BEVERLY, MA–(Marketwire – Apr 16, 2012) – Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a biopharmaceutical company developing small molecule drugs to treat severe medical conditions including drug-resistant cancers, announced today that it has received a response from the Food and Drug Administration (“FDA”) related to its pre-IND submission and meeting request on Prurisol™ (also known as KM-133), the Company’s compound in development as a novel treatment for psoriasis. The FDA has confirmed mid-June 2012 for a pre-IND meeting focused on Prurisol™ to offer guidance on the Cellceutix initiatives to advance development of this new drug for treating psoriasis. In March 2012, Cellceutix submitted documentation in support of a meeting with the FDA for guidance to attain approval for a section 505(b)(2) designation for Prurisol™ from the FDA, allowing its proposed clinical trials to begin in advanced stages.
“This is another milestone in the advancement of Prurisol™ as we are hopeful that we will be able to take it directly into a Phase 2/3 clinical trial based on its active moiety already being approved by the FDA,” said Cellceutix Chief Executive Officer Leo Ehrlich. “The market potential for an effective psoriasis treatment that outperforms today’s therapies is significant and could possibly generate billions of dollars annually. Big pharma had seen the pictures that we had posted on our website and requested data. That resulted in the signing of Non-Disclosure Agreements related to Prurisol™ with some of the world’s largest pharmaceutical companies. The meeting with the FDA is now a critical step for Cellceutix to advance this drug to clinical trials with the goal of bringing this drug to market.”
Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, added, “For most developmental companies, Prurisol™ would be a lead drug candidate based on its composition, the strong research data that we have collected and the great need for a new drug for psoriasis. Our research of human xenografts in mouse models shows the type of stark differences in treatment with Prurisol™ as compared to standard treatments that are rarely demonstrated by a new drug. While we believe our flagship drug, Kevetrin™, which has attracted so much attention by showing it can re-activate p53 to destroy cancer cells, has greater market potential, Prurisol should not be underestimated as in preclinical studies it too has shown significant qualities that can make it an important drug for Cellceutix. Cellceutix is in a very fortunate position now with two breakthrough drugs in the regulatory process. By advancing Prurisol™ to this stage, we are increasing our leverage in the industry as we continue to strive to make Cellceutix the most exciting pharmaceutical company today.”
Cellceutix has previously disclosed images of mice treated with Prurisol™ demonstrating its effectiveness as compared to methotrexate, a standard care treatment for psoriasis today. More information on Prurisol and those images can be found at:http://www.cellceutix.com/product-candidates/km-133—psoriasis-compound.html.