BPTH announces successful completion of safety cohort in a Phase II in AML.
(I thought the early results in this small study were very impressive, although not emphasized in the PR header.)
Stock up 36% in pre-Market.
April 5, 2021 7:00 AM
BIO-PATH HOLDINGS ANNOUNCES SUCCESSFUL COMPLETION OF SAFETY COHORT OF TRIPLE COMBINATION OF PREXIGEBERSEN, DECITABINE AND VENETOCLAX IN STAGE 2 OF PHASE 2 CLINICAL TRIAL IN ACUTE MYELOID LEUKEMIA
HOUSTON, April 05, 2021 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize ® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced the successful completion of the safety run-in of the Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients. The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.
“We are particularly pleased with the clean side effect profile and lack of toxicity shown in this segment of the study, as our Phase 2 efficacy segment will include de novo fragile AML patients for whom drug side effect profiles are particularly important. We are also very encouraged by the efficacy signals shown in this dataset, with five of six evaluable relapsed, refractory and newly diagnosed AML patients demonstrating clinical activity. These positive signals give us further confidence in the potential for this program in these late-stage and compromised patients,” stated Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings.
“We look forward to advancing this Phase 2 study, as we believe its unique design provides us with several definable registration pathways. We believe that prexigebersen, with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapies,” concluded Mr. Nielsen.
In the safety run-in, six evaluable patients were treated with the combination of prexigebersen, decitabine and venetoclax. These patients included four relapsed/refractory AML patients, and two newly diagnosed AML patients. In the preliminary safety data review, five of the patients (83%) responded to treatment, including four (67%) achieving complete response (CR) and one (17%) complete response with incomplete hematologic recovery (CRi). CR rates to combination treatment with decitabine and venetoclax for relapsed/refractory AML patients is 42-52% 1,2 and 0-39% 1,2 for relapsed/refractory secondary AML patients. Response rates to frontline treatment decitabine and venetoclax for newly diagnosed AML patients is 62-71% 3 ,4 . These preliminary data showed the treatment was well-tolerated and there were no dose limiting toxicities attributed to prexigebersen. Three patients remained on treatment for more than one cycle.
Stage 2 of the Phase 2 clinical trial has three treatment cohorts, which the Company believes provides for several potential regulatory pathways. The first two cohorts will treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes newly diagnosed AML patients and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort treats relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.
The Phase 2 clinical trial continues with 21 patients currently enrolled across all three cohorts. Enrollment of 19 patients in each cohort should enable a data review to determine if there is a comparative increase in efficacy versus the decitabine and venetoclax combination therapy sufficient to support petitioning the FDA for approval to switch to breakthrough therapy for accelerated approval. The Phase 2 trial will be conducted at up to ten clinical sites in the U.S. For more information on the Phase 2 study, visit www.clinicaltrials.gov .
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