BEVERLY, MA – November 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.”
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/
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.