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Bio-Path Holdings admits & doses first acute myeloid leukemia patient in Phase 2 trial of BP1001.

M2 EQUITYBITES-November 3, 2016-Bio-Path Holdings admits & doses first acute myeloid leukemia patient in Phase 2 trial of BP1001


Biotechnology company Bio-Path Holdings (NasdaqCM:BPTH) said on Wednesday that it has dosed the first patient under the efficacy portion of its Phase 2 clinical study of BP1001 for the treatment of acute myeloid leukemia (AML).

The company added that the objective of the Phase 2 study is to further assess the efficacy and safety of BP1001, its lead development candidate and a liposomal Grb2 antisense.

This multicentre Phase 2 clinical trial of BP1001 in combination with low dose cytarabine (LDAC) is evaluating patients with previously untreated AML who are not otherwise eligible for standard or high-intensity chemotherapy regimens or who have elected a low-intensity regimen.

According to the company, the trial is a single arm, open label, two-stage design to assess the safety profile, pharmacokinetics, pharmacodynamics and efficacy of 60 mg/m2 of BP1001 in combination with LDAC compared to historical response rates documented for LDAC alone. The primary endpoint of the study is the number of patients who achieve Complete Remission (CR), including CR with incomplete hematologic recovery (CRi) and CR with incomplete platelet recovery (CRip).

In conjunction, the full trial design includes 54 evaluable patients with an interim analysis performed after 19 patients. In the event the interim results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined thresholds, the company may seek to convert the trial into a registration trial for accelerated approval.

Among the sites registered to conduct the study are Weill Medical College of Cornell University, Baylor Scott & White Health, The University of Kansas and The University of Texas MD Anderson Cancer Center, concluded the company.

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Publication:M2 EquityBites (EQB)
Date:Nov 3, 2016
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