Cellceutix Corp (OTCMKTS:CTIX) continues to explode upwards on record breaking volume; over the past 5 years CTIX has done nothing but go up and make spectacular gains for shareholders running from pennies a shares at the start of 2011 to recent highs of $3.50.
While CTIX has already more than doubled this year alone and is up over 10,000% since it started this run years ago most investors in the Company would tell you it’s just getting started!
It is easy to get excited about CTIX here; the Company has not 1 but 2 drugs currently in development that could potentially turn the multi-billion dollar drug-resistant cancers market upside down. Some developments we can expect news on soon including estimated time line to phase 2/3 trials myriad B indications. Start of K UoB trial against AML K cohort 10 decisions and Bottom line B-ABSSSI p2.
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.
Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. 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.
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. Kevetrin has proved to be successful in activating the P53, P21 and also CEA pathways in a pancreatic tumor patient. Results that came from Dana Farber, Kevetrin FDA 1 trial have exponential value when viewed bilaterally with Beth Israel’s Sutent/Kevetrin renal study.
Back in September CTIX updated on its recently completed Phase 2b study of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”).
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The study was a 215-patient blinded trial with four treatment arms and approximately 50-55 patients per arm. Three of the arms evaluated Brilacidin, two single-dose arms and one 3-day regimen, and the fourth arm was daptomycin of once per day for seven days. Daptomycin for injection is marketed by Cubist Pharmaceuticals under the brand name Cubicin(R) and generated approximately $447 million in sales in the first half of 2014.
Dr. Krishna Menon, Chief Scientific Officer of Cellceutix said “We are very excited about the prospect of using a novel class of antibiotics to treat serious infections caused by Staph aureus, including MRSA, and potentially, with a single-dose, Because of the extremely unlikely chance of developing resistance, and the other benefits conferred by a short or single-dose therapy, such as near 100% compliance, we feel Brilacidin is a game-changer in the field of antibiotics for serious and resistant infections.”
Cellceutix is also pleased to announce the submission of an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) to commence a Phase 2 clinical trial of Brilacidin-OM for the treatment of oral mucositis.
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Cellceutix Product 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.
Autism is an area where there is a desperate need for new therapies. There are no drugs currently approved to treat the core conditions of autism. Autism affects as many as 1 in 100 births and takes a terrible toll on the families it affects.
Conclusion: CTIX continues to make impressive gains recently topping $3.20 per share swelling the Company’s total market valuation over the $300 million mark. Cellceutix chief scientific officer Dr. Krishna Menon is on to some really big things here. Kevetrin which has historically been CTIX lead drug candidate on its own could satisfy a multi-billion dollar market let alone the massive potential of Brilacidin.
Brilacidin is a new class of antibiotic to treat serious infections and is considered to be at low risk of developing resistance. It will most likely be the first to market of the CTIX pipeline since it is further along in its trials than either Kevetrin or Prurisol.
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.
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