BEVERLY, MA–(Marketwire – Jun 26, 2012) – Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, is pleased to follow-up on its press release from Friday, June 22, 2012 in which the Company announced that the U.S. Food and Drug Administration (“FDA”) has approved the Investigational New Drug (IND) application for Kevetrin™, Cellceutix’s novel anti-cancer compound. The Phase 1 trials are to be conducted at Harvard Cancer Center’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center.
The Company received notification of clearance to proceed with the clinical trials from the FDA as well as notification of approval of the protocol from both the Institutional Review Board (“IRB”) and the Scientific Review Committee (“SRC”) throughout the day on Thursday, June 21, 2012.
The trial, titled, “A Phase I, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (thioureidobutyronitrile) Administered Intravenously in Patients with Advanced Solid Tumors,” will be conducted for the determination of the pharmacokinetics, pharmacodynamics, tolerance, safety, and maximum tolerated dose in patients with the diagnosis of refractory solid tumors. Approximately 40 patients will be enrolled in the dose escalation portion of study. In addition, once the MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level to further evaluate this dosage safety and pharmacodynamics.
The Principal Investigator for the trial is Geoffrey Shapiro, MD, PhD, Director, Early Drug Development Center and Associate Professor of Medicine, Harvard Medical School.
The primary objectives are the following:
- To determine the maximum tolerated dose (MTD) of Kevetrin.
- To determine the dose limiting toxicities (DLT) of Kevetrin.
- To establish a safe dose level of Kevetrin that can be used for future studies.
- The secondary objectives are to determine the following:
The pharmacokinetics of Kevetrin in humans.
Observe for evidence of antitumor activity following administration of Kevetrin.
If there is a pharmacodynamic relationship between the plasma concentrations of Kevetrin and a clinical/cellular effect.
If Kevetrin induces changes in the biomarker p21 in peripheral blood lymphocytes.
“In many, if not the majority, of instances, approval from the IRB and SRC can take months to receive. For us to be notified the same day as the FDA clearance that the protocol has been approved by the hospital is extremely rare and I believe that shows the commitment to commence the human trials as quickly as possible,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Everything is coming together very nicely and we will now be meeting with the host hospitals regarding the scheduling of patient enrollment and the first doses of Kevetrin™ to be administered.”
To learn more about Kevetrin™ and the potent anti-cancer activity that it has demonstrated across multiple cancer lines, please visit:http://www.cellceutix.com/product-candidates/kevetrin-our-lead-compound.html
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin’s unique ability to affect both wild and mutant types of p53 (often referred to as the “Guardian Angel Gene” or the “Guardian Angel of the Human Genome”) and that Kevetrin strongly induced apoptosis (cell death), 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.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein’s protective function, which Kevetrin appears to be doing the majority of the time.