On December 7, 2022 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 the enrollment and dosing of the first patient in a 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, DEC 7, 2022, View Source [SID1234624883]).
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"The dosing of the first patient in this study of BP1001-A is an important achievement that brings us closer to delivering this potentially life-saving treatment to patients with solid tumor cancers that have few or limited treatment options," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Solid tumors continue to be a treatment challenge with many therapies failing to provide durable benefit to patients. We are excited and hopeful that BP1001-A will prove to be both safe and effective in fighting these most difficult to treat tumors."
BP1001-A is a modified drug product with the same drug substance as 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.
The dose escalation portion of the Phase 1/1b clinical trial is planned to be conducted at more than six 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. 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.