WPD Pharmaceuticals’ Annamycin Received Positive Interim Results From Phase 1/2 Clinical Studies in Acute Myeloid Leukemia
No evidence of cardiotoxicity to date; 40% of 10 patients dosed at ≥120 mg/m² demonstrate efficacy; trial progresses in Europe to 210 mg/m²
VANCOUVER, British Columbia, Feb. 27, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”), a clinical stage pharmaceutical company is pleased to provide an update on the clinical drug studies of Annamycin in Acute Myeloid Leukemia (“AML”). WPD’s license partner Moleculin Biotech, Inc, (“Moleculin”) (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/m2 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. In the US trial, one patient has completed treatment in the second cohort at 120 mg/m2. This brings the total number of patients treated and evaluated at or above 120 mg/m2 to 10. An additional patient in the US has begun treatment at 120 mg/m2 but has yet to complete post-treatment evaluation. 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%). 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/m2 who have demonstrated efficacy.