Bio-Path Holdings finalizes safety testing in Phase 2 trial targeting AML
Category: #health  By Pankaj Singh  Date: 2019-11-28
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Bio-Path Holdings finalizes safety testing in Phase 2 trial targeting AML

Bio-Path Holdings Inc., a biotechnology company developing novel therapeutics, has reportedly announced the successful completion of safety testing of prexigebersen combined with decitabine in patients with AML (acute myeloid leukemia) and MDS ( myelodysplastic syndrome) in Stage 2 of a Phase 2 clinical trial.

Speaking on the accomplishment, Peter Nielsen, CEO and President, Bio-Path Holdings, said that the company is pleased to have successfully completed this safety testing of Phase 2 clinical trial. With this, the company would move forward to the final efficacy portion of Stage 2 of the Phase 2 trial.

Nielsen added that Bio-Path is amid the process of documentation to submit for approval of the final efficacy portion of the trial. These results encourage the company to develop promising treatment for MDS and AML patients.

The efficacy profile in this testing was encouraging with 50% of patients shown response, including two patients (33%) demonstrated complete responses with inadequate hematologic recovery and one patient (17%) demonstrated partial response. However, the combined prexigebersen and decitabine therapy is not the treatment planned for the final efficacy evaluation of Stage 2 of Phase 2 clinical trial.

Reportedly, in Stage 1 of Phase 2 clinical trial, patients suffering from novo AML were dosed with a combination of LDAC (low dose cytarabine) and prexigebersen, which showed similar safety results and better efficacy as compared to treating disease with LDAC alone.

Meanwhile, the company’s amended Stage 2 of Phase 2 clinical trial would have two groups of patients. The first group of patents comprises untreated AML patients as existed in pre-amended trial and high-level risk MDS patients. The second cohort comprises relapsed /refractory AML patients and high-level risk MDS patients, cite sources.

Bio-Path believes that prexigebersen with its favorable safety and efficacy results has potential to be the best combination candidate with frontline treatment. The approval of the frontline therapy venetoclax has also offered an opportunity to add prexigebersen to the combination with decitabine and venetoclax.

Source Credit - http://www.biopathholdings.com/wp-content/uploads/2019/11/BPTH_pr_20191126.pdf



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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