Thursday, September 14, 2017 7:38:21 AM
Kevetrin, Prurisol, Brilacidin
BioCentury’s “NewsMakers” Conference
September 8, 2017
https://static1.squarespace.com/static/5715352e20c647639137f992/t/59b2f34946c3c498ebfe112e/1504899917915/IPIX+Company+Presentation+BioCentury+NewsMakers+Conference++8Sep2017.pdf
Audio...
https://www.ipharminc.com/s/IPIX-Company-Presentation-AUDIO-BioCentury-NewsMakers-8Sep20171.mp3
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As we near the end of trials, specifically designed through CDA's with large pharmas I expect this to gain much more volatility and quite possibly a decent push up.
Flashing back a bit. So far, 'Innovation Pharmaceuticals Inc. hasn't "missed" on one trial. The following are still as relevant today as they were when they were written.
The highlighted "sticky posts" on this sites thread should also be reviewed.
One of the many excellent KarinCA posts...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=130326950
Did The Medicines Company Trump Cellceutix And Others In A $1B-Plus Skin Infection Market?
https://seekingalpha.com/article/2422945-did-the-medicines-company-trump-cellceutix-and-others-in-a-1b-plus-skin-infection-market
Cellceutix's Fundamental Strength Outweighs Market Cap
https://seekingalpha.com/article/3270535-cellceutixs-fundamental-strength-outweighs-market-cap
Interview With New Cellceutix President Dr A Bertolino
https://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino
New Oral Psoriasis Drug Tops Cellceutix Catalysts
https://seekingalpha.com/article/4029310-new-oral-psoriasis-drug-tops-cellceutix-catalysts
Cellceutix: A New Standard Of Care In Oral Mucositis In The Making
https://seekingalpha.com/article/4059084-cellceutix-new-standard-care-oral-mucositis-making
http://www.ipharminc.com/stages-of-development/
BooDog Friday, 08/25/17 07:50:28 AM
Re: None
Post # of 196673
Catalyst anticipation building. Technical side priming for a move on up. Stochastics setting up for the move. Thinking shares will begin to be harder to find at these levels very soon.
Innovation Pharmaceuticals to Discuss Recent Positive Clinical Results in IBD and Upcoming Milestones in Oral Mucositis and Psoriasis Trials at BioCentury’s “NewsMakers” Conference
The presentation for the 2017 BioCentury's "NewsMakers" Conference is scheduled for 2:30 pm (EDT) on Friday, September 8, 2017 in Room 302/303. A corresponding presentation slide deck will be made available here following the event.
https://www.biocentury.com/conferences/newsmakers-2017
Interim data for Prurisol anticipated this quarter.
This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis.
Topline results anticipated in 4Q2017 for Phase 2 Study of Brilacidin for the Prevention of Severe Oral Mucositis
A Phase 2 Study of Kevetrin (Thioureidobutyronitrile) in Subjects With Platinum-Resistant/Refractory Ovarian Cancer.
Estimated Study Completion Date: December 31, 2017
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Kevetrin
- 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-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, Recruiting)
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, Recruiting)
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, Recruiting)
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
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133036320
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Message in reply to:
Leo has done an outstanding job managing available resources while efficiently moving multiple clinical trials forward. For a small biotech, IPIX has an enviable pipeline that should handsomely reward investors. Some comments about the pipeline:
Brilacidin
Brilacidin- Oral mucositis
Accelerated enrollment and now full enrollment of the Phase 2 trial reflect (1) increasing number of clinical trial sites and (2) very positive interim results. Back-end loaded enrollment after interim results is very positive. People forget that the enrollment criteria for this trial was very stringent. We knew it would be slow going from the beginning. The tradeoff with the stringent enrollment criteria and slow enrollment is that the targeted patient population is extremely likely to suffer from severe oral mucositis. The interim results were fantastic and, imo, results were adversely skewed by a single nonresponder. I'm betting that topline results will be as good or better than interim results.
Also, B-OM is a distinct formulation of Brilacidin that could easily be carved out of the Brilacidin franchise for partnering without compromising the Brilacidin franchise.
Brilacidin- ulcerative proctitis
Very positive results from a POC trial surely has Big Pharma attention. Perhaps by itself one could be skeptical of results but Brilacidin-OM data and pre-clinical data strongly supports Brilacidin's anti-inflammatory properties. With minimal GI absorption, technology is available to formulate Brilacidin for Crohn's and ulcerative colitis. It's known territory for Big Pharma.
B-ABSSSI: Phase 2b data is very strong and I am happy with Leo's decision to hold off on a very expensive Phase 3 trial while the Brilacidin franchise is further developed. I am confident that Brilacidin will prove superior to Vancomycin.
Kevetrin: a short duration open label dose escalation trial focusing on biomarkers and safety potentially positions Kevetrin for partnering in the coming months. Is it safe? Does it appear to have a positive impact on biomarkers? Is there a clinical response with such a short duration of treatment and likely sub-optimal dosing?
Prurisol: The phase 2b trial is further exploring the dose/response relationship and is critical to knowing what we really have. The trial should be fully enrolled. We've discussed hoped for results at length in previous threads and results in the neighborhood of Otezla should give us a very lucrative deal.
Deals take time, negotiations are not publicized, and they don't usually occur in our imagined timeframes. One morning in the hopefully not too distant future we'll get some kind of deal. And then there will be another. And perhaps another.
I have full confidence in Leo and the IPIX team.
biodoc
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Hope some find this useful.
$IPIX
btw, prurisol interim data is next.
all imo.
"Perfection is not attainable, but if we chase perfection we can catch
excellence." Vince Lombardi
Do your research! Play the TA. All posts are my opinion.
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