Cellceutix Plans for European Funded Leukemia Phase 1 Trial
Kevetrin anti-cancer drug to be tested in combination with compounds from leading pharmaceutical company
BEVERLY, MA – September 10, 2012– Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs for hard to treat diseases, is pleased to announce that it is in discussions with a major university (the “University”) in Europe wishing to conduct clinical trials on Kevetrin™, the Company’s flagship anti-cancer compound. The University, which is ranked in the top ten of universities in Europe by review firm 4 International Colleges & Universities (www.4icu.org) wishes to test Kevetrin™ as a combination therapy for leukemia with drugs proprietary to one of the world’s largest pharmaceutical companies. Pursuant to a confidentiality agreement, Cellceutix cannot identify the University or the pharmaceutical company at this time.
“It seems that the potential of Kevetrin is starting to circle the globe. This University has a distinguished reputation in hematological diseases,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Our patent has been published. Only when a compound looks extremely promising do major pharmaceutical companies and universities approach a smaller company like Cellceutix. This gives us a great sense of confirmation as to the potential of Kevetrin and validation in our beliefs about the possible robust number of indications where it could provide a therapeutic benefit.”
“Effectively, a University sponsored phase 1 clinical trial on blood cancers will save Cellceutix millions of dollars,” added Cellceutix Chief Executive Officer Leo Ehrlich. “We feel that we are in a phenomenal position with our own clinical trials on solid tumors being conducted at Dana-Farber and Beth Israel Deaconess, additional studies on melanoma and renal cancers at Beth Israel Deaconess in combination with Pfizer drugs, and now this prestigious University wishing to host additional clinical trials on blood cancers in combination with drugs from another of the world’s largest pharmaceutical companies. The recent valuations paid for early stage blood cancer therapeutics makes this a very hot segment in biotech and potentially makes the Kevetrin franchise even more valuable.”
Therapies for blood cancers such as leukemia are in great demand because of few viable treatments on the market today and a limited number of candidates showing strong promise in clinical research. Acquisitions this year by major pharmas have demonstrated this demand and value of new compounds. In January, Celgene Corporation acquired Avila Therapeutics in a deal valued up to $925 million. Celgene’s focus of the acquisition was AVL-292 as a treatment for patients with B-cell blood cancers. AVL-292 was in Phase I clinical trials at the time of acquisition.
On August 30, a Johnson & Johnson unit, Janssen Biotech Inc., signed a deal to obtain global license rights to blood cancer compound daratumumab from Danish pharmaceutical group Genmab. All told, the deal could total $1.1 billion for Genmab for a drug that is presently in phase I/II clinical trials.
Rodman and Renshaw Annual Global Investment Conference
Additionally, Cellceutix reports that its CEO Leo Ehrlich and Chief Scientific Officer Dr. Krishna Menon will be presenting a corporate presentation at the Rodman and Renshaw Annual Global Investment Conference’s (14th Annual Healthcare Conference) on Tuesday, September 11, 2012, at 3:40 p.m. Eastern Time at the Waldorf Astoria Hotel in New York City. A live webcast of the presentation will be available at http://www.wsw.com/webcast/rrshq22/ctix. An archived webcast of the presentation will be available on the Investors page at www.cellceutix.com.
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin’s unique ability to affect both wild and mutant types of p53 (often referred to as the “Guardian Angel Gene” or the “Guardian Angel of the Human Genome”) and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein’s protective function, which Kevetrin appears to be doing the majority of the time.
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including Prurisol, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
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To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix’s success are more fully disclosed in Cellceutix’s most recent public filings with the U.S. Securities and Exchange Commission.