Phase 2a Trial of p53 Drug Candidate Kevetrin

Phase 2a Trial of p53 Drug Candidate Kevetrin in the Treatment of Platinum-Resistant/Refractory Ovarian Cancer



Cellceutix Corporation:



A small mid-stage study is being initiated at a Texas cancer center which is designed to evaluate Kevetrin for safety, tolerability, as well as assess changes in select biomarkers and objective tumor response. Cellceutix believes that this clinical trial, using IV dosing, will directly inform how Kevetrin modulates the p53 signaling pathway—one of the key questions asked by pharmaceutical companies under Confidential Disclosure Agreement (CDA). Furthermore, as the Company has recently achieved 79 percent bioavailability of Kevetrin by oral administration in animal testing, Cellceutix anticipates being able to subsequently switch to oral dosing in future clinical trials, resulting in more frequent and convenient drug delivery. Bridging toxicology studies are now underway to enable this transition to oral dosing of patients.



The trial, we will be using sophisticated molecular mapping technology to analyze ovarian cancer tissue samples removed from study participants. Such data, complementing that already generated by testing discrete ovarian cancer cell-lines, will anchor Cellceutix’s understanding of Kevetrin’s multimodal mechanism of action, providing a more complete understanding of its full potential as a novel cancer treatment.



About Cellceutix Phase 2a Ovarian Cancer Trial Design



CTIX-KEV-201 is an open-label, Phase 2a study evaluating the safety, tolerability, and pharmacokinetics of Kevetrin as well as changes in select biomarkers and objective tumor response when administered to patients with platinum-resistant/refractory ovarian cancer. The clinical trial comprises two different short-term treatment regimens and will enroll an estimated 10 patients. Primary outcome measures include the incidence of Treatment-Emergent Adverse Events (TEAEs) and changes in pre-specified biomarkers (via tumor biopsy, examination of ascites fluid and peripheral blood), pre-treatment and post-treatment, at 3 weeks. Secondary outcome measures include objective tumor response, per Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) and plasma concentrations of Kevetrin.



For more information on the CTIX-KEV-201 Phase 2a study, please visit:
https://clinicaltrials.gov/ct2/show/NCT03042702