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Perhaps it’s referring to decimal position?
Loan rangers post:
Member Level
Re: olden_grumpini post# 401522
Thursday, 02/01/2024 11:36:53 AM
That was old news from 2022..... Not now. The new news is from 2/16/2024
This is from 2022 in December. Innovation Pharm was sold 2/16/2024 as per Owler
If I was merk or pfizer, would I want to make an agreement with IPIX for combo drug (after some free testing of course)? If I was Leo, would i be able to sell to both companies: merk for A. fumigatus and pfizer for Mucorales? license different combos for different indications? but maybe i'm big pharma and want BRI all to myself?... What about the eye fungus?
i have no idea on how this works. What are the possibilities?
wow reviewed questions to paper and their responses/alterations/increased research experiments from those questions! pretty cool.
nice to see deGrados name on the paper.
For Viral Infections
i.e. Coronavirus Disease 2019 (COVID-19
one OR more biologically-active agent is selected from an antiviral, such as Brilacidin
AND OTHER anti-IL-6 antibodies, such as Brilacidin
in
aerosol inhalation: gases such as oxygen, hydrogen, nitric oxide, and combinations thereof
Did i just get a tickle in my nose???? hmmmmmmmmm HAPPY INHALER DAY!
please attach link. this mentions aerosol.... you know; THE INHALER!!
Brilacidin[color=red][/color]
COVID-19 (SARS-CoV-2), Additional Viruses
In December 2020, the U.S. Food and Drug Administrations (FDA) approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a randomized, placebo-controlled Phase 2 clinical trial (NCT04784897) of Brilacidin in moderate-to-severe hospitalized patients with COVID-19. Similar regulatory approval was obtained from the Russian Ministry of Health. This Phase 2 clinical trial of intravenously-administered Brilacidin (3- and 5-day dosing) for COVID-19 conducted at sites in the United States and Russia has since completed (n=120). While the trial’s primary endpoint of time to sustained recovery through Day 29 was not met, patients who started study treatment within fewer than 7 days of onset of COVID-19 symptoms achieved sustained recovery more quickly (Brilacidin 5-dose group versus pooled placebo, p=0.03). Other beneficial treatment effects based on the trial’s primary endpoint of sustained recovery were also observed in subgroups of patients with the highest (upper quartile) baseline values for key COVID-19 biomarkers. On two secondary endpoints, more patients treated with Brilacidin (5-dose group) achieved clinical improvement by 10 days as measured by National Emergency Warning Score 2 (NEWS2) criteria, and the mean change from baseline in NEWS2 was greater for Brilacidin treatment groups at all assessment timepoints. Additionally, under compassionate use of Brilacidin in critical cases of COVID-19, where Brilacidin was administered more frequently and over a longer duration than in the Phase 2 trial, investigators reported positive changes to subject status. Pursing a biomarker-driven approach, increasing Brilacidin dosing, targeting different patient populations, testing Brilacidin in combination with other drugs (e.g., remdesivir, given synergistic in vitro data) -- all are areas under consideration for potential future Brilacidin COVID-19 clinical trials pending obtaining government, partnership-based or other financial support. Antiviral data on Brilacidin in non-SARS-CoV-2 viruses has been generated and presented at scientific conferences. Results from the Brilacidin COVID-19 clinical trial, as well as findings from in vitro testing of Brilacidin in multiple viruses, are being prepared for publication.
IBD, Ulcerative Proctitis/Proctosigmoiditis (UP/UPS) study - A Phase 2a trial has previously been completed by the Company, comprised of three sequential cohorts, with progressive dose escalation by cohort: cohort A (6 patients) - 50 mg, cohort B (6 patients) - 100 mg, and cohort C (5 patients) - 200 mg, respectively. Treatment with Brilacidin by daily enema administration was performed for 42 days. The primary efficacy endpoint of clinical remission (accounting for stool frequency, rectal bleeding and endoscopy findings subscores) was met by the majority of patients across the cohorts. Brilacidin was generally well-tolerated. Patient quality of life (as assessed by the short inflammatory bowel disease questionnaire, or SIBDQ) showed notable improvements. Limited systemic exposure to Brilacidin was demonstrated as measured by plasma Brilacidin concentrations. In July 2019, the Company entered into a license agreement with Alfasigma, granting Alfasigma the worldwide right to develop, manufacture and commercialize rectally administered Brilacidin for UP/UPS. Phase 1 studies in healthy volunteers using Brilacidin in a proprietary Alfasigma formulation have successfully completed, and Alfasigma notified the Company in late September 2022 that a Phase 2 multinational clinical trial is estimated to start in 2H2023. There can be no assurance that Alfasigma will meet their estimated timeline.
IBD, Ulcerative Colitis (UC) - Brilacidin has also been developed as a treatment in more extensive forms of IBD. Development of a delayed release oral formulation has been in progress, with development work expanding into immediate release formulations due to unexpected findings encountered. Such findings appear due to the inherent physiochemical properties of the compound, and those of polymers used to achieve delayed release. An immediate release, multi-particulate, capsule formulation has been developed, although further work has since been halted due to instability of that formulation being identified. Hence, further advancement in the indication of ulcerative colitis requires conduct of additional formulation development work prior to Phase 1 testing of that oral formulation. Completion of formulation/analytical development work, clinical trial supply manufacturing, and subsequent progression into clinical trials, are pending securing sufficient drug supply and working capital.
Oral Mucositis (OM) study - In a randomized, double-blind Phase 2 study of Brilacidin for the prevention and control of OM in patients receiving chemoradiation for treatment of Head and Neck Cancer (HNC), Brilacidin (administered three times daily as an oral rinse) markedly reduced the rate of severe OM (WHO Grade ≥ 3), delayed onset of severe OM and decreased duration of severe OM. The Company and the FDA have completed an End-of-Phase 2 meeting concerning the continuing development of Brilacidin oral rinse to decrease the incidence of severe OM in HNC patients receiving chemoradiation. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on severe OM when cisplatin, the preferred chemotherapy regimen in HNC care, is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen.
An optimized oral rinse formulation has been developed, and 12-month stability testing shows it to be stable. Further advancement in the indication of oral mucositis requires additional drug formulation/analytical work, followed by clinical trial supply manufacturing prior to progressing to Phase 3 clinical trials. Given the low price per share of our common stock and the many multiple million dollar costs associated with a Phase 3 program, at this time clinical trial supply manufacturing and Phase 3 clinical trial conduct are delayed, with such activities pending securing sufficient working capital and/or partnership.
ABSSSI - In February 2016, the Company submitted a Special Protocol Assessment (SPA) request, along with a final protocol, to the FDA, for a Phase 3 clinical trial of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). We received from the FDA comments and considerations for incorporation into our study design. Management decided to delay its response to the FDA due to the low price per share of our common stock and the many multiple million dollar costs associated with a Phase 3 program. Our strategy, for now, is to achieve success with other trials and attract partnering opportunities that may provide significant upfront payments and milestone payments, which can then be used to fund the ABSSSI program. We see ABSSSI as the appropriate gateway indication in infectious diseases, enabling potential further studies of Brilacidin’s use for implant coating and biofilm infections.
Antifungal - Recent data generated from independent researchers suggest Brilacidin has potential to be developed as a novel antifungal agent. Brilacidin converted caspofungin from a fungistatic into a fungicidal drug, enabling it to overcome both drug resistance and biofilm formation. Brilacidin exerted, to a lesser degree, synergistic effects with voriconazole in A. fumigatus. Further in vitro testing showed Brilacidin synergized with caspofungin in C. albicans, C. auris and C. neoformans. In an A. fumigatus immunosuppressed mouse model in invasive pulmonary aspergillosis, Brilacidin plus caspofungin cleared infection in the lungs by almost 95 percent, compared to ~50 percent when each compound was administered individually. In an A. fumigatus mouse model in keratitis, compared to control, Brilacidin reduced fungal burden and disease severity, while also improving corneal thickness. Brilacidin also showed in vitro an additive inhibitory effect when combined with posaconazole in several species of Mucorales, the main etiological agents of mucormycosis, commonly referred to as black fungus. Brilacidin further showed potent in vitro stand-alone efficacy in C. neoformans, a major driver of illness in people living with HIV/AIDS. Additional Minimum Inhibitory Concentration (MIC) in vitro testing via a third-party vendor has shown promising Brilacidin activity in other hard-to-treat fungal pathogens.
Expenditures on Brilacidin were $0.3 million and $2.4 million during the six months ended December 31, 2022 and 2021, respectively.
We have no product sales to date and we will not receive any product revenue until we receive approval from the FDA or equivalent foreign regulatory agencies to begin marketing a pharmaceutical product. Developing pharmaceutical products, however, is a lengthy and very expensive process and there can be no assurance that we will complete such development or commercialize such for several years, if ever.
https://www.otcmarkets.com/filing/html?id=16409574&guid=eY7-kFr_DsE_B3h
Business Development and Licensing
The Company is actively engaged in business development and licensing initiatives with specialty and global pharmaceutical companies. The Company may also seek to enter into agreements with other third-party entities for research, development, and commercialization of other types of technologies or products. The goal of these efforts is to diversify and add value to the Company’s assets. From time to time, the Company may be party to various indications of interest and term sheets and participate in preliminary discussions and negotiations regarding potential licensing or partnership arrangements. It remains the Company’s primary objective to complete licensing deals, territorial and/or global, to provide access to non-dilutive capital to advance clinical assets forward in the most expeditious and cost-effective manner. The Company can make no assurance that partnerships will occur, but is committed toward executing on these potential alliance and partnership opportunities.
In July 2019, the Company entered into a license agreement with Alfasigma S.p.A. (“Alfasigma”), granting Alfasigma the worldwide right to develop, manufacture and commercialize rectally administered Brilacidin for ulcerative proctitis/ulcerative proctosigmoiditis (“UP/UPS”). The license agreement provides Alfasigma with a right of first refusal for Brilacidin for the treatment of more extensive forms of inflammatory bowel disease (IBD), such as ulcerative colitis and Crohn’s disease, as well as a right of first negotiation for Brilacidin in other gastrointestinal indications. Phase 1 studies in healthy volunteers using Brilacidin in a proprietary Alfasigma formulation have successfully completed. In late September 2022, Alfasigma notified the Company that a revised clinical development plan for UP/UPS, incorporating regulatory authority feedback, is being enacted. Alteration to treatment duration requires further preclinical research, and the Company has been advised by Alfasigma that a Phase 2 multinational clinical trial conduct is estimated to start in 2H2023. Brilacidin drug substance is manufactured under direction of the Company as part of the licensing agreement with Alfasigma. The Company is eligible to receive $24 million in upfront and milestone payments, and a 6 percent royalty (net sales) upon the successful marketing of Brilacidin for UP/UPS. There can be no assurance that Alfasigma will meet their estimated timeline.
The Company and Fox Chase Chemical Diversity Center, Inc. (“FCCDC”) have a collaborative research agreement related to an antifungal drug discovery program. In exchange for a six percent fee tied to all potential future proceeds, the Company granted FCCDC all discovery, intellectual property and commercialization rights related to its share of this joint antifungal drug program which is for a compound other than Brilacidin. On May 3, 2022, the Company received payment of $18,000 from FCCDC based on FCCDC’s third-party license of this compound. Subsequently, this third party license was terminated in January 2023.
Development Programs
Compound
Target/Indication
Clinical Status
Brilacidin
Oral Mucositis (OM)
Phase 2 Study (completed)
Phase 3 planned, contingent upon sufficient funding
Inflammatory Bowel Disease (IBD)
Phase 2 UP/UPS Proof of Concept Study (completed)
Phase 1 Safety/toleration/PK of oral dosage form (completed)
ABSSSI (Acute Bacterial Skin and Skin Structure Infection)
Phase 2 (completed)
We have no product sales to date and we will not receive any product revenue until we receive approval from the FDA or equivalent foreign regulatory agencies to begin marketing a pharmaceutical product. Milestone payments from our licensee are also dependent on clinical/regulatory milestones. We are actively engaged in business development for partnering Brilacidin. Developing pharmaceutical products, however, is a lengthy and very expensive process and there can be no assurance that we will complete such development or commercialize such pharmaceutical products for several years, if ever. Advancement of our Brilacidin clinical programs is dependent on securing sufficient working capital.
The Company devotes most of its efforts and resources on Brilacidin. We expect to concentrate on product development and engage in a limited way in product discovery, avoiding the significant investment of time and financial resources that is generally required for a promising compound to be identified and brought into clinical trials.
Set forth below is an overview of our most recent research and development efforts on Brilacidin through the date of this Quarterly Report on Form 10-Q:
https://www.otcmarkets.com/filing/html?id=16409574&guid=eY7-kFr_DsE_B3h
Recent Developments
As of the date of this filing, Brilacidin is being studied by independent researchers funded by US Government grants, as a potential broad-spectrum antiviral therapeutic for the treatment of viruses. Additionally, the antifungal properties of Brilacidin are being studied by several academic groups, including NIH/NIAID-affiliated researchers. We anticipate these studies to continue as long as researchers remain positive about the antiviral and antifungal properties and therapeutic potential of Brilacidin and government funding is available.
On November 15, 2022, the Company announced a scientific poster on the antiviral activity of Brilacidin was accepted for presentation at the 2022 Chemical and Biological Defense Science & Technology Conference. Data generated in alphaviruses and bunyaviruses showed that Brilacidin possesses both antiviral and anti-inflammatory properties, reinforcing its potential as a broad-spectrum antiviral.
On November 28, 2022, the Company announced BT BeaMedical Technologies (“BTL”), a company in which it maintains a minority stake, received FDA clearance for its surgical laser family. The BTL technology was cleared by the FDA in five different wavelengths and for soft tissue use in a number of clinical specialties.
On December 13, 2022, the Company reported new in vivo antifungal data showing Brilacidin’s potential for treating fungal keratitis. In an A. fumigatus mouse model, compared to control, Brilacidin reduced fungal burden and disease severity, while also improving corneal thickness.
On January 9, 2023, the Company announced BTL and Shina Systems Ltd., a company specializing in medical imaging software platforms, entered into a definitive strategic agreement. The agreement is intended to accelerate the development, regulatory clearance and commercial deployment of BTL laser technology for brain surgery.
In January 2023, the Company was notified by the United States Patent and Trademark Office (USPTO) that its US Patent Application 16/991812 – Host Defense Protein (HDP) Mimetics for Prophylaxis And/Or Treatment of Inflammatory Bowel Diseases of the Gastrointestinal Tract is allowed for issuance as a patent; Notice of Allowance was issued by USPTO on January 25, 2023.
In January 2023, the Company and University of São Paulo (USP), Brazil, entered into a collaborative research agreement related to investigating the broad-spectrum activity and treatment potential of Brilacidin in fungal diseases. Under terms of the agreement, USP researchers are to conduct pre-clinical efficacy, mechanism, resistance and immunological studies of Brilacidin against Aspergillosis, Cryptococcus and Candida, with USP eligible to receive future royalties should Brilacidin eventually be marketed as an antifungal.
https://www.otcmarkets.com/filing/html?id=16409574&guid=eY7-kFr_DsE_B3h
On April 13, 2022, the Company entered a Patent Assignment Agreement with Fox Chase Chemical Diversity Center, Inc. (“FCCDC”), pursuant to which the Company assigned the title, rights and interest in and to the applications of certain patents in accordance with an earlier collaborative research agreement related to antifungal drug discovery work to which the Company had rights.
On May 3, 2022, the Company received payment of $18,000 from FCCDC based on FCCDC’s third-party license of broad-spectrum anti-fungals and a separate agreement between the Company and FCCDC. Some of the preliminary data used in the FCCDC research program had been obtained as part of an earlier collaboration with the Company supported by funding from the National Institutes of Health.
On January 18, 2023, the Company was notified by FCCDC that its third-party license with Basilea Pharmaceutica for development of broad-spectrum antifungals was terminated by the licensee.
https://www.otcmarkets.com/filing/html?id=16409574&guid=eY7-kFr_DsE_B3h
BRI should really be tested for intavaginal.....
Ummm wow. so true! Goes to show you that what we think, then we believe, then somehow make true as time passes. This conversation is complete BS. Wasting my time....annoying. Thanks for putting me straight. For Gods sake.... WHERE IS MY NASAL SPRAY?! I sure hope its soon.
oh, wait now I see. so Basilea was never testing BRI? Well I"ll be.... what in the world is this inconspicuous medication?
I am missing what you both are seeing. please elaborate to show me. It seems to me Basiliea dumped B. Im not seeing anything besides. is there another antifungal that Basiliea has beside s BRI they could have dumped?
ABSSSI opened the door...lets see if B can keep it open. apparently not for mold?
https://www.basilea.com/news/news/basilea-announces-licensing-of-a-novel-first-in-class-antifungal-program-from-fox-chase-chemical-diversity-center?type=1546938654
LR, eek. They were specifically looking at "the activity against difficult-to-treat mold infections". But I agree with you... its looking like the FOX deal is done.
They do not have rights to the Nasal Spray.... right?
You said:
If that's true there may be an impact on IPIX if they gave the rights back to Fox.
"the company decided to return the program to the licensor"
Will IPIX ever see more than the $18K that their Fox deal already generated?
What other implications to IPIX could this have in your opinion?
hahhahahha add Vision and Patience!
interesting we were "hoping" for the same thing at the same time... ABSSSI and OM... i left out IBD, but yeah, this too!
Happy Holidays for ALL!
Welp, in 2023 we will def have updates on both the Nasal Formulation for Broad Spectrum Anti-Viral Military Countermeasure and on Anti-Fungal Broad Spectrum properties.
Both of these areas are really exciting! Perhaps, if positive news re: either of these, we will also get news that we are able to fund OM ph3 and possibly ABSSSI ph3 in 2023.
I agree, we are close enough to be confident in receiving valuable insight/tangible updates in this upcoming year!
"In collaboration with the NIH/NIAID’s mycology division, Brilacidin also is to be screened in multiple fungal species to further characterize its broad-spectrum antifungal activity. Future updates are planned."
https://www.ipharminc.com/press-release/2022/12/13/innovation-pharmaceuticals-reports-new-in-vivo-antifungal-data-showing-brilacidins-potential-for-treating-fungal-keratitis
"Our observations with brilacidin in the context of acutely infectious viruses support the idea of brilacidin functioning in a broad-spectrum capacity as
a novel antiviral compound. Brilacidin has also undergone several successful clinical studies in acute bacterial skin and skin structure infections. Research and development efforts are focused on identifying optimal dosing strategies to improve brilacidin in vivo effectiveness in the form of a nasally-delivered countermeasure."
https://cbdstconference.com/wp-content/uploads/2022/09/2022CBDSTconference-abstract-363.pdf
I love what Mack said! His lips and fingertips to Gods ears! Then you'll be a Lemoncat drinking lots of sweet lemonade!
"ol' Sourpuss" = Lemoncat?!!!! hahahhaha hysterical! I hadnt ever put that together and im glad i havent because reading this and seeing "ol' Sourpuss"....man. Thanks for this! Brilliant.
eh, not if we are averaging. single penny for me is <.015
hahahahah. love this too! I really appreciate everyone's humor. We got some very funny people on this board!
Really appreciate this! Thank you!! I actually have an e-trade account that i dont use from many, many years ago. Perfect! Thanks!
i really enjoy your witty Rhetoric! If we can't always be positive, which its def. hard to be, at least bringing in the humor lightens the load of frustration. I genuinely LOL to this stuff.
who even cares about the laser savior lights? last PR was pretty go but whateves. i got my sights and smells on the Nasal Spray. Dr. Aarthi Narayanan is bringing the heat. Shes the lead gal, and shes gonna get the poop done! Next week, i am hoping for an updated poster presentation. Perhaps it will say "and now we have optimized dosing and waiting on human subject approval"! OHHHHH MANNNN and so it is!
Pete, I was going to do this and set up a schwab IRA account but got in an email that TD and Schawb are one in the same so now i need another direction. Where would you point me to, if not schwab or TD?
I have to admit, todays PR is very nice. The 510(k) pathway was expedited from what I expected. I read your post today and then saw the PR from today, so all together I got very excited! I totally agree with what you said here and then to see the BeaMed actually moving forward, this maybe how things happen for us!
Then, after what I just said, I read frenchs' post about the publication from friday! It mentions BRIs success and in the same breadth, the seemingly disregard of BRI by the agencies who oversee pharmaceutical advancement.
All of this today is very interesting and my fingers are crossed to what lies ahead.
Yes, Im definitely glad for the this! The researchers have the poster presentation scheduled.
As looking into this other one, I am hoping Leo will make an appearance to network. He should, at minimum, attend to see our competition if he's not gonna chum it up with others and find someone who can help us....
If not attending as a poster presentation, I would hope that Leo goes and networks.... So either way, IPIX. better be there.
I think they should be formulating topical absolutely! Intravaginal, absolutely!! Continue to study Intravenous, ABSOLUTELY!
yes, i did leave out the zero on accident. ugghhhh dont even say it.