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Sunday, November 27, 2022

Fast Track Designation Sparks Cellceutix Corp (OTCMKTS:CTIX)

Cellceutix Corp (OTCMKTS:CTIX) has seen a long awaited and much welcomed surge in volume and price after the Company announced the FDA granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company’s novel defensin-mimetic Brilacidin for the prevention of oral mucositis.

Over the past 4 years CTIX rose from pennies to a high of $4.93 last December becoming one of the top traded stocks on the entire bb’s before repeated short attacks some featuring SA hit pieces decimated the share price to current levels.

Cellceutix Corp (OTCMKTS:CTIX) is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships.

Cellceutix has just been granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company’s novel defensin-mimetic Brilacidin, for the prevention of oral mucositis. Oral mucositis, a common and often debilitating inflammation and ulceration that occurs in the mouth as a side-effect of certain cancer treatments, afflicts approximately 450,000 patients each year in the United States and can affect the course and outcome of cancer therapy. There are no FDA approved drugs for the prevention of oral mucositis.

Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations.

Cellceutix’s anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction.

It all comes back to Cellceutix 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 CTIX he developed Kevetrin which just received Orphan Drug Designation for the treatment of ovarian cancer.. Kevetrin 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.

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.

If testing is successful, Mr. Ehrlich says 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..

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Earlier this month CTIX announced that based upon ongoing laboratory studies, the Company intends to use docetaxel for the combination therapy arm in the planned Phase 2 clinical trial to treat patients with platinum-resistance ovarian cancer. Cellceutix is designing the multi-arm study to evaluate Kevetrin as a monotherapy and as a component of combination therapy.

In planning the combination therapy arm of the study, several different chemotherapies were tested with Kevetrin. Nude mice were implanted with a human ovarian cancer tumor. After tumors were established, mice were treated with 200 mg/kg of Kevetrin in combination with docetaxel at 15 or 30 mg/kg. Interim findings showed that mice treated with Kevetrin in combination with 15 mg/kg docetaxel exhibited a significant reduction in tumor growth. Kevetrin in combination with 30 mg/kg docetaxel further reduced tumor burden.

On November 25 the FDA granted Fast Track Designation for the Company’s lead drug candidate Brilacidin-OM. According to the release ”In an ongoing Phase 2 trial, Brilacidin-OM is being evaluated for its safety and efficacy in preventing oral mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer. Seven clinical sites and two satellite sites are currently enrolling patients in the trial, with additional sites expected to open enrollment in the coming weeks.”

The FDA established the Fast Track Designation process to facilitate the development, and expedite the review of, drugs that have the potential to treat serious and life threatening conditions and fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to the FDA and could qualify for other programs to expedite development, including priority review and accelerated approval.

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Currently trading at a $186 million market valuation CTIX has $10 million in the treasury, manageable debt and no revenues to date. The stock was the darling of the bb’s all the way to $4.93 share before the shorts took to to the woodshed decimated the share price to lows of $0.941. CTIX looks to be making a big recovery after the Company announced the FDA granted Fast Track Designation for the Company’s lead drug candidate Brilacidin-OM. CTIX is the same exciting story it always has been with several drugs in advanced clinical trials sitting on drugs in development that could potentially turn the multi-billion dollar drug-resistant cancers market upside down. We will be updating on CTIX when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CTIX.

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

 

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