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TetraLogic Pharmaceuticals Announces Initiation of a Phase 1/2 Clinical Trial of TL32711 in Patients with Acute Myelogenous Leukemia (AML)


12/5/2011 11:02:04 AM

MALVERN, Pa., Dec. 5, 2011 /PRNewswire/ -- TetraLogic Pharmaceuticals, a biopharmaceutical company developing novel small molecule Smac mimetic drugs to treat cancer, today announced the initiation of a Phase 1/2 clinical trial of its lead Smac mimetic drug candidate, TL32711, in elderly patients with acute myelogenous leukemia (AML). The investigator-initiated study is being conducted at the Hospital of the University of Pennsylvania and is an open-label, non-randomized trial that will evaluate the safety, tolerability and clinical response activity of TL32711 in patients aged 60 years or greater who have relapsed or primary refractory AML.

"In preclinical studies on primary human AML samples, TL32711 inhibits the growth and survival of AML cells as demonstrated in colony forming assays and a xenotransplantation model of the disease," said Martin Carroll, M.D., of the Hospital of the University of Pennsylvania. "These encouraging data along with TL32711's novel mechanism of action support its clinical development for AML where new treatment options are needed especially for the elderly."

"This clinical study represents another important step in advancing TL32711 as a potential treatment for AML and supports our goal of providing improved therapies for patients with cancer," said John Gill, TetraLogic's President and Chief Executive Officer. "The ability of TL32711 to antagonize Inhibitor of Apoptosis Proteins (IAPs) represents a new broadly applicable approach to treat cancers that are normally resistant to therapies, including AML."

About TL32711
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 IAPs. TL32711 has demonstrated preclinical anti-tumor activity that supports its clinical development for solid tumor and hematological malignancies as a monotherapy and in combination with other anti-cancer therapies. TL32711 is nearing completion of a single agent Phase 1 study in solid tumors and lymphomas and a Phase 1b five-arm combination clinical study in solid tumors. In the clinical studies to date, TL32711 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 BioVentures, 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 www.tetralogicpharma.com.

Media Contact:
Russo Partners, LLC
Tony Russo, Ph.D., or Andreas Marathovouniotis
212-845-4251 or 212-845-5235
tony.russo@russopartnersllc.com
andreas.marathis@russopartnersllc.com

TetraLogic Pharmaceuticals
James Goldschmidt, Ph.D.
610-889-9900

SOURCE TetraLogic Pharmaceuticals


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