BEVERLY, MA–(Marketwire – Jun 18, 2012) – Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to announce that since the Food and Drug Administration (“FDA”) conveyed last week that Prurisol™, the Company’s drug in development for psoriasis, would be eligible for a 505(b)(2) designation, progress is immediately being made by the Company toward the goal of filing an Investigational New Drug (“IND”) application to advance Prurisol into late-stage clinical trials.
Cellceutix is organizing data to effectively and efficiently assemble the regulatory filing. Manufacturers have been contacted to synthesize the compound in the required quantities under GMP (good manufacturing practice) guidelines. Further, clinics and hospitals have already been contacted as well to host the Phase 2 clinical studies.
“The Phase 2 study will consist of a significant number of patients across multiple centers,” commented Leo Ehrlich, CEO at Cellceutix. “Our intentions are to pursue a CE mark in Europe at the same time as applying for clearance in the United States, so we are exploring some clinical sites overseas as well to host a portion of the trials. We want to broaden our footprint globally with Prurisol™ should the trials go as we anticipate, so we are working at full speed to make this a successful project in an attempt to receive approval as expeditiously as possible.”
Cellceutix has released the following text from its documentation sent to the FDA.
“Prurisol™, also known as KM-133, has demonstrated significant activity on psoriasis in humanized, xenograft animal models.”
“The efficacy of Prurisol was tested in vivo using a human psoriatic skin xenograft model in SCID mice. Endpoints included: appearance, histology, Psoriasis susceptibility-related RNA Gene Induced by Stress [PRINS, Sonkoly, et al. 2005], and blood levels of IL-20, CD4+ T cells, and CD8+ T cells. Activity was compared to standard therapies of methotrexate (MTX), a folate antagonist which inhibits proliferation of psoriatic cells and efalizumab, an immunosuppressive, recombinant humanized anti-CD11a monoclonal antibody that blocks the activation, adhesion, and trafficking of T-cells used in the treatment of psoriasis.”
“Mice treated with Prurisol showed no reoccurrence of psoriatic lesions during the experiment, whereas animals treated with MTX showed a median reoccurrence of lesions by the 57th day.”
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.