MALVERN, Pa., April 21, 2015 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today announced that research describing birinapant's preclinical activity in a mouse model of chronic human hepatitis B virus (HBV) has been published in the journal Proceedings of the National Academy of Sciences.
Cellular inhibitor of apoptosis proteins prevent clearance of hepatitis B virus http://www.pnas.org/content/early/2015/04/15/1502390112.full.pdf?sid=683e56b9-6a97-4370-9add-7a3df97f2f5d
Eliminating hepatitis B by antagonizing cellular inhibitors of apoptosis http://www.pnas.org/content/early/2015/04/15/1502400112.full.pdf?sid=683e56b9-6a97-4370-9add-7a3df97f2f5d
The publication reports preclinical studies performed at the Walter and Eliza Hall Institute of Medical Research (WEHI), Melbourne, Australia in collaboration with TetraLogic Pharmaceuticals. In studies performed by Dr. Marc Pellegrini and his colleagues in mouse models of human hepatitis B, administration of birinapant resulted in loss of HBV-DNA, loss of HBsAg and the appearance of anti-HBsAg antibodies. A second paper describes similar results in mice where the targets of birinapant, cIAP1 and cIAP2, were ablated in the liver ("knock-out mice"). That result provides independent genetic confirmation of birinapant's mechanism of action.
These experiments provided the scientific rationale for TetraLogic's ongoing multiple ascending dose study of birinapant in subjects with chronic HBV. The trial is being conducted in subjects over the age of 18 with chronic HBV who are receiving treatment with either tenofovir or entecavir and who are HBsAg positive. The trial is expected to enroll approximately 6 cohorts of 8 subjects each, who will receive 4 weekly treatments with either birinapant or placebo in a 3:1 ratio. The study is being conducted at multiple clinical sites in Australia. Although predominantly a safety and tolerability study, patients will also be monitored for reductions in HBsAg and formation of antibodies to HBsAg as indications of therapeutic activity.
About Birinapant
Cancer and chronically infected cells are able to evade a critical mechanism by which the immune system normally kills abnormal or genetically modified cells. They do this by upregulating the Inhibitors of Apoptosis (IAP) Proteins. Birinapant (TL32711) is a potent, bivalent SMAC-mimetic that binds with differential affinity to multiple members of the IAP family in order to re-establish the immune system's ability to kill abnormal cells via an extracellular TNF signal. Birinapant has been studied in over 350 patients, and is currently in Phase 1 and Phase 2 trials for Myelodysplastic Syndrome (MDS), Ovarian Cancer and Hepatitis B.
About the Walter and Eliza Hall Institute of Medical Research
The Walter and Eliza Hall Institute of Medical Research is Australia's oldest medical research institute. It is home to more than 750 researchers who are working to understand, prevent and treat diseases including infectious diseases, cancers and immune disorders. It is located in Parkville, Melbourne, and is closely associated with The University of Melbourne and The Royal Melbourne Hospital.
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 February 26, 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.