MALVERN, Pa., Dec. 18, 2014 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced the initiation of a randomized Phase 2 clinical trial of SHAPE in subjects with early stage cutaneous T-cell lymphoma (“CTCL”).
SHAPE has been evaluated in a randomized, dose escalation, placebo-controlled Phase 1 clinical trial in early-stage CTCL subjects that met safety endpoints and demonstrated clinical activity. Four of fifteen patients receiving SHAPE attained an objective response as measured by a greater than 50% improvement in their Composite Assessment of Index Lesion Severity, or CAILS, score during and after 28 days of dosing. No placebo patients responded.
The randomized Phase 2 trial will be conducted in approximately sixty subjects with Stage IA-IIA CTCL. The objectives of the Phase 2 clinical trial are to evaluate the dose, clinical effect at 6 months (based on CAILS score), time to response, and tolerability of treatment of >2% body surface area.
“We are excited to advance our second molecule into a randomized Phase 2 trial,” said J. Kevin Buchi, President and Chief Executive Officer of TetraLogic. “SHAPE’s Phase 1 data suggests that it may provide significant clinical benefit over existing CTCL therapies, and we are hopeful that those data are replicated over a longer duration and a broader body surface area.”
About SHAPE
SHAPE is an HDAC inhibitor being developed for topical use for the treatment of cutaneous T-cell lymphoma, or CTCL. SHAPE is a novel therapeutic designed to maximize HDAC inhibition locally in the skin with limited systemic exposure. As a result, SHAPE has characteristics that could allow it to be used topically over large body surface areas with minimal systemic absorption. SHAPE’s composition of matter patent in the U.S. extends until at least 2028; in addition, SHAPE has been granted U.S. orphan drug designation for CTCL. We have acquired worldwide development and commercialization rights to SHAPE for all indications.
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 tested in Phase 1 and Phase 2 clinical trials for hematological malignancies and solid tumors, and is also being tested in a Phase 1b/2a clinical trial in hepatitis B. SHAPE is currently being tested in a Phase 2 clinical trial for 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 March 19, 2014 and in our form 10-Q filed with the SEC on November 5, 2014. 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: Company Contact: Pete A. Meyers Chief Financial Officer and Treasurer TetraLogic Pharmaceuticals Corporation (610) 889 - 9900, x103 Pete.meyers@tlog.com Investor Relations Contact: Ami Bavishi Burns McClellan, Inc. (212) 213-0006 abavishi@burnsmc.com
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