Beverly, MA — 06/17/13 — Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, announces today that the pharmaceutical tablets for the Company’s clinical trial of Prurisol as a new drug candidate for the treatment of psoriasis have been formulated by Dr. Reddy’s Laboratories and are currently undergoing stability testing. The stability testing is scheduled to be completed in about 45 days.
“We have been advised that stability testing began approximately two weeks ago and that the Prurisol tablets will be shipped to the clinical site in Europe before the end of the 60-day stability research in preparation for the commencement of the clinical trial,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We are enthusiastic about reaching another milestone for our company with the start of second clinical trial. We are very optimistic about the potential for Prurisol to reproduce the laboratory results showing the drug to effectively eliminate all signs of psoriasis.”
Cellceutix also wishes to inform shareholders that it has recently conducted discussions with the University of Bologna regarding Kevetrin, the Company’s novel anti-cancer drug currently in clinical trials at Dana-Farber Cancer Center and Beth Israel Deaconess Medical Center, for the planned clinical trial as a new drug candidate for Acute Myelogenous Leukemia, or AML. All regulatory submissions have been made and the hospital is awaiting Kevetrin reaching its Maximum Tolerated Dose in the trials at Dana-Farber before commencing their trial.
“We are taking a different approach to realize some of the benefits of conducting the clinical trials of both Prurisol and Kevetrin in Europe,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “It is a similar strategy that companies like Clovis Oncology employ to follow European protocol to target a broader, yet more specific, patient population. Through a promising pipeline and efficient development model, Clovis has built an impressive valuation. In our current trials at Dana-Farber, the protocol requires that we only treat Stage IV cancer patients, which presents its own set of unique challenges that can slow research. The good news is we are likely more than half way there in terms of the trial, and we are still increasing dosage. We are very pleased with the results to date especially considering the lower doses to date. With reference to the planned University of Bologna trial, by utilizing protocol where a ‘measurable stage’ of the disease is not required for the patient, i.e., we are not limiting the trial to Stage IV patients, this should allow the trial to go much faster, and hopefully get that perfect “poster”.