CTIX is easily one of the most exciting stories in Penny Stocks!
Cellceutix Corp. (OTC: 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.
Over the past 4 years CTIX has risen from pennies a share to recent highs near $5. Not only is the stock on fire with most investors suggesting this one goes way higher the stock continues to average over a million in daily dollar volume.
OTCMAGIC has been covering CTIX since the stock was just over $0.50 per share back in early 2012 when it had run up from pennies, long before it went into multi dollar land and became one of the top traded stocks on the entire OTCBB exchange.
CTIX lead drug Brilacidin continues to be the major catalyst in recent days after the FDA granted Qualified Infectious Disease Product (QIDP) status to Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). Cellceutix is scheduled to meet with the FDA later this month on a planned Phase 3 trial evaluating the safety and efficacy of Brilacidin for ABSSSI.
Cellceutix Corp (OTCMKTS:CTIX) is an emerging clinical stage biopharmaceutical company based in Beverly, Massachusetts. The Company develops innovative therapies in oncology, dermatology and antibiotic applications. The Company's chief scientific officer, Dr. Krishna Menon 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.
From OTCMAGIC 2012 Article on CTIX ''CTIX is quickly turning into the most exciting story in penny stocks; potentially sitting on the multi-billion dollar drug-resistant cancers market the Company's stock has been making a big move up off the $0.50 base where it sat for most of last summer.
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.''
CTIX flagship is Brilacidin, a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the “front line” of defense in the human immune system and mange suggest Brilacidin could rival Cubist’s (NASDAQ:CBST) Daptomycin as the antibiotic of primary choice.
On December 8 CTIX said ''that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation for Brilacidin as a new treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ahead of its meeting this month with Cellceutix regarding Cellceutix's planned Phase 3 trial of Brilacidin for ABSSSI. Brilacidin, the Company's lead drug in a new class of antibiotics called defensin-mimetics, completed a Phase 2b trial in September showing, amongst other things, a single dose of Brilacidin to be as effective in treatment of ABSSSI as a FDA-approved seven-day dosing regimen of daptomycin.
The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity. ''
CTIX investors know how lucky they are to have Mr. Ehrlich and Dr. Menon running the show. With a Brilacidin phase III trial in 2015 and a truly magnificent drug pipeline opening up the significant short position currently in CTIX has to be seriously concerned, especially after today.
Currently CTIX has over $7 million in the treasury and is fully funded going forward. The stock is just now coming into the price range where they will be noticed by the primary players of biotechnology who could be all over this one. As I have been saying CTIX already looks and feels like a big board stock and is fast outgrowing the bb’s.
Cellceutix Drug Pipeline:
1. Brilacidin – Licensed from the University of Pennsylvania. Brilacidin is the first of a completely new class of antibiotics called defensin-mimetics. The defensin-mimetic antibiotics are modeled after host defense proteins, which are the “front-line” of defense in the human immune system. Cellceutix just completed a Phase 2b clinical trial with brilacidin for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The trial compared three different dosing regimens of Brilacidin (two single-dose regimens and one 3-day regimen) to a standard 7-day regimen of daptomycin, a drug marketed in the United States by Cubist Pharmaceuticals under the brand name Cubicin.
2. Kevetrin™ – CTIX Lead Compound – The Phase 1 trial for solid tumors is at Harvard Cancer Center’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center. The trial is titled “A Phase I, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (thioureidobutyronitrile) Administered Intravenously in Patients with Advanced Solid Tumors,”
3. Prurisol™ Compound – Cellceutix met with the U.S. Food and Drug Administration (“FDA”) pertaining to their psoriasis compound, Prurisol™ The FDA informed the Company that a 505(b)(2) application would be an acceptable approach for Prurisol™ based upon the FDA guidance; Cellceutix has begun the preparatory work necessary for a Phase 2 clinical trial application for Prurisol™ Cellceutix selected Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) for the manufacturing of Prurisol™ Dr. Reddy’s will manufacture Prurisol for oral dosing at levels sufficient for the Company’s planned phase 2/3 clinical trials. In November CTIX announced an agreement with a European Union (EU) clinical site for a Proof-of-Concept (PoC) trial of Prurisol™ The trial, a double blind study, is planned for the first quarter of 2013.
4. Autism Compound – KM-391 is a novel compound being developed for the treatment of autism. CTIX acquired the compound late last year and has been working as rapidly as possible to learn more about its potential for development. All initial research has been very encouraging so far.
Disclosure: we have not been compensated for this article and we hold no share in CTIX long or short.