Bio-Path begins patient dosing in amended Phase 2 Prexigebersen trial

The trial focuses on the effects of Prexigebersen when combined with Decitabine and Venetoclax on AML patients.

Bio-Path Holdings, Inc., a biotechnology company renowned for creating therapeutic nucleic acid anticancer drugs, has recently announced that it has initiated patient dosing in the firm’s amended Phase 2 Prexigebersen trial targeted towards treating AML (Acute Myeloid Leukemia).

According to reliable sources, a key update in the amended Phase 2 study is the involvement of patients with refractory/relapsed AML and high-risk MDS (Myelodysplastic Syndrome). The newly streamlined Phase 2 clinical trial has two groups of patients, first being unsupervised AML patients with the addition of high-risk MDS patients, and the second compromises of relapsed/refractory AML patients and high-risk MDS patients.

Moreover, the amended Phase 2 study will carry on assessing the safety of prexigebersen when combined with decitabine in both groups of patients at a dose of 60 mg/m2. The study will also involve a sum of six evaluable patients for checking the safety of decitabine and prexigebersen.

Reportedly, the company has managed to register five evaluable patients as for now including two patients who are currently undergoing the amended Phase 2 trial and three untreated AML patients who have previously received a therapy before amending the trial.

Furthermore, after assuming an effective completion of the safety assessment, the trials will tweak the testing of both groups of patients by combining venetoclax to the decitabine/prexigebersen combination treatment following which it plans to initiate the efficacy segment of this trial.

Sources cite that it is expected that each group will involve an interim assessment of 19 evaluable patients that would evaluate if the treatment efficacy of the combination of decitabine/ prexigebersen / venetoclax surpasses the efficacy of existing standard-of-care therapy with statistical consequence.

Commenting on the announcement, Peter Nielsen, President and Chief Executive Officer, Bio-Path, said that the company is excited to complete the dosing of the first patient in its amended clinical trial and is assured that the modification made to the protocol will effectively demonstrate the potential of prexigebersen in numerous cancer indications which have limited treatment options.

Source Credit: http://www.biopathholdings.com/wp-content/uploads/2019/08/BPTH_Patient_Dosing_in_Amended_AML_Trial.pdf