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TetraLogic Provides Update on Hepatitis B Clinical Program
July 20, 2015 16:02 ET | Source: TetraLogic Pharmaceuticals
MALVERN, Pa., July 20, 2015 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (NASDAQ:TLOG) a clinical-stage biopharmaceutical company focuses on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today provided an update on the status of its hepatitis B virus (HBV) clinical program.
The company intends to initiate a combination single ascending dose/multiple ascending dose clinical trial, with birinapant as a single agent, in chronic HBV subjects. These subjects will not be taking other antiviral medication.
In the single ascending dose phase of the trial, subjects will be given a single dose of birinapant. The dose of birinapant will be escalated until at least one of the subjects shows evidence of activity, defined as an increase in liver transaminases and/or a decline in circulating viral DNA. At that point the cohort will be expanded and additional subjects will each receive four weekly administrations, at that dose, of birinapant. The starting dose of birinapant will be 2.8 mg/m2.
The company has retained a clinical research organization and currently expects to initiate this trial at multiple sites in India in early 2016. Timing of results will depend upon enrollment rates and upon the cohort in which activity, if any, is seen.
About TetraLogic Pharmaceuticals Corporation
TetraLogic is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases. TetraLogic has two clinical-stage product candidates in development: birinapant and SHAPE. Birinapant is currently being evaluated for the treatment of solid and liquid tumors and certain intracellular pathogens. SHAPE is being evaluated for the treatment of early-stage cutaneous T‑cell lymphoma.
- See more at: http://globenewswire.com/news-re ... thash.wpWktPXU.dpuf
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发表于 2015-7-21 09:38
