March 31, 2011
, a biopharmaceutical
company focused on discovering and developing small molecule drugs to treat severe medical conditions including drug-resistant cancers,
is pleased to announce that additional research has been concluded on Kevetrin™, the Company's flagship cancer compound. Kevetrin was shown to increase levels of p21, a key protein responsible for cell cycle arrest, in the lymphocytes of mice. Cellceutix will be incorporating the p21 assay into its Investigational New Drug application scheduled to be filed with the Food and Drug Administration in approximately six weeks (
). If the data are duplicated in human studies, p21 as a biomarker will be another major step forward in cancer research for Kevetrin™, which has already been shown to be a non-genotoxic drug that reactivates p53; a major development of its own.
, Chief Scientific Officer for Cellceutix, commented, "There has been a big movement in oncology research to establish new biomarkers as they are an earlier measure of activity in the body's cells. p21 has been proven to play a critical role in cell cycle arrest leading to cell death. No one has been able to validate it as a biomarker, to the best of our knowledge, so this will be a major event not only for Cellceutix, but for the cancer clinical trials." Dr. Menon continued, "Increased levels of p21 are not only a predictor of cell death, but a benchmark in judging effectiveness of Kevetrin™. Our pre-clinical research on p21 has met its endpoints and we are optimistic that the upcoming human trials will yield similar results."
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
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.