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WPD Pharmaceuticalsa?? Annamycin Received Positive Interim Results From Phase 1/2 Clinical Studies in Acute Myeloid Leukemia

VANCOUVER, British Columbia, Feb. 27, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the a??Companya?? or a??WPDa??), a clinical stage pharmaceutical company is pleased to provide an update on the clinical drug studies of Annamycin in Acute Myeloid Leukemia (a??AMLa??). WPDa??s license partner Moleculin Biotech, Inc, (a??Moleculina??) (Nasdaq: MBRX) disclosed additional positive interim safety and efficacy data from one of the two ongoing open label, single arm Phase 1/2 studies of Annamycin for the treatment of relapsed or refractory AML.Annamycin belongs to the group of anthracyclines, considered one of the most effective groups of oncological drugs. Annamycin was originally developed for the treatment of relapsed or refractory acute AML. Unlike clinically used anthracyclines, Annamycin effectively penetrates cancer cells, regardless of the presence of MDR proteins, while maintaining high safety and lack of cardiotoxicity.The Phase 1 portion of these clinical trials, which are described in more detail later in this press release, is designed to establish the safety of Annamycin and to determine the Recommended Phase 2 Dose to be used in the Phase 2 portion of the trials. While the Primary Endpoint of the Phase 1 portion is safety, a Secondary Endpoint is the assessment of efficacy generally defined as an improvement in bone marrow biopsy results sufficient to qualify patients for a potentially curative bone marrow transplant.The third cohort in Poland receiving a single dose of 180 mg/m2A in the Phase 1 dose escalation portion of the trial was completed with no adverse events and the trial will continue to the next cohort of 210 mg/m2.A  In the US trial, one patient has completed treatment in the second cohort at 120 mg/m2.A  This brings the total number of patients treated and evaluated at or above 120 mg/m2A to 10.A  An additional patient in the US has begun treatment at 120 mg/m2A but has yet to complete post-treatment evaluation.A  The interim results for these 10 patients are 1 CRi (defined as a complete response with incomplete recovery of white blood cells and/or platelets) and 2 partial responses ("PRs" or where bone marrow blasts are reduced 50% and to below 25%).A  One additional patient was bridged to bone marrow transplant ("BT") based on a sufficient reduction in bone marrow blasts, bringing the total to 4 out of 10 patients at or above 120 mg/m2A who have demonstrated efficacy.In the latest cohort in Poland, 1 of the 3 patients treated at 180 mg/m2A had a PR sufficient to qualify for a potentially curative bone marrow transplant. The results for all 3 patients were reviewed by the Safety Review Committee, which determined that no drug-related adverse events were observed that would prevent advancing the trial to the next higher dose level of 210 mg/m2.A  To date in the European trial, only one adverse event related to Annamycin has been reported; a patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days).A  In the parallel US clinical trial, one new patient (the first of cohort #2) achieved a "morphologically leukemia free state" or MLFS, which also constitutes a CRi, after receiving a single dose of 120 mg/m2.
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