On October 7, 2014 Bio-Path Holdings reported that it has successfully completed Cohort 6 of its Phase I clinical trial evaluating lead compound, Liposomal Grb-2, in blood cancers (Filing 8-K , Bio-Path Holdings, OCT 8, 2014, View Source [SID:1234500808]). Bio-Path now plans to move the compound into Phase II clinical trials.

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Three patients were evaluated in Cohort 6 of the Phase I clinical trial and this cohort was consistent with previous cohorts in demonstrating that Liposomal Grb-2 is safe and well tolerated with the drug showing signs of anti-leukemia activity. As a result of the safety profile of the drug, a maximum tolerated dose has yet to be reached.

A total of 34 patients, of which 21 were evaluable, enrolled into the Phase I clinical trial, which evaluated escalating doses of Liposomal Grb-2 (5, 10, 20, 40, 60 and 90 mg/m2 ). Patients were treated twice a week for four weeks, for a total of eight doses.

Bio-Path is now completing an analysis of the Phase I data to submit to the U.S. Food and Drug Administration (FDA). It expects to begin its Phase II program by the end of 2014. It is anticipated that the first of three Phase II clinical trials will evaluate Liposomal Grb-2 as a combination therapy in Acute Myeloid Leukemia (AML).

"The completion of Cohort 6 is a significant milestone for Bio-Path and moves the Company into its next phase of development with its novel liposomal delivery technology," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "We will now move this program into Phase II while also extending the Phase I portion to continue testing higher doses since we have not yet reached a maximum tolerated dose."