BEVERLY, Mass., March 14, 2011 /PRNewswire/ -- Cellceutix Corporation (OTCQB: CTIX) is pleased to announce that Kevetrin™, the Company's flagship compound for the potential treatment of cancers not responding to existing drugs (drug-resistant cancers), has begun production for clinical trials. This was confirmed by Formatech Inc.( Andover , MA) which formulates developmental medications for clinical trials.
"We appreciate being given the opportunity to develop and manufacture Kevetrin™, Cellceutix's first clinical candidate," said Indu Javeri, Ph.D., CEO of Formatech. "We have worked closely with Dr. Menon and his team at Cellceutix over the recent months and we look forward to encouraging results from their clinical trials. We understand that Kevetrin has a unique mechanism of action that could dramatically impact the treatment of multiple cancers. In an industry that produces very few truly novel products, it is refreshing to see a new potential chemotherapy compound like Kevetrin™."
Leo Ehrlich, CEO of Cellceutix, commented, "We are thrilled that the production process is underway. I very much appreciate Dr. Javeri's comments." Mr. Ehrlich continued, "Our lead compound Kevetrin™ is moving forward, and rapidly garnering attention. People are now realizing the results and potential of our hard work. Kevetrin™ has a unique chemical structure; the first in its class of chemistry to be used as an anti-cancer agent. Our preclinical testing results were beyond our best expectations against drug-resistant cancers. Most important of all was the discovery of the p53--Guardian angel--mechanism of action. These factors are quite important as we move towards clinical trials. Should we achieve proper efficacy during the planned clinical trials, we hope that the FDA may grant Accelerated Approval or Priority Review for Kevetrin™. While there are no assurances of success in biotechnology research, at Cellceutix we are enthusiastic about what has been achieved thus far, and believe the best is yet to come."
Accelerated Approval or Priority Review programs by the FDA programs were put into effect approximately twenty years ago specifically for new drugs that provide the best opportunity for a viable therapy in an area of unmet medical need. In these cases, it is to the advantage of all involved to get these compounds to late-stage clinical trials quickly, without sacrificing any safety.
Cellceutix is currently finalizing and reviewing all Investigational New Drug (IND) documentation for submission to the United States Food and Drug Administration, in May 2011.
Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, KM-133, for the treatment of psoriasis, and KM-391, for the treatment of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
Kevetrin, KM133, and KM-391 have not been studied in humans at this time. The Company's positive results in animal studies do not necessarily guarantee success in humans, though they may form the basis for beginning Phase 1 trials.
Formatech, founded in 1993, is based in Andover, Massachusetts. The company provides contract services that deliver unique solutions to product development/manufacturing challenges, including preformulation/formulation development of all common dosage forms, such as lyophilized dosage forms, cell culture/fermentation process development and purification/downstream process optimization. www.formatech.com
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by Cellceutix Corporation are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities.
SOURCE Cellceutix Corporation