Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Haha, I know where you're coming from. IMO it doesn't seem like apples/oranges since it was the RBL that tied the two together.
But it's a big deal to me as to whether it's right since if it is true that the dose that the RBL tested is higher than what was used in the ABSSSI trial, it's a big red flag. Will the hospitalized COVID patients be able to tolerate brilacidin at the dose indicated by the RBL? If the math is correct, I assume that IPIX is well aware of this difficulty and could lower the dose or pretreat the patients to minimize the side effects. It adds to the uncertainties.
I'm seeing it differently. If a single IV dose of 0.6 mg/kg yielded a plasma concentration of 7.67µM, then one would need a higher IV dose of 0.78 mg/kg to achieve the 10µM concentration tested by the RBL and an IV dose of 1.56 mg/kg to achieve 20µM concentration.
That's very helpful. Using some simple math I come up with:
10µM = 0.78 mg/kg
20µM = 1.56 mg/kg
The single-dose in the 2015 ABSSSI study was 0.6 mg/kg. The 3-day regimen was dosed at 0.6 mg/kg D1; 0.3 mg/kg D2 & D3 and this group had >26% hypertensive events. Evidence points to high blood pressure as being a contributor to developing severe COVID illness.
Can you convert those values to µM? I have a vague memory of molarity from organic chemistry, but that's it.
A possibility as to why BP and others are cautious about B was laid out in the April 2015 presentation of Brilacidin in ABSSSI. Here's the link to the slide deck:
Slide deck
The summary of Adverse Events and Conclusions are towards the end of the deck. Focus on the fact the conclusions of efficacy are based on a single dose.
Single-dose brilacidin was safe and well tolerated in a phase 2b ABSSSI study
Figure 2A. Brilacidin inhibits SARS-CoV-2 replication (Vero cells)
(A) Vero cells were pretreated for 2h with 2 or 10µM brilacidin, infected with SARS-CoV-2 non-directly at MOI 0.1 for 1h, and post-treated with media containing brilacidin as described in Materials and Methods.
Figure 2D, 2E. Brilacidin appears to disrupt the integrity of the SARS-CoV-2 virion
(D) Vero cells were pre-treated for 2h with 10µM brilacidin. SARS-CoV-2 was diluted to MOI 0.1 in culture media containing brilacidin and incubated for 1h.
Figure 3. Brilacidin exhibits potent inhibition of SARS-CoV-2 in a human cell line (Calu-3 cells)
(A) Calu-3 cells were pretreated for 2h with 10 or 20µM brilacidin and infected with SARS-CoV-2 at MOI 0.1 non-directly or (B) directly with brilacidin for 1h as described in Materials and Methods.
Yeah, there have been some odd bid/asks. Good to see $0.20.
Today's 10Q also included information about the grant application. It was "unsuccessful". (I added bold underline emphasis to quote below)
The Company is collaborating with a Regional Biocontainment Laboratory (RBL) for federal grants to fund continued research on Brilacidin as a treatment for
SARSCoV2. An earlier grant application was unsuccessful. At the time of that grant filing deadline, the only research data available was limited to nonhuman
Vero cells. Subsequent to the filing, human cell line experiments were completed and the data is now available. Additional grant applications incorporating the
new data are planned for submission before the end of 2020.
They are diluting constantly. From today's 10Q:
From October 1, 2020 to November 16, 2020, the Company has generated additional proceeds of approximately $1.4 million under the 2020 Agreement with
Aspire Capital from the sale of 7 million shares of its common stock.
Another in vitro study with promising results:
Bausch Health Announces Investigational In Vitro Data Indicating Complete Inactivation Of SARS-CoV-2 With LUMIFY® And BESIVANCE® Eye Drops Preserved With Benzalkonium Chloride
Stress in vitro. Also note vero cells.
The results indicated complete inactivation of SARS-CoV-2 virus at all contact times.
Agree. It's like selling the siding off your house to pay your mortgage.
To make matters worse, he's wasting time and money on this lawsuit that I see him having little chance of winning.
He's filing suit 16 months after the lease renewed. Do you really think he was not told in advance? It's beyond belief.
Remember the $200k/yr office lease they're burdened with because LE didn't meet the deadline to cancel. It's a drop in the bucket in the overall financial picture, but speaks volumes about management competence.
News just out: Innovation Pharmaceuticals Receives Pre-IND Response from FDA on COVID-19 Trial
Innovation Pharmaceuticals Receives Pre-IND Response from FDA on COVID-19 Trial
This is beyond my wildest expectations! Really, really, really happy with last sentence of pr: "The publication will be solely focused on Brilacidin, with a pre-print made available."
This could generate real and lasting interest from investors.
I agreee. And I don't think Menon is back on the team. As an author, Menon would have known the article had been published back in August and he didn't even give Leo a heads up. Leo saw the article in his news feed this morning and rushed out the 10 am PR.
The research paper is fabulous, don't get me wrong. But Leo was clueless about it's publication and clueless about the science in it. Any one else want to venture a guess as to why Leo's PR mentioned that the company is planning to formulate Kevetrin for oral delivery? Is that the preferred method of treating AML? Why not say IV delivery has been proven safe? The guy was flustered this morning.
Per the PDF:
Received December 24, 2019; Accepted June 16, 2020
It's sad because he didn't know about it and has no capacity to connect with that community. He's out of his element, clueless. After I read the article and reread the headline of his PR I couldn't help but see that he doesn't get it. No reason for him to save it.
I agree that this article doesn't help much short term, but I've been here nearly 10 years and came here because of K, so for me it's a big deal.
I think it's amazing news!
From the "Discussion" session of the article:
Given the importance of the TP53 gene in cancer and the frequency of its mutation, several compounds have been tested with the aim of restoring wt p53 function or of degrading the mutated protein to promote apoptosis. Despite the lack of in vivo experiments, which represents a limitation to the present study, the results suggest that kevetrin may be a promising novel drug for the treatment of AML patients carrying either wt or mutant TP53, with the latter representing an imperative medical need due to its associated dismal prognosis (Fig. 6) (9). A phase I clinical trial evaluating kevetrin activity in advanced solid tumors has been successfully completed, and its results indicate good tolerability and the potential for therapeutic response (NCT01664000) (36,48). The data presented herein provide a rationale for an experimental trial in AML patients, particularly those carrying TP53 mutation, for whom the therapeutic options are currently limited.
This is good news. Might not boost the share price today, but the next PR of scientific data with his name on it will get read.
Company now has someone to speak authoritatively to fda, labs, interested parties, etc.
The op linked to a PR issued today by Starpharma for SPL7013, a nasal antiviral. The SI for their drug is up to 2200 (yes, 2,200).
Here's the full paragraph from the PR:
The data confirms that SPL7013 inhibits infection of host cells by SARS-CoV-2 when it is applied to the cells either before or after exposure to the virus (see Figure 1 below). The selectivity of SPL7013 for SARS-CoV-2 in these assays was very high (selectivity index[3] up to ~2200), indicating potent antiviral efficacy compared with minimal cellular toxicity. The selectivity index is a measure of therapeutic window. The high selectivity index of SPL7013 compares very favourably with the selectivity index against SARS-CoV-2 reported in the literature of 279 for remdesivir and 172 for chloroquine.[4]
Interesting that the Starpharma PR gives Remdesivir an SI of 279. A post on this board from DaubersUP on the morning of 8/24 gave Remdesivir an SI at 129.87. That made the 300+ SI for B look like a world beater. I think a few posters commented on the difference in SIs to suggest there was no comparison.
The high selectivity index of SPL7013 compares very favourably with the selectivity index against SARS-CoV-2 reported in the literature of 279 for remdesivir and 172 for chloroquine.[4]
I've been in for 10 years and agree about the many false starts and missteps. There may have been some 2-person biotechs headed by a scientist/founder that have succeeded . . . but an accountant?
Extreme speculation. Hoping for the best.
I agree that it’s ridiculous to ask for $35k if the drug you’re researching is the world-changing COVID therapeutic.
My assumption is that the RBL is doing benchmark testing on hundreds of drugs, including B. These hundreds of drugs are considered the longest of long-shots. They don’t merit grants, they cannot attract private financing, and the companies/institutions that control them cannot afford to do the benchmark testing on their own. The government is doing this testing so that every possibility is explored.
When the results are released, I expect B to be a line item on a table. Hopefully, it will appear among chemicals that merit further investigation. And I'm hopeful that inclusion on that list will spark some interest.
A concern I have had for some time is that the RBLs are testing Brilacidin as one of a host of potential therapeutics. Perhaps hundreds. This would explain getting data in drips as it takes the labs several weeks to perform tests on each of these compounds. My concern was reinforced when Ipix paid money for additional testing. This suggested to me that the lab was stopping at a certain point and companies had to pay for additional work.
I do expect a “peer reviewed” paper to be produced, but am prepared for Brilacidin to appear on a table with many other candidates deserving of more study.
I can tell you the issues I have with these specific sentences.
"In the RBL assay (which included Brilacidin pre-incubated with virus), Brilacidin exhibited approximately 90 percent inhibition against SARS-CoV-2 at a concentration similar to that of Remdesivir™, which again reported 50 percent inhibition of the coronavirus. The Brilacidin inhibition assay was tested in a human lung epithelial cell line, with Remdesivir™ tested in Vero cells."
2017 Aspire vs 2020 Aspire.
I was happy to see the Aspire deal and out of curiosity went back to see how the terms compared to the one from Sept 2017.
The terms of share purchase are the same, but the commitment shares went from 300,000 to 6,250,000.
What struck me the most is the dilution that has taken place between the two deals. There were 135.3 million shares added in a 3-year period, or 181,125 shares per day (747 business days)
Sept 6, 2017 deal -- 131.4 million shares outstanding as of March 31
July 31, 2020 deal -- 266.7 million shares outstanding as of March 31
Oh, that's a beauty! Did you click on the "COVID-19 Information" links for any of the other treatments surrounding IPIX? Check them out. They're announcing trials, collaborations, compassionate use, clearance from the FDA. They're moving forward.
The first sentence of the IPIX listing looks ridiculous in comparison:
"Innovation has received inquiries asking about Brilacidin’s potential to treat the coronavirus (COVID-19) given the urgent worldwide need to find effective treatments for this deadly epidemic."
Some people on this site think the battle is IPIX's to win. These other companies aren't waiting to find out. They're going forward at warp speed. It's like IPIX is standing at the side of the road thumbing for a ride.
I appreciate all of your posts over the years and your levelheadedness, but I think comparing b to Bucillamine is wildly optimistic. Bucillamine has been a treatment for rheumatoid arthritis for 30 years in Japan and South Korea.
PR about Revive Therapeutics exploring the use of Bucillamine to treat COVID-19
I know it's not what people want to hear, but I can't see how they can be treated as equals.
I own IPIX and have since 2010.
BARDA is funding Mediwound, a small biotech with market cap similar to CTIX. They're headquartered in Israel.
[url][/url][tag]http://ir.mediwound.com/news-releases/news-release-details/barda-upsizes-support-nexobrid-additional-21-million-fund[/tag]
So there is an opportunity to get their attention.
I remember the PR for Obama! That was amateur hour for sure! How many years ago was that? And I still own the stock. I guess I'm a dope.
I agree with your 4 "We need"(s), but realistically how is all of that supposed to happen with a company as stunted as IPIX? The competition isn't 1 or 2 people working from their kitchen tables.
I sold some shares when the price went above 50 cents and will sell more when we get another pr that causes it to pop. Leo has gotten much better at writing press releases.
Having b become a therapeutic for covid will be nothing less than a miracle imo.
I’ve owned this stock since Nov 2010. Obviously I’m delighted by the recent stock movement. This is my first post.
I read the WaPo article and learned more about the Ridgeback drug referenced (EIDD-2801). The potency of that Ridgeback drug is a sobering reality check as to the level of competition that Brilacidin will face.
For example, here’s a research article from April 29th (the authors include 3 researchers from the CDC):
“An orally bioavailable broad-spectrum antiviral inhibits SARS-CoV-2 in human airway epithelial cell cultures and multiple coronaviruses in mice”
And here’s one from June 19th announcing the initiation of a Phase II trial:
“Ridgeback Biotherapeutics Announces Launch of Phase 2 Trials Testing EIDD-2801 as Potential Treatment for COVID-19”
I’m not trying to be a downer. I still have about 400k shares of CTIX and am rooting for Brilacidin to be a success. But it’s not a sure thing. Far, far from that. GLTA