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I am also one of the people who bought at a gamut of prices although my lowest is $.11 which will come in handy when Brilacidin is the main drugs' used to fight covid. We should know that soon...
Great post cybermich!
Go Leo & IPIX!
well if you bought in (when you were telling people to sell) you would possibly be riding free shares by now..
at only an 80 million dollar market cap.. the science imo is more than compelling:)
Everyone will need to do their own DD..
but again imo.. there will be speculation leading up to the trial results.. and considering the safety profile of B and the data we have so far from the RBLs people will need to decide where to add shares.
What about the folks that don't have any position?
I'm personally glad that I bought shares at this level and below.
Heck, some folks (myself included) bought at much higher levels and there was a lot less going on then!
Last thought, who is to say that IPIX is not worth multiples of where it is at now?
There could easily be an argument for pricing IPIX in the hundreds of millions (market cap) now.
Your comment of "crazy to buy now" kind of points to an all or nothing approach..
not sure I agree with that:)
Great post TheDane! It appears nefarious in nature...
Go Leo & IPIX!
I don’t see how it’s not already a dollar. What am I missing...
BrilAcidin:
-multiple human trials already successful for other diseases
-RBL tested and recommended for human trials for Covid -19
-Human Trials for Covid-19 approved by FDA
-Fast Track granted by FDA
-Selectivity Index of 429
-Human trials imminent lasting about a month
For this the company is only valued at less than $80 million? It should be $half a billion right now.*
*Others dispute this
A pr at 4pm explaining the details of the trial and sites would be great.
Go Leo & IPIX!
With only two weeks left in “this month” I would hope Leo already knows whether the trial will start. Things can happen, of course.
23 die in Norway after receiving Pfizer COVID-19 vaccine
https://nypost.com/2021/01/15/23-die-in-norway-after-receiving-pfizer-covid-19-vaccine/
This will not look good for Pfizer.
Go Leo & IPIX!
“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Fast Track designation is well-timed as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”
Take this over the finish line Leo!
Very nice work!
Go Leo & IPIX!
He happens to know and respect a guy named Dr. DeGrado
https://profiles.ucsf.edu/william.degrado
https://profiles.ucsf.edu/davida.kessler
This appointment by the Biden administration feels like a last warning shot across the bow of shorts, naked or otherwise.
Quote:
Can you explain why? Thank you.
de rien
Thanks LilKahuna! There is a lot of potential for the company who will be manufacturing Brilacidin for covid.
Go Leo & IPIX!
“ The sponsor of a product that receives an expedited drug development designation may need to pursue a more rapid manufacturing development program to accommodate the accelerated pace of the clinical program. The sponsor’s product quality and CMC teams should initiate early communication with FDA to ensure that the manufacturing development programs and timing of submissions meet the Agency’s expectations for licensure or marketing approval.40
When sponsors receive an expedited drug development designation, they should be prepared to propose a commercial manufacturing program that will ensure availability of quality product at the time of approval. The proposal should consider estimated market demand and the commercial manufacturing development plan. The proposal should also consider manufacturing facilities and a lifecycle approach to process validation. Additionally, the proposal should include a timeline for development of the manufacturing capabilities with goals aligned with the clinical development program. After the initial discussion following designation, frequent communication during development will generally facilitate meeting manufacturing development goals and product quality goals.”
—Expedited Review, A. Manufacturing and Product Quality Considerations, p. 25
https://www.fda.gov/media/86377/download
Anyone know who can trade premarket on IPIX?
Go Leo & IPIX!
Shorting is a dangerous way to trade.
Did they really? I predict longs/IPIX/Leo for the win!
Go Leo & IPIX!
They win again. Though we’re over .21+
I think so too fareell90. Exciting to get our next update with more information about the human trials for COVID.
Go Leo & Ipix!
It is my understanding that a part of the IND process is reviewing, tweeking, and approving the proposed protocol.
The protocol for Brilacidin should be set in place now. I would be surprised if the FDA would make changes since they just approved the protocol a few weeks ago.
I do not believe we will have any more delays and the next PR should be to announce the human clinical trial sites.
GLTA Farrell
100% agree farrell90!
Go Leo & IPIX!
My bet is the days next week are going to be bigger days in volume and price.
GLTA, Farrell
Check this out!
January 14, 2021
Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track Designation Brilacidin Phase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month
WAKEFIELD, MA – January 14, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.
Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval.
“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Fast Track designation is well-timed as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”
To date, Brilacidin has received Fast Track designation for three different clinical indications: COVID-19, Oral Mucositis, and Acute Bacterial Skin and Skin Structure Infection (qualifying for Fast Track under Qualified Infectious Disease Product designation).
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 established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of 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. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.
· Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company’s website ( http://www.ipharminc.com ), and at the following link:
https://ipixcovid19tracker.com/
Longs - IPIX is getting a lot of positive attention today via social media. I hope Brilacidin keeps making continued progress.
Leo - Make Brilacidin Great and free this world of COVIDs noose!
I would prefer it to exceed $.2382067 but I will take $.238206. :)
There’s no reason the stock can’t get up over .238206 the next couple weeks.
Fast track didn't help Absssi much... It's a nice carrot but everything still has to play out....
IF FAST TRACK designation is not an endorsement of Brilacidin as a potentially highly effective Covid-19 Candidate...why doesn't FDA give FAST TRACT status to ALL potential therapeutics?
...name all the Covid-19 Therapeutic competition ...which has received FAST TRACT designation!
...big things coming IPIX way... EYES WAKING UP TO BRILACIDIN,
Go Leo & Brilacidin!
Justfactmam, today is another great day for IPIX share holders & humanity and I don't think that is an overstatement. Hopefully Leo sends us a Friday 4:00 pm press release to start the weekend.
What is Brilacidin worth if it brings the world back to equilibrium? Stay tuned to find out.
Is this a two press release week?
Go Leo & Brilacidin!
LilyGDog...you highlight the huge edge IPIX will have over (Non-fast-tract) therapy candidates...
...detractors of Leo won't admit it ... but Fast Tract Designation clearly indicates that the FDA believes Brilacidin (and possibly at the urging of a BP) success if very likely... an extremely positive development in Brilacidin..."coming out party"..
IMO even better news coming ... shortly! Look for "overseas" jurisdiction to give equivalent of "Fast Track" also!
Question about OWS..."Is fast track faster than OWS?"... OWS overlays Fast Track ... two run side by side.
Don't worry about the pennies...look at the dollars...and imo BP lurking and watching attentively...News will slowing spread for MOMO buildup...
ps. Sunspotter ...says..
Quote:
"Fast Tract Designation clearly indicates that the FDA believes Brilacidin ..... success if very likely."
No it doesn't. "
YES IT DOES...they ONLY GRANT FAST TRACT TO PROMISING DRUGS...not Dogsh*t which you have been indicating Brilacidin is.
Safety has been addressed...or didn't you notice we are in Phase 11! (not safety trials in Phase 1)
Mine are all locked at more then $25. But I get what you are saying. Is this worth the short term wait? I think it is! :)
Go Leo & Brilacidin!
Yes, lock up your shares to help the uptrend.
Set all of your shares to sell at 25.00 per share. This will keep the short sellers from using your shares to pressure a down cycle for their flips.
Couldn't agree more! Tick Tock shorties! The odds of Brilacidin success just went up one more notch today... Yeehaw!
Go Leo & Brilacidin!
We know that Brilacidin is special, a novel therapeutic with no other competitors in the same class. Hat's off to you Dr. DeGrado, Leo and all the LONGS who helped support the company to get us to this monumental achievement! COVID-19 is a serious health threat around the world!
Brilacidin's FDA's FAST TRACK approval gives humanity more hope that we can stop the spread and stop the misery... it could be the tipping point for a high dollar BP or BioTech acquisition to take it world wide within months...
I would guess he applied for the FTD when he received the RBL preliminary results.
Go Leo & Brilacidin!
But fast track after approval wouldn’t even make sense. We don’t know when Leo applied for Fast Track but since the go ahead on the trial only came a month ago my bet is he applied for Fast Track two months ago, about the same time as the IND application or perhaps a little after. It looks like a plan unfolding (reliant on bureaucracy).
Agreed cybermich! this is big for IPIX and Brilacidin no matter what anyone on social media says.
Brilacidin has been validated!
Go Leo & IPIX!
Finally:).. some acknowledgement.. as it should be. Now let's get it done. Congrats to all longs.
For those wanting more information about Fast Track Designation.
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track Designation
Phase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month
WAKEFIELD, MA – January 14, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.
Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval.
“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”
To date, Brilacidin has received Fast Track designation for three different clinical indications: COVID-19, Oral Mucositis, and Acute Bacterial Skin and Skin Structure Infection (qualifying for Fast Track under Qualified Infectious Disease Product designation).
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 established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of 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. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.
Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Great post!
Go Leo & IPIX!
I remember a small biotech company that I was invested in about 15 years ago that partnered their phase 3 with another biotech while conducting their phase 3. Let me tell you what I experienced before the partnership news occurred.
The company announced plans for their phase 3 trial according to the FDA and gave estimated timeframes for trial details.
This company actually started the trial before partnership and provided minimal interim updates.
After interim results we didn't hear anything for almost 3 months after the scheduled completion of the actual Phase 3 results. Most investors started to wonder what was going on and many stated there must be an issue.
Volume lagged and news was completely absent during the 3 months leading to the received news.
I took money off the table because I was new to investing in biotech and didn't know why there would be a hold up for 3 months after the scheduled completion date and I wrongly perceived it as a negative.
One morning I woke up to an email about the partnership with early trading 15x's the value of previous day's close.
A family member, much more experienced, explained that the company was negotiating, in a quiet period and that volume was stagnant because anyone with large amount of shares did not trade during the time period.
Information was not provided because the negotiations consisted of full NDA of all materials and information associated with the trial and the partnership details.
I took half my investment off the table during those three months. I didn't invest a lot in entirety but I did miss out on decent coin for my lack of knowledge.
I am willing to wait, and if any of the items above apply to IPIX, I will gladly wait while being amused by what I read here. If I wake up to another partnership agreement, I have a feeling 15x's previous close is not nearly in the realm of what I would be expecting here, but if it is, I expect DUDLEY to be happy for once in his life.
If the piranha don't get fed soon they will have to go somewhere else to get nourishment.
Leo - if you are listening, please don't make any releases until the trials are over.
Go Leo & IPIX!
I am very pleased that Leo is too busy to bother doing a press release that will only bump the sp a few cents. I will wait until the big one...
Go Leo & IPIX!
A very worth while read! Thanks,
Go Leo & IPIX!
Jhawker...
You are correct...referring to a landlord-tenant issue as "sloppy" and in some way is determinative of IPIX/Brilacidin's success or failure is beyond irrational...
Lease...non-issue
Besides being totally irrelevant to the science and task at hand of moving Brilacidin forward on Covid-19, UC and OM...
...as an aside to this non-issue, I, for one, am pleased the rent for this Commercial Space is not around the neck of the company.
In a billiantly thought out post...it was noted:
Quote:
"The Company has been unable to enter into a sub-lease agreement for this leased office on September 30, 2019.]" and that " The Company vacated the leased office space as of December 31, 2019, and in January 2020 the Company initiated a lawsuit against the lessor relating to an automatic extension of the lease for the office space and related matters (see Note 15. Subsequent Events to the condensed consolidated financial statements)."
Sloppy?...hardly.
In this year of Covid ... The Tenant who rejected IPIX's right to extend sublease...is probably (figuratively and financially) "Hanging from a Noose"... with vacant or tenants not paying rent!(Look for Massive Commercial Property Losses, Devaluation and Foreclosures just around the corner). Very few company's are USING OR EVEN NEEDS the Office space (and Lab functions are totally contracted out by Leo)...so this event is a NET GAIN to IPIX working virtually...and accomplishing all noted by FARRELL (below) and not paying for totally unnecessary space.
"Sloppy" ... is an accurate adjective for FDA BUREAUCRACY...not for LEO. (though no doubt even Bureaucracies are hit with Covid, causing staff shortages and delays too)
If one does not receive on the TIME TABLE PROMISED, INDICATED OR MANDATED...Private Sector companies (within reason) have to suck wind and wait...or they face retribution for complaining...
Then what would the "complainers" here say about retribution...? (We all know)
"Sloppy"... DOES NOT ACCOMPLISH THE LIST BELOW!
My advice...stop the hyperventilating...suck it up and be BIG GIRLS AND BOYS...and listen to FARREL (yesterday):
"My bet is news, and a lot of it, is coming soon.
GLTA,
Farrell9"
-2/18 Initial announcement of Brilacidin for Covid 19
-2/24 Material transfer agreements to virology labs
-2/28 Brilacidin sent to Regional Biodefense Labs {RBL)for study
-3/2 Brilacidin PDF outlines scientific rationale for use against Covid19
-3/9 Brilacidin studies planned at RBL
-3/12 Testing to begin 3/16
-4/1 Brilacidin effective against Covid19 in Vero monkey cells
-4/6 Early discussions of human trials
-4/20 Screening of 11,552 compounds shows Brilacidin a leading drug against Covid19 by inhibiting the M-protease
-4/27 Initial research confirms anti Covid properties more research planned
-5/5 PHRI studies announced
-5/19 Brilacidin reduces Covid 75% in preincubtion Vero cell study
-5/26 Brilacidin reduces Covid in human renal cell line; blocks viral cell entry
-6/11 Brilacidin study to include MERS and SARS pan corona virus testing; Grant application application made
-6/17 Brilacidin inhibits Covid 97% in infected Human respiratory cells
-7/7 Brilacidin active against Covid 19 before during and after Covid infects cells
-7/13 Human clinical trial planning/manufacture of Brilacidin announced
-7/20 Brilacidin at low dosage is effective against Covid19; lower than ABSSI dose
-8/4 Brilacidin shown effective against entire Covid life cycle
-8/24 Brilacidin Selectivity index among highest reported
-8/26 Dr Degrado announced as science advisor
-9/15 Brilacidin synergistic with remdesivir;reduces viral load almost 100%
-10/2 Pre IND meeting; Brilacidin human clinical trials
-10/30 RBL preprint article released; Selectivity index 426 one of highest achieved
-11/2 FDA pre IND response received;CRO secured
-11/16 Overseas CTA submitted;Brilacidin viral resistance unlikely
-11/30 New research for Brilacidin as a pancoronavirus treatment
FDA application submitted
-12/21 Brilacidin for phase 2 Covid study approved
More FACTS! Brilacidin is going to human trials soon.....
Go Leo & IPIX!
November 30, 2020
Innovation Pharmaceuticals COVID-19 Clinical Trial to Support Additional Development of Brilacidin as a “Pan-Coronavirus” Therapeutic
Brilacidin
· Company advancing Brilacidin as a next-generation broad-spectrum antiviral for the treatment of common colds and deadly coronavirus infections
WAKEFIELD, MA – November 30, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces additional independent preliminary laboratory research suggests Brilacidin, the Company’s flagship defensin mimetic, has the potential to treat other endemic human coronaviruses (H-CoVs), such as those causing common colds, and not just SARS-CoV-2, the novel coronavirus responsible for the ongoing global COVID-19 pandemic. Research shows Brilacidin exerted potent in vitro inhibition of multiple strains of H-CoVs. On completion of testing, the H-CoV findings are expected to be submitted for peer-review publication. The Company is evaluating these data alongside previously obtained SARS-CoV-2 data, strategizing with its scientific advisors and consultants, to develop Brilacidin as a “pan-coronavirus” therapeutic.
In related news, requisite documentation has been filed with the appropriate regulatory agencies, including an Investigational New Drug application (IND) with the FDA, for conduct of a multinational Phase 2 clinical trial of Brilacidin in patients hospitalized with COVID-19.
Innovation Pharmaceuticals believes Brilacidin is a clearly differentiated leading antiviral drug candidate backstopped by a growing library of laboratory data documenting Brilacidin’s potent ability to inhibit coronaviruses, primarily by disrupting viral integrity and blocking viral entry. The Company is planning to conduct additional in vitro and in vivo Brilacidin studies on multiple coronaviruses, to further inform the drug’s anti-coronavirus properties and prepare for potential future clinical testing.
“Given the alarming recent global spike in COVID-19 cases, coupled with a long-term perspective around the possibility of future pandemics, the appetite for novel anti-coronavirus therapeutics remains strong, as evidenced by Merck paying $425 million in cash last week to acquire OncoImmune to bolster its COVID-19 pipeline,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Early data on vaccines are an encouraging development in combatting the virus. But vaccines have their own challenges—notably, reticence among the public to get vaccinated, combined with delivery obstacles and potential resistance developing due to mutations. Vaccines offer only a partial solution. Major pharma understands this and it is why they are making significant investments in promising COVID-19 therapeutics. The clinical trial of Brilacidin for COVID-19 will be instrumental in taking the first step to develop Brilacidin as a ‘pan-coronavirus’ drug, benefiting patients with illnesses ranging from variants of the common cold to the most serious coronavirus infections.”
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 established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2. In a human lung cell line, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin anti-viral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of 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. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded on bioRxiv.org at the link below.
· Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Facts are below and are not my opinion or anyone else's. Brilacidin will be in human trials soon... hahahahahahahaha - BAM!
December 21, 2020
FDA Grants IND Approval for Phase 2 Clinical Trial of Innovation Pharmaceuticals’ Brilacidin for Treating COVID-19
Brilacidin
· Brilacidin’s potent in vitro inhibition of the Washington and Italian strains of SARS-CoV-2 support its potential to inhibit emerging coronavirus mutations (variants), such as those in the United Kingdom, Denmark and South Africa
· 120-patient trial to be conducted at U.S. and international clinical sites
· Primary endpoint time to sustained recovery through Day 29
WAKEFIELD, MA – December 21, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company developing Brilacidin, a Host Defense Protein (HDP) mimetic representing a new class of drug with antiviral, anti-inflammatory and anti-bacterial properties, is pleased to announce that the U.S. Food and Drug Administrations (FDA) has approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19.
Brilacidin has been shown in vitro to be effective against different SARS-CoV-2 strains (Washington and Italian), as well as multiple human coronaviruses, making it less likely to be affected by emerging mutations (in the United Kingdom, Denmark and South Africa) and further differentiating the drug from other COVID-19 treatments in development today.
With its unique HDP mimetic properties, Brilacidin has potential to exert antiviral activity across SARS-CoV-2 variants. The sudden emergence of highly contagious new variants of the coronavirus illuminates the urgent need for drugs, like Brilacidin, with a different mechanism of action from current antivirals to get this resilient virus under control.
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, multi-national, multi-center study expected to enroll approximately 120 patients with moderate-to-severe COVID-19. The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale. The Company will now complete site initiation visits and contracts to add additional clinical sites to the study.
“It’s clear from comments of infectious disease experts like Dr. Anthony Fauci and recent news reports on emerging COVID-19 variants that we are not out of the woods yet with the coronavirus, by any stretch of the imagination. Even with vaccines starting to be rolled-out, it is going to be many more months for them to reach the masses and potentially years before vaccines are available worldwide,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “There is now and will be into the foreseeable future a real need for new therapeutics to treat people who contract the infection. We have great hopes Brilacidin will emerge as a novel therapeutic to help fight the global pandemic.”
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 established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of 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. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.
· Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company’s website ( http://www.ipharminc.com ), and at the following link:
https://ipixcovid19tracker.com/
http://www.ipharminc.com/press-release/2020/12/21/fda-grants-ind-approval-for-phase-2-clinical-trial-of-innovation-pharmaceuticals-brilacidin-for-treating-covid-19
Great reminder Blue Fin! This is going to get exciting soon...and Brilacidin can change the world.
Go Leo & IPIX!
WAKEFIELD, MA – November 30, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces additional independent preliminary laboratory research suggests Brilacidin, the Company’s flagship defensin mimetic, has the potential to treat other endemic human coronaviruses (H-CoVs), such as those causing common colds, and not just SARS-CoV-2, the novel coronavirus responsible for the ongoing global COVID-19 pandemic. Research shows Brilacidin exerted potent in vitro inhibition of multiple strains of H-CoVs. On completion of testing, the H-CoV findings are expected to be submitted for peer-review publication. The Company is evaluating these data alongside previously obtained SARS-CoV-2 data,
https://www.ipharminc.com/press-release/2020/11/30/innovation-pharmaceuticals-covid-19-clinical-trial-to-support-additional-development-of-brilacidin-as-a-pan-coronavirus-therapeutic
Nice find George!
Go Leo and IPIX!
Very interesting fairly recent patent
United States Patent Application 20200368232
Kind Code A1
MENON; Krishna November 26, 2020
Host Defense Protein (HDP) Mimetics For Prophylaxis And/Or Treatment Of Inflammatory Diseases Of The Gastrointestinal Tract
Abstract
The present invention provides methods for treating and/or preventing inflammatory diseases of the gastrointestinal tract with one or more compounds, or pharmaceutically acceptable salts thereof, disclosed herein, and the use of compositions comprising the same.
Inventors: MENON; Krishna; (Beverly, MA)
Applicant:
Name City State Country Type
INNOVATION PHARMACEUTICALS INC.
Beverly
MA
US
Assignee: INNOVATION PHARMACEUTICALS INC.
BEVERLY
MA
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220200368232%22.PGNR.&OS=DN/20200368232&RS=DN/20200368232
Good luck and GOD bless
"when the company states "it will visit the trial sites" it means the CRO it hires (contracts as its representative) will visit the site. NOT LEO OR JANE!"
I can't believe you thought they actually went to each trial site. Imagine the amount of time and money that would cost. I think Leo's time is better spent getting the manufacturing of Brilacidin ready for the millions of sick people with covid & flu.
Whenever it starts/finishes it will be good for long shareholders. I am willing to wait and I think you are going to have to wait.
Go Leo & IPIX!
Also, After Leo signs contracts for additional sites I'm assuming he'll have to visit them also? My late Feb trial start may go up in flames... March, here we come... God, one would believe he was doing a large trial? LOL
The Company will now complete site initiation visits and contracts to add additional clinical sites to the study.
http://www.ipharminc.com/press-release/2020/12/21/fda-grants-ind-approval-for-phase-2-clinical-trial-of-innovation-pharmaceuticals-brilacidin-for-treating-covid-19
Agreed!
Leo - make us all rich!
She’s the wicked witch of the West! Nah, she’s been consistently good and I hope she and all of us who’ve stuck it out make a killing.
I am seriously hoping you are right Pete. I think Leo is wanting to get Brilacidin on the big stage and this is his chance.
Go Leo & IPIX!
I am now of the belief that our next PR will be upon completion of the trial. No real need for any interim data to be given out since the trial is so short and all such PRs would bring about is more derision as fluff and nonsense. No need giving any info to those that don't need it or would twist it.
I believe the trial is currently ongoing and fully underway with all patients enrolled. Figure that should have taken only as long as needed to do the admin work to admit them. They certainly didn't have to look hard to find them.
As such, I believe nothing this week in the way of news, possibly some late next week, but more likely one of the last 2 weeks of the month. I can wait as that will be the BIG ONE IMO as to PRs. We sink or swim with Brilacidin CV according to those results.
In the meantime, price varies at about the current levels with a small dip possible. Only thing it will accomplish is allow those shorting to dig a deeper hole IMO.
I have always heard in important trials that the less heard and the longer it takes to get the word is a good sign.
This is just my WAG.(so it wouldn't surprise me that much if something came about this week - I would laugh at myself as much as others would)
That is main function of CRO assist in formulating trial proposals and supervising the trials and assembling the data.
AND THIS IS NOT SUPERVISION of CLINICAL TRIAL????
" What Are Clinical Research Organizations?
A CRO is an outsourcing company that a sponsoring company hires as an independent contractor to lead clinical trials and other research support services on its behalf. CROs typically contract with companies in the pharmaceutical, biotechnology, or medical device industries, but their clients also include governmental institutions, foundations, and universities. These organizations contract with CROs to acquire the specific expertise needed to carry out trials safely and efficiently without hiring permanent staff.
Given the complexity of drug and device development and the need to bring products to market rapidly to edge out the competition and meet patient needs, pharmaceutical companies are increasingly outsourcing critical functions including manufacturing and research. This has led to a surge in the hiring of CROs.1?
CROs play a key role in all aspects of the drug or device development process, from initial discovery to launch, but focus on Phase I–III clinical trials.2? Trials require a host of complex activities ranging from protocol design to preparation of materials for submission to the Food and Drug Administration (FDA).3? Rather than hire permanent employees with the specialized knowledge needed to perform these tasks in-house, trial sponsors such as pharmaceutical companies can outsource them to a CRO by formally transferring their responsibilities to the CRO in writing.
The CRO, acting as an independent contractor with specialized knowledge, can perform a range of tasks on behalf of the sponsor to help bring new drugs or devices to the market faster, more efficiently, and at a lower cost."
example: https://scope-international.online/services/
STRATEGIC CONSULTING
Development plan
Product development
Scientific advice
Pharmacoeconomics
Regulatory guidance
–STUDY EXECUTION
Clinical trial planning
Collaboration with phase 1 units
Proof of concept / feasibility studies
Protocol design
Paediatric investigational plans
-Contact us to discover how we can support your clinical operations:
Feasibility and planning
Project Management
Clinical Monitoring & Site Management
Clinical trial protocols and protocol amendments
Subject information and informed consent forms (ICFs)
Integrated clinical trial report meeting global regulatory requirements
Observation plans and final reports for post-marketing studies
Development safety update reports (DSURs)
Paediatric investigation plans (PIPs)
OUR CDM SERVICES
CRF design
Electronic Data Capture setup
Data Management plan
Clinical database setup
Data Validation Plan
Data review, reconciliation and cleaning
Data transfer specifications and data integration
Team trainings
Double-data entry
Data quality control
Status reporting
Ad-hoc reports
Centralized evaluations, e.g. central-diary evaluation and clinical outcomes assessment evaluation
Randomization and custom IMP logistic workflows
Database lock
Scanning and bookmarking
Archiving deliverables
Biostatistical Services
SAS® Programming
Data mining and exploratory data analysis
Safety Management
Experienced and expert drug safety physicians
Medical monitoring combined with data management for highest safety standards
Full range of medical services – monitoring, writing, coding, pharmacovigilance and 24/7 consulting
Medical expertise to support your study and goals
Quality Management
Clinical Trial Protocol
Informed Consent Form (ICF)
Investigator sites
Clinical Database
Clinical Trial Report (CTR)
Local and Global Regulatory Affairs
Advice on regulatory procedures for clinical studies at any stage in the process.
Preparation and submission of initial applications and substantial modifications under involvement of our local study teams
Local accompanying of the approval process and communication with competent authorities as well as ECs / IRBs and other parties
Reporting, notification for information during and after the clinical study (non-safety and safety via Pharmacovigilance)
Reporting, notification for information during and after the clinical study
Import / export licenses (incl. narcotics and psychotropic drugs)
Support in entering information in registry platforms and databases (incl. result disclosure)
Trial Master File (TMF)
Third-party service providers
Case Report Form (CRF)
Vendor Management
Sunspotter
Quote:
1) "CRO supervises ALL aspects of trials...from strategy, to regulatory compliance"
No. the responsibility for every aspect of the study rests with the Sponsor of the study, in this case IPIX
The Answer is YES: The CRO is responsible to Company to "Supervise" but the Company is Responsible to the FDA for the study (work product of CRO).
They are not mutually exclusive. The above statement does not state that the Sponsor is not ultimately responsible. It clearly states that the CRO SUPERVISES ...CRO is responsible to the Company, and Company is responsible for CRO's work product.
So what is your point?
Sunspotter...
YOU KNOW: The FDA sets forth in minute detail how a Clinical Trials will be run, and a Full Service CRO will have to comply and confirm to the FDA and company that those details have been fulfilled at all sites... IF CRO fails to carry out its mission...it does not get paid. The FDA is final judge. That is why a small biotech, (and most BP) hires a full service CRO. Internal non-officer admin company employees have very little do with the actual physical trial...
CRO supervises ALL aspects of trials...from strategy, to regulatory compliance to the following details:
1. selecting, in consultation with company, trial sites,
2. to the pre-inspection (they already know, because they know reliable sites from being there before,
3. to shipping of medical equipment specified by FDA/IND, type of equipment and materials used...
including, but not limited to:
A. the Basic IV Equipment, B. Administration Sets, C. Needles, D.Basic Types of IV Solutions,E. Devices for Regulation of IV Administration, F. Devices for Holding Infusion Fluids,
G. Supplies for Applying Local Anesthesia (if necessary or relevant before Venipuncture H. Supplies for Protection of Infusion Site, I. etc., etc., etc.
Additionally,a TOP FULL SERVICE INTERNATIONAL CRO will use sites (unless a site is used which has been insisted upon by the the company) where they have had a continued employee presence and experience...they know the reliable sites, they have their pulse on the patient flow and competing studies (if any) within the hospitals, and guide the companies who engage them and after consultation with Clinical Trial staff at hospital site.
CRO knows which sites are likely to fill the patient needs of the trial asap.
They also interact with the FDA re: compliance with the trial requirements...and validated lab results done in U.S.
If CRO does not perform according to their function...they do not get paid. Great incentive to do it right.
IMO... IPIX will have hired one of the world top "full-service" CRO's to fully comply with company's obligation under FDA/IND Clinical Trials...
Awesome post. I believe it will work and humanity can begin to stabilize.
Go Leo & IPIX!
It could literally save the planet if it works as well as it did in the lab. We will know very soon. The bar is SO LOW with the CURRENT therapeutics and their effectiveness, Brilacidin would be a HUGE success even if it does half as well in human trials, although based on years of science and research on it thus far, its mechanism of action SHOULD work against covid. Its anti- viral effect should also work against the other viruses ( common cold, flu, ebola, hiv, etc... ) Because of the life cycle of covid and its duration in most patients, we should know in about 1 month. It's anti- bacterial effect is great for secondary bacterial infections causing harm in hospitalized patients, and its anti-inflammatory effect is great for cytokinin storm ( as well as inflammatory bowel ds, oral mucositis, and other inflammatory processes. The chance to change ones future by getting in EARLY is still here. Some will chase it up after the news and get in at much higher prices ( and still do well!) This is like a "miracle" drug ( if it works)and even if you are not invested , hope that is does do what is has already shown in the lab - great for humanity, combatting covid and the next potential pandemic
Another great post. Thanks JFM!
Go Leo & IPIX!
Dreamer0...Happy New Year
re: trials
... lots of speculation on the Trials...as to where IPIX is and what has been done and/or when...and on a totally as separate matter, the speculation on the drug source of reported Russian (alleged)"antidote".
IMO..."controlled release" of info is intentional.
I prefer the dribble of PRs as events happen in real time... But, there are those shorts who take advantage of short PR's, twist them and/or intentionally undermine them, questioning why there is not more information (in the form of Strawman questions) especially from this board (though I am told he does not read)...It's easier to question and dance on a short PR. I am not implying that is the reason, but perhaps Leo is looking at the most "impactful" PR to form a tapestry of Brilacidin's value.
IMO...bigger things and players are likely in play, as has been referenced in prior PRs and might be considered in the roll out of PRs.
The Question of whether IPIX has received a CTA from an "overseas" eastern Europe country (Russia, as discussed here before)...is an interesting one. "Overseas" jurisdictions are said to be easier (bureaucratically) than U.S. FDA, and it was reported in PR we got the IND/FDA. Also consider that the company isn't required to report everything as it happens...I believe it has 21 days to report such an event. So has it happened? Has 21 days passed?
Few would dispute that "now" is optimum time, and should be for several months, for recruiting CV trial candidates EVERYWHERE in the world...IPIX/CRO is or will likely have an easy time lining up sites previously screened, recruiting the candidates (if it has not already been completed).
I could see Leo waiting on reporting events (within 21 days of occurance if he lining up all completed thresholds he wants to accomplish for B, for its next phase of development, while he/CROs line up Covid-19 CT (and the other indications progress, which have been alluded to in previous PRs) on which he indicated he wanted Brilacidin to move forward.
IMO...in the next one to three (several) weeks we should see Brilacidin will blow away the competition as a Therapeutic ...at which point IMO IPIX should start going beyond the "serious look" phase to "serious actionable interest" phase by BP especially if we get, as cited in previous RP, movement on Brilacidin for the other indications PR'd (OM and UC.)
Perhaps the plan is letting it all rip at once with a MOA PR's...as there appears to be a lot that is or could be happening!
IMO, speculation about the Russian alleged "antidote"...as being Brilacidin...is likely misguided. As noted by others...the PR references the Russian gov. as "developing" the "antidote", (imo best they could be doing is to make a feeble attempt to take credit for Brilacidin...post trials..LOL) But, imo, even more misguided is believing they have one, or one that is 99% effective (or even 10%) effective.
https://112.international/russia/russia-promises-to-present-covid-19-antidote-57775.html.
If we look at the Sputnik vaccine "success" we can likely guess what the truth success of the supposed "Antidote" is and will be.
My personal GP happened to graduate from a major State Medical University which is a top medical university in Russia. https://fmsmu.com/about-university/...he has had conversations with some former colleagues in the hospitals...and told that the vaccine wards are empty. Few are taking it...few believe it works... It appears that is so because there is likely no anecdotal (or credible scientific) evidence in the street.
If we measure the success of the Sputnik Vaccine's by the credibility response of the Russian population...it is an utter failure. (likely does not work...but Putin, in his own mind, has to look like he's beating Trump...LOL)
https://www.npr.org/sections/coronavirus-live-updates/2020/12/24/949943260/putin-promotes-homegrown-covid-19-vaccine-but-most-russians-are-skeptical
Some further interesting development there is that Russia has been accused of underreporting cases and deaths by 2/3rds of official report...meaning they are 200% more or 3x that which has been reported...sounds like a crisis greater than the U.S and China (under-reporting by 10X).
Know what you own!
ps...before it is raised here...regarding credibility of "overseas" Clinical Trials..(from prior conversations with a 20+ year research MD who has run extensive overseas trials for 4 BP) it was explained that when internationally reputable CRO's supervise and run trials the "overseas gov." or the site hospital staff do not control the trial...they "facilitate" the order under direct supervision of and chain of custody controls by CROs ...identifying the right patients, using the equipment specified and sending it to and receiving it at the site etc is all controlled by CRO. Those CRO's establish the integrity of the trial...if they screw up...they don't get paid...a good incentive for getting it done right!
Full disclosure...I don't flip nor sell. I just add with each PR or as SP opportunities present itself.