Cellceutix has participated in a meeting with the U.S. Food and Drug Administration (“FDA”) pertaining to our psoriasis compound, Prurisol™. Cellceutix had requested the meeting for guidance on its initiatives to seek a section 505(b)(2) designation for Prurisol™, which would allow the Company to forgo early-stage trials and advance Prurisol™ into later-stage clinical trials.
The FDA informed the Company that a 505(b)(2) application would be an acceptable approach for Prurisol™.
Cellceutix has begun the preparatory work necessary for a Phase 2 clinical trial application for Prurisol™ based upon the FDA guidance.
Cellceutix selected Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”), a New York Stock Exchange-listed company traded under the ticker “RDY,” for the manufacturing of Prurisol™, the Company’s new drug candidate for the treatment of psoriasis.
Dr. Reddy’s has extensive knowledge of this technology and has expressed excitement to work on this project for Cellceutix. Dr. Reddy’s will manufacture Prurisol for oral dosing at levels sufficient for the Company’s planned phase 2/3 clinical trials. Currently in meetings with clinical sites in Europe and the U.S., the Company intends to begin the clinical trials upon completion of the manufacturing.
On November 12, 2012, Cellceutix announced that it 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.
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.
Prurisol is a small molecule with a molecular weight of less than 500 MW. It is synthesized through a five-step process using commercially available starting materials. It is 25% orally bioavailable allowing the potential for oral administration. Prurisol acts through immune modulation and PRINS reduction.
A patent application covering Prurisol was filed in January of 2012.
Prurisol Animal Studies
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. Groups of ten mice were treated with Prurisol orally for 21 days with either 10 mg/kg Prurisol once/day or 10 mg/kg Prurisol twice/day, or with 7.5 mg/kg methotrexate IP once/day for 5 days. The mice were followed for 180 days. Endpoints were skin appearance, histological observations, PRINS expression, and blood levels of IL-20. For these parameters, Prurisol was compared to controls and methotrexate. In a second experiment, groups of 10 immunocompetent CD-1 mice were treated with one or two doses of 10 mg/kg Prurisol daily or 3 mg/kg efalizumab SC once per week for 3 weeks. CD4+ and CD8+ lymphocyte counts were also measured and compared to efalizumab.
Prurisol significantly reduced all psoriatic endpoints measured relative to controls (For a more detailed summary of this study please click here).
A variation of Prurisol in human xenograft model. The top row animals show a relatively clean coat with limited discernibility of psoriasis. The bottom row are the untreated control animals.
By SAR, the lead candidate Prurisol is selected. Prurisol in human xenograft model. The top row animals show a clean coat with no evidence of psoriasis, essentially showing that Prurisol cured the psoriasis in the mice. The bottom row shows the untreated control animals.