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Re: petemantx post# 22695

Wednesday, 01/30/2013 11:40:43 PM

Wednesday, January 30, 2013 11:40:43 PM

Post# of 402946
The Kevetrin Phase 1 Clinical Trial is run at two of the Harvard Cancer Center affiliates, the Dana-Farber Cancer Institute and the Beth Israel Deaconess Medical Center.

However I haven't seen a specific update to indicate the number of patients between the two locations.

BEVERLY, MA – November 8, 2012– Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to report that dosing of patients is now being conducted in clinical trials with Kevetrin(TM), the Company’s novel anti-cancer drug candidate, at Harvard University’s Dana Farber Cancer Center and Beth Israel Deaconess Medical Center.



And then:

In the clinical trials, being conducted at Harvard University’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center, the cohort which began treatment with Kevetrin early in November has completed the initial cycle.

To date, the group of subjects has been reported to be within normal parameters of the clinical protocol. A total of 84 blood samples from the patients have just been sent to the laboratory for pharmacokinetics analysis. December 3, 2012



And here I see the Institutional Review Board (IRB) is also involved in approving the escalated dosing level. It wasn't clear to me in my prior post if only the Safety Committee was required with this already approved in the protocol, and the IRB only for amendments to the dosing, such as increasing the dose for a prior cohort.

Cellceutix ... announces today that clinical trials being hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center for the Company’s flagship anti-cancer drug Kevetrinä, have advanced to the next cohort. In addition to patients in the first cohort now receiving their second cycle of dosing, the Institutional Review Board (“IRB”) and Safety Committee have approved escalated dosing levels for the second cohort. The Company has been advised that the second cohort will begin dosing during the week beginning December 16.

“We are very encouraged with the way the Kevetrin trials are progressing,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “At this time, we are eagerly awaiting the pharmacokinetics analysis of the first dosing.” Dec 14, 2012



Here we see from the protocol that a cohort is 6 patients.

A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Kevetrin study details provided by Cellceutix on Clinicaltrials



But I haven't seen that there would be 3 and 3 at each hospital. It could be all 6 at one, or split unevenly.
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