Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) has seen a highly explosive move up after the Company announced it signed a non-binding term sheet with a global pharmaceutical company to develop and commercialize locally-administered Brilacidin on a worldwide basis, for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis. The non-binding term sheet also includes a Right of First Refusal for rights to Brilacidin for the treatment of more extensive forms of Inflammatory Bowel Disease, such as Ulcerative Colitis and Crohn’s Disease, and a Right of First Negotiation for rights to Brilacidin in other Gastrointestinal (GI) indications.
Completion of the transaction, as specified in the non-binding term sheet, is subject to further negotiation and execution of a definitive agreement. If the definitive agreement is reached and signed, the Company anticipates that it would receive an upfront payment, plus potential additional regulatory and commercial milestone payments, as well as royalties.
Everyone remembers the historic run this one made several years back. MicroCapDaily has been covering this Company since 2014 when we reported “Cellceutix Corp (OTCMKTS:CTIX) is one penny stock that has got everyone’s attention. Not only does CTIX continue to lead the OTCBB in volume and gains the Company is sitting on drugs in development that could potentially turn the multi-billion dollar drug-resistant cancers market upside down.
Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.
A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infections.
Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations, and has successfully completed a Phase 2 trial in ovarian cancer. Prurisol, an oral psoriasis drug candidate acting through immune modulation and PRINS reduction, has now completed a Phase 2b trial and is awaiting statistical analysis.
It all comes back to IPIX chief scientific officer, Dr. Krishna Menon; the man is a real whiz; he played key roles in developing two blockbuster cancer drugs; Gemzar and Alimta for Eli Lilly & Co.(NYSE:LLY) back in the late 90’s. For IPIX he developed Kevetrin which is successful in regulating the p53 pathway that has long been the holy grail of cancer research and big pharma. Industry leaders spent hundreds of millions of dollars trying to achieve what Dr. Krishna Menon has achieved with Kevetrin.
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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.
About Brilacidin for IBD: Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 10 million people worldwide, including 3 million people in the U.S., with 70,000 newly diagnosed cases each year. World IBD Day occurs on May 19, every year, to raise awareness about this common condition. The overall GI market sector is estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022. Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation plans including oral tablets for Ulcerative Colitis and Crohn’s Disease, and foam and/or gel for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of IBD. As released previously, a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring) in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. In addition, mucosal healing was evidenced by endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. In late 2018, the Company presented a scientific poster—Brilacidin for Inflammatory Bowel Disease (available for download here, pdf)—at the inaugural “IBD Innovate 2018” conference, hosted by the Crohn’s & Colitis Foundation. Brilacidin may be particularly beneficial in treating IBD due to: 1) its ability to inhibit Phosphodiesterase 4 (PDE4), which is being pursued as a novel therapeutic avenue in IBD; and 2) its potential to compensate for defensin deficiencies that are implicated in the pathogenesis of IBD.
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Currently trading at a $38 million market valuation IPIX has $2.4 million in the treasury, over $8 million in debt and no revenues to date. IPIX was the darling of the bb’s all the way to $4.93 a share back when it was trading as CTIX and before the shorts led by Mako Research took it to the woodshed. From current levels IPIX couldn’t be more exciting; the stock is at rock bottom prices and moving up fast. IPIX is an exciting company with several drugs in advanced clinical trials that could potentially turn several multi-billion dollar markets upside down. 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 a