NEW YORK, July 15, 2015 /PRNewswire/ --
ACI Association has initiated research coverage on TetraLogic Pharmaceuticals Corporation (NASDAQ: TLOG). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.
Today, membership is open to readers on a complementary basis at the following URL: http://www.aciassociation.com/?c=TLOG
Highlights from our TLOG Report include:
- Preliminary Clinical Trial Data - In a press release dated June 30, 2015, TetraLogic Pharmaceuticals Corporation announced preliminary clinical trial data from the ongoing Phase 2A study of birinapant in combination with azacitidine. The study was conducted in patients with first line higher risk myelodysplastic syndromes (MDS), which is a form of cancer of bone‑marrow stem cells resulting in fewer than normal mature blood cells in the circulation. The study is being conducted as a precursor to the ongoing randomized Phase 2B study.
- Administration of Birinapant during the trial - The Company highlighted that during the study, birinapant was given to nine patients at 13 mg/m2 twice a week in combination with the approved dose of azacitidine for three weeks, during a four-week cycle. The primary assessment of efficacy was the response rate using the modified International Working Group criteria (Cheson 2006) at the end of cycle four.
- Participation of Patients & Response - The Company further informed that out of the nine patients who participated in 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. Although the regimen was well tolerated, certain common side effects such as fatigue, neutropenia and thrombocytopenia were observed among the patients under trial.
- Forward Statement - Dr. Lesley Russell, Chief Medical Officer at TetraLogic stated, "While acknowledging the small number of patients involved in the study, we find these data encouraging. 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."
- Prior Trials on Birinapant - Prior to this, almost over a year ago, TetraLogic Pharmaceuticals conducted its Phase 1b study of birinapant in combination with azacitidine in patients with relapsed/refractory or naïve higher risk MDS, wherein it selected a dose of 13mg/m2 twice weekly for three weeks out of four to be used in its Phase 2 clinical trial. The main objective of the Phase 1b clinical study was to understand the safety and tolerability and determine the recommended phase 2 dose of birinapant when administered in combination with azacitidine, besides evaluating any preliminary indications of efficacy and pharmacodynamics of the combination.
To find out how this influences our rating on TetraLogic Pharmaceuticals Corporation, read the full report in its entirety here: http://www.aciassociation.com/?c=TLOG
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