BEVERLY, MA–(Marketwire – Dec 13, 2011) – Cellceutix Corporation (OTCBB: CTIX) (“the Company”), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, today provided an update on the development of Kevetrin™, the Company’s flagship anti-cancer compound. The U.S. Food and Drug Administration has reviewed the Investigational New Drug (IND) application for Kevetrin™ and advised that the batch formulation is needed to be redone as a result of the ceasing of operations at Formatech, the company that produced the filled vials. Formatech filed for bankruptcy shortly before the IND filing. Cellceutix management has already identified an alternative formulation site with production planned for January 2012.
Additionally, Cellceutix has been approached by the Pioneer Valley Life Sciences Institute, a Baystate Medical Center/University of Massachusetts Amherst Research Partnership (“the Institute”), to collaborate on an innovative research project on Kevetrin™. The Institute wishes to investigate Kevetrin’s antitumor activity related to risk factor aging and, as such, Cellceutix has initiated a major study in collaboration with the Institute.
Kevetrin™ has potent antitumor activity in several wild type and mutant p53 human tumor xenografts. It is well established that aging is a major risk factor for tumorigenesis. As mitochondrial function declines with age, it provides survival advantages to cancer cells. In mitochondrial respiration-deficient cells, p53 levels are reduced to undetectable levels. Since Kevetrin has been shown to be very effective in wild and mutant p53 tumors, it is highly desirable and important to understand Kevetrin’s role in antitumor activity in the context of age-related mitochondrial dysfunction.
This study will provide vital insight and may have a considerable impact on the treatment of tumors associated with mitochondrial dysfunction due to aging. Dr. Nagendra Yadava, a leader in mitochondrial disease and aging, in the Department of Biology at University of Massachusetts Amherst, will initially head the research.
“We have already moved quickly towards manufacturing a new batch of Kevetrin™ for the clinical trials,” commented Leo Ehrlich, CEO of Cellceutix. “It’s a bit of a disappointment that was completely out of our hands. In the grand picture, the remanufacturing will only set us back a short time that we will use to focus on other aspects of development of Kevetrin™ and our other compounds. We have been approached recently by several major universities wanting to research Kevetrin and anticipate more of these joint efforts to be coming in the near term as we continue to associate ourselves with the biggest names in the oncology arena.”