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Thursday, August 11, 2022

Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) Breaking Out as Biotech Reports Brilacidin Inhibits Omicron, Delta, Gamma and Alpha SARS-CoV-2 Variants Based on In Vitro Testing

Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) is moving steadily northbound with power after the Company reported Brilacidin, its defensin-mimetic drug candidate exhibiting broad-spectrum antiviral activity, inhibited the Omicron and Delta variants of SARS-CoV-2 based on in vitro testing conducted in collaboration with (NIH) and (NIAID) scientists. Researchers at Rutgers University have also shown Brilacidin inhibited in vitro the Gamma and Alpha variants of SARS-CoV-2. Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested, independent of cell type, at generally attainable systemic concentrations (based on established human pharmacokinetics of IV-administered Brilacidin).  

Emerging SARS-CoV-2 variants, and increasingly their sub-variants, contain immunity-evading mutations. These mutations alter key parts of the SARS-CoV-2 spike protein that attach to human cells, making the virus more transmissible and potentially more virulent. Unlike other antivirals, such as monoclonal antibodies, and most vaccines, Brilacidin has been shown not to target the Spike S1 and Spike RBD regions of SARS-CoV-2, acting instead through dual-acting neutralizing and blocking antiviral properties, able to target virus and host. These antiviral traits support Brilacidin’s ability to maintain its anti-coronavirus activity and suggest Brilacidin would be less subject to resistance. Taken together, the results from NIH/NIAID testing of Brilacidin are supportive of previously completed research and give the Company confidence in the compound’s antiviral potential. The Company remains active in pursuing additional government-based funding opportunities, as well as licensing partnerships, to advance Brilacidin in the highly attractive area of developing novel broad-spectrum medicines for treating viral diseases. Microcapdaily has been reporting on IPIX for a long time and we were there when the stock (then trading as CTIX) made a legendary run skyrocketing to $4.93 per share. 

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Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) is a clinical stage pharmaceutical company developing innovative therapies with anti-infective, oncology, anti-inflammatory and dermatology applications. The Company owns the rights to Brilacidin, its lead drug in a new class of compounds called defensin-mimetics, and Kevetrin (thioureidobutyronitrile), its anti-cancer compound. Brilacidin is being studied by the Company, as well as other independent researchers, as a potential broad-spectrum antiviral therapeutic for the treatment of viruses including the novel coronavirus (SARS-CoV-2), which is responsible for COVID-19. 

Brilacidin is Innovation Pharma’s lead drug candidate in its Host Defense Protein (HDP)-mimetic franchise. Brilacidin has been granted Fast Track designation by the FDA and currently is being evaluated in a randomized, placebo-controlled Phase 2 clinical trial in hospitalized COVID-19 patients (see NCT04784897). Two independent Machine Learning (AI) studies also identified Brilacidin as one of the most promising inhibitors of SARS-CoV-2, the virus responsible for COVID-19, based on Brilacidin’s molecular properties. Modeled after HDPs, the “front-line” of defense in the body’s innate immune system, it is a synthetic, non-peptidic small molecule that kills pathogens swiftly, significantly reducing the likelihood of drug resistance developing. Just as importantly, Brilacidin functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. 

Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In most cancers, regardless of origin, type, and location, the p53 pathway becomes inactivated (dysfunctional), thus preventing the body from performing its natural anti-tumor functions. The TP53 gene is the most studied gene of all time. Conducted at the Dana-Farber Cancer Institute and at Beth Israel Deaconess Medical Center, a Phase 1 clinical trial evaluating Kevetrin in treating Advanced Solid Tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response. The Company has concluded its open-label, dose-escalation Phase 2a trial of Kevetrin in Platinum-Resistant/Refractory Ovarian Cancer. Highly encouraging preliminary data from the first patients treated in the trial showed modulation of the p53 protein in response to administration of Kevetrin. With a promising bioavailability profile, and to leverage its short half-life (the drug exits the body in approximately 8 to 10 hours), efforts are underway to develop Kevetrin as an oral anti-cancer agent (tablet or capsule) that can be administered daily, potentially even multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for Ovarian Cancer, Pancreatic Cancer, and Retinoblastoma, qualifying it for developmental incentives and an extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood Retinoblastoma. 

Microcapdaily has been covering IPIX for years starting with CTIX back in 2015 reporting on the stocks legendary run to $4.93 per share. We stated on CTIX back in the day: “As anyone in the industry knows, regulating the p53 pathway has long been the holy grail of cancer research and big pharma has spent hundreds of millions of dollars researching ways to achieve this with no success thus far. It seems Kevetrin(TM) has accomplished this; extensive preclinical research on Kevetrin shows the re-activation of p53 across a wide spectrum of cancer lines including colon, lung, breast and pancreatic cancers. The market potential for Kevetrin in treating drug-resistant cancers is worth $5 billion a year. Other cancers could easily represent an additional $5 billion annually, he adds.”

IPIX has established a valuable intellectual property portfolio: 

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On June 23 IPIX reported Brilacidin, the Company’s defensin-mimetic drug candidate exhibiting broad-spectrum antiviral activity, inhibited the Omicron (B.1.1.529) and Delta (B.1.617.2) variants of SARS-CoV-2 based on in vitro testing conducted in collaboration with National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) scientists. Researchers at Rutgers University have also shown Brilacidin inhibited in vitro the Gamma (P.1) and Alpha (B.1.1.7) variants of SARS-CoV-2. Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested, independent of cell type, at generally attainable systemic concentrations (based on established human pharmacokinetics of IV-administered Brilacidin). Identifying COVID-19 countermeasures with novel mechanisms of action is vital. SARS-CoV-2 continues to evolve at an accelerated pace, raising questions as to what the dominant variant (or sub-variant) may be this fall and winter, when infections often spike — and if today’s COVID-19 vaccines and therapeutics can maintain their effectiveness. 

Emerging SARS-CoV-2 variants, and increasingly their sub-variants, contain immunity-evading mutations. These mutations alter key parts of the SARS-CoV-2 spike protein that attach to human cells, making the virus more transmissible and potentially more virulent. Unlike other antivirals, such as monoclonal antibodies, and most vaccines, Brilacidin has been shown not to target the Spike S1 and Spike RBD regions of SARS-CoV-2, acting instead through dual-acting neutralizing and blocking antiviral properties, able to target virus and host. These antiviral traits support Brilacidin’s ability to maintain its anti-coronavirus activity and suggest Brilacidin would be less subject to resistance. Related, results from new NIH/NIAID in vitro testing of Brilacidin in over 20 acutely infectious viruses, and from the Brilacidin Phase 2 COVID-19 clinical trial, are being prepared for publication. Findings from the Rutgers’ Brilacidin research can be accessed at the link below1 and build on earlier published Brilacidin research conducted by scientists at George Mason University and at University of Arizona and University of California-San Francisco. 

In 2021, the Company completed a Phase 2 clinical trial of Brilacidin (NCT04784897) for treatment of moderate-to-severe COVID-19 patients. While the trial did not meet its primary endpoint in reducing time to sustained recovery through day 29, certain patient subgroups did show treatment benefits of Brilacidin for that primary endpoint. For example, patients treated early from onset of symptoms achieved sustained recovery more quickly (Brilacidin 5-dose group vs pooled placebo, p=0.03). To date, only a modicum of success has been demonstrated by any company conducting clinical trials in moderate-to-severe hospitalized cases of COVID-19. A possible reason for this may be owing to frequent changes in the standard of care with patients receiving a cocktail of fluctuating concomitant medications, which complicates the interpretation of the clinical trial data and that of the new drug candidate being evaluated. Clinical observations of COVID-19 patients treated with Brilacidin further lead us to believe that higher and more frequent dosing of Brilacidin may be more appropriate to tackle this complex disease in the hospital setting. 

Taken together, the results from NIH/NIAID testing of Brilacidin are supportive of previously completed research and give the Company confidence in the compound’s antiviral potential. The Company remains active in pursuing additional government-based funding opportunities, as well as licensing partnerships, to advance Brilacidin in the highly attractive area of developing novel broad-spectrum medicines for treating viral diseases. 

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Currently trading at an $18 million market valuation IPIX has $8.7 million in the treasury, over $11 million in assets vs. $4.5 million in total liabilities. IPIX is CTIX reincarnated and this stock can move skyrocketing to $4.93 per share back in the day; a run we reported on from the beginning. IPIX is heating up and getting noticed by investors after the Company reported Brilacidin, its defensin-mimetic drug candidate exhibiting broad-spectrum antiviral activity, inhibited the Omicron and Delta variants of SARS-CoV-2 based on in vitro testing conducted in collaboration with (NIH) and (NIAID) scientists. Researchers at Rutgers University have also shown Brilacidin inhibited in vitro the Gamma and Alpha variants of SARS-CoV-2. Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested, independent of cell type, at generally attainable systemic concentrations (based on established human pharmacokinetics of IV-administered Brilacidin). We will be updating on IPIX when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with IPIX.

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Disclosure: we hold no position in IPIX either long or short and we have not been compensated for this article.

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