On July 17, 2023 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, reported completion of the first dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1001-A (liposomal Grb2) in patients with solid tumors, including ovarian, endometrial, pancreatic and breast cancer (Press release, Bio-Path Holdings, JUL 17, 2023, View Source [SID1234633254]).
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"We are delighted to have completed the first cohort of this first-in-human Phase 1/1b study of BP1001-A as it further demonstrated the drug’s favorable safety profile, which is critical for the treatment of these very vulnerable cancer patients," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Importantly, this achievement enables us to advance to the second cohort of this important study in solid tumor cancers, for which we hope to complete enrollment by year end 2023."
The dose escalation portion of the Phase 1/1b clinical trial is ongoing at more than eight leading cancer centers in the United States, including The University of Texas MD Anderson Cancer Center, The Mary Crowley Cancer Research Center, and Karmanos Cancer Center. Initially, a total of nine evaluable patients are scheduled to be treated with BP1001-A monotherapy in a standard 3+3 design, with a starting dose of 60 mg/m2 and continuing with 90 mg/m2 and 135 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after successful completion of BP1001-A monotherapy cohorts and will assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors, and BP1001-A with gemcitabine in patients with metastatic pancreatic tumors.
Three patients were enrolled into the first dose cohort of BP1001-A at 60 mg/m2 at three different centers in the study, including one patient with hepatic lesions (and lung metastases) and two with advanced gynecologic lesions. All three patients had undergone extensive previous chemotherapies and/or surgeries for their disease prior to enrollment in this Phase 1 study. No patient experienced any treatment related adverse events or any adverse events deemed related to the study drug.
About BP1001-A
BP1001-A is a modified drug product with the same drug substance as Bio-Path’s lead drug candidate, prexigebersen, but includes formulation enhancements to produce smaller drug nanoparticles. The goal of this product enhancement is to produce smaller drug nanoparticles that can pass through vasculature pore spaces, thereby enabling release of the drug product into the interior of the tumor to enhance drug effectiveness. In preclinical testing in mice, results clearly demonstrated that the reduced size formulation produced a reduction in tumor burden, evidence that the drug product effectiveness was improved with the smaller drug product nanoparticles.