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Cellceutix Provides Update on Developing p53 Drug Candidate Kevetrin as an Oral Anti-Cancer Agent
Cellceutix Provides Update on Developing p53 Drug Candidate Kevetrin as an Oral Anti-Cancer Agent.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n\n BEVERLY, Mass., March 03, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to update shareholders on continuing efforts to develop the oral dosing of Kevetrin.\n Based on positive results from Cellceutix’s Phase 1 trial of Kevetrin in solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, the Company is moving forward with a Phase 2 trial of intravenously-administered Kevetrin in patients with late-stage, platinum-resistant ovarian cancer. Cellceutix has decided to pursue an oral formulation for Kevetrin to improve patient convenience and potentially increase therapeutic efficacy given the drug’s short half-life and other pharmacokinetics, as discussed below. As background, pre-clinical work determined the bioavailability of Kevetrin was 79 percent when given orally in Sprague-Dawley rats. To further establish the efficacy of oral Kevetrin, in vivo mouse studies were carried out in an ascites ovarian tumor model using OVCAR-3 and OV-90 tumor models, both of which possess different mutant p53 genes. Importantly, these pre-clinical results showed that the overall efficacy of Kevetrin was similar across both oral and intraperitoneal routes of drug administration. Cellceutix has initiated a series of GLP (Good Laboratory Practice) studies to assess the safety of Kevetrin given orally. Considering that Kevetrin is a non-cytotoxic drug, our intent, with FDA permission, is to next proceed with a Phase 1 clinical trial in healthy volunteers using the oral route. These studies are being conducted by approved vendors and include: photosafety testing, pharmacokinetics, in vivo metabolism, metabolic stability, protein binding, and genetic and physiological toxicology reports. Preliminary data analyses in a pharmacokinetic study in rats revealed a half-life of approximately 1 hour and a clearance of 78ml/min/kg for both oral and intravenous (IV) dosing. Results of an initial photosafety study demonstrated a molar extinction coefficient value of less than 5 L/mol*cm over a range of wavelengths above 290 nm, well below the 1000 L/mol*cm limit stated in ICH guidelines—indicating K...