BioPath Holdings announced the U.S. FDA has approved an Investigational New Drug Application (IND) for BP1002 (liposomal Bcl-2). The IND approval was based on preclinical studies which showed BP1002 to be a potent inhibitor against the Bcl-2 target, with a benign safety profile which may enable BP1002 to be combined with approved agents.
A phase 1 trial is planned to evaluate BP1002 in the treatment of refractory/relapsed lymphoma and chronic lymphocytic leukemia. The trial will be conducted at several leading cancer centers, including The University of Texas MD Anderson Cancer Center and the Georgia Cancer Center. Initially, six evaluable patients will be enrolled and treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days.
The trial will be conducted under the direction of Principal Investigator William G. Wierda, M.D., Ph.D. Dr. Wierda is a Professor and Center Medical Director for the Department of Leukemia at The University of Texas MD Anderson Cancer Center. Dr. Wierda also serves as Section Chief – Chronic Lymphocytic Leukemia in the Department of Leukemia at MD Anderson.
BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with relapsed, aggressive non-Hodgkin’s lymphoma.