Cellceutix Corporation has reported that the Company has filed its Investigational New Drug (IND) application for Kevetrin™, a novel anti-cancer drug, with the U.S. Food and Drug Administration (FDA).
The Company must now wait 30 calendar days before initiating the clinical trial. During this time, the FDA reviews the data in the IND and determines the conditions under which human trials can commence.
The Phase I trial is planned to take place at Dana-Farber Cancer Institute and its partner hospitals including Beth Israel Deaconess Medical Center.
The clinical trial will test Kevetrin™ against a variety of different cancer types in patients with advanced-stage cancers.
Primary endpoints for the study will be safety, tolerable dosing levels and establishing the dose for a future Phase II clinical trial.
Cellceutix is focused on developing Kevetrin™ as a new class of chemotherapy for treatment of solid tumors.
Mechanism of action studies showed Kevetrin's unique ability to affect both wild and mutant types of p53, and that Kevetrin strongly induced apoptosis, characterized by activation of Caspase 3 and cleavage of PARP.
Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA.
p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence. It is often referred to as the "Guardian Angel of the Human Genome."
"The filing of the IND represents a historic day for Cellceutix and its shareholders. We cannot possibly express how pleased we are to be making the shift to a clinical stage company," stated Leo Ehrlich, CEO of Cellceutix.