The U.S. Food and Drug Administration (FDA) recently approved Cellceutix's Investigational New Drug (NYSE:IND) application for Kevetrin™, the company's novel anti-cancer compound. In addition, the biopharmaceutical company was notified that both the Institutional Review Board (IRB) and the Scientific Review Committee (NYSE:SRC) have approved clinical trial protocol.
The noted FDA-approval authorizes the company to move forward with the phase 1 trial, which will be conducted at Harvard Cancer Center's Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center.
"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," Dr. Krishna Menon, chief scientific officer at Cellceutix stated in the press release. "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."
Among stated objectives of the clinical trial, the company hopes to determine the pharmacokinetics, pharmacodynamics, tolerance, and maximum tolerated dose (NYSE:MTD) of Kevetrin in patients with refractory solid tumors. To achieve these endpoints, Cellceutix will enroll and dose 40 patients in the dose escalation portion of the study.
Once the MTD is established, the company will enroll up to 12 additional patients at the MTD dose level to further evaluate this dosage safety and pharmacodynamics.
For more information visit cellceutix.com
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