I sent the following email to a couple of close friends today:
I know that many of you follow IPIX as closely as me but there are some that don’t and this is mainly for them. There are one or two postings (not official Press Releases) that I also cite that should prove informative.
The bottom line is that the human trial is going quite well and the opportunities for Brilacidin across many revenue streams seem to be increasing daily – and increasing by a LOT!!
We knew the trial was on hold until an OK was given to increase the days of dosing from 3 to 5 (thus 5 total IVs per patient) to be on an apples to apples basis with Remsdesivir and Fav……, the standard of care (SOC) treatments to which B is being compared. They stopped the trial after 30 patients (per the protocol so nothing new here) so that there would remain 90 patients to go and that would give statistical validity to the results.
It now looks like with PRs (2) today and Monday that Leo had been waiting for April to start the rollout of positive Brilacidin news.
PR from 4/5: http://www.ipharminc.com/press-release/2021/4...9-patients
What does the above PR mean to IPIX? First, and most importantly, it shows that the safety profile to date has been rock solid (as was expected) for the dosing days to be extended to 5 from 3. That means about 50% of the trial risk is gone and all that is left is the efficacy of the drug in killing viruses. Though the committee didn’t look at efficacy at all (in fact they weren’t even shown results to date, only safety data to date) if there was no efficacy shown on the first 30 patients they wouldn’t be eager to start on the last 90 or the trial may even have been halted. As stated in the PR, “The clinical rationale for consideration of expanding treatment duration to 5 days, from the initial dosing regimen of 3 days, is to provide a longer duration of systemic Brilacidin exposure at a level that can strongly suppress SARS-CoV-2 virus replication, and associated symptoms, and thus maximize therapeutic benefits to hospitalized patients with moderate or severe COVID-19. The expanded dosing regimen has particular value in that a 5-day dosing is the recommended initial treatment duration for Gilead Sciences’ Veklury® (remdesivir), the only FDA-approved antiviral drug for treatment of COVID-19. Trial data for Veklury could serve as a benchmark in evaluating Brilacidin outcomes.”
Secondly, this extract from the PR is extremely affirmative for Brilacidin IMO:
“With its unique mechanism of action to directly disrupt the novel coronavirus, we believe Brilacidin possesses potential to address these worrisome reminders that SARS-CoV-2 isn’t going anywhere. More broadly, Brilacidin’s antiviral potency also appears to extend beyond coronaviruses to other types of viruses, based on independent ongoing laboratory research, further supporting Brilacidin’s broad spectrum antiviral potential.”
This statement is a teaser (though a true teaser) that extends the belief that Brilacidin will prove effective against a FAR broader range of viruses than just CV19.
For those that haven’t delved deeply into B yet, viruses can be enveloped or non-enveloped. Enveloped simply means the virus has an outer casing that protects the guts of the virus. Most (if not all) drugs available today cannot KILL viruses, they simply try and stop them from replicating. Brilacidin KILLS viruses almost completely, so we don’t treat the problem, we END the problem. I have attached a website below that compares enveloped vs non-enveloped viruses. This ability for B to KILL viruses is due to its unique properties as a new arm of science. It is why the expectation is that since we know that B can kill CV19, it should also be expected that B will kill all variants of CV19, all coronaviruses, all enveloped viruses, and I believe it will show itself to be extremely effective against non-enveloped viruses as they are very common in the GI tract and we have already shown B can kill ulcerative proctitis and likely ulcerative colitis as IPIX is anxious to get going on a P2 trial for that. Bottom line – Brilacidin could become the gold standard to kill ALL viruses worldwide and end this deadly threat to mankind that has been dogging us since time began.
Also, this PR states that IPIX “announced” this 5 day dosing today, 5 April, but it did not state exactly when it received this news. Could have been early last week and Leo was sitting on it until after Easter. Just speculating here, but we do know that now the trial will be ramped up considerably and some informed friends of mine think the trial may be fully enrolled by the end of this week or the end of next week. I would tend to believe the end of next week at the earliest making the trial finish around the middle of May. IPIX then will have a good clue as to the final results and at that time (mid-May) we may see some great news in the way of EUA approval, possible large orders from Russia, or even a large buy from the US govt. Again, pure speculation but the point is we don’t have to wait until mid-July to get some very positive word on how the trial played out.
Today, April 7, we received our second PR of the week stating “Innovation Pharma Announces Brilacidin Abstract Accepted for Oral Presentation at the American Society for Virology’s Annual Meeting” to be held July 19-23 (Anybody notice final results for our current human trial is expected for that same time frame? My guess is that maximum effort will be made to have the final report published by 19 July)
There were a couple of mind-boggling statements in this PR. The most thrilling was Leo stating “If Brilacidin goes on to realize its promise as a broad spectrum antiviral, the potential benefits to patients and shareholders for this drug would likely be greater than I or anyone could have ever imagined.”
To put this statement into context, I am attaching a post from IHUB that illustrates the size of the antiviral market: https://investorshub.advfn.com/boards/read_ms...=163012211
Bottom line is that the antiviral market is expected to be $74B by 2023 and $130B by 2030 and Brilacidin is being evaluated as the “gold standard” treatment that could work against the entire broad spectrum of viruses.
Now I don’t want to get anybody overly excited, but the “other’ drug, Kevetrin, that IPIX is finalizing in pill form for vast testing on many forms of cancer/complementary cocktail for cancer treatments) is about as unique as is Brilacidin and the yearly revenues for cancer is $479B/yr. That get anyone’s attention?
Another highlight of this 7 April post is that this presentation will be based on “ongoing” independent lab research at the RBL (Regional Bio Lab/National Center for Biodefense and Infectious Diseases (NCBID) at George Mason University (GMU). That means that GMU has been studying Brilacidin for over a year now!! Wonder what new info they have since the last we heard was the results for the CV19 testing on human lung tissue and kidney tissue? This is where I get my belief the US government has been all over Brilacidin in quiet investigational work since Spring of last year.
Let’s be serious and consider the chances for Brilacidin to succeed across the broad spectrum of viruses. I don’t believe anything I am going to be saying is “fluff” or “Pollyanna” thinking but basic logic per investigational and clinical trial results to date:
1. Brilacidin has been proven rock solid safe in many clinical trials when given at correct dosing strength and all testing for CV is at levels that should prove no problem for Brilacidin to cause any safety issues.
2. Brilacidin has shown itself to be a master KILLER of viruses, to date the only drug that has shown this ability.
3. All enveloped viruses are basically structured the same and the unique MOA of how B attacks the virus should work across the entire spectrum of enveloped viruses.
4. Brilacidin CANNOT be buried by any government worldwide or any government agency. The peer reviewed articles, Russian trial sites, and upcoming presentation to the American Society of Virology in July prevent this.
5. Does Brilacidin need a BP partner for viruses if they intend to only sell massive orders to governments worldwide and let each govt distribute to their citizens as they see fit? I have no clue as to this but it appears quite rational to me.
6. Brilacidin has the scientific cred in Brilacidin due to it being developed by a recognized world class biological chemical engineer, Dr. William Degrado.
7. Dr. DeGrado and Leo have personal contacts within various governmental agencies that will greatly aid further advancement of Brilacidin.
I will be the first to admit I like our chances and that IPIX could become one of the greatest success stories in the history of medicine and the world.