MALVERN, Pa., Dec. 16, 2014 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced that it intends to proceed with the expansion phase of its study in patients with ovarian cancer. The study is being conducted in patients who have failed up to three rounds of prior chemotherapy. In the study birinapant has been dosed twice weekly, 3 weeks out of 4, or 4 weeks out of 4, in combination with Amgen's TRAIL receptor 2 agonist antibody, conatumumab, dosed every 2 weeks. Patients are scanned for disease status after every 8 weeks (2 cycles).
To date eighteen patients have been dosed in the Phase 1b portion of the study. Results thus far suggest a pharmacodynamic interaction between the two drugs, manifested as the appearance of adverse events at lower than anticipated doses. In addition, one patient showed a partial response and two patients have maintained stable disease, one through four cycles of treatment, and one through two. Three additional patients are on study awaiting scans.
Following a review of the data with the investigators, the recommendation is to continue the study, but to reduce the dose of birinapant and to limit dosing to 3 weeks out of 4. TetraLogic intends to continue the study until approximately thirty patients have been enrolled.
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 entering 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.