short sales is incorrect. This is what FINRA, the exact same source which you used to post the #, said.
"Thank you for contacting FINRA’s Office of the Ombudsman. Regarding your question, it would be incorrect to assume that short sales comprise 32% of the total volume on that trading day for IPIX. FINRA publishes the daily short sale volume pursuant to an SEC mandate; however, there are various trading anomalies that result in the reported short sale volume often being exaggerated. Thus, the true total short sales volume may be significantly lower than the volume that is reported. Third parties sometimes ignore this and try to claim the ratio is valid to further their own objectives."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135537542
MMs mark shares short temporarily to execute trades and they are almost always covered in the same day, therefore the actual short % is much lower than the # suggests. If the short volume indicates actual naked shorting, would the criminals be stupid enough to leave incriminating evidence in the FINRA file?
You can also check out these two posts for some detailed explanations.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133263103
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=132584168
Here are the official short interest and failure-to-deliver data.
Settlement Date: 4/13/2018
Current Short: 1,131,509
Previous Short: 1,105,305
Change: 26,204 (2.37%)
Average Daily Volume: 302,523
Days to Cover: 3.74
http://otce.finra.org/ESI
0.77% of the outstanding shares were short interest.
“In a “naked” short sale, the seller does not borrow or arrange to borrow the securities in time to make delivery to the buyer within the standard two-day settlement period. As a result, the seller fails to deliver securities to the buyer when delivery is due (known as a ”failure to deliver” or “fail”).”
https://www.sec.gov/investor/pubs/regsho.htm
According to the SEC, only 23,188 shares (0.016% of the OS) were failure-to-deliver as of April 13.
20180413|45782D100|IPIX|23188|INNOVATION PHARMACEU|0.51
https://www.sec.gov/data/foiadocsfailsdatahtm
Today I told Leo he should’ve picked 11, 16, 38, 50, 69, 19 for yesterday’s Powerball. Aspire is history if he did that.
Ever wonder why so many non-shareholders stick around and express “concerns” about this company daily? I’ve been saying that the #1 reason for the constant decline is Aspire. Today’s 10-Q backs up my claim.
Supply > demand -> stock goes down.
KFC, I should be more specific and said IPIX had $1.3M as of March 31st and raised another $2M afterward. I don’t know the exact cash balance as of today.
I see what you mean. I don’t think Leo is looking to simply hire a formulator for B-Dermatitis like he did with Evonik. It sounds more like a partnership to me.
“The goal of the negotiations is to reach terms on a strategic partnership for addressing these markets.”
http://www.ipharminc.com/press-release/2018/1/29/innovation-pharmaceuticals-brilacidin-franchise-anchored-in-three-clinical-indications-oral-mucositis-inflammatory-bowel-disease-and-serious-skin-infections-expands-into-dermatologic-diseases
New investors, the statement “52% of today's volume was short sales" wasn’t in the source file. The most recent short interest is < 1% of the OS and the most recent failure-to-deliver (naked short) # is a measly 23,188 shares. IMHO interpreting short volume as actual short sales is incorrect. This is what FINRA, the exact same source which you used to post the #, said.
"Thank you for contacting FINRA’s Office of the Ombudsman. Regarding your question, it would be incorrect to assume that short sales comprise 32% of the total volume on that trading day for IPIX. FINRA publishes the daily short sale volume pursuant to an SEC mandate; however, there are various trading anomalies that result in the reported short sale volume often being exaggerated. Thus, the true total short sales volume may be significantly lower than the volume that is reported. Third parties sometimes ignore this and try to claim the ratio is valid to further their own objectives."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135537542
MMs mark shares short temporarily to execute trades and they are almost always covered in the same day, therefore the actual short % is much lower than the # suggests. If the short volume indicates actual naked shorting, would the criminals be stupid enough to leave incriminating evidence in the FINRA file?
You can also check out these two posts for some detailed explanations.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133263103
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=132584168
Here are the official short interest and failure-to-deliver data.
Settlement Date: 4/13/2018
Current Short: 1,131,509
Previous Short: 1,105,305
Change: 26,204 (2.37%)
Average Daily Volume: 302,523
Days to Cover: 3.74
http://otce.finra.org/ESI
0.77% of the outstanding shares were short interest.
“In a “naked” short sale, the seller does not borrow or arrange to borrow the securities in time to make delivery to the buyer within the standard two-day settlement period. As a result, the seller fails to deliver securities to the buyer when delivery is due (known as a ”failure to deliver” or “fail”).”
https://www.sec.gov/investor/pubs/regsho.htm
According to the SEC, only 23,188 shares (0.016% of the OS) were failure-to-deliver as of April 13.
20180413|45782D100|IPIX|23188|INNOVATION PHARMACEU|0.51
https://www.sec.gov/data/foiadocsfailsdatahtm
Good catch. Actually it’s the second time the word “negotiations” is used. The first time being,
"To further these efforts, the Company is in negotiations with a leading drug formulator to develop topical formulation(s) of Brilacidin for these three dermatology indications, starting in 1H2018. The goal of the negotiations is to reach terms on a strategic partnership for addressing these markets."
http://www.ipharminc.com/press-release/2018/1/29/innovation-pharmaceuticals-brilacidin-franchise-anchored-in-three-clinical-indications-oral-mucositis-inflammatory-bowel-disease-and-serious-skin-infections-expands-into-dermatologic-diseases
B-Dermatitis could surprise us as the first to reach a deal.
Dilutions come with the territory. An investor complaining biotech is volatile is like a fish complaining water is wet.
With $3.3M cash in hand, Leo should be done selling to Aspire this quarter. Now we wait for P result. With B-OM data completed yesterday, final negotiations can start. Competitions give leverage to IPIX. From the 10-Q,
“The results have attracted inquiries, additional confidential disclosure agreements, and discussions with pharmaceutical companies."
B-OM: "The Company is engaged in discussions and negotiations regarding the out-licensing of its mid-stage, first-in-class clinical assets to global and/or specialty pharmaceutical companies who have expressed an interest in one or more assets in our pipeline. Successfully securing partnerships would afford the Company access to immediate and potentially recurring sources of non-dilutive capital, including upfront fees, milestone-based payments and tiered royalties. Recently, we released results from our completed Phase 2 Brilacidin study on Oral Mucositis. The results have attracted inquiries, additional confidential disclosure agreements, and discussions with pharmaceutical companies."
B-UP: "Our development programs depending on available financial resources include new formulations (oral and foam type) with potential associated toxicology studies and clinical studies to be defined."
B-ABSSS: "Our strategy for now is to achieve success with other trials and attract partnering opportunities with significant down-payments and milestone payments which can fund these trials."
K-OC: "The Company has completed approximately half the Toxicology studies to support progression to oral dosing in humans, but the remainder of this work is on hold until the Company secures additional resources."
P: "We are currently awaiting data from the trial."
https://www.sec.gov/Archives/edgar/data/1355250/000147793218002302/ipix_10q.htm
Shares Outstanding: 155,091,427
"During the period from September 6, 2017 to March 31, 2018, the Company generated proceeds of approximately $5.7 million under the 2017 Agreement from the sale of approximately 8.7 million shares of its common stock. As of March 31, 2018, the available balance under the 2017 Agreement is approximately $24.3 million."
"From April 1, 2018 to May 9, 2018, the Company has generated additional proceeds of approximately $2.0 million under the Common Stock Purchase Agreement with Aspire Capital from the sale of approximately 8.0 million shares of its common stock."
https://www.sec.gov/Archives/edgar/data/1355250/000147793218002302/ipix_10q.htm
So from April 1, 2018 to May 9, 2018, the selling pressure by Aspire is:
8M shares / 28 days = 285,714 shares/day
That's a lot of supply for MMs to play with. Now you guys know why the SP is in a constant decline.
New investors, the statement “42% of today's volume was short sales" wasn’t in the source file. The most recent short interest is < 1% of the OS and the most recent failure-to-deliver (naked short) # is a measly 23,188 shares. IMHO interpreting short volume as actual short sales is incorrect. This is what FINRA, the exact same source which you used to post the #, said.
"Thank you for contacting FINRA’s Office of the Ombudsman. Regarding your question, it would be incorrect to assume that short sales comprise 32% of the total volume on that trading day for IPIX. FINRA publishes the daily short sale volume pursuant to an SEC mandate; however, there are various trading anomalies that result in the reported short sale volume often being exaggerated. Thus, the true total short sales volume may be significantly lower than the volume that is reported. Third parties sometimes ignore this and try to claim the ratio is valid to further their own objectives."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135537542
MMs mark shares short temporarily to execute trades and they are almost always covered in the same day, therefore the actual short % is much lower than the # suggests. If the short volume indicates actual naked shorting, would the criminals be stupid enough to leave incriminating evidence in the FINRA file?
You can also check out these two posts for some detailed explanations.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133263103
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=132584168
Here are the official short interest and failure-to-deliver data.
Settlement Date: 4/13/2018
Current Short: 1,131,509
Previous Short: 1,105,305
Change: 26,204 (2.37%)
Average Daily Volume: 302,523
Days to Cover: 3.74
http://otce.finra.org/ESI
0.77% of the outstanding shares were short interest.
“In a “naked” short sale, the seller does not borrow or arrange to borrow the securities in time to make delivery to the buyer within the standard two-day settlement period. As a result, the seller fails to deliver securities to the buyer when delivery is due (known as a ”failure to deliver” or “fail”).”
https://www.sec.gov/investor/pubs/regsho.htm
According to the SEC, only 23,188 shares (0.016% of the OS) were failure-to-deliver as of April 13.
20180413|45782D100|IPIX|23188|INNOVATION PHARMACEU|0.51
https://www.sec.gov/data/foiadocsfailsdatahtm
I guess Leo didn’t have your 20/20 hindsight vision so he couldn’t predict the constant short and distort attacks on his company.
I didn’t even mention the fact of running eight trials and succeeding in seven of them (one pending). Why choose the most difficult route by spending millions on trials while they can prolong the *con* by saving the money and claim they are working on preclinical studies like NanoViricides?
Nope, if IPIX wanted to get all $30M from Aspire, they could’ve done so before the previous S-3 expired. Same reason for the $45M shelf.
If you are running a con to milk investors for as long as possbile, would you do the following?
1. Defer your salaries for four years.
2. Add sites to speed up trials.
3. End trial (K-OC) early to save money.
4. Cut your salary by 50%.
New investors, the statement "59% of today's volume was short sales" wasn’t in the source file. The most recent short interest is < 1% of the OS and the most recent failure-to-deliver (naked short) # is a measly 23,188 shares. IMHO interpreting short volume as actual short sales is incorrect. This is what FINRA, the exact same source which you used to post the #, said.
"Thank you for contacting FINRA’s Office of the Ombudsman. Regarding your question, it would be incorrect to assume that short sales comprise 32% of the total volume on that trading day for IPIX. FINRA publishes the daily short sale volume pursuant to an SEC mandate; however, there are various trading anomalies that result in the reported short sale volume often being exaggerated. Thus, the true total short sales volume may be significantly lower than the volume that is reported. Third parties sometimes ignore this and try to claim the ratio is valid to further their own objectives."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135537542
MMs mark shares short temporarily to execute trades and they are almost always covered in the same day, therefore the actual short % is much lower than the # suggests. If the short volume indicates actual naked shorting, would the criminals be stupid enough to leave incriminating evidence in the FINRA file?
You can also check out these two posts for some detailed explanations.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133263103
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=132584168
Here are the official short interest and failure-to-deliver data.
Settlement Date: 4/13/2018
Current Short: 1,131,509
Previous Short: 1,105,305
Change: 26,204 (2.37%)
Average Daily Volume: 302,523
Days to Cover: 3.74
http://otce.finra.org/ESI
0.77% of the outstanding shares were short interest.
“In a “naked” short sale, the seller does not borrow or arrange to borrow the securities in time to make delivery to the buyer within the standard two-day settlement period. As a result, the seller fails to deliver securities to the buyer when delivery is due (known as a ”failure to deliver” or “fail”).”
https://www.sec.gov/investor/pubs/regsho.htm
According to the SEC, only 23,188 shares (0.016% of the OS) were failure-to-deliver as of April 13.
20180413|45782D100|IPIX|23188|INNOVATION PHARMACEU|0.51
https://www.sec.gov/data/foiadocsfailsdatahtm
An oral psoriasis drug which completed a Phase 2 POC trial was worth $640M. Let’s see how Prurisol performs in a Phase 2b trial.
Article - Study offers new approach to starve p53 deficient tumors
One major hallmark of cancer cells is their ability to adapt to stressful conditions such as nutrient deprivation. Rapidly growing tumor cells must compete for the ever-diminishing supply of nutrients in the surrounding environment to survive and proliferate. Targeting these adaptive mechanisms represents a promising approach for cancer therapeutics.
Sanford Prebys Medical Discovery Institute (SBP) researchers recently discovered an alternative metabolic pathway that might be used by cancer cells to survive nutrient deprivation. As reported May 3 in the journal Molecular Cell, two proteins belonging to the PI5P4K family of enzymes— PI5P4Ka and PI5P4Kß —are critical for a process called autophagy, which provides nutrients to starving cells by recycling cellular compartments. According to the authors, targeting these proteins to disrupt autophagy in cancer cells is an exciting therapeutic strategy that could minimize toxicity.
"The importance of this alternative pathway has been obscure since the discovery of these enzymes by the Lewis Cantley laboratory 20 years ago," says senior study author Brooke Emerling, Ph.D., assistant professor of the Cancer Metabolism and Signaling Networks Program at SBP. "Our study identifies a novel regulatory step in the process of autophagy and sheds light on the anti-cancer potential of PI5P4K inihibitors."
Surviving stress
Cells that are deprived of nutrients can maintain sufficient energy levels by degrading and recycling unnecessary or dysfunctional cellular components. This survival mechanism, known as autophagy, also plays key roles in a variety of processes such as development and aging, and is often perturbed in various diseases including neurodegenerative disorders, skeletal muscle myopathies, heart disease, liver disease and cancer.
During autophagy, cellular components such as abnormal molecules or damaged organelles are first sequestered within vesicles known as autophagosomes. These vesicles then fuse with organelles called lysosomes, which contain enzymes that break down various molecules. Even though tight control of autophagy is key to survival, relatively little is known about the signaling molecules that regulate this essential process.
In the new study, Emerling and Lewis Cantley, Ph.D., of Weill Cornell Medical College discovered that the PI5P4K family of enzymes, whose biological functions were previously unclear, plays a critical role in autophagy during times of metabolic stress. Deletion of the genes encoding the two most active enzymes in this pathway, Pip4k2a and Pip4k2b, in the liver of mice caused an accumulation of lipid droplets and autophagic vesicles during fasting. Similar changes were observed in nutrient-starved worms lacking the PI5P4K ortholog.
Additional experiments revealed what caused these autophagy defects. Nutrient-starved cells lacking Pip4k2a, Pip4k2b, and the tumor suppressor protein p53 showed evidence that autophagosomes could not successfully fuse with lysosomes. This impairment reduced the supply of nutrients such as glutathione and amino acids in addition to key cellular metabolites including Acetyl-CoA. "Taken together, the findings reveal a novel, evolutionarily conserved pathway that enhances the ability of multicellular organisms to digest lipids and survive starvation during periods of food deprivation," Emerling says.
Starving tumors
In a study published in the journal Cell in 2013, Emerling and Cantley found that a subset of breast cancers express high levels of PI5P4Ka and PI5P4Kß. They also showed that these enzymes are essential for the growth of p53-deficient breast cancer cells. Moreover, deficiency in Pip4k2a and Pip4k2b dramatically reduced tumor formation and increased tumor-free survival in mice lacking p53. But at the time, it was not clear exactly how PI5P4Ks promoted the growth of p53-deficient cancer cells.
The new study sheds light on this question, suggesting that these enzymes enhance the ability of cancer cells to adapt to nutrient scarcity commonly found in the tumor microenvironment. Collectively, the studies suggest that PI5P4K inhibitors could effectively treat cancers with mutations in p53 by interfering with autophagy.
However, additional research is needed to dissect the distinct roles of the PI5P4Ks and their relationship with p53 in tumor metabolism. Emerling's lab is now focused on determining the role of the PI5P4K enzymes in p53-deficient cancers, especially the triple-negative breast cancer subgroup, which is associated with a poor prognosis due to the lack of effective targeted therapies.
"Given the high frequency of p53 mutations in human cancers, and how difficult it is to directly target p53 with drugs, our findings provide vital information for developing successful PI5P4K inhibitors for p53-mutant cancers," Emerling says. "These enzymes are extremely druggable, so it is exciting to think that targeting them with novel compounds could be an effective therapy for cancer and other autophagy-related conditions."
https://medicalxpress.com/news/2018-05-approach-starve-p53-deficient-tumors.html
New investors, the statement "37% of today's volume was short sales" wasn’t in the source file. The most recent short interest is < 1% of the OS and the most recent failure-to-deliver (naked short) # is a measly 23,188 shares. IMHO interpreting short volume as actual short sales is incorrect. This is what FINRA, the exact same source which you used to post the #, said.
"Thank you for contacting FINRA’s Office of the Ombudsman. Regarding your question, it would be incorrect to assume that short sales comprise 32% of the total volume on that trading day for IPIX. FINRA publishes the daily short sale volume pursuant to an SEC mandate; however, there are various trading anomalies that result in the reported short sale volume often being exaggerated. Thus, the true total short sales volume may be significantly lower than the volume that is reported. Third parties sometimes ignore this and try to claim the ratio is valid to further their own objectives."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135537542
MMs mark shares short temporarily to execute trades and they are almost always covered in the same day, therefore the actual short % is much lower than the # suggests. If the short volume indicates actual naked shorting, would the criminals be stupid enough to leave incriminating evidence in the FINRA file?
You can also check out these two posts for some detailed explanations.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133263103
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=132584168
Here are the official short interest and failure-to-deliver data.
Settlement Date: 4/13/2018
Current Short: 1,131,509
Previous Short: 1,105,305
Change: 26,204 (2.37%)
Average Daily Volume: 302,523
Days to Cover: 3.74
http://otce.finra.org/ESI
0.77% of the outstanding shares were short interest.
“In a “naked” short sale, the seller does not borrow or arrange to borrow the securities in time to make delivery to the buyer within the standard two-day settlement period. As a result, the seller fails to deliver securities to the buyer when delivery is due (known as a ”failure to deliver” or “fail”).”
https://www.sec.gov/investor/pubs/regsho.htm
According to the SEC, only 23,188 shares (0.016% of the OS) were failure-to-deliver as of April 13.
20180413|45782D100|IPIX|23188|INNOVATION PHARMACEU|0.51
https://www.sec.gov/data/foiadocsfailsdatahtm
Recent Psoriasis Deals
1. Allergan in $640M Vitae buyout deal as it further expands dermatology pipeline
"Allergan buys into the Fort Washington, PA-based biotech’s dermatology pipeline that includes VTP-43742, a midstage, first-in-class, orally active ROR?t (retinoic acid receptor-related orphan receptor gamma) inhibitor for the potential treatment of psoriasis, as well as other autoimmune disorders."
http://www.fiercebiotech.com/biotech/allergan-640m-vitae-buyout-deal-as-it-further-expands-dermatology-pipeline
"The compound recently completed a Phase 2 proof-of-concept multiple ascending dose trial in patients with moderate to severe psoriasis."
https://www.allergan.com/news/news/thomson-reuters/allergan-to-acquire-vitae-pharmaceuticals-adding-i
2. Fumarate makes weight as Xenoport, Dr. Reddy's ink potential $490M deal
"The terms call for $47.5 million up front and another $2.5 million related to the transfer of certain clinical trial materials to Dr. Reddy's. Xenoport will be eligible for as much as $190 million if regulatory milestones are met, which could happen over a period of several years, the companies said. Up to $250 million more may come if commercial goals are hit, and royalties as high as the midteens are included for U.S. sales."
http://www.bioworld.com/content/fumarate-makes-weight-xenoport-dr-reddys-ink-potential-490m-deal-0
"Shares of Santa Clara, CA-based XenoPort were down 25 percent by midmorning Tuesday after the company announced positive preliminary results from a Phase 2 clinical trial of its oral psoriasis drug.
Although the biotech said it expects to begin Phase 3 trials of its drug, XP23829, in 2016, a high rate of gastrointestinal side effects may impede its efforts. XenoPort’s shares had initially been up 19 percent earlier Tuesday morning."
https://www.dddmag.com/news/2015/09/xenoport-shares-dive-after-psoriasis-drug-study-results
3. Purdue Strikes $790 Million Exicure Deal to Diversify
"Purdue Pharma LP has struck a deal with Exicure Inc. to buy the rights to an experimental psoriasis treatment for as much as $790 million, the latest in a string of moves to diversify away from opioid pain drugs, the backbone of the company’s business."
https://www.bloomberg.com/news/articles/2016-12-12/purdue-strikes-790-million-exicure-deal-to-diversify-from-pain
4. AbbVie hands over $595M upfront to partner with Boehringer on PhIII psoriasis drug
"AbbVie $ABBV) is handing over $595 million in an upfront payment to partner with Boehringer Ingelheim on its late-stage psoriasis drug, the anti-IL-23 BI 655066."
http://www.fiercebiotech.com/partnering/abbvie-hands-over-595m-upfront-to-partner-boehringer-on-phiii-psoriasis-drug
Recent IBD Deals
1. Janssen, Theravance ink GI pact worth up to $1B
“Janssen and Theravance Biopharma are teaming up to develop a JAK inhibitor for inflammatory bowel disease. Theravance will pick up $100 million up front, with the potential to earn another $900 million in milestone payments and royalties.”
“Under the agreement, Theravance will conduct a phase 2 study of the candidate, TD-1473, in Crohn’s disease, as well as a phase 2b/3 induction and maintenance study in ulcerative colitis, both slated to start this year. If all goes well, Janssen may pull the trigger on an exclusive license agreement for the program and take the lead on developing the drug in Crohn’s, according to a statement.”
“If the drug is approved, Janssen will be responsible for ex-U.S. marketing, with Theravance receiving tiered royalties, while the pair has the option of co-commercializing within the U.S. They will also split profits in the U.S., as well as development costs, with Janssen picking up 67% of the tab.”
https://www.fiercebiotech.com/biotech/janssen-theravance-ink-gi-pact-worth-up-to-1b
2. Johnson & Johnson commits $990M to land Protagonist’s oral Crohn’s drug (preclinical)
"Johnson & Johnson has landed rights to Protagonist Therapeutics’ preclinical Crohn’s disease asset PTG-200. The deal gives J&J a stake in an oral interleukin-23 (IL-23) receptor antagonist in return for $50 million upfront and up to $940 million in milestones."
"The asset is due to enter the clinic this year. Protagonist will run and fund the trial with J&J taking over—and covering 80% of the costs—once it advances to phase 2. Beyond this, a series of major paydays await Protagonist. J&J will pay Protagonist $125 million if it moves the drug into phase 2b and a further $200 million if it sticks with the asset after getting a look at data from the trial. The rest of the cash is tied to regulatory and sales milestones."
http://www.fiercebiotech.com/biotech/j-j-commits-990m-to-land-protagonist-s-oral-crohn-s-drug
3. Celgene Completes Acquisition of Receptos, Advancing Leadership in Immune-Inflammatory Diseases
"Celgene Corporation (CELG) today announced it has closed its acquisition of Receptos, Inc. Receptos stockholders received $232.00 per share in cash, for a total of approximately $7.2 billion, net of cash acquired."
http://www.fiercepharma.com/pharma/celgene-completes-acquisition-of-receptos-advancing-leadership-immune-inflammatory-diseases
4. Celgene enters deal potentially worth over $2.5 billion for Nogra Pharma's Crohn's disease drug
"Celgene announced a global licensing deal Thursday potentially valued at more than $2.5 billion to develop and market Nogra Pharma's experimental drug GED-0301 for moderate-to-severe Crohn's disease and other indications."
https://www.firstwordpharma.com/node/1205296?tsid=1
5. Gilead swoops down on Galapagos JAK1 candidate filgotinib in $2.075B deal
"Gilead Sciences Inc., is stepping in where Abbvie Inc. stepped out, laying down a whopping $725 million, with up to $1.35 billion more to come in milestones, for rights to Galapagos NV's Janus kinase 1 (JAK1)-selective inhibitor filgotinib (GLPG0634)."
http://www.bioworld.com/content/gilead-swoops-down-galapagos-jak1-candidate-filgotinib-2075b-deal
6. Salix Expands in GI Drugs and Beyond with $2.6B Santarus Acquisition
"Salix Pharmaceuticals said it will acquire Santarus for about $2.6 billion, in an all-cash deal that expands the buyer’s gastrointestinal (GI) drug portfolio and extends its product offerings into primary care and diabetes."
http://www.genengnews.com/gen-news-highlights/salix-expands-in-gi-drugs-and-beyond-with-2-6b-santarus-acquisition/81249089
IPIX Milestones, Clinical Trials, Recent Articles, Corporate Overview, Patents
Potential Milestones (Q2)
1. Prurisol - Topline Data (Phase 2b)
2. B-OM - Breakthrough Therapy Designation
Past Milestones
Kevetrin
- Positive primary endpoint (Phase 2a)
http://www.ipharminc.com/press-release/2018/2/8/innovation-pharmaceuticals-concludes-successful-phase-2a-trial-of-kevetrin-for-ovarian-cancer-intra-tumor-modulation-of-p53-observed
- Highly encouraging preliminary data (Phase 2a)
http://www.ipharminc.com/press-release/2017/12/27/innovation-pharmaceuticals-obtains-direct-evidence-of-molecular-pathways-modulation-in-tumors-from-first-patients-in-kevetrin-ph2a-ovarian-cancer-trial
- Positive primary endpoint and p21 data (Phase 1)
http://www.ipharminc.com/press-release/2016/11/12/assay-results-from-cellceutix-phase-1-clinical-trial-of-kevetrin-for-cancer-show-increased-p21-expression-in-675-of-evaluable-patients
- Orphan drug designation for ovarian cancer
http://www.ipharminc.com/press-release/2016/11/16/cellceutixs-kevetrin-receives-fda-orphan-drug-designation-for-the-treatment-of-ovarian-cancer
- Orphan drug designation for pancreatic cancer
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-receives-fda-orphan-drug-designation-for-kevetrin-for-the-treatment-of-pancreatic-cancer
- Orphan drug designation for retinoblastoma
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-receives-fda-orphan-drug-designmation-for-kevetrin-for-the-treatment-of-retinoblastoma
- Rare pediatric disease designation for retinoblastoma
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-receives-rare-pediatric-disease-designation-from-fda-for-kevetrin-for-the-treatment-of-retinoblastoma
Brilacidin
- B-OM positive secondary endpoint (Phase 2)
http://www.ipharminc.com/press-release/2018/1/3/innovation-pharmaceuticals-brilacidin-meets-key-secondary-endpoint-in-phase-2-trial-delays-onset-of-severe-oral-mucositis-som
- B-OM positive top-line data (Phase 2)
http://www.ipharminc.com/press-release/2017/12/11/innovation-pharmaceuticals-reports-positive-topline-results-from-phase-2-placebo-controlled-trial-of-brilacidin-for-the-prevention-of-oral-mucositis-in-head-and-neck-cancer-patients
- B-UP positive top-line data (Phase 2 POC)
http://www.ipharminc.com/press-release/2017/7/13/innovation-pharmaceuticals-phase-2-poc-trial-for-inflammatory-bowel-disease-achieves-induction-of-remission-in-a-majority-of-patients-treated-with-brilacidin
- B-ABSSSI positive top-line data (Phase 2b)
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-announces-positive-top-line-data-from-phase-2b-absssi-trial-single-dose-brilacidin-comparable-to-7-days-of-daptomycin
- QIDP designation for B-ABSSSI
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-antibiotic-brilacidin-receives-qidp-designation-from-fda
- Fast track designation for B-OM
http://www.ipharminc.com/press-release/2016/11/16/fda-grants-fast-track-designation-to-cellceutixs-brilacidin-om-for-oral-mucositis
- MTA extension for prophylactic testing in implanted devices
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-completes-lab-testing-of-brilacidin-for-planned-phase-3-trial-for-acute-bacterial-skin-and-skin-structure-infections
- Formulation stable at room temperature
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-announces-breakthrough-in-the-formulation-of-novel-antibiotic-brlaicidin-plans-studies-to-treat-diabetic-foot-ulcers
- American Society for Microbiology journal publication
http://aac.asm.org/content/early/2014/06/11/AAC.02955-14#corresp-1
Prurisol
- Positive top-line data (Phase 2a)
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-phase-2-trial-of-prurisol-for-mild-to-moderate-psoriasis-meets-primary-endpoint
- Positive primary endpoint (Phase 1)
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-anti-psoriasis-drug-prurisol-meets-primary-endpoint-of-clinical-trial
- 505(b)(2) pathway
http://www.ipharminc.com/press-release/2016/11/17/cellceutix-informed-by-fda-that-505b2-approval-would-be-an-acceptable-approach-for-its-psoriasis-drug
Clinical Trials
1. K-OC (Phase 2a, Completed)
https://clinicaltrials.gov/ct2/show/NCT03042702?term=cellceutix&rank=1
2. P (Phase 1, Completed)
https://clinicaltrials.gov/ct2/show/NCT02101216?term=cellceutix&rank=2
3. B-OM (Phase 2, Completed)
https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3
4. P (Phase 2a, Completed)
https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=4
5. P (Phase 2b, Completed)
https://clinicaltrials.gov/ct2/show/NCT02949388?term=cellceutix&rank=5
6. B-ABSSSI (Phase 2b, Completed)
https://clinicaltrials.gov/ct2/show/NCT02052388?term=cellceutix&rank=6
7. K (Phase 1, Completed)
https://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=7
8. B-UP (Phase 2 POC, Completed)
http://www.ipharminc.com/press-release/2016/11/10/cellceutix-receives-update-on-first-patient-enrollment-in-phase-2-proof-of-concept-study-of-brilacidin-for-ulcerative-proctitis
Pipeline
Recent Articles
-Taking a Page from Merck’s Gardasil and Glaxo’s Requip, These Small Companies Look to Cement Riches for Shareholders in New Category of Oral Mucositis
http://www.baystreet.ca/articles/stockstowatch/38594/Taking-a-Page-from-Mercks-Gardasil-and-Glaxos-Requip-These-Small-Companies-Look-to-Cement-Riches-for-Shareholders-in-New-Category-of-Oral-Mucositis
- A Billion Dollar Market Just Waiting for a New Oral Mucositis Drug: Five Companies That Want It
http://www.baystreet.ca/stockstowatch/2658/A-Billion-Dollar-Market-Just-Waiting-for-a-New-Oral-Mucositis-Drug-Five-Companies-That-Want-It
- Innovation Pharmaceuticals Stock May Be A Triple-Crown Winner With Brilacidin By Year End
https://seekingalpha.com/article/4088788-innovation-pharmaceuticals-stock-may-triple-crown-winner-brilacidin-year-end
- 2017 Q3 Conference Call Transcript
https://seekingalpha.com/article/4080068-innovation-pharmaceuticals-ipix-ceo-leo-ehrlich-q3-2017-results-earnings-call-transcript
- 2017 Q1 Conference Call Transcript
http://seekingalpha.com/article/4023682-cellceutix-corporation-ctix-ceo-leo-ehrlich-q1-2017-results-earnings-call-transcript
- Interview with New Cellceutix President Dr A Bertolino
http://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino
- Cellceutix Pipeline Continues to Hit Milestone After Milestone
https://www.streetwisereports.com/pub/na/cellceutix-pipeline-continues-to-hit-milestone-after-milestone
- A Small-Cap Biotech with Big Ideas for Acute Infections and Cancers: Cellceutix's Leo Ehrlich and Dr. Daniel Jorgensen
http://www.thelifesciencesreport.com/pub/na/a-small-cap-biotech-with-big-ideas-for-acute-infections-and-cancers-cellceutixs-leo-ehrlich-and-dr-daniel-jorgensen
Corporate Overview
- April 2018
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5acbbec2562fa79982ad5e22/1523302089564/2018+Apr+IPIX+Corporate+Overview.pdf
- 2018 Biotech Showcase
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5a4e50e39140b721186d1a6f/1515081962344/2018Jan+IPIX+Corporate+Overview.pdf
- BioCentury NewsMakers Conference
https://static1.squarespace.com/static/5715352e20c647639137f992/t/59b2f34946c3c498ebfe112e/1504899917915/IPIX+Company+Presentation+BioCentury+NewsMakers+Conference++8Sep2017.pdf
- Drug Discovery and Therapy World Congress
https://static1.squarespace.com/static/5715352e20c647639137f992/t/596cac7df14aa1a6e7118ed8/1500294274057/IPI+DDTWC+Brilacidin+presentation+%28final-u%29+13Jul2017.pdf
Patents
- Kevetrin
https://www.google.com/patents/US8338454
- Brilacidin
https://www.sec.gov/Archives/edgar/data/1355250/000147793214002418/ctix_ex1037.htm
https://www.google.com/patents/US20160243117
https://www.google.com/patents/EP2709619A2
- Prurisol
https://www.google.com/patents/WO2013103601A1
MP Advisors Report
https://drive.google.com/file/d/0Bz15O4eaX-asWVpoclB2WUhENFk/view
Abbreviations
K – Kevetrin
B – Brilacidin
P – Prurisol
OC – ovarian cancer
ABSSSI – acute bacterial skin and skin structure infections
OM – oral mucositis
UP – ulcerative proctitis
QIDP – qualified infectious disease product
B-UP Due Diligence
IBD Development Update (10/24/2017)
"Oral formulation plans are underway to deliver Brilacidin more widely throughout the GI tract so as to enable treatment of more extensive forms of IBD—Crohn’s Disease and Ulcerative Colitis. A meeting with the Food and Drug Administration (FDA) is being requested to help inform appropriate next steps for our Brilacidin-IBD program, such as the size and scope of subsequent clinical trials. Finally, the Company plans to continue exploration of Brilacidin’s various mechanisms of action, including its anti-inflammatory and anti-bacterial properties, as well as its immunomodulatory and wound healing capabilities—all of which likely have a role in Brilacidin’s ability to treat IBD."
http://www.ipharminc.com/press-release/2017/10/24/innovation-pharmaceuticals-provides-development-update-on-brilacidin-for-inflammatory-bowel-disease
Positive Trial Result (7/13/2017)
Rate of Clinical Remission (% of patients achieving)
- 60% Cohort A (3 of 5 patients)
- 67% Cohort B (4 of 6 patients)
- 75% Cohort C (3 of 4 patients)
(i) #Endoscopy subscore ≤ 1 (% of patients achieving)
- 80% Cohort A (4 of 5 patients)
- 67% Cohort B (4 of 6 patients)
- 75% Cohort C (3 of 4 patients)
(ii) Rectal Bleeding subscore of 0 (% of patients achieving)
- 80% Cohort A (4 of 5 patients)
- 100% Cohort B (6 of 6 patients)
- 100% Cohort C (4 of 4 patients)
(iii) Stool Frequency subscore, improvement or no change from baseline (% of patients achieving)
- 100% Cohort A (5 of 5 patients)
- 100% Cohort B (6 of 6 patients)
- 100% Cohort C (4 of 4 patients)
Endoscopic Image (Cohort B, 100 mg)
http://www.ipharminc.com/press-release/2017/7/13/innovation-pharmaceuticals-phase-2-poc-trial-for-inflammatory-bowel-disease-achieves-induction-of-remission-in-a-majority-of-patients-treated-with-brilacidin
Patient Treatment Update (6/26/2017)
"With the study treatments now completed, Brilacidin has consistently shown strong signs of efficacy while exhibiting a good safety profile even as dosing increased, supporting its potential as a novel, non-corticosteroid, non-biologic anti-inflammatory drug candidate in treating IBD. Innovation Pharmaceuticals’ formulation development plans for Brilacidin include foam and/or gel for the treatment of UP/UPS, and pills for oral dosing for the treatment of Ulcerative Colitis and Crohn’s Disease."
http://www.ipharminc.com/press-release/2017/6/24/innovation-pharmaceuticals-completes-treatments-in-phase-2-poc-trial-for-induction-of-remission-in-inflammatory-bowel-disease-topline-results-with-endoscopic-response-to-be-presented-july-13-2017
Third Cohort Update (5/18/2017)
“What is perhaps most remarkable about this trial is that Brilacidin was administered to patients in water as a retention enema,” said Leo Ehrlich, Chief Executive Officer at Cellceutix. “The logical next step is transitioning to a foam and gel/lotion formulation, with planning already underway, which would greatly facilitate Brilacidin’s adhesion to the mucosal lining of the gastrointestinal tract and may lead to even greater efficacy. Brilacidin for UP/UPS is well-positioned to become first-in-class.”
http://www.ipharminc.com/press-release/2017/5/15/cellceutix-completes-patient-enrollment-of-final-cohort-in-phase-2-trial-of-brilacidin-for-inflammatory-bowel-disease-topline-results-anticipated-in-july
Investor & Shareholder Update (4/20/2017)
https://www.youtube.com/watch?v=kzFu-jItfMw&t=474s
First & Second Cohort Top-line Data (3/21/2017)
Primary Efficacy Endpoint of Clinical Remission (accounting for Stool Frequency, Rectal Bleeding and Endoscopy Findings subscores)—50 percent of patients in Cohort A (3 of 6) and 50 percent of patients in Cohort B (3 of 6) met this endpoint; all 6 of the remaining patients in Cohorts A and B met 2 of the 3 criteria (Partial Response).
Full MMDAI (accounting for Stool Frequency, Rectal Bleeding, Physician’s Global Assessment and Endoscopy Findings subscores)—notable improvements observed in 10 of 11 patients (one patient declined endoscopy at end of treatment):
- 100 percent reduction in 2 patients in Cohort A and 2 patients in Cohort B
- 50-75 percent reduction in 2 patients in Cohort A and 4 patients in Cohort B
- 20 percent reduction in 1 patient in Cohort A
Partial MMDAI (accounting for Stool Frequency, Rectal Bleeding and Physician’s Global Assessment subscores)—notable improvements observed in 11 of 12 patients:
- 100 percent reduction in 3 patients in Cohort A and 3 patients in Cohort B
- 50-83 percent reduction in 2 patients in Cohort A and 3 patients in Cohort B
- 0 percent reduction in 1 patient in Cohort A
Patient Quality of Life (as assessed by the Short Inflammatory Bowel Disease Questionnaire, SIBDQ)—notable improvements in all 12 patients; 50 percent of patients in Cohort A (3 of 6) and 80 percent of patients in Cohort B (5 of 6) reported significant improvements of 15 points to more than 50 points higher on the 70-point SIBDQ scale.
Other Clinically Meaningful Observations
- Endoscopy subscore of ≤ 1 met in 7 of 11 patients (1 patient declined final endoscopy).
- PGA subscore improved for 10 of 12 patients.
- Rectal Bleeding subscore improved for all 12 patients.
- Stool Frequency subscore demonstrated improvement by study end for all patients who were abnormal at study start.
http://www.ipharminc.com/press-release/2017/3/19/cellceutix-releases-favorable-topline-findings-as-part-of-interim-analysis-of-phase-2-drug-candidate-brilacidin-for-the-treatment-of-inflammatory-bowel-disease
Second Cohort Update (3/8/2017)
All 12 patients experienced a beneficial response, as measured by the Modified Mayo Disease Activity Index (MMDAI).
- At Day 42, the Primary Efficacy Endpoint of Clinical Remission (accounting for Stool Frequency, Rectal Bleeding, and Endoscopy sub-scores) was met in half (n=6) of all patients (3 of 6 in Cohort A; 3 of 6 in Cohort B).
- Among the remaining patients (n=6) in Cohorts A and B not meeting all three criteria for Clinical Remission, two of the three criteria were achieved by all of these patients (defined as a Partial Response).
Patient Quality-of-Life, as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was improved in all 12 patients after six weeks of daily Brilacidin treatment. Specifically, over 40 percent of patients reported significant improvements, ranging approximately from 20 points to more than 50 points higher on the 70-point SIBDQ scale.
http://www.ipharminc.com/press-release/2017/3/8/cellceutix-releases-preliminary-efficacy-and-safety-data-in-interim-analysis-of-first-two-cohorts-in-phase-2-trial-of-brilacidin-for-the-induction-of-remission-of-mild-to-moderate-ulcerative-colitis
Second Cohort Update (1/23/2017)
"Site investigators report enthusiastic feedback from patients currently receiving treatment in the second cohort with Brilacidin at 100 mg daily (by retention enema) for six weeks —comments included how the treatment already has greatly improved or eliminated their symptomatic complaints, daily functioning and overall quality of life. There is significant interest by new patients wishing to participate in the third (final) cohort once enrollment opens."
http://www.ipharminc.com/press-release/2017/1/22/cellceutixs-brilacidin-demonstrates-promise-in-treating-ulcerative-colitis-supported-by-endoscopic-assessment-patient-reported-outcomes
First & Second Cohort Update (12/7/2016)
"Review of safety data from the first cohort revealed that Brilacidin, administered for 6 weeks as a retention enema, at 50 mg once daily, appeared well-tolerated, with no measurable systemic absorption detected. This drug profile, at the lowest dose, allowed the approval of dose escalation to the second cohort (100 mg, once daily). Clinically meaningful improvements in symptoms of UP/UPS were also demonstrated in the first cohort, as measured by physician assessments and patient reported outcomes, further supported with endoscopic evaluation of disease activity."
http://www.ipharminc.com/press-release/2016/12/6/cellceutix-phase-2-trial-dose-escalates-in-2nd-cohort-for-brilacidin-as-a-novel-anti-inflammatory-drug-candidate-for-ulcerative-colitis
First Cohort Update (10/10/2016)
At Day 42, on the Partial MMDAI (accounting for Stool Frequency, Rectal Bleeding, and Physician’s Global Assessment scores), 2 of 4 patients achieved full response (100% reduction) and the other 2 patients had notable improvement (50% reduction).
At Day 42, on the MMDAI (equivalent to Partial MMDAI + Endoscopy score; completed by 3 of 4 patients), 1 of 3 patients achieved full response (100% reduction) and 2 of 3 patients had notable improvement (50% reduction). One patient who had demonstrated a full response on the Partial MMDAI (as defined in first bullet point) did not consent to the final endoscopy, so their data cannot be included in these initial results.
Patient quality of life, as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was improved after 6-weeks of treatment with Brilacidin.
Brilacidin was generally well-tolerated and patients maintained stable normal vital signs during treatment.
http://www.ipharminc.com/press-release/2016/10/27/cellceutix-phase-2-trial-initial-data-shows-potential-of-brilacidin-as-a-novel-anti-inflammatory-drug-candidate-for-induction-of-remission-of-mild-to-moderate-ulcerative-colitis
First Patient Update (07/18/2016)
"Cellceutix has been advised that the first patient in Cohort A remains on study. The clinical site administering Brilacidin to this patient has informed the Company, “Both the patient and the site staff have been amazed how the study drug works as all the symptoms decreased significantly within the 1st week of treatment.” "
http://www.ipharminc.com/press-release/2016/11/10/cellceutix-receives-update-on-first-patient-enrollment-in-phase-2-proof-of-concept-study-of-brilacidin-for-ulcerative-proctitis
About Ulcerative Proctitis
Ulcerative proctitis (UP), a limited type of ulcerative colitis (UC), is a mucosal inflammatory disease of unknown cause involving only the rectum. When it involves both the rectum and the distal colon, it is called Ulcerative Proctosigmoiditis (UPS). It is characterized by inflammation, redness, and ulcerations of the mucosa. The course of the disease is variable and ranges from complete resolution to easily maintained remission to chronic relapses or refractory disease. Diagnosis can occur at any point in life, with approximately 30-50 percent of patients developing more extensive UC. There is currently no cure. According to estimates provided by GlobalData, the worldwide UC market, which includes products for UP/UPS, is expected to increase at a compound annual growth rate of 4.7 percent, from $4.2 billion in 2012 to approximately $6.6 billion by 2022.
http://www.ipharminc.com/press-release/2016/11/10/cellceutix-starts-phase-2-trial-of-brilacidin-as-a-novel-therapy-for-ulcerative-proctitis
Trial Design
The primary objective of the P-o-C trial is to assess the frequency of clinical and endoscopic remission with Brilacidin administered per rectum in subjects with active UP or UPS after 6 weeks of treatment. Secondary objectives include evaluation of safety and tolerability of Brilacidin when administered per rectum, evaluation of clinical remission at Week 2 and Week 4, assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum, assessment of the efficiency of Brilacidin by biomarker evaluation of biopsy samples for interleukin (IL)-6 and IL-1beta, and estimation of statistical power for subsequent trial(s) in UP and UPS.
The P-o-C trial will include 18 patients divided evenly into three cohorts. Cohort A is receiving 50 milligrams (mg) of Brilacidin once daily for 42 days. Dosing will be increased to 100mg and 200mg once daily for 42 days for Cohort B and Cohort C, respectively. Endoscopic evaluation of the rectum and mucosa up to 40 cm from the anal verge will be performed at screening and at the end of treatment/Day 42 (± 3 days). Per protocol, a safety committee will review safety and retention data (clinical laboratory findings, vital signs and adverse events) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment in the subsequent cohort.
http://www.ipharminc.com/press-release/2016/11/10/cellceutix-receives-update-on-first-patient-enrollment-in-phase-2-proof-of-concept-study-of-brilacidin-for-ulcerative-proctitis
Q1 2017 Conference Call
During September we received initial comments on the first patient enrolled in our Phase 2 trial of Brilacidin for the inflammatory bowel disease, IBD, ulcerative proctitis or ulcerative proctosigmoiditis which detailed a significant decrease in symptoms within one week of Brilacidin activity. Early in the current quarter we followed that up with even better news of clinically meaningful improvements in the first four patients of the first cohort who completed the trial at the lowest dosing level. Yes, the lowest grossing level. Dr. Bertolino will provide some more color on the results. But the key is the fact that Brilacidin concentrations in the patient's plasma at all timeframes were basically undetectable. This is incredibly important in the safety profile that is being built for the FDA. We believe that a highly effective new drug with minimal systemic exposure will have competitive advantages to capture market share in a market for IBD medicine, the vision gain forecast to client to $9.3 billion in 2019.
Unidentified Analyst
Brilacidin seems to have very broad potential across a number of indications. Can you comment on why you chose to start with inflammatory bowel disease and ulcerative proctitis? Can you expand on the critical path for these indications and what other indications would you consider pursuing?
Leo Ehrlich
There is currently a significant medical need for effective treatment of inflammatory bowel disease. We look for massive markets with unmet needs, so IBD certainly qualified. The simplest way for us to do a proof-of-concept evaluation was to first explore ulcerative proctitis, ulcerative proctosigmoiditis. We have certainly been encouraged by preliminary results if it holds true that we can achieve significant clinical benefits with localized treatment and no significant systemic drug levels. We also anticipate potential for use in expanding IBD indications and in a number of dermatological diseases.
Unidentified Analyst
Dr. Bertolino, can you explain more about what is known of the science underlying the anti-inflammatory actions of Brilacidin?
Arthur P. Bertolino
Brilacidin is an immunomodulatory and anti-inflammatory agent. It inhibits the production of a number of key molecular targets, TNF-alpha, IL- 1 beta, MCP-1, MMP-9 and IL-6. Recent encouraging results in ulcerative proctitis, ulcerative proctosigmoiditis reassure us that the science is meaningful.
http://seekingalpha.com/article/4023682-cellceutix-corporation-ctix-ceo-leo-ehrlich-q1-2017-results-earnings-call-transcript
Interim Data
"A: Let me first touch on the ulcerative proctitis (UP) and oral mucositis (OM) trials. The UP trial is progressing smoothly and barring any unforeseen complications, we think that we will have some interim results sometime next quarter. This is a proof-of-concept study, which I believe can have a significant impact on the value of the Brilacidin franchise by serving as a gateway to other gastrointestinal diseases and conditions.”
http://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino#alt2
Modified Mayo Disease Activity Index (MMDAI)
Clinical improvement was defined as a greater than or equal to 3 point improvement from baseline in the total MMDAI score and a greater than or equal to 1 point improvement from baseline in the rectal bleeding subscale of the MMDAI. Secondary efficacy end points included the proportion of patients in clinical remission, defined as a score of 0 for rectal bleeding and a combined score of less than or equal to 2 for bowel frequency and physician's assessment using the MMDAI subscales.
https://www.ncbi.nlm.nih.gov/pubmed/19491859
Ulcerative Proctitis
Abstract
Ulcerative proctitis is an idiopathic mucosal inflammatory disease involving only the rectum and is therefore an anatomically limited form of ulcerative colitis. Diagnosis is made based on clinical presentation, endoscopic appearance, and histopathology. Additionally, other etiologies of proctitis are excluded. The course of the disease is variable ranging from complete resolution to easily maintained remission to frequent relapses or refractory disease. Extension of inflammatory changes involving the proximal colon occurs in some cases. Rectal 5-aminosalicylic acid (5-ASA) or steroids are the initial treatments of choice with oral 5-ASA, sulfasalazine, or steroids used for treatment failures or patients unable to tolerate rectally administered drugs. Immunomodulators like azathioprine and 6-mercaptopurine have been used successfully in small groups of patients who have not responded to 5-ASA or steroids. Oral or rectal 5-ASA products maintain remission but long-term steroid use should be avoided. Rare cases may require surgical therapy.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780078/
Foam Preparations
Abstract
Patients with ulcerative colitis uniformly have disease involving the distal colon. When patients have disease limited to the left colon or symptoms suggestive of active rectal inflammation, guidelines recommend topical rectal therapies as first-line agents either as monotherapy or in conjunction with oral products. Rectal delivery modalities offer the advantage of delivering high local concentrations of active medication to the site of maximal inflammation with minimization of systemic side effects. Methods of rectal administration include suppositories, liquid enemas and foams. Suppositories are limited to the treatment of rectal disease, and patients often have difficulty retaining the liquid enema secondary to its high volume and consistency. Rectal foams reliability extend to the descending and sigmoid colon with application. Foams are further characterized by increased viscosity, lower volumes, finer dispersion on the colonic mucosa, and increased adhesiveness to the colonic mucosa compared with liquid enemas. Additionally, rectal foam agents demonstrate equal efficacy to their liquid enema counterparts yet consistently yield better patient tolerance, lower incidence of side effects, and increased patient acceptability. Currently available agents include 5-aminosalicylic acid and corticosteroids, both first and newer generation. This review focuses on clinical trials assessing efficacy, tolerability, and patient preferences for these agents as well as describing the currently available rectal foam products.
http://www.ncbi.nlm.nih.gov/pubmed/21235478
Placebo Response Rate
Experience with foam preparations has demonstrated better retention and adherence, as well as more uniform distribution of medication in the distal colon and rectum, as compared with enemas and suppositories.
Analysis of the individual trials showed that 38.3% and 44% of patients in the budesonide arm achieved remission at 6 weeks as compared with 25.8% and 22.4% of the placebo groups (P=0.0324 and P<0.0001, respectively). Combined results showed a remission rate of 41.2% with budesonide foam and 24% with placebo (P<0.0001).
http://www.medpagetoday.com/meetingcoverage/acg/42311
Current and Future Therapies
Ulcerative Colitis and Crohn’s Disease
UC is a gastrointestinal (GI) disease that is localized to the large intestine, or colon, where inflammation can affect either the entire organ or a portion of it. Approximately 1.86 billion patients have been diagnosed with UC globally, with 1.54 billion patients currently receiving treatment. Traditional therapies have yielded $4.18 billion in annual sales around the world, a figure expected to increase to $6.85 billion by 2022 with the approval of various pipeline drugs.
CD can affect any part of the GI tract, but most commonly involves both the large and small intestines. Although CD is more severe than UC, the global prevalence is much lower, with only 1.3 million patients diagnosed and 0.8 million who currently receive treatment. Still, traditional therapies have resulted in an impressive $3.17 billion in global market sales, which is predicted to increase to $4.20 billion by 2022.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4123809/
Mesalamine in the Treatment and Maintenance of Remission of Ulcerative Colitis
Abstract
Ulcerative colitis (UC) is a chronic disease of the GI tract that is characterized by mucosal inflammation in the colon. Mesalamine (mesalazine) is a 5-aminosalicylic acid compound that is the first-line treatment for patients with mild-to-moderate UC. There are multiple formulations of mesalamine available, primarily differentiated by their means of delivering active mesalamine to the colon. Mesalamine has been demonstrated in randomized controlled trials to induce both clinical response and remission, and maintain clinical remission, in these patients. It has few serious adverse effects and is generally well tolerated by patients. The main areas of uncertainty with use of mesalamine in patients with UC center on the optimal dose for induction of response, how to maintain patient adherence and the role of mesalamine in cancer chemoprophylaxis. Generic forms of mesalamine have yet to be approved by regulatory bodies in the USA.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3314328/
Potential Market
The global ulcerative colitis (UC) market value will increase steadily over the coming years, growing from almost $4.2 billion in 2012 to approximately $6.6 billion by 2022, at a Compound Annual Growth Rate (CAGR) of 4.7%, according to a new report from research and consulting firm GlobalData.
Johnson & Johnson (J&J) has been continually dominating the UC market due to the success of Remicade. However, Remicade’s patent is set to expire between 2015 and 2018, which will knock J&J’s sales down from approximately $2 billion in 2012 to $1.5 billion by 2022, according to GlobalData.
Another key player in the UC industry, AbbVie’s Humira, will also lose its patent during the forecast period, with sales slipping from $1.2 billion in 2012 to $569 million by 2022.
https://healthcare.globaldata.com/media-center/press-releases/pharmaceuticals/global-ulcerative-colitis-market-simponi-and-entyvio-launches-to-boost-growth-by-2022-says-globaldata
http://www.prnewswire.com/news-releases/anti-inflammatory-therapeutics-market-is-expected-to-reach-1061-billion-globally-by-2020---allied-market-research-528652061.html
Recent IBD Deals
1. Janssen, Theravance ink GI pact worth up to $1B
“Janssen and Theravance Biopharma are teaming up to develop a JAK inhibitor for inflammatory bowel disease. Theravance will pick up $100 million up front, with the potential to earn another $900 million in milestone payments and royalties.”
“Under the agreement, Theravance will conduct a phase 2 study of the candidate, TD-1473, in Crohn’s disease, as well as a phase 2b/3 induction and maintenance study in ulcerative colitis, both slated to start this year. If all goes well, Janssen may pull the trigger on an exclusive license agreement for the program and take the lead on developing the drug in Crohn’s, according to a statement.”
“If the drug is approved, Janssen will be responsible for ex-U.S. marketing, with Theravance receiving tiered royalties, while the pair has the option of co-commercializing within the U.S. They will also split profits in the U.S., as well as development costs, with Janssen picking up 67% of the tab.”
https://www.fiercebiotech.com/biotech/janssen-theravance-ink-gi-pact-worth-up-to-1b
2. Johnson & Johnson commits $990M to land Protagonist’s oral Crohn’s drug (preclinical)
"Johnson & Johnson has landed rights to Protagonist Therapeutics’ preclinical Crohn’s disease asset PTG-200. The deal gives J&J a stake in an oral interleukin-23 (IL-23) receptor antagonist in return for $50 million upfront and up to $940 million in milestones."
"The asset is due to enter the clinic this year. Protagonist will run and fund the trial with J&J taking over—and covering 80% of the costs—once it advances to phase 2. Beyond this, a series of major paydays await Protagonist. J&J will pay Protagonist $125 million if it moves the drug into phase 2b and a further $200 million if it sticks with the asset after getting a look at data from the trial. The rest of the cash is tied to regulatory and sales milestones."
http://www.fiercebiotech.com/biotech/j-j-commits-990m-to-land-protagonist-s-oral-crohn-s-drug
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=138464059
UP Presentation
2017 Drug Discovery and Therapy World Congress
https://static1.squarespace.com/static/5715352e20c647639137f992/t/596cac7df14aa1a6e7118ed8/1500294274057/IPI+DDTWC+Brilacidin+presentation+%28final-u%29+13Jul2017.pdf
UP Blog
10/24/2017 - Deficient Defensins and Missing Mucins in the Pathogenesis of Inflammatory Bowel Disease
http://www.ipharminc.com/new-blog/2017/10/24/deficient-defensins-and-missing-mucins-in-the-pathogenesis-of-inflammatory-bowel-disease
7/13/2017 - Ulcerative Proctitis / Ulcerative Proctosigmoiditis — Opportunity for Newer Therapies Like Brilacidin to Emerge
http://www.ipharminc.com/new-blog/2017/7/13/ulcerative-proctitisulcerative-proctosigmoiditissubstantial-opportunity-exists-for-newer-therapies-like-brilacidin-to-emerge
7/6/2017 - Growing Interest in Novel Treatments for Inflammatory Bowel Disease
http://www.ipharminc.com/new-blog/2017/7/3/growing-interest-in-novel-non-biologic-treatments-for-inflammatory-bowel-disease
6/2/2017 - Dr. Francis A. Farraye on the Use of Endoscopy in Inflammatory Bowel Disease (IBD)
http://www.ipharminc.com/new-blog/2017/6/2/dr-francis-farraye-on-the-use-of-endoscopy-in-ibd
4/6/2017 - IBD Inpatient Costs Skyrocketing
http://www.ipharminc.com/new-blog/2017/2/2/ibd-inpatient-costs-skyrocketing-1
2/17/2017 - Endoscopic Remission in the Treatment of Ulcerative Colitis
http://www.ipharminc.com/new-blog/2017/2/2/endoscopic-remission-in-the-treatment-of-ulcerative-colitis
Dr. Francis A. Farraye – Scientific Advisor, Gastroenterology
Dr. Francis A. Farraye serves as Professor of Medicine, Clinical Director, Section of Gastroenterology and Co-Director, Center for Digestive Disorders, at Boston University School of Medicine. Dr. Farraye is a Fellow of the American College of Physicians, American Society of Gastrointestinal Endoscopy, American Gastroenterological Association and the American College of Gastroenterology. Across his professional career, he has published over 350 original manuscripts, abstracts and book chapters, with particular clinical interest in inflammatory bowel disease and colorectal cancer. Dr. Farraye has been named Humanitarian of the Year by the New England Chapter of the Chrohn’s & Colitis Foundation of America. Dr. Farraye received a MD from Albert Einstein College of Medicine in New York and a MSc (Epidemiology) from Harvard University.
http://www.cellceutix.com/senior-management-1/
Books
Questions & Answers About Ulcerative Colitis
https://books.google.com/books?id=45iIz7k14pwC&printsec=frontcover&dq=ulcerative+colitis+farraye&hl=en&sa=X&ved=0ahUKEwi5lJHKndHPAhVHQSYKHTgBCCwQ6AEINDAA#v=onepage&q=ulcerative%20colitis%20farraye&f=false
Curbside Consultations in IBD: 49 Clinical Questions
https://books.google.com/books?id=JQaR2Sk2Ek4C&printsec=frontcover&dq=curbside+consultation&hl=en&sa=X&ved=0ahUKEwiruMDTnNHPAhXIVyYKHd68A3gQ6AEIHjAA#v=onepage&q=curbside%20consultation&f=false
Presentations
Health Maintenance for your IBD Patient (Slide 104)
http://www.galamericas.org/dallas/library/PPTS/June2014/Inflammatory_Bowel_Disease.pdf
The role of chromoendoscopy in ulcerative colitis patients: Should we incorporate the SCENIC recommendations? (Slide 10)
http://advancesinibd.com/archive/2015/presentations/Friday/Clinical/Session-IVA/1030_Challenges%20in%20IBD_Med.pdf
Publications
https://www.researchgate.net/profile/Francis_Farraye/publications
YouTube
How can we best determine endoscopic severity in ulcerative colitis and Crohn's disease
https://www.youtube.com/watch?v=mdR7UCm33xg&t=23s
Diagnosis and Management of Colorectal Neoplasia in Inflammatory Bowel Disease
https://www.youtube.com/watch?v=kV5-9qwetmc
B-OM Due Diligence
Lastest Update
4/23/2018 - Innovation Pharmaceuticals Signs Drug Supply Contract with Evonik to Bulk Produce Commercial-Grade Brilacidin
"Securing a commercial-grade drug supply of Brilacidin with a leading Contract Development and Manufacturing Organization (CDMO), such as Evonik, is an important and necessary step that will enable Innovation Pharmaceuticals to more rapidly advance the Brilacidin Franchise, toward getting much-needed treatments to patients."
http://www.ipharminc.com/press-release/2018/4/23/innovation-pharmaceuticals-signs-drug-supply-contract-with-evonik-to-bulk-produce-commercial-grade-brilacidin
4/16/2018 - Innovation Pharmaceuticals Data from Phase 2 Brilacidin Oral Mucositis (OM) Trial in Head and Neck Cancer Show Notable Reductions in Median Duration of Severe OM and in Number of Unplanned Visits/Hospital Admissions Due to OM
· Median Duration of Severe Oral Mucositis (SOM) Reduced to Less Than One Day
· No Unplanned Office Visits, Emergency Department Visits, and/or Hospital Admissions Due to OM in Brilacidin-OM Arm vs. Four in Placebo Arm
· Data Align with Previously Reported 80.3% Risk Reduction in Incidence of Severe OM in Per Protocol Population Receiving Aggressive Chemotherapy Regimen Compared to Placebo
http://www.ipharminc.com/press-release/2018/4/16/innovation-pharmaceuticals-data-from-phase-2-brilacidin-oral-mucositis-om-trial-in-head-and-neck-cancer-show-notable-reductions-in-median-duration-of-severe-om-and-in-number-of-unplanned-visit
4/9/2018 - Innovation Pharmaceuticals Phase 2 Oral Mucositis Trial Additional Data Show Brilacidin-OM Demonstrated A Significant Reduction in the Incidence of Severe Oral Mucositis in Patients with Head and Neck Cancer (HNC) Receiving Aggressive Chemotherapy Regimen
“For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249).”
http://www.ipharminc.com/press-release/2018/4/9/innovation-pharmaceuticals-phase-2-oral-mucositis-trial-additional-data-show-brilacidin-om-demonstrated-a-significant-reduction-in-the-incidence-of-severe-oral-mucositis
3/15/2018 - Innovation Pharmaceuticals Views Brilacidin-OM as Clearly Differentiated Compared to Limited Competition for Preventing Severe Oral Mucositis
“The Company is currently focused on completing the Clinical Study Report for its Phase 2 clinical trial (see NCT02324335) evaluating Brilacidin’s ability to safely prevent and attenuate SOM in HNC patients receiving chemoradiation and compiling a Briefing Package for discussion with the FDA.”
http://www.ipharminc.com/press-release/2018/3/15/innovation-pharmaceuticals-views-brilacidin-om-as-clearly-differentiated-compared-to-limited-competition-for-preventing-severe-oral-mucositis
1/29/2018 - Innovation Pharmaceuticals Brilacidin Franchise Anchored in Three Clinical Indications — Oral Mucositis, Inflammatory Bowel Disease and Serious Skin Infections; Expands into Dermatologic Diseases
"A leading international drug manufacturer has been engaged with to bulk produce commercial-quality Brilacidin, aimed at lowering patient drug cost and anticipating future drug needs in preparation for expedient market introduction. This critical step also proactively facilitates future patient and insurance reimbursement adoption through favorable cost savings;"
http://www.ipharminc.com/press-release/2018/1/29/innovation-pharmaceuticals-brilacidin-franchise-anchored-in-three-clinical-indications-oral-mucositis-inflammatory-bowel-disease-and-serious-skin-infections-expands-into-dermatologic-diseases
1/3/2018 - Innovation Pharmaceuticals Brilacidin Meets Key Secondary Endpoint in Phase 2 Trial, Delays Onset of Severe Oral Mucositis (SOM)
"Onset of Severe Oral Mucositis: Based on Kaplan-Meier curves, Brilacidin-OM oral rinse showed a clear separation from placebo in delaying the onset of SOM—particularly the period from approximately 28-42 days, after the initiation of treatment, during which the incidence of SOM rose strikingly in the placebo group while not in the group being treated with Brilacidin."
http://www.ipharminc.com/press-release/2018/1/3/innovation-pharmaceuticals-brilacidin-meets-key-secondary-endpoint-in-phase-2-trial-delays-onset-of-severe-oral-mucositis-som
Kaplan-Meier Curves
12/18/2017 - Innovation Pharmaceuticals Brilacidin Oral Mucositis Program Moving Forward Based Upon Positive Anchoring Phase 2 Results and Increased Brilacidin Franchise Value
"Towards commercial planning, the Company has begun exploring potential unit dose drug product packaging in the form of a sachet. Sachets, which people are very familiar with and use on an almost daily basis (e.g., sugar packets, artificial sweeteners) increasingly are being developed as a novel means of patient-friendly, drug delivery. Manufacturing plans for drug substance appropriate for late phase testing and eventual market introduction are also underway."
http://www.ipharminc.com/press-release/2017/12/18/innovation-pharmaceuticals-brilacidin-oral-mucositis-program-moving-forward-based-upon-positive-anchoring-phase-2-results-and-increased-brilacidin-franchise-value
12/12/2017 - Innovation Pharmaceuticals Granted European Patent for Brilacidin in the Prevention of Oral Mucositis
"The European patent supplements other Brilacidin-OM patents that have been granted in the United States, Asia (Japan, Taiwan, China), Oceania (Australia) and South Africa. All currently issued patents have an expiration date of 2032. Additional Brilacidin-OM patent applications are pending in other key markets including Russia and South Korea."
http://www.ipharminc.com/press-release/2017/12/12/innovation-pharmaceuticals-granted-european-patent-for-brilacidin-in-the-prevention-of-oral-mucositis
12/11/2017 - Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients
Summary of Topline Results from the Placebo-Controlled Phase 2 Trial
· Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.
· Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
· Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.
· Trial results support continued and expedited development of Brilacidin-OM.
http://www.ipharminc.com/press-release/2017/12/11/innovation-pharmaceuticals-reports-positive-topline-results-from-phase-2-placebo-controlled-trial-of-brilacidin-for-the-prevention-of-oral-mucositis-in-head-and-neck-cancer-patients
11/16/2017 - Innovation Pharmaceuticals Offers Perspectives on Brilacidin as a Potential Preventative Treatment for Oral Mucositis in Head and Neck Cancer Patients
"Formal collaboration with pharmaceutical companies that have expressed an interest in partnering Brilacidin-OM may well assist further with expediting the drug candidate’s development timetable. Some of these partnering conversations have matured to the point of potentially structuring mutually beneficial licensing agreements, pending the final Phase 2 study results."
http://www.ipharminc.com/press-release/2017/11/16/innovation-pharmaceuticals-offers-perspectives-on-brilacidin-as-a-potential-preventative-treatment-for-oral-mucositis-in-head-and-neck-cancer-patients
10/26/2017 - Innovation Pharmaceuticals Aims to Develop First Drug for Approval in Prevention of Oral Mucositis in Head and Neck Cancer Patients as Phase 2 Clinical Trial of Brilacidin Completes
"The Company has begun the process of closing trial study sites and is now aggregating patient data for top-line analysis, to be reported this quarter."
http://www.ipharminc.com/press-release/2017/10/25/jk5qd8ltvc4ed00ekrbqwbej1vz0x1
10/18/2017 - Innovation Pharmaceuticals to Complete Phase 2 Trial of Brilacidin for Oral Mucositis in Cancer Patients
"After the final patient post-treatment follow-up is conducted next week, the Company will focus on the process of concluding the study, including closing clinical sites and aggregating and analyzing data."
http://www.ipharminc.com/press-release/2017/10/18/innovation-pharmaceuticals-to-complete-phase-2-trial-of-brilacidin-for-oral-mucositis-in-cancer-patients
10/2/2017 - Final Patient Completes Treatment in Innovation Pharmaceuticals Phase 2 Trial of Brilacidin for Preventing Oral Mucositis in Cancer Patients
"... today announces that the last patient has completed study treatment in the Company’s Phase 2 clinical trial of Brilacidin for the prevention and treatment of severe Oral Mucositis (OM) in patients undergoing chemoradiation for Head and Neck Cancer."
http://www.ipharminc.com/press-release/2017/10/2/final-patient-completes-treatment-in-innovation-pharmaceuticals-phase-2-trial-of-brilacidin-for-oral-mucositis
8/7/2017 - Innovation Pharmaceuticals Completes Patient Enrollment in Phase 2 Study of Brilacidin for the Prevention of Severe Oral Mucositis
"... today announces that it has completed patient enrollment for its ongoing Phase 2 clinical study of Brilacidin for the prevention of Severe Oral Mucositis (OM). A total of 61 patients have been enrolled, with topline results anticipated in 4Q2017."
http://www.ipharminc.com/press-release/2017/8/6/innovation-pharmaceuticals-completes-patient-enrollment-in-phase-2-study-of-brilacidin-for-the-prevention-of-severe-oral-mucositis
3/27/2017 - Cellceutix Reports Very Encouraging Interim Analysis of Phase 2 Drug Candidate Brilacidin for Severe Oral Mucositis (OM) in Head and Neck Cancer Patients; High Potential for Preventative Treatment
"Study showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent)"
Primary Efficacy Results: Incidence of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): 2 of 9 patients (22.2 percent)
• Control Arm (Placebo): 7 of 10 patients (70 percent)
Secondary Efficacy Results: Duration of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): Mean 10.5 days (Range 3 to 18 days; 2 patients)
• Control Arm (Placebo): Mean 14 days (Range 3 to 39 days; 7 patients)
http://www.ipharminc.com/press-release/2017/3/27/cellceutix-reports-very-encouraging-interim-analysis-of-phase-2-drug-candidate-brilacidin-for-severe-oral-mucositis-om-in-head-and-neck-cancer-patients-high-potential-for-preventative-treatment
Fast Track
11/25/2015 - FDA Grants Fast Track Designation to Cellceutix’s Brilacidin-OM for Oral Mucositis
"The FDA established the Fast Track Designation process to facilitate the development, and expedite the review of, drugs that have the potential to treat serious and life threatening conditions and fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to the FDA and could qualify for other programs to expedite development, including priority review and accelerated approval."
http://www.ipharminc.com/press-release/2016/11/16/fda-grants-fast-track-designation-to-cellceutixs-brilacidin-om-for-oral-mucositis
Study Design
CTIX-BRI-205 is a Phase 2 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Brilacidin as an oral rinse in preventing and controlling OM in patients receiving chemoradiation therapy for Head and Neck Cancer. The study is anticipated to enroll approximately 60 patients in the United States, 30 each to Brilacidin treatment or to placebo (water). Brilacidin (45 mg/15 ml oral rinse—“swish and spit”) is administered 3 times daily across 7 weeks (49 days). Pharmacokinetics of Brilacidin are to be evaluated if there is measurable systemic exposure (from drug concentrations in plasma).
The Brilacidin OM trial uses a World Health Organization (WHO) OM Grading Scale, a common measurement tool in assessing the presence and severity of OM, as defined below.
WHO Scale for OM
• Grade 0 = None
• Grade 1 = Erythema and Mouth Pain Soreness; no Ulceration/Pseudomembrane formation
• Grade 2 = Ulceration/Pseudomembrane formation; solid diet
• Grade 3 = Ulceration/Pseudomembrane formation; liquid diet
• Grade 4 = Ulceration/Pseudomembrane formation; not able to tolerate a solid or liquid diet (except enough liquid for medication)
About Oral Mucositis
Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation commonly manifesting in the treatment of Head and Neck Cancer. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak or eat (requiring the insertion of a feeding tube) and are more susceptible to bacterial infections, with severe cases leading to hospitalization and increased treatment costs of up to $25,000. Affecting over 500,000 people in the United States, there currently are no approved medications for the prevention of OM in this population, with only limited palliative care options available. Worldwide, the potential market for OM is expected to exceed $1 billion in the next few years.
For more information on the CTIX-BRI-205 Phase 2 study, please visit:
https://clinicaltrials.gov/ct2/show/NCT02324335
OM Market
"Head and Neck Cancer (HNC) patients -- comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source: GLOBOCAN) -- are at greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM during the course of their chemo/radiotherapy.
Estimates vary as to the market size (in dollars) of an effective OM treatment, for HNC-only patients, across major markets (U.S., Europe and Japan), ranging between $500 million and $1.5 billion on an annual basis (sources: GlobalData; Redington Inc., pdf). One company in the OM space projects the worldwide OM market opportunity to be as high as $2.6 billion annually."
http://www.ipharminc.com/new-blog/2017/10/17/the-market-opportunity-in-oral-mucositis
Potential Competitors
Taking a Page from Merck’s Gardasil and Glaxo’s Requip, These Small Companies Look to Cement Riches for Shareholders in New Category of Oral Mucositis
http://www.baystreet.ca/articles/stockstowatch/38594/Taking-a-Page-from-Mercks-Gardasil-and-Glaxos-Requip-These-Small-Companies-Look-to-Cement-Riches-for-Shareholders-in-New-Category-of-Oral-Mucositis
A Billion Dollar Market Just Waiting for a New Oral Mucositis Drug: Five Companies That Want It
http://www.baystreet.ca/stockstowatch/2658/A-Billion-Dollar-Market-Just-Waiting-for-a-New-Oral-Mucositis-Drug-Five-Companies-That-Want-It
Some of the players operating for the oral mucositis are
- Izun Pharmaceutical Ltd (US)
- Shoreline Pharmaceuticals Inc. (USA)
- Himalaya (India)
- AMAG Pharmaceuticals Inc. (USA)
- Kinnear Pharmaceuticals (US)
- Celleutix Corporation(USA)
- Soligenix Inc. (US)
- Oragenics (US)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135072984
Amgen Kepivance (IV)
"In addition to a lower incidence of severe oral mucositis, patients receiving palifermin had almost one week less severe mucositis compared to those receiving placebo (10.4 days vs 3.7 days). Furthermore, palifermin-treated patients reported 60 percent less soreness of the mouth and throat, required lower doses of painkillers and less total parenteral nutrition use (11 percent versus 40 percent with placebo)."
http://www.amgen.com/media/news-releases/2003/06/phase-3-data-suggest-palifermin-significantly-reduces-the-duration-and-incidence-of-oral-mucositis-in-cancer-patients/
"The cost for Kepivance intravenous powder for injection 6.25 mg is around $14,401 for a supply of 6 powder for injection, depending on the pharmacy you visit."
https://www.drugs.com/price-guide/kepivance
Soligenix SGX942 (IV)
"n the 1.5 mg/kg treatment group, the median duration of severe oral mucositis was decreased by 50%, from 18 days to 9 days (p=0.099), meeting the prospectively defined statistical threshold of p<0.1 in the study protocol. Further, patients receiving the most aggressive CRT in this dose group had even more striking reductions in their median duration of severe oral mucositis of 67%, from 30 days to 10 days (p=0.040)."
http://www.soligenix.com/news/soligenix-announces-positive-preliminary-results-from-its-phase-2-clinical-trial-of-sgx942-for-the-treatment-of-oral-mucositis-in-head-and-neck-cancer-patients/
Validive (applies to gum)
"The incidence of SOM (primary endpoint) was reduced by 26.3% (40% relative to placebo) in OPC patients treated with Validive (100 µg) (p=0.09)"
http://monopartherapeutics.com/phase_II
"Onxeo Grants Exclusive Worldwide License of Validive® developed for the treatment of oral severe mucositis to Monopar Therapeutics"
https://www.onxeo.com/onxeo-grants-exclusive-worldwide-license-validive-developed-treatment-oral-severe-mucositis-monopar-therapeutics/
Izun IZN-6N4 (oral rinse)
"Not only did patients treated with IZN-6N4 have less mouth and throat pain and soreness than controls, but importantly, they were also more able to maintain their weights throughout the course of radiotherapy. The data supports that the best efficacy of IZN-6N4 was related to its initiation of use at the start of chemoradiation."
http://www.businesswire.com/news/home/20171011005127/en/Izun-Pharmaceuticals-Announces-Positive-Results-Phase-2
Oragenics AG013 (oral rinse)
"Data from the Phase 1B trial published in the journal Cancer showed AG013 was safe, well tolerated, and demonstrated preliminary efficacy with a 35% reduction in the duration of ulcerative OM compared to placebo."
https://www.oragenics.com/news-media/press-releases/detail/37/oragenics-announces-positive-results-from-confirmatory
OM Presentation
January 2018 Corporate Overview
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5a4e50e39140b721186d1a6f/1515081962344/2018Jan+IPIX+Corporate+Overview.pdf
2017 Drug Discovery and Therapy World Congress
https://static1.squarespace.com/static/5715352e20c647639137f992/t/596cac7df14aa1a6e7118ed8/1500294274057/IPI+DDTWC+Brilacidin+presentation+%28final-u%29+13Jul2017.pdf
25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2015)
https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f83821b631be3d85bc071/1480557442978/ECCMID-2015-OM-poster.pdf
OM Blog
5/4/2018 - Brilacidin-OM in the News: Oral Mucositis Market Untapped—Framed as “Blue Sky” Opportunity
http://www.ipharminc.com/new-blog/2018/5/4/brilacidin-om-in-the-news-oral-mucositis-market-untappedframed-as-blue-sky-opportunity
12/11/2017 - Brilacidin-OM Called a “Top Contender” in Oral Mucositis Market
http://www.ipharminc.com/new-blog/2017/12/11/brilacidin-om-called-a-top-contender-in-oral-mucositis-market
10/17/2017 - The Market Opportunity in Oral Mucositis
http://www.ipharminc.com/new-blog/2017/10/17/the-market-opportunity-in-oral-mucositis
8/7/2017 - Brilacidin for the Prevention of Severe Oral Mucositis
http://www.ipharminc.com/new-blog/2017/8/7/brilacidin-for-oral-mucositis
5/19/2017 - On the Unmet Medical Need in Oral Mucositis: Brilacidin as a Potential First-in-Class Preventative Treatment
http://www.ipharminc.com/new-blog/2017/5/17/on-the-unmet-need-in-oral-mucositis-and-brilacidin-as-a-promising-one-of-a-kind-treatment
Stephen Sonis, MD
Scientific Advisor, Oral Mucositis
Dr. Sonis is one of the world’s foremost experts in the research and clinical treatment of cancer-related oral mucosal toxicities. He currently holds appointments at the Harvard School of Dental Medicine as Professor of Oral Medicine (part-time), and is a Senior Surgeon at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital. Dr. Sonis also is a Founder and Chief Scientific Officer of Biomodels, LLC, a preclinical contract research organization. Widely respected by his professional peers, he is the author of over 250 original publications, reviews and chapters, 11 books, and 5 patents, serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology. Dr. Sonis is a graduate of Tufts University and Harvard University and completed his post-doctoral education at Oxford University.
http://www.ipharminc.com/senior-management-1/
Cellceutix Corporation Welcomes Dr. Stephen T. Sonis to its Scientific Advisory Board
http://www.ipharminc.com/press-release-2/2016/9/19/cellceutix-corporation-welcomes-dr-stephan-t-sonis-to-its-sceintific-advisory-board
Stephen T. Sonis, DMD, DMSc, on Radiotherapy-Induced Oral Complications
https://vimeo.com/182309692
IPIX Clinical Trial Summaries
B-OM (Phase 2)
Kaplan-Meier Curves
"Onset of Severe Oral Mucositis: Based on Kaplan-Meier curves, Brilacidin-OM oral rinse showed a clear separation from placebo in delaying the onset of SOM—particularly the period from approximately 28-42 days, after the initiation of treatment, during which the incidence of SOM rose strikingly in the placebo group while not in the group being treated with Brilacidin."
http://www.ipharminc.com/press-release/2018/1/3/innovation-pharmaceuticals-brilacidin-meets-key-secondary-endpoint-in-phase-2-trial-delays-onset-of-severe-oral-mucositis-som
Topline Results
· Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.
· Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
· Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.
· Trial results support continued and expedited development of Brilacidin-OM.
http://www.ipharminc.com/press-release/2017/12/11/innovation-pharmaceuticals-reports-positive-topline-results-from-phase-2-placebo-controlled-trial-of-brilacidin-for-the-prevention-of-oral-mucositis-in-head-and-neck-cancer-patients
Subgroup Analysis
“For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249).”
http://www.ipharminc.com/press-release/2018/4/9/innovation-pharmaceuticals-phase-2-oral-mucositis-trial-additional-data-show-brilacidin-om-demonstrated-a-significant-reduction-in-the-incidence-of-severe-oral-mucositis
B-UP (Phase 2 POC)
Before and after endoscopic images (Cohort B, 100 mg)
Topline Results
Rate of Clinical Remission (% of patients achieving)
- 60% Cohort A (3 of 5 patients)
- 67% Cohort B (4 of 6 patients)
- 75% Cohort C (3 of 4 patients)
(i) #Endoscopy subscore ≤ 1 (% of patients achieving)
- 80% Cohort A (4 of 5 patients)
- 67% Cohort B (4 of 6 patients)
- 75% Cohort C (3 of 4 patients)
(ii) Rectal Bleeding subscore of 0 (% of patients achieving)
- 80% Cohort A (4 of 5 patients)
- 100% Cohort B (6 of 6 patients)
- 100% Cohort C (4 of 4 patients)
(iii) Stool Frequency subscore, improvement or no change from baseline (% of patients achieving)
- 100% Cohort A (5 of 5 patients)
- 100% Cohort B (6 of 6 patients)
- 100% Cohort C (4 of 4 patients)
http://www.ipharminc.com/press-release/2017/7/13/innovation-pharmaceuticals-phase-2-poc-trial-for-inflammatory-bowel-disease-achieves-induction-of-remission-in-a-majority-of-patients-treated-with-brilacidin
B-ABSSSI (Phase 2b)
Topline Results
"In treated patients assessed at 48-72 hours, 47/51 (92.2%), 46/48 (95.8%), 51/52 (98.1%), and 45/48 (93.8%) achieved clinical success in the Brilacidin 0.6 mg/kg single-dose group, Brilacidin 0.8 mg/kg single-dose group, Brilacidin 1.2 mg/kg 3-day group, and daptomycin 7-day group, respectively."
"On December 22nd 2014, Cellceutix also reported positive results in the Microbiological Intent-to-Treat (MITT) population. This is an important population that includes patients with baseline cultures positive for common ABSSSI pathogens, such as Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA). In this population, Clinical Success rates at 48-72 hours were again very high (above 90% across all treatment groups) and again very similar (with overlapping 95% confidence intervals)."
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-releases-confidence-interval-statistics-showing-clinical-success-rates-for-brilacidin-in-treatment-of-absssi
Prurisol (Phase 2a)
Topline Results (200 mg)
"Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 (“moderate”) as compared to those with a baseline score of 2 (“mild”). Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower."
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-phase-2-trial-of-prurisol-for-mild-to-moderate-psoriasis-meets-primary-endpoint
"Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites."
"Additional preliminary data analyses of secondary endpoints show patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point improvement (using the IGA scoring system) at a higher rate than that of patients in the placebo arm. This is another clear indication of the drug’s efficacy."
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-provides-additional-insight-into-successful-phase-2-trial-for-treating-psoriasis
K-OC (Phase 2a)
P53 Modulation
"Modulation of the p53 protein was observed in response to administration of Kevetrin. Pathways analyses also point to concomitant cell cycle modulation at the level of gene expression. Importantly, these data are the first to directly support, in ovarian cancer patient tumors, Kevetrin’s ability to affect p53 and associated molecular pathways—a central gene signaling network involved in regulating cell growth and the cell cycle, helping to prevent cancer."
"In more detail, preliminary analyses used Western Blots to assess relative levels of key proteins extracted from tumor biopsies before and after a series of nine Kevetrin infusions administered over three weeks. The level of phospho-p53, the activated form of the protein, in addition to the noted p53 modulation, was also seen to change in response to Kevetrin administration. These findings confirm in patient tumors Kevetrin-induced anti-cancer effects similar to those demonstrated (pdf) preclinically in ovarian cancer cell-lines. These new data reinforce prior clinical data, from the earlier concluded Phase 1 study of Kevetrin in advanced solid tumors (see NCT01664000), in which observations of p21 expression in peripheral blood monocytes supported p53 involvement in Kevetrin’s mechanism of action."
http://www.ipharminc.com/press-release/2017/12/27/innovation-pharmaceuticals-obtains-direct-evidence-of-molecular-pathways-modulation-in-tumors-from-first-patients-in-kevetrin-ph2a-ovarian-cancer-trial
New investors, the statement "27% of today's volume was short sales" wasn’t in the source file. The most recent short interest is < 1% of the OS and the most recent failure-to-deliver (naked short) # is a measly 8820 shares. IMHO interpreting short volume as actual short sales is incorrect. This is what FINRA, the exact same source which you used to post the #, said.
"Thank you for contacting FINRA’s Office of the Ombudsman. Regarding your question, it would be incorrect to assume that short sales comprise 32% of the total volume on that trading day for IPIX. FINRA publishes the daily short sale volume pursuant to an SEC mandate; however, there are various trading anomalies that result in the reported short sale volume often being exaggerated. Thus, the true total short sales volume may be significantly lower than the volume that is reported. Third parties sometimes ignore this and try to claim the ratio is valid to further their own objectives."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135537542
MMs mark shares short temporarily to execute trades and they are almost always covered in the same day, therefore the actual short % is much lower than the # suggests. If the short volume indicates actual naked shorting, would the criminals be stupid enough to leave incriminating evidence in the FINRA file?
You can also check out these two posts for some detailed explanations.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133263103
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=132584168
Here are the official short interest and failure-to-deliver data.
Settlement Date: 3/29/2018
Current Short: 1,105,305
Previous Short: 1,107,705
Change: -2,400 (-0.22%)
Average Daily Volume: 328,260
Days to Cover: 3.37
http://otce.finra.org/ESI
0.76% of the outstanding shares were short interest.
“In a “naked” short sale, the seller does not borrow or arrange to borrow the securities in time to make delivery to the buyer within the standard two-day settlement period. As a result, the seller fails to deliver securities to the buyer when delivery is due (known as a ”failure to deliver” or “fail”).”
https://www.sec.gov/investor/pubs/regsho.htm
According to the SEC, only 8820 shares (0.006% of the OS) were failure-to-deliver as of March 9.
20180309|45782D100|IPIX|8820|INNOVATION PHARMACEU|0.68
https://www.sec.gov/data/foiadocsfailsdatahtm