Business
Cellceutix Prepares Phase 2a Ovarian Cancer Trial of Kevetrin, a Novel p53-Modulating Drug Candidate, Based Upon Phase 1 Topline Data
Cellceutix Prepares Phase 2a Ovarian Cancer Trial of Kevetrin, a Novel p53-Modulating Drug Candidate, Based Upon Phase 1 Topline Data.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\nCellceutix Prepares Phase 2a Ovarian Cancer Trial of Kevetrin, a Novel p53-Modulating Drug Candidate, Based Upon Phase 1 Topline Data\n\nCellceutix Prepares Phase 2a Ovarian Cancer Trial of Kevetrin, a Novel p53-Modulating Drug Candidate, Based Upon Phase 1 Topline Data\n\nBEVERLY, MA--(Marketwired - August 03, 2016) - Cellceutix Corporation, (OTC: CTIX) (\"the Company\"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to provide topline data on the completed Phase 1 clinical trial of Kevetrin for the treatment of advanced solid tumors, which are among the hardest-to-treat types of cancers. In the Phase 1 study, conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, Kevetrin, which in a preclinical setting has been shown to activate p53 as measured by increased expression of the protein p21, was evaluated following intravenous (IV) administration. Each patient received one dose each week for three weeks across a four-week cycle. The primary objective of this study was to evaluate safety and tolerability of Kevetrin. Secondary objectives were to determine the pharmacokinetic (PK) profile and assess anti-tumor activity of Kevetrin.The Phase 1 dose-escalation study, with dosing amounts ranging from 10mg/m2 to 750mg/m2, met its primary endpoint in showing no clinically significant adverse effects of Kevetrin in patients based on clinical laboratory parameters through all dosing levels and across the duration of treatment. With regards to secondary endpoints, it was determined that Kevetrin has a relatively short apparent biological half-life (less than 2 hr) in plasma. Plasma half-life (T1/2) clearance (CL) and volume of distribution (Vd) suggest that drug elimination predominantly involves hepatic mechanisms and Kevetrin undergoes rapid extensive distribution from systemic circulation into tissues. PK data, as measured by AUC and Cmax levels, further revealed that Kevetrin exhibited a dose-dependent response, has as stated a relatively short half-life (approximately 2 hours) and clears the body within one day -- on average between 8 and 10 hours -- though the drug can remain in the body up to approximately 24 hours, depending upon individual patient variations.When the duration of the tre...