< 2004 News Listings Inotek Pharmaceuticals Announces Designation of INO-1001 as a Fast Track Product for the treatment of patients with ST elevated Myocardial Infarction Phase II trials to begin in Third Quarter of 2004 BEVERLY, MA June 22, 2004 Inotek Pharmaceuticals Corporation announced today that INO-1001 has been designated a "Fast Track" drug product by the FDA for the treatment of patients with ST elevated Myocardial Infarction (STEMI) undergoing primary Percutaneous Coronary Intervention (PCI). The Fast Track designation follows the acceptance by the FDA of Inotek's Phase II IND to study INO-1001 in human clinical trials for the treatment of STEMI. The multicenter Phase II trial will commence during the third quarter of 2004 and will be conducted through the TIMI Study Group under the leadership of Drs. Eugene Braunwald and David Morrow. INO-1001 is a potent inhibitor of the nuclear cell death enzyme poly (ADP-ribose) polymerase (PARP). Over activation of PARP has been associated with cell death, inflammation and acute disease in a variety of clinical conditions. INO-1001 has previously been designated a Fast Track drug product by the FDA for the prevention of complications in patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair surgery. The Phase II trial for TAAA is expected to commence during the third quarter of 2004. Under the FDA Modernization Act of 1997, the Fast Track Program is designed to facilitate the development and expedite the review of applications for the approval of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. About Inotek Pharmaceuticals Inotek Pharmaceuticals Corporation is a private, high-growth, research-based pharmaceutical company. Since the firm was founded in 1996, Inotek researchers have been focused on discovering and optimizing small-molecule therapeutics that target free radical and oxidant mediated mechanisms of cell necrosis, tissue injury and inflammation. The Company's teams of molecular biologists, chemists & pharmacologists have discovered thousands of potent, small-molecule compounds which act on various critical targets associated with cell death and inflammation including nitric oxide, super oxide, peroxynitrite, poly (ADP-ribose) polymerase (PARP), adenosine receptors, xanthine oxidase and others. Inotek has two products in Phase II human clinical development and six other products that are about to enter human clinical trials. Contact: Jeffrey T. Walsh Vice President, Corporate Development and Commercial Planning Inotek Pharmaceuticals Corporation (978) 232-9660 x388 This news release contains forward-looking statements. Such statements are subject to certain factors which may cause Inotek's plans to differ or results to vary from those expected, including the results of pre-clinical or clinical studies (including termination or delay in clinical programs or inability to move forward to the next Phase of clinical development), the need for additional research and testing, delays in developing or arranging satisfactory manufacturing capability, inability to access capital and funding on a timely basis and on favorable terms, delays in development of or adverse changes in status of commercial relationships, the possibility that favorable results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, dependence on strategic partners for performance of development and commercial matters, the risk that third parties won't agree to license us on reasonable terms their intellectual property necessary for us to develop and commercialize our products, and a variety of other risks.
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