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I thought you meant the Lavatory where they make Lava soap. I didn’t think B quite works like a lye and pumice cleanser. Lol
The proposition that one can’t extract from all previous Brilacidin preclinical and clinical data a probability for success is itself patently false. Such a proposition is not simply healthy cynicism, it goes beyond that strongly into willful ignorance of data meaning and implications for successful trial outcomes.
Previous trial outcomes indicate a far stronger safety and efficacy profile than Remdesivir. Had it not been for “better than nothing” efficacy outcomes with its marginal safety, Remdesivir never would have been approved outside a world health emergency environment. The FDA had already failed to approve the drug previously following phase 3 studies.
Brilacidin is safer and shows efficacy profiles stronger than Remdesivir’s. One can easily assess a good likelihood for emergency approval. After all, it only has to be demonstratively better than both nothing and Remdesivir. Is it a slam dunk? No. But it’s much better odds than average.
Here is one set of in vero culture results (link to full article provided):
Maximum yields were detected at 48 hpi in Vero E6 cells (>6 logs at MOI = 0.1 and 0.01 PFU/cell), 24 hpi in Vero cells infected at MOI = 0.1 PFU (>5 logs), 48 hpi in Vero cells infected at MOI = 0.01 PFU/cell (>5 logs), 72 hpi in Calu3 2B4 cells (>4 logs at MOI = 0.1 PFU/cell), and 48 hpi in Huh7 cells (>4 logs at MOI = 0.1 PFU/cell and <2 logs at MOI = 0.01 PFU/cell). These results indicate that Vero E6, Vero, and Calu3 2B4 cells support varying levels of SARS-CoV-2 replication and that the cell type should be chosen for a given study depending on the study goals. — https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340027/#!po=1.57895
The clinical trial outcomes for ABSSSI. There were problems with BP that were worrisome, but not enough to stop any trial. The issue was resolved by dose reduction of both frequency and amount. In the final trial for ABSSSI three were no safety issues.
Gosh, here’s one independent verification of safety:
The DSMB recommended that Cellceutix continue the trial as planned. That is the best possible outcome. Independent experts did not observe any concerning safety signals in the study. In addition, the Company reports there are no treatment-related Serious Adverse Events (SAEs), and none classified as cardiovascular or neurological, thus far in the study.
Previous brilacidin phase 1 and 2 studies have indicated the drug is safe and effective in the treatment of ABSSSI caused by Staph aureus, including methicillin-resistant Staph aureus (MRSA). Any treatment-related adverse events in past trials were more likely due to a higher total dose of study drug. However, in the current study, brilacidin is given as a single-dose regimen in two treatment arms (0.6 or 0.8 mg/kg), and in the third arm, it is given as a 3-day regimen, which represents the highest amount a subject could receive (total 1.2 mg/kg). Of note, the highest amount is still lower than the lowest amount of brilacidin given in the previous phase 2 ABSSSI study, which concluded in 2012.
https://www.biospace.com/article/releases/cellceutix-brilacidin-absssi-trial-gets-positive-review-by-data-safety-monitoring-board-best-possible-outcome-no-treatment-related-serious-adverse-e/
You need to look a little deeper. All safety issues were resolved during multiple phase 2 testing. The only issue should be clinical efficacy and best method of delivery.
You also have to search using PMX-30063. 4 trials result from that.
Yes, that’s why there are trials. I speaking of trials, not lab tests. The testing against SARS-CoV-2 shows signals that Brilacidin works against that virus in much the same way as well as the expectation that it should modulate inflammation as a symptom just as it did against bacterial infection inflammation. It simply indicates there is a good likelihood this upcoming trial will be successful. What’s hard to understand about that?
It’s not fluff. It’s a letter to shareholders explaining the need for therapeutics, something the previous administration dropped from the focus in operation warp speed when it went all in for vaccines.
Brilacidin is not Prurisol. Brilacidin has 8 trials showing high efficacy and safety. Very different results than Prurisol.
Once again this was a letter to shareholders. It wasn’t a PR, it didn’t claim anything. It put in context the need for advancing drugs that are treatments and not just vaccines, therapeutics and not just prophylactic. Your post is silly and baseless.
Shareholder Alert: Rise of Coronavirus Variants
Innovation Pharmaceuticals (IPIX) posted today an update to its website, linked below, discussing the emergence of new coronavirus variants, which are raising concerns among scientists and public health officials worldwide. Early data suggests these variants might lessen vaccine efficacy and potentially even escape the body’s immune response.
http://www.ipharminc.com/new-blog/2021/1/20/the-rise-of-coronavirus-variants-early-signs-of-immune-escape
This worrisome situation illustrates a large, and likely prolonged, unmet need for COVID-19 therapeutics to supplement the use of vaccines, as the coronavirus continues to evolve and adapt. Innovation will be initiating a Phase 2, randomized, placebo-controlled clinical trial, enrolling hospitalized patients with moderate-to-severe COVID-19, to further evaluate Brilacidin’s COVID-19 treatment potential.
A very good consolidation day. The inauguration is over, the market seems happy enough, and IPIX has finally corrected waiting for the next news.
An application is unlikely to be approved without a clear path to distribution. Big Pharmas are approved based on existing infrastructure. Little biopharma startups are unlikely to be approved for fast track without a clear plan in place.
OPERATION WARP SPEED would be a program available to IPIX for further support, development and manufacturing etc. of Brilacidin...
www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html] https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html
"Operation Warp Speed's goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures)"
Program is transitioning over to the next administration...and will continue.
—From Justfactsmam
“ 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
Fast track also means that manufacturing and distribution has already been worked out, so in that way, yes, there are agreements in place.
No, I didn’t say it would slow the program down. I said they needed the fast track included in the protocol before it was approved. If fast track is granted then the protocol must be modified and reapproved for accelerated chains of assessment. That means updating the staff on revised process.
The final trial protocol must include the plan under fast track. The fast track after approval would cause great delay.
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).
Just when we thought things were looking up...
Pfizer tells U.S. officials it cannot supply additional vaccine until late June or July
Trump administration officials deny there will be availability issues, but others say problems are possible in the second quarter.
https://www.washingtonpost.com/health/2020/12/07/pfizer-vaccine-doses-trump/
A phase 2 study would be safety and optimization for Brilacidin with a drug already optimized and approved. So, with such a low number of patients, 127 if I remember correctly, the study won’t leave much room for much more escalation than a low and higher dose. It doesn’t take much B to trigger adverse events, while peak efficacy against several bacterial infections is significantly less than the adverse event threshold. So, the first combo cohort is likely look for conflicts between the two drugs, then the next cohort will have a little higher dose.
Again if I recall correctly, in the MRSA Phase IIb the doses were 0.6mg/kg, 0.8mg/kg, and 1.2mg/kg. I would suspect there is already some idea to start with something like 0.6mg/kg and then 0.8mg/kg. But, what do I know? It’s unlikely that the protocol will use anything but the already approved Remdesivir dosing.
The likely protocol is to add Brilacidin to Remdesivir as treatment. It would be unethical have an unproven drug go against any standard of care along with a placebo group. Brilacidin has tested as a combination with Remdesivir, so the grouping would be Remdesivir plus B and Remdesivir plus placebo. The R
+ B group would then have an escalation for only B to find optimization. The outcomes would then look for increased efficacy over R alone. Remdesivir has such a low benefit over no treatment that increased benefit is a very low bar.
Innovation Pharmaceuticals and George Mason University Announce Public Release of Laboratory Testing Results Demonstrating Brilacidin’s COVID-19 Treatment Potential
Preprint article details research conducted at George Mason’s Regional Biocontainment Laboratory:
Brilacidin shown in vitro to potently inhibit SARS-CoV-2, the novel coronavirus causing COVID-19.
In a human lung cell line infected by SARS-CoV-2, Brilacidin achieved a high Selectivity Index of 426.
The primary mechanism of action of Brilacidin appears to disrupt viral integrity and block viral entry.
Brilacidin and FDA-approved remdesivir exhibit excellent synergistic activity in vitro against SARS-CoV-2.
The preprint article is being submitted for peer-review publication
WAKEFIELD, MA and FAIRFAX, VA – October 30, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, and George Mason University’s (Mason’s) National Center for Biodefense and Infectious Diseases (NCBID), today jointly announce completion of extensive laboratory testing supporting anti-SARS-CoV-2 activity of Brilacidin, a defensin-mimetic drug candidate, which is being developed as a potential COVID-19 treatment.
Research findings are being submitted for peer-review publication. A preprint, available for download at the link below, is in the process of being posted to bioRxiv.org.
“Preprint: Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2”
http://www.ipharminc.com/new-blog/2020/10/30/preprint-brilacidin-a-covid-19-drug-candidate-exhibits-potent-in-vitro-antiviral-activity-against-sars-cov-2
“We thank the scientists who have conducted an impressive amount of antiviral research on Brilacidin, which strongly supports its treatment potential in the fight against COVID-19,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “It is timely to have Brilacidin anchored in such sound science, as we anticipate commencing soon a clinical trial of Brilacidin for treatment of COVID-19. We look forward to continuing our antiviral research collaborations, while Brilacidin advances into clinical testing against COVID-19, where we believe Brilacidin can have a beneficial patient impact.”
“During the global COVID-19 pandemic, we selectively formed new external industry partnerships, including this opportunity to research a drug candidate like Brilacidin,” said Aarthi Narayanan, PhD, Associate Professor of Systems Biology in Mason’s College of Science. “In testing at GMU’s BSL-3 lab, we showed that Brilacidin potently inhibits SARS-CoV-2 in vitro against the live virus. Beyond exhibiting treatment potential for those already infected by COVID-19, Brilacidin’s ability to disrupt viral integrity and block viral entry indicates it has the added potential to prevent infection, upon appropriate formulation, as a prophylactic. I look forward to working with Innovation to investigate further Brilacidin’s antiviral properties,” Narayanan added.
“Brilacidin’s demonstration of potent antiviral activity against SARS-CoV-2 is important, particularly given its apparent ability to impact the virus directly,” said William F. DeGrado, PhD, Professor in the Department of Pharmaceutical Chemistry at University of California San Francisco and Scientific Advisor to Innovation Pharmaceuticals. “This antiviral mechanism of action suggests Brilacidin might be able to inhibit other viruses and be less prone to resistance developing due to viral mutations—a weak spot for other antivirals, antibody-based treatments and vaccines. I am extremely hopeful Brilacidin will emerge as an effective COVID-19 treatment given the ongoing worldwide need for COVID-19 therapeutics.”
And yet, the text just before the chart you cite states the opposite of what you claim the report recommends:
“To help slow the spread of SARS-CoV-2, precautions should be implemented to stay home once exposed to someone in addition to adhering to recommendations to wash hands often, wear masks, with COVID-19,** and social distance.†† If a family member or other close contact is ill, additional prevention measures can be taken to reduce transmission, such as cleaning and disinfecting the home, reducing shared meals and items, wearing gloves, and wearing masks, for those with and without known COVID-19.”
Sorry, the notion that mask wearers gain nothing is not included in the summary of findings and is based on a single data point out of context. The summary instead concludes this:
Summary
What is already known about the topic?
Community and close contact exposures contribute to the spread of COVID-19.
What is added by this report?
Findings from a case-control investigation of symptomatic outpatients from 11 U.S. health care facilities found that close contact with persons with known COVID-19 or going to locations that offer on-site eating and drinking options were associated with COVID-19 positivity. Adults with positive SARS-CoV-2 test results were approximately twice as likely to have reported dining at a restaurant than were those with negative SARS-CoV-2 test results.
What are the implications for public health practice?
Eating and drinking on-site at locations that offer such options might be important risk factors associated with SARS-CoV-2 infection. Efforts to reduce possible exposures where mask use and social distancing are difficult to maintain, such as when eating and drinking, should be considered to protect customers, employees, and communities.
According to BBC:
Dexamethasone
Monoclonal antibody therapy
Remdesivir
zinc,
vitamin D
famotidine
melatonin
aspirin
Trump’s Cocktail (shaken, not stirred)
Just 40 minutes ago .23 was a brick wall. So what gives with .237? Is that you?
A little something on mask efficacy: https://www.ucsf.edu/news/2020/06/417906/still-confused-about-masks-heres-science-behind-how-face-masks-prevent
My point was this statement: “Evidently the Covid19 emergency allowed the FDA to grant the Remdesivir IND without the animal studies normally required.”
The FDA does not require animal studies for an IND approval unless there is a safety issue. There only need be a theoretical argument of probable higher efficacy if safety and minimal efficacy is already well-established.
The advantage of simultaneous animal studies is the ability to perform tests that cannot be performed on human subjects. That part of an agreement would have been designed into the IND submission for SARS-CoV-2 testing.
That’s not accurate. There were no animal studies performed against SARS-CoV-2, but there was extensive testing against EBOV among several virus types. There was also extensive human efficacy trials previously. It was approved primarily because the lack of effective treatment created a very low bar. This is similar to the case of Tamiflu initial approval against H5N1 when there was that worldwide scare.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214279/
It’s not a matter of knowing anything about anyone’s cultural high holiday. It’s about making a stink over a letter that shares a newly released article mentioning a member of the company, making that stink because the release was at midnight. It’s both silly and insulting.
He issued it to shareholders via email. Who cares what time it went out?
Also, what part of high holidays is confusing you?
It’s the high holidays. And, it is addressed to shareholders. Give him a break.
There is no evidence that I know of to think Brilacidin would be effective on cancer cells. It’s use in cancer therapy is limited to destroying infections caused by immune system suppression due to other therapeutics.
One would think eye popping numbers would get more attention, all things being equal. But, one needs to take into account the “what’s in it for me” kakocracy that currently presides over all DC and the HHS. That and all funding going to the “biggest and best” big pharmas who are loathe to share even billions if they are currently working on grant money for development.
Short, definitive answer, yes. But, the “potential” is that the result is outside a closed, natural bio-system such as a human one. The observed result is in an isolated culture.
“ One more time:
Does "potential effectiveness is nearly 100 percent" mean the same thing as "overall viral load was reduced by 99.85 percent" and "increasing overall inhibition against the novel coronavirus to 99.85 percent"? ”
I just realized I didn’t answer the question. For a simplified answer for what the molecule is that mimics a defensin peptide I went to Wiki: “... is an arylamide foldamer designed to replicate the amphiphilic properties of antimicrobial peptides while solving the problems encountered by peptide-based antimicrobials.”
Defensin peptide mimitics are artificial molecules that mimic the ability of proteins, nucleic acids, and polysaccharides to fold into well-defined conformations, such as helices and ß-sheets.
Arylamide foldamer: an aromatic ring molecule containing peptide bonds that folds on itself. “ They are artificial molecules that mimic the ability of proteins, nucleic acids, and polysaccharides to fold into well-defined conformations, such as helices and ß-sheets.”
Yes, Brilacidin is a non-peptide mimetic.
Brilacidin is a peptide mimetic, meaning it mimics a string of amino acids forming peptides which are the building blocks of proteins. It is a host defense protein mimetic.