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.
Forward Looking Statements
Some of the statements in this release are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events or TetraLogic’s pre-clinical and clinical development of birinapant, SHAPE and other clinical programs, future expectations, plans and prospects. Although TetraLogic believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. TetraLogic has attempted to identify forward looking statements by terminology including ''believes,’' ''estimates,’' ''anticipates,’' ''expects,’' ''plans,’' ''projects,’' ''intends,’' ''potential,’' ''may,’' ''could,’' ''might,’' ''will,’' ''should,’' ''approximately’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 26, 2015 and in our Form 10-Q filed with the SEC on May 14, 2015. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACT: Pete A. Meyers Chief Financial Officer and Treasurer TetraLogic Pharmaceuticals Corporation (610) 889-9900, x103 pete.meyers@tlog.com
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