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Clinical Pharmacokinetic Data on TetraLogic Pharmaceuticals' Lead Smac Mimetic Birinapant Presented at ASCO.

- Birinapant possesses excellent PK profile with dose proportional kinetics -

-- PK of Birinapant remained unchanged when combined with multiple chemotherapy regimens --

MALVERN, Pa. -- TetraLogic Pharmaceuticals, a biopharmaceutical company developing a novel small molecule Smac mimetic drug to treat cancer, today announced that pharmacokinetic (PK) data from its lead investigational drug birinapant was featured at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 1 - 5, 2012 in Chicago, IL. The abstract was selected by ASCO's Scientific Program Committee for presentation in a Poster Discussion Session. Clinical data demonstrates that birinapant has an excellent PK profile with dose-proportional kinetics as a single agent and in combination with standard-of-care chemotherapeutic agents. Birinapant is currently in Phase 2 clinical development for solid tumors, as well as in a Phase 1/2 study in acute myeloid leukemia (AML).

The poster titled "Clinical pharmacokinetics of the Smac mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens" (Abstract# 3029) reported clinical results from 114 patients with advanced malignancies. Dose levels of birinapant, ranging from 0.18 to 35 mg/m2, were administered alone via a 30 minute intravenous infusion (n=30) or in combination with other chemotherapeutic agents at standard dose and schedule including irinotecan, docetaxel, gemcitabine, liposomal doxorubicin and paclitaxel/carboplatin (birinapant was administered approximately 30 minutes after chemotherapy; n=84).

Study Results

Birinapant displayed linear plasma PK across the dose range with no significant accumulation following weekly dosing. The drug has a long terminal half-life for target coverage and low/moderate interpatient variability in clearance. Importantly, birinapant can be co-administered with other chemotherapy regimens without affecting birinapant PK, or increasing chemotherapy-related toxicities. An increase in plasma exposure with paclitaxel/carboplatin was not associated with any change in birinapant tolerability.

About Birinapant

Birinapant (formerly TL32711) is a small molecule peptidomimetic of Smac (Second mitochondrial-derived activator of caspases), an endogenous regulator of apoptotic cell death that selectively antagonizes multiple Inhibitor of Apoptosis Proteins (IAPs). Birinapant has entered Phase 2 clinical development for solid tumors and a Phase 1/2 study in acute myeloid leukemia (AML) is ongoing. In the clinical studies to date, birinapant has been well tolerated and exhibited rapid suppression of IAPs and antitumor activity.

About TetraLogic Pharmaceuticals

TetraLogic Pharmaceuticals is a privately held biopharmaceutical company that focuses on the discovery and development of Smac mimetics, small molecule drugs that mimic Smac (Second mitochondrial-derived activator of caspases) for the treatment of cancers. The company's institutional investors include Clarus Ventures, HealthCare Ventures, Quaker Partners, Novitas Capital, Nextech Invest Ltd, Hatteras Venture Partners, Pfizer Ventures, Latterell Venture Partners, the Vertical Group, Amgen Ventures, and Kammerer Associates. For additional information, please refer to the company's Web site at
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Publication:Business Wire
Geographic Code:1U2PA
Date:Jun 2, 2012
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