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I believe we can hit $60 - $80 per share if the trial reads out. Brilacidin could help rid a PANDEMIC people.... forget $25 per share, think $60-$80 per share may be too low!!!
Attention: Cramer, Baker Brothers, Big Pharma, more sharp investors.... Wake the heck up and read the science and recent data!!!
Attention Baker Brothers, Pfizer at el... time jump on board the IPIX Express!!!
You cannot deny the science any longer, read the data!!!!
Brilacidin may well be a household name very soon! Huge upside for us longs!
IPIX's AMAZING PR - I'm in the industry and have been part of Biotech Start Up's (Pharmacyclics) SOLD at $261.25 per share and present late breaking clinical data for a living. - KEY TAKEAWAYS:
#1 Unbiased Clinical Data - From Ongoing Independent Testing at U.S. Regional Biocontainment Laboratories.
#2 Amazing EFFICACY and a P VALUE of (p<0.0001) - Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and by 97 percent, compared to control, at two therapeutic concentrations tested. Based on a CC50 value—the concentration of drug at which 50 percent of cells maintain viability.
#3 SAFE - Brilacidin was also shown to be non-cytotoxic in the lung cell line.
#4 Virucidal - Kills, not just prevents replication after the fact like the others.
#5 Already studied in human trials in OM, ABSSI and UP and UC .... safety has been tested, Phase III ready.
Good luck and don't give your shares away on the cheap, stay long!!!!
Data adds to growing body of research in both human and animal cell lines supporting Brilacidin’s robust antiviral properties against SARS-CoV-2
Brilacidin is a unique 3-in-1 antiviral, anti-inflammatory, antimicrobial COVID-19 drug candidate
WAKEFIELD, MA – June 17, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, reports today receiving data from ongoing laboratory testing being conducted at a U.S. Regional Biocontainment Laboratory (RBL).
Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and by 97 percent, compared to control, at two therapeutic concentrations tested. Based on a CC50 value—the concentration of drug at which 50 percent of cells maintain viability—Brilacidin was also shown to be non-cytotoxic in the lung cell line.
The new lung cell line data reinforce previous testing conducted at the RBL, in VERO cells, where Brilacidin showed a similar robust inhibition, of 75 percent, against SARS-CoV-2 compared to control. Brilacidin has also been shown, in testing at the RBL, to be non-cytotoxic in VERO cells.
Additional details on the Brilacidin anti-SARS-CoV-2 testing being conducted at the RBL are planned to be submitted for publication upon completion.
“Brilacidin has now demonstrated potent inhibition of SARS-CoV-2 in human lung and kidney cell lines, and in VERO cells, in laboratory testing conducted by independent academic researchers at two institutions, both of whom plan to submit their findings for peer-review publication,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “The antiviral data we are compiling provides compelling proof of Brilacidin’s impressive ability to inhibit the novel coronavirus, toward initiating a clinical study of Brilacidin for COVID-19.”
Testing results observed to date formed the basis for a federal grant application that was submitted last week by the RBL, in collaboration with the Company, proposing to evaluate Brilacidin’s potential as a pan-coronavirus therapeutic, with possible extension into other viruses. The Company is in the process of manufacturing Brilacidin for intravenous (IV) dosing and will be seeking FDA guidance for a planned COVID-19 clinical study.
For researchers and institutions interested in collaborating on Brilacidin for COVID-19, please send inquiries to: covid19@ipharminc.com
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin’s potential to inhibit IL-6, IL-1ß, TNF-a and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. These data collectively support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—anti-COVID-19 therapeutic candidate.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
June 11 (Reuters) - Innovation Pharmaceuticals Inc :
* INNOVATION PHARMACEUTICALS COLLABORATING WITH REGIONAL BIOCONTAINMENT LAB ON GRANT APPLICATION TO RESEARCH BRILACIDIN AS A PAN-CORONAVIRUS THERAPEUTIC Source text for Eikon: Further company coverage:
Our Standards:The Thomson Reuters Trust Principles.
Congrats Leo, Net/Net it's a Potential RARE HOME RUN against this Pandemic!
PR worded a little differently but the same meaning:
The proposed research of Birlicidan will be conducted by a US Regional Biocontainment Lab With free Federal Grants!!! They will evaluate Brilacidin as a potential pan-coronavirus therapeutic, for treating SARS-CoV-2, SARS-CoV-1 and MERS-CoV, including extending the current in vitro testing of Brilacidin to in vivo testing.
Longer-term objectives include potentially performing additional research to develop Brilacidin as a broad-spectrum antiviral, with possible application beyond coronaviruses, e.g., treating other viruses, such as encephalitic alphaviruses and filoviruses.
Net/Net it's a Potential RARE HOME RUN and a realistic Boon for Researchers, Innovation Pharmaceuticals and investors$$$!!! Expect game changing PR's soon! Maybe a Buyout???
The RBL is submitting for the grants. These research grants for In VIVO testing must be earned by supportive and positive research results before you submit for them... not surprised you didn't know this either.
FOX Business, Innovation's Brilacidin was acknowledged today, getting mentioned, getting attention on a short list of possibilities. The citied Source: WHO, FDA news reports.
Brilacidin is earning more attention because it's progressing thru RBL trials virtually free of charge, who would've imagined this a few months ago. In life, timing is everything. While we all hate what this virus has done to wreak havoc to mankind around the world, it is a cause of celebration to see it eliminated ASAP. Brilacidin could be a very effective single agent against COVID-19 when the dust settles or a very important combo agent.
If Brilacidin continues to show strong efficacy & safety in the more advanced trials at the RBL's, it will ultimately overcome all the doubters and dumpers and get the attention for partnership or a buyout. Shrewd big pharma/biotech who see and jump on the opportunity after successful RBL clinical trials against COVID-19 to include B-OM, B-IBD and also get Kevetrin would be very attractive... the stock will soar and could be the stock investment of the year!!!
Gilead's Remdesivir recent data (yesterday) is good progress as a single agent, not a home run, the death rate is not a great improvement vs. placebo... Maybe a Remdesivir and Brilacidin combo possibility in the future?
The author of the top COVID-19 potentials listed according to stage of clinical development. Brilacidan is in the TOP 10 of all known candidates world wide. The author, Michael Cembalest is the Chairman of Market and Investment Strategy for J.P. Morgan Asset Management. He is responsible for leading the strategic market and investment insights across the firm's Institutional, Funds, and Private Banking businesses.
Brilacidin has already completed Phase II in human trials and is currently moving along in the Regional Biocontainment Lab Testing. The chart was updated as of April 23rd.
Why the price hasn't taken off, many factors?? Will it take off if it keeps preforming in testing?? I don't see why it wouldn't, still a long shot if you look at the stock price but being listed among the top 10 potential candidates, HUGE and on the radar!!! The demand and federal funding is still sky high for a cure or fix.
There is a will ...there WILL be a Way!!! Everyone is behind (the Will) to RID COVID-19!
FACT: A RBL led investigation, Brilacidin is "Extremely Encouraging" human trial negotiations to follow!
Healthcare Professionals, Researchers, Big Pharma and Biotech investments, Investors and Manufacturing will scramble to get it done if Brilacidin has efficacy and safety data against COVID-19. There's no time to wait, the green light for Human Trials is a major hurdle cleared... Innovation Pharmaceuticals Brilacidin could end up as the Best therapeutic of them all, the science is amazing!
Just bought more this morning... putting more money on the line, getting less risky after the last few PR's than ever before. Staying LONG and supporting a COVID-19 cure at the same time.
Step it up LEO and Locust Walk, get the word out! We need Pharma/Biotech investors and more public PR's to disseminate the full potential of Brilacidin and amazing science of this Novel treatment.
Based on your Wild hunch, wishful thinking or the only thing that matters...facts??? What do you know?
Go IPIX
" ...received data supporting Brilacidin’s direct inhibition of SARS-CoV-2"
http://www.ipharminc.com/press-release/2020/4/1/innovation-pharmaceuticals-receives-data-supporting-brilacidins-direct-inhibition-of-sars-cov-2-the-novel-coronavirus-responsible-for-covid-19
general information:
Direct-acting antivirals (DAAs) are a newer class of drugs. DAAs target specific steps in the virus life cycle. DAAs have shorter treatment times, fewer side effects, and higher SVR (sustained virologic response) rates than older drugs.
for more info:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3323075/
Info published 2004 provides insight into the current testing utilizing a drug-screening assay that scores for virus-induced cytopathic effects on cultured cells. This is provided for information and context for current testing.
Inhibition of SARS Coronavirus Infection In Vitro with Clinically Approved Antiviral Drugs, April 2004
"The aim of this study was to investigate whether a panel of currently available antiviral agents exhibit in vitro anti–SARS-CoV activity. Three general antiviral strategies are generally found (13): (1) direct antiviral effects (2), inhibition of viral entry and replication at the cellular level by targeting virus-related processes, and (3) enhancement of host immune response. A total of 19 drugs approved for clinical use in the treatment of viral infections were tested in this study. They are representative compounds from major antiviral pharmacologic classes that are currently commercially available: nucleoside analogs, interferons, protease inhibitors, reverse transcriptase inhibitors and neuraminidase inhibitors.
A cell-based assay utilizing cytopathic endpoints (CPE) was set up using Vero E6 cells to screen these antiviral compounds. SARS-CoV has been shown to infect Vero E6 cells, an African green monkey kidney cell line (3), and this remains the only in vitro model of SARS-CoV infection. The initial screen was followed by a plaque reduction assay to determine the 50% effective concentration (EC50) of compounds showing positive results. These experiments allow rapid screening of commercially available antiviral agents, enabling those with in vitro evidence of activity to move expeditiously into clinical studies, since safety and pharmacokinetic information in humans is already available for other disease indications.
Here we report that certain interferon subtypes exhibit in vitro inhibitory activity against SARS-CoV and are candidates for follow-up studies in animal models and patients to determine their efficacy in vivo."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3323075/
Fake news - Deceptive post. I was here prior to 2017. There was no Reverse Stock Split. The company did change its name from Cellceutix to Innovation Pharma to reflect it's expanding platform.
We need for Rapid testing and production from a Biotech or Pharmaceutical company. Outright BUY IPIX, to take Brilacidin and Kevetrin to the next level.
Brilacidin... "INNOVATION PHARMACEUTICALS RECEIVES DATA SUPPORTING BRILACIDIN’S DIRECT INHIBITION OF SARS-COV-2, THE NOVEL CORONAVIRUS RESPONSIBLE FOR COVID-19" Easily >20 million shares traded today... how much attention is needed.
Brilacidin is ready on a Gold Platter!!! .... Pfizer, AbbVie, Roche, Merck, BMS, Gilead, .... step up!!! Who wants to be the Hero, save potentially 100's of thousands of lives or more. Low Risk and HIGH Reward!
Must Read - CTAP - Coronavirus Treatment Acceleration Program -
FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness.
There are a variety of therapeutic areas being evaluated, including antiviral drugs like remdesivir that might treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients. There's also interest in examining whether therapies such as convalescent plasma and hyperimmune globulin, antibody-rich blood products that are taken from blood donated by people who have recovered from the virus, could shorten the length or lessen the severity of the illness. Work is also ongoing to evaluate whether existing therapies such as chloroquine and hydroxychloroquine (with or without other medications) help treat patients with COVID-19.
"It is management’s understanding that few compounds advance to this next stage of SARS-CoV-2 research. "
ATTN: Leo - opportunity for manufacturing assistance from Pfizer
https://www.bostonherald.com/2020/03/14/pfizer-opens-doors-to-biopharma-industry-to-combat-coronavirus/
The poster (Blue Fin) posted on Trump's FB said the poster made a small investment... get it right.
Thank you Blue Fin for getting Innovation's story out there, could be the answer to this current situation!
Just the facts: Can be approved to use before Phase 3 for "right to try" and compassionate use. Ahead of many other agents being tested at the Regional Labs. Pharmacyclics (PCYC) was floundering and left for dead by most without any FDA approved therapies .... then BOOM $261 per share.
Anything is possible when you're in the game!
More FACTS: Innovation Pharmaceuticals has shipped to a U.S. REGIONAL BIOCONTAINMENT LAB TO BEGIN TESTING OF BRILACIDIN AGAINST CORONAVIRUS (COVID-19) NEXT WEEK 3/16. It's already been safely tested in humans in a Phase 2 trial and it can be relatively inexpensively mass produced. BUYOUT potential ???
An email — covid19@ipharminc.com — has been set up by the Innovation Pharmaceuticals to receive inbound inquiries regarding Brilacidin as a potential novel treatment for COVID-19.
If you haven't checked out the Innovation website in awhile, I strongly recommend you do - it's very professional with lots of updates etc...
Sometimes it's possible to catch lightening in a bottle. The COVID-19 outbreak has become an overnight world wide health crisis that needs a quick and effective treatment. The stars might have aligned for IPIX. Brilacidin might be right novel medication at the right time, if it is expect IPIX stock to skyrocket! Why, Brilacidin is novel defensin-Mimetic with already very positive ABSSSI Phase 2 data. There could be many pharmaceutical suitors overnight for the chance to have this potential HUGE BLOCK BUSTER in their portfolio!!!
Brilacidin could be great for mankind and the stock opportunity of a lifetime!
Yes, very positive. "Physicians have been waiting for a new therapy like this for their patients." Check out the Lupus Foundation website: BREAKING NEWS: Monumental Treatment Breakthrough for Lupus Kidney Disease
Phase III trial of voclosporin has met all primary and secondary endpoints with a clean safety profile.
Yes, very positive. "Physicians have been waiting for a new therapy like this for their patients." Check out the Lupus Foundation website: BREAKING NEWS: Monumental Treatment Breakthrough for Lupus Kidney Disease
Phase III trial of voclosporin has met all primary and secondary endpoints with a clean safety profile.
Why sell near $15.00 - 20.00 when in short order (BuyOut) get $40.00 to 60.00 to 160.00 a share???
Links to 8-K & Company Presentations
8-K:
http://app.quotemedia.com/data/downloadFiling?webmasterId=91030&type=HTML&ref=12681999
Corporate Overview - Feb 2019:
https://www.sec.gov/Archives/edgar/data/1100397/000149315219001515/ex99-1.htm
Immuno-Onc 360 Presentation - Feb2019
https://www.sec.gov/Archives/edgar/data/1100397/000149315219001515/ex99-2.htm
Mastiff - you can find the presentation on the company website under the Investors tab - Events & Presentations
https://ir.advaxis.com/sites/advaxis.investorhq.businesswire.com/files/doc_library/file/ADXS_IO360_Conf_6_Feb_2019.pdf
The Fascinating Rise of Innovation Pharmaceuticals Inc (OTCMKTS: IPIX)
https://www.microcapdaily.com/the-fascinating-rise-of-innovation-pharmaceuticals-inc-otcmkts-ipix/122311/
Go Longs!
Better than the Aspire Deal.... BUT, LEO as a long term stock holder, CLOSE a Strong Partnership Agreement Now on B-OM & IBD or Sell the whole pipeline for even more!!!.
When can we expect to see the Purisol Phase 2b results $$$ ?
Leo please share, when did you submit the BTD on B-OM to the FDA???
Celgene Opts Out of Licensing Option For OncoMed's Navicixizumab
BY MT Newswires
— 9:08 AM ET 09/20/2018
09:08 AM EDT, 09/20/2018 (MT Newswires) -- OncoMed Pharmaceuticals ( OMED)said Thursday that Celgene ( CELG ) has decided not to exercise its option to license the bispecific antibody navicixizumab and said both companies were working to formalize the termination of the collaboration agreement.
OncoMed said it expects to retain worldwide rights to navicixizumab and is currently conducting a phase 1b clinical trial in combination with paclitaxel in patients with platinum-resistant late-stage ovarian cancer.
Celgene ( CELG ) continues to retain its options to license OncoMed's etigilimab and rosmantuzumab under the collaboration.
Price: 2.80, Change: -0.11, Percent Change: -3.78
MT Newswires does not provide investment advice. Unauthorized reproduction is strictly prohibited.
Intersting timing IMO
Hang in there longs! We know the science - big markets, Fast Track Designation for OM, novel therapy, great hope for patients! Negotiations are pending. Deal will be coming. Added more shares today.
Thanks, there is something to be said for taking an oral med vs using an auto injection route of admin.
TALTZ
SERIOUS SIDE EFFECTS
Taltz may cause serious side effects, including
Serious allergic reactions. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
feeling faint
swelling of your face, eyelids, lips, mouth, tongue, or throat
trouble breathing or throat tightness
chest tightness
skin rash
Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) can happen during treatment with Taltz, including worsening symptoms. Tell your HCP if you have new or worsening symptoms of inflammatory bowel disease during treatment with Taltz, including stomach pain, diarrhea (with or without blood in stool), or weight loss
FirstWord News Release today - Industry News Top Stories
Gilead, Galapagos' experimental drug filgotinib hits main goal of Phase III study in rheumatoid arthritis
Bristol-Myers Squibb reports promising mid-stage data for TYK2 inhibitor in plaque psoriasis
Foamix moves closer to US filing for acne treatment FMX101 after late-stage study success
Takeda to move US headquarters in Deerfield to Massachusetts
Merck KGaA, Pfizer say combination of Bavencio, Inlyta improves PFS versus Sutent in kidney cancer study
Merck & Co. set to seek EU, US approval of Zerbaxa for pneumonia after late-stage study hits goals
In The Know: Analyst answers — Are changes coming to the way we treat MS?
ViewPoints: Bristol-Myers Squibb's oral play in psoriasis slowly coming into focus
In June, Bristol-Myers Squibb began enrolling the first of two pivotal-stage studies for its TYK2 inhibitor BMS 986165 in psoriasis and this week the company will present the Phase II data that supported this decision at the European Academy of Dermatology and Venereology (EADV) meeting.
Key opinion leaders (KOLs) have identified TYK2 inhibitors as a potentially valuable new class of therapy, which administered orally could compete with Celgene's Otezla for the treatment of plaque psoriasis. The stakes are raised further with Bristol-Myers Squibb choosing to select Otezla as an active control arm in one of its recently initiated Phase III studies.
IPIX is going to payoff longs very soon $$, I'm very confident, I've been in the industry over 20 years and been part of many successful buyouts (biggest thus far PCYC/ AbbVie... I've done my homework and there is a buyout imminent, BP knows B-OM and Brilacidin itself (ABSSI) is a Franchise Blockbuster with all the unmet needs it can satisfy across numerous large market disease states.
Plaque Psoriasis treatment (Prurisol) is another MULTI Billion dollar a year market, with ALL THE advantages of PURISOL being a Non Biologic and Oral, newly diagnosed patients every year and large numbers of second line patients that fail the other treatments over time (resistance and Adverse Events ... e.g. (Ortezla - not to mention Ortezla's major AE - DEPRESSION). I expect the Prurisol data will be amazingly safe and highly efficacious based on preliminary public data already out there.
Look at the BMS press release today - September 12, 2018, there is High interest in the Plaque Psoriasis Market,
"Bristol-Myers plaque psoriasis drug shows promise in mid-stage trial.
(Reuters) - Bristol-Myers Squibb said on Wednesday its experimental drug helped reduce the severity of the most common form of psoriasis in a mid-stage trial.
The study tested the drug, BMS-986165, in 267 patients with plaque psoriasis, a chronic condition that causes dry, red skin lesions covered with silvery scales.
After 12 weeks, between 67 percent and 75 percent of patients given a 3-milligram dose twice daily, or a higher dose, showed reduction on a scale called PASI-75 that is considered the benchmark of main goals for most psoriasis clinical trials.
The PASI-75 scale showed reduction versus 7 percent in the placebo group. It measures the effectiveness of a drug by recording how many patients achieve a reduction in the area affected and severity of their psoriasis.
The drug is a tyrosine kinase 2 inhibitor, a class of medicines that work to regulate overactive immune responses that drive autoimmune diseases.
Three cases of serious side effects were reported, but none of those were in patients given the 6-mg and the 12-mg doses, the highest being tested, the company said.
Bristol-Myers said it plans to study the drug's use in a "wide spectrum of immune-mediated diseases", saying currently only few oral treatment options are available.
The company is currently enrolling patients for a late-stage trial and also testing BMS-986165 for use in patients with lupus or Crohn's disease.
An approval by the U.S. Food and Drug Administration for the plaque psoriasis treatment will offer Bristol-Myers, which relies heavily on its blockbuster cancer drug Opdivo, a chance to diversify its portfolio.
The FDA earlier this year declined to approve Bausch Health Cos Inc's plaque psoriasis lotion Duobrii and analysts now expect that drug to hit market only after 2019."
"In dermatology, the current focus is on managing Psoriasis with Prurisol. For cancer, the emphasis is on Ovarian Carcinomas, a gateway indication toward Kevetrin treating many other types of hematological malignancies and tumors. In the area of infectious disease, Acute Bacterial Skin and Skin Structure Infection (ABSSSI) is the target indication. As to gastrointestinal conditions, a study is underway evaluating Brilacidin's anti-microbial and anti-inflammatory properties in treating Inflammatory Bowel Disease. Brilacidin is also being tested in Oral Mucositis."
Bristol-Myers plaque psoriasis drug shows promise in mid-stage trial.
(Reuters) - Bristol-Myers Squibb said on Wednesday its experimental drug helped reduce the severity of the most common form of psoriasis in a mid-stage trial.
The study tested the drug, BMS-986165, in 267 patients with plaque psoriasis, a chronic condition that causes dry, red skin lesions covered with silvery scales.
After 12 weeks, between 67 percent and 75 percent of patients given a 3-milligram dose twice daily, or a higher dose, showed reduction on a scale called PASI-75 that is considered the benchmark of main goals for most psoriasis clinical trials.
The PASI-75 scale showed reduction versus 7 percent in the placebo group. It measures the effectiveness of a drug by recording how many patients achieve a reduction in the area affected and severity of their psoriasis.
The drug is a tyrosine kinase 2 inhibitor, a class of medicines that work to regulate overactive immune responses that drive autoimmune diseases.
Three cases of serious side effects were reported, but none of those were in patients given the 6-mg and the 12-mg doses, the highest being tested, the company said.
Bristol-Myers said it plans to study the drug's use in a "wide spectrum of immune-mediated diseases", saying currently only few oral treatment options are available.
The company is currently enrolling patients for a late-stage trial and also testing BMS-986165 for use in patients with lupus or Crohn's disease.
An approval by the U.S. Food and Drug Administration for the plaque psoriasis treatment will offer Bristol-Myers, which relies heavily on its blockbuster cancer drug Opdivo, a chance to diversify its portfolio.
The FDA earlier this year declined to approve Bausch Health Cos Inc's plaque psoriasis lotion Duobrii and analysts now expect that drug to hit market only after 2019.
(Reporting by Tamara Mathias in Bengaluru; Editing by Sriraj Kalluvila)
Big Pharma's high interest in Oral Plaque Psoriasis Treatments! Let's Make a Deal IPIX!!!
Bristol-Myers plaque psoriasis drug shows promise in mid-stage trial.
(Reuters) - Bristol-Myers Squibb said on Wednesday (September 12, 2018) its experimental drug helped reduce the severity of the most common form of psoriasis in a mid-stage trial.
The study tested the drug, BMS-986165, in 267 patients with plaque psoriasis, a chronic condition that causes dry, red skin lesions covered with silvery scales.
After 12 weeks, between 67 percent and 75 percent of patients given a 3-milligram dose twice daily, or a higher dose, showed reduction on a scale called PASI-75 that is considered the benchmark of main goals for most psoriasis clinical trials.
The PASI-75 scale showed reduction versus 7 percent in the placebo group. It measures the effectiveness of a drug by recording how many patients achieve a reduction in the area affected and severity of their psoriasis.
The drug is a tyrosine kinase 2 inhibitor, a class of medicines that work to regulate overactive immune responses that drive autoimmune diseases.
Three cases of serious side effects were reported, but none of those were in patients given the 6-mg and the 12-mg doses, the highest being tested, the company said.
Bristol-Myers said it plans to study the drug's use in a "wide spectrum of immune-mediated diseases", saying currently only few oral treatment options are available.
The company is currently enrolling patients for a late-stage trial and also testing BMS-986165 for use in patients with lupus or Crohn's disease.
An approval by the U.S. Food and Drug Administration for the plaque psoriasis treatment will offer Bristol-Myers, which relies heavily on its blockbuster cancer drug Opdivo, a chance to diversify its portfolio.
The FDA earlier this year declined to approve Bausch Health Cos Inc's plaque psoriasis lotion Duobrii and analysts now expect that drug to hit market only after 2019.
(Reporting by Tamara Mathias in Bengaluru; Editing by Sriraj Kalluvila)
Wrong!!! Stupid prediction! I'm laughing all the way to the bank (LONG and STRONG).
LilKahuna you 100% correct. Us longs will get the last laugh. Tolls have to be the most miserable souls on the planet. We should pray for them!!!
Move on already... We get it, you sold... Congratulations!!!! Don't you have anything more important to do now with your life than to be constantly negative??? Very Pathetic use of your time!
I just hope you don't disappear when the stock soars!!!
Not sound logic!!! You have no proof they didn't submit either. Let's just say I have more faith in Leo, Arthur and Krishna who have delivered and are poised for amazing news in the next few months than your rhetoric!!!
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