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Inotek Pharmaceuticals Announces Commencement of Enrollment in Phase 2 Trial on Lead Compound


Posted on: 12/20/2004

Inotek Pharmaceuticals Announces Commencement of Enrollment in Phase 2 Trial on Lead Compound

December 20, 2004 12:55 PM US Eastern Timezone
BIOWIRE2K
BEVERLY, Mass.--(BUSINESS WIRE)--Dec. 20, 2004--Inotek Pharmaceuticals Corporation announced today that it has commenced enrollment in a Phase 2 trial for its lead compound, INO-1001, for the prevention of cardiac necrosis (heart damage) in patients undergoing emergent angioplasty after an acute myocardial infarction. INO-1001 is a potent inhibitor of the nuclear cell death enzyme poly(ADP-ribose) polymerase or PARP. The trial, managed in collaboration with the TIMI Group under the leadership of Dr. Eugene Braunwald, is a placebo-controlled, randomized, single-blind study in 40 patients. The primary endpoint is safety and pharmacokinetics with secondary endpoints evaluating markers of PARP activation and myocyte injury. Enrollment is expected to be completed in the second or third quarter of 2005.

A second INO-1001 Phase 2 trial for this indication is expected to commence in the third or fourth quarter of 2005. This study will be a placebo-controlled, randomized, double-blind trial in the same population of patients, those undergoing emergent angioplasty after an acute myocardial infarction. This trial will evaluate myocardial infarct size as well as safety in over 300 patients.

About INO-1001

INO-1001 is a potent inhibitor of PARP. PARP has been widely studied and is believed to be one of the last effectors in the cascade of cell and tissue damage caused by ischemia and reperfusion injury.

Inotek is studying INO-1001 in a variety of other scheduled procedures that have a high incidence of complications caused by ischemia and reperfusion injury, including high risk cardiopulmonary bypass surgery, certain aortic aneurysm repair surgeries, and prostatectomy (surgical removal of the prostate gland causing a high incidence of post-operative erectile dysfunction). Phase 2 trials for these indications are expected to be conducted throughout 2005 and 2006.

Inotek is also studying INO-1001 as a therapy for the treatment of certain late-stage cancers that are refractory to existing chemotherapy. In the first quarter of 2005, Inotek is expecting to commence Phase 1b trials in glioma and stage IV melanoma patients who have developed resistance to temozolomide.

About Inotek Pharmaceuticals

Inotek Pharmaceuticals Corporation is a private, high-growth, development-stage pharmaceutical company. Inotek has one product in Phase II human clinical development, one product in Phase I human clinical trials and five other products that will enter human clinical trials in the next 6-12 months. Since the firm was founded in 1996, Inotek researchers have been focused on discovering and optimizing small-molecule therapeutics that target mechanisms of cell necrosis, tissue injury and inflammatory disease. The Company's teams of molecular biologists, chemists and pharmacologists have discovered thousands of potent, small-molecule compounds which act on various critical targets associated with cell death, inflammation and vascular dysfunction including nitric oxide, super oxide, peroxynitrite, poly (ADP-ribose) polymerase (PARP), adenosine receptors (A1, A2a and A3), xanthine oxidase and others.

Contacts
Inotek Pharmaceuticals Corporation
Jeffrey T. Walsh, 978-232-9660 x388


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