Tracleer and PPH News Predix Pharmaceuticals Initiates Phase I Clinical Trial of 5-HT2B Receptor Antagonist for Pulmonary Hypertension WOBURN, Mass. & RAMAT GAN, Israel--(BUSINESS WIRE)--May 3, 2005--Predix Pharmaceuticals, a drug discovery and development company, today announced the initiation of Phase I first in human studies with PRX-08066, its highly selective, proprietary 5-HT2B receptor antagonist for the treatment of pulmonary hypertension (PH) and hypoxia-induced PH syndromes caused by chronic obstructive pulmonary disease and mountain sickness. This drug candidate is the third compound Predix has discovered and advanced into clinical development in less than three years. As a selective 5-HT2B antagonist, PRX-008066 has the potential to act both as a vasodilator of pulmonary but not systemic blood vessels, and as a disease-modifying agent to slow the progression of the disease. The primary objectives of the Phase I study are to evaluate the safety and tolerability of the compound and to obtain pharmacokinetic data in humans. "There currently exists a significant market need for additional PH therapies that can be used alone or in combination which do not reduce patients' systemic blood pressure, are not associated with liver toxicity issues, and which can slow disease progression" said Silvia Noiman, Ph.D., founder, senior vice president of pipeline management and general manager in Israel for Predix. "To address this need, Predix Pharmaceuticals has moved rapidly from biological proof of concept, which demonstrated the activation of 5-HT2B receptors as a limiting step in the development of PH, to the initiation of Phase I trials." Christine H. Wang, vice president of drug development operations, added, "Predix is able to move rapidly from discovery to clinical development because of our dedication to operational excellence and commitment to teamwork. Our organization is empowered to make decisions and take rapid action to ensure the highest levels of quality throughout our drug discovery and clinical development efforts. Our program teams never lose sight of our ultimate goal: to develop safe and effective drugs that will benefit patients." About Pulmonary Hypertension Pulmonary hypertension (PH) is a progressive, debilitating and often fatal disease that results from an increase in pulmonary blood pressure associated with abnormal vascular proliferation. PH is estimated to affect 100,000 people worldwide. Current treatments include systemically administered intravenous and subcutaneous prostacyclin analogs and orally active endothelin receptor antagonists, which mainly cause pulmonary arterial dilation to relieve symptoms. There is only one approved orally active agent for PH available for patients, a non-specific endothelin A and B receptor antagonist which requires liver toxicity monitoring. Recent industry research estimates the global market for PH to be under-penetrated, and is expected to grow from approximately $600 million in 2004 to over $1 billion in 2007. The Role of 5-HT2B Receptor Antagonists 5-HT2B receptor antagonists have the potential to be selective for diseased pulmonary vasculature (i.e., vessels affected by hypoxic conditions) compared to normal pulmonary and systemic vessels. Due to this selectivity, 5-HT2B antagonists offer a possible therapeutic advantage over the available agents for the treatment of pulmonary hypertension. About Predix
Predix is a privately held, clinical stage drug development company that uses a proprietary discovery and lead optimization system to develop drugs for G-protein coupled receptor (GPCR) and ion channel targets. Over the past two and a half years, the company has discovered several novel drug candidates, three of which are now in human clinical trials. Predix has completed three Phase I trials and initiated a Phase II trial with PRX-00023, a 5-HT1A receptor agonist for anxiety and depression, as well as initiated Phase I trials with PRX-03140, a 5-HT4 receptor agonist for Alzheimer's disease and cognitive impairment, and a Phase I trial with PRX-08066, a novel 5-HT2B antagonist for pulmonary hypertension and other hypoxia-associated diseases. For more information on Predix, please visit www.predixpharm.com.
Contacts
Predix Pharmaceuticals
Chris Hayden, 781-376-0821, ext. 1010
Sheryl Seapy, 949-608-0841
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