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TLOG TetraLogic Announces Update on MDS Clinical Program

June 30, 2015 16:01 ET | Source: TetraLogic Pharmaceuticals

MALVERN, Pa., June 30, 2015 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (NASDAQ:TLOG), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today announced preliminary data from the ongoing Phase 2A study of birinapant in combination with azacitidine in first line higher risk myelodysplastic syndromes (MDS). The study is being conducted as a precursor to the ongoing randomized Phase 2B study.

In this study, birinapant was administered, at 13 mg/m2 twice a week, three weeks out of four, during a four week cycle in combination with the approved dose of azacitidine. The primary assessment of efficacy was the response rate using the modified International Working Group criteria (Cheson 2006) at the end of cycle four. Of the nine patients who entered the study, six completed four cycles of therapy and underwent a repeat bone marrow assessment. Three patients experienced a complete response, one patient experienced a bone marrow complete response, one patient experienced a partial response and underwent a stem cell transplant and one patient had stable disease. Three patients discontinued the study prior to receiving four cycles of treatment. The regimen was generally well tolerated, the most common side effects being fatigue, neutropenia and thrombocytopenia.

"While acknowledging the small number of patients involved in the study, we find these data encouraging," said Dr. Lesley Russell, TetraLogic's Chief Medical Officer. "We plan to conduct an interim analysis of the ongoing randomized trial around the end of the year and look forward to reviewing those results."

http://globenewswire.com/news-release/2015/06/30/748742/10140249/en/TetraLogic-Announces-Update-on-MDS-Clinical-Program.html