Cellceutix Corp (OTCMKTS:CTIX) has seen a massive surge in volume and price in recent days after wallowing away for less than $1 for several months hitting a low of $0.9412.. The move comes after CTIX announced the conclusion of the last patient visit in its randomized, double-blind Phase 2 trial of orally-administered Prurisol for the treatment of mild to moderate chronic plaque psoriasis. The unblinding of the study and top-line data is expected to be available in May. Although the data is still blinded, there were no safety items of concern.
CTIX is the biotech that rose from pennies to a high of $4.93 last December before the whole thing collapsed. Mako Research published a number of false and misleading hit pieces on Seeking Alpha that are now subject to an ongoing lawsuit as Mako has gone dark.
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 was 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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On August 6 of last year Mako Research disclosing they were short published the first of a number of false and misleading hit pieces on CTIX claiming ”Cellceutix: Empty Office, Unviable ‘Science’, Misleading Disclosures, 96% Downside” The articles claimed that Cellceutix’s pipeline of drugs in clinical trials are ineffective and the company is essentially without worth. Over the next 6 weeks Mako Research published 5 more articles on Seeking Alpha all with the aim of decimating CTIX share price before the outfit went dark with the last article published on September 23, 2015.
The Mako Research articles were effective, especially the first one on August 5 causing a sharp drop in CTIX’s share value. Later that day the Rosen Law Firm of NYC announced it is investigating potential securities claims on behalf of shareholders of CTIX resulting from allegations that Cellceutix may have issued materially misleading business information to the investing public. It stated that CTIX had misrepresented the efficacy of its drug candidates Brilacidin, Kevetrin, and Prurisol.
In November 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.”
On March 17 CTIX announced it has concluded the last patient visit in its randomized, double-blind Phase 2 trial of orally-administered Prurisol for the treatment of mild to moderate chronic plaque psoriasis. The unblinding of the study and top-line data is expected to be available in May. Although the data is still blinded, there were no safety items of concern.
CEO Leo Ehrlich said “We eagerly await the Phase 2 results for Prurisol, now less than two months away. We do significant laboratory research before engaging in a trial. That may be a reason why we have successfully completed three different studies on three very different compounds. The need for newer, non-biologic drugs, especially those that are easily-administered and well-tolerated for hard-to-treat psoriasis, is considerable. AbbVie’s recent $595 million deal with Boehringer demonstrates the level of interest among large pharmaceutical companies in novel psoriasis treatments. Outside of Celgene’s blockbuster Apremilast (Otezla), a drug expected to generate over $1 billion annually, only a handful of orally-administered drugs currently are in the pipeline for psoriasis. Prurisol is now one step closer to the goal line. We look forward to sharing the Prurisol trial results once they become known to us.”
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Currently trading at a $187 million market valuation CTIX has $6 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 led by Mako Research took it to the woodshed decimated the share price to lows of $0.941. 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. The Company also recently announced the FDA granted Fast Track Designation for the Company’s lead drug candidate Brilacidin-OM as well as the conclusion of the last patient visit in its randomized, double-blind Phase 2 trial for Prurisol with top-line data expected in May. 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.