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FDA Schedules a Date With Cellceutix (CTIX) on New Psoriasis Drug
4/16/2012 8:05:12 AM
BEVERLY, MA, Apr 16, 2012 (MARKETWIRE via COMTEX) -- Cellceutix Corporation CTIX 0.00% (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(TM) (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(TM) 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(TM) from the FDA, allowing its proposed clinical trials to begin in advanced stages.
"This is another milestone in the advancement of Prurisol(TM) 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(TM) 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(TM) 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(TM) as compared to standard treatments that are rarely demonstrated by a new drug. While we believe our flagship drug, Kevetrin(TM), 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(TM) 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(TM) 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 .
About Psoriasis According to the National Psoriasis Foundation, psoriasis is a chronic, autoimmune disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis is the most prevalent autoimmune disease in the United States, affecting as many as 7.5 million people, or 2.2 percent of the U.S. population, with associated costs of $11.25 billion annually. According to the World Psoriasis Day consortium, as many as 125 million people worldwide (2 to 3 percent of the Earth's population) have psoriasis.
About Cellceutix Headquartered in Beverly, Massachusetts, Cellceutix is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin(TM), is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today's cancer therapies (drug-resistant cancers). Clinical trials are planned at one of the world's most renowned cancer centers in Boston, Massachusetts. Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com .
Safe Harbor Forward-Looking Statements To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission.