SOURCE: Cellceutix

November 12, 2012 07:00 ET

Cellceutix Signs Agreement for Clinical Trial in Europe on New Psoriasis Drug

BEVERLY, MA--(Marketwire - Nov 12, 2012) - 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, reports that the Company has signed an agreement with a European Union (EU) clinical site for a Proof-of-Concept (PoC) trial of Prurisol™, the Company's lead drug candidate for the treatment of psoriasis. The trial, a double blind study, is planned for the first quarter of 2013 and will include patient dosing over a 30-day period with follow up visits over the next 30 days. Cellceutix decided on this protocol after discussions with pharmaceutical industry executives and believes this is the quickest path to evaluate the efficacy of Prurisol in humans with the objective of bringing it to market and creating greater shareholder value.

"Our laboratory research showed Prurisol to visually eliminate all traces of psoriatic tissue in human xenograft models in a short period of time. We are very optimistic that the lab research will be replicated in a clinical setting," said Leo Ehrlich, Chief Executive Officer at Cellceutix. "There are more than 2 million people in the United States that suffer from psoriasis with few effective therapies available. We believe that a new therapeutic bridging that gap could generate sales in excess of $1 billion annually, so we are naturally eager to see the effectiveness of Prurisol in human trials. The pharmaceutical industry bases the value of a new drug on market size and the therapeutic benefit to patients, so we consulted with industry leaders on the most expeditious manner to give them that information. A PoC trial in Europe was the answer. The trials early next year are another milestone for us to continue to build value for our shareholders."

About Prurisol

Prurisol is a small molecule, acting on the principles of immune modulation and PRINS reduction that has been found to be effective against psoriasis in animal models, both in induced psoriasis as well as a xenograft model with human psoriatic tissue. It is 25% orally bioavailable allowing the potential for oral administration. Prurisol was studied in SCID mice that were irradiated then engrafted with human psoriatic tissue by inserting human psoriatic tissue under the skin using a trocar. The results of the research showed that Prurisol significantly reduced all psoriatic endpoints measured relative to controls. More detailed information and images of the animal models can be found at: http://cellceutix.com/prurisol/

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 a publicly traded company under the symbol "CTIX". It 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™, 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). 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.

Contact Information