BEVERLY, MA–(Marketwire – Nov 7, 2011) – Cellceutix Corporation (OTCBB: CTIX) (“the Company”), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, is pleased to report that the Company has filed its Investigational New Drug (IND) application for Kevetrin™, a novel anti-cancer drug, with the U.S. Food and Drug Administration (FDA). The Company must now wait 30 calendar days before initiating the clinical trial. During this time, the FDA reviews the data in the IND and determines the conditions under which human trials can commence.
The Phase I trial is planned to take place at Dana-Farber Cancer Institute and its partner hospitals including Beth Israel Deaconess Medical Center. The clinical trial will test Kevetrin™ against a variety of different cancer types in patients with advanced-stage cancers. Primary endpoints for the study will be safety, tolerable dosing levels and establishing the dose for a future Phase II clinical trial.
Cellceutix is focused on developing Kevetrin™ as a new class of chemotherapy for treatment of solid tumors. Mechanism of action studies showed Kevetrin’s unique ability to affect both wild and mutant types of p53, and that Kevetrin strongly induced apoptosis, 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. It is often referred to as the “Guardian Angel of the Human Genome.”
“The filing of the IND represents a historic day for Cellceutix and its shareholders. We cannot possibly express how pleased we are to be making the shift to a clinical stage company,” stated Leo Ehrlich, CEO of Cellceutix.
Alerts: Sign-up for Cellceutix email alerts by visiting:
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.