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Predix Pharmaceuticals Initiates Phase II Clinical Trial In Patients With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

Posted on: Monday, 7 August 2006, 09:00 CDT

Predix Pharmaceuticals, which recently announced a definitive agreement to merge with EPIX Pharmaceuticals (NASDAQ:EPIX), announced today that it has initiated a Phase II clinical trial to evaluate the short-term efficacy and safety of PRX-08066, a serotonin 5-HT2B antagonist, in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).

"We hope to build on the promising results seen in our recently completed Phase Ib trial, where adults conditioned to exercise at high altitudes that were given PRX-08066 experienced a statistically significant reduction in systolic pulmonary blood pressure during exercise-induced hypoxia," said Michael G. Kauffman, M.D., Ph.D., president and CEO of Predix Pharmaceuticals. "There are currently no approved drugs to treat PH associated with COPD, and based on our promising Phase I data, we believe PRX-08066 may benefit patients suffering from this disease."

Trial Design

The randomized, double-blind, placebo-controlled Phase II trial is expected to enroll approximately 72 patients with PH associated with COPD. The primary endpoint of the trial is to assess the effect of PRX-08066 compared to placebo on systolic pulmonary artery pressure in patients with PH associated with COPD following two weeks of treatment. The trial will also assess the safety and tolerability of PRX-08066 during the course of therapy.

About PRX-08066

Discovered and designed using its PREDICT(TM) proprietary G-protein coupled receptor (GPCR) modeling and optimization technology, Predix is developing PRX-08066 to provide both symptomatic improvement - through selective dilation of diseased pulmonary blood vessels - and to also slow disease progression - by inhibiting the thickening of the pulmonary artery vessels. Predix believes PRX-08066 is the first 5-HT2B selective antagonist under development for pulmonary arterial hypertension (PAH) and pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease. The 5-HT2B receptor represents a novel target for the treatment of pulmonary hypertension, as it has been linked to both pulmonary vasoconstriction, as well as the smooth muscle hypertrophy found in pulmonary vessels during pulmonary hypertension of various types.

Predix has completed three Phase I clinical trials of PRX-08066 in healthy volunteers, including a Phase Ib trial in athletes conditioned to exercise at high altitudes whose pulmonary artery pressures were increased by breathing a gas with a reduced oxygen level. The results of the Phase Ib trial indicated that PRX-08066 significantly reduced the increase in pulmonary artery blood pressure during hypoxic exercise, without affecting systemic blood pressure. Predix is also exploring other potential indications targeting the 5-HT2B receptor, such as the treatment of irritable bowel syndrome and other diseases in which this receptor may play a key role.

About Pulmonary Hypertension

High blood pressure in the arteries that supply the lungs is called pulmonary hypertension. There are several types of pulmonary hypertension (PH). Pulmonary arterial hypertension (PAH) is a serious, often fatal cardiovascular disease characterized by elevation of pulmonary artery blood pressure and progressive thickening and narrowing of the blood vessels of the lungs, which can lead to heart failure. Like other heart failure syndromes, symptoms of PAH include fatigue after minimal exertion, dizzy spells, chest pain, shortness of breath and fainting. Predix believes that PAH afflicts nearly 60,000 people in the United States and 146,000 combined in the United States, Europe and Japan. According to Datamonitor, the global market for PAH drugs is growing rapidly, from over $800 million in 2005, to an estimated $1.8 billion in 2010, as more patients with PAH are diagnosed and initiated on drug therapy.

Another form of PH is associated with chronic lung diseases such as chronic obstructive pulmonary disease (COPD). According to Datamonitor, PH is estimated to be present in approximately 15-20% of patients who have COPD, a progressive lung disease affecting nearly 30 million people worldwide which is characterized by airflow obstruction that interferes with normal breathing and impairs the ability to exercise and perform daily activities. There are currently no approved drugs for the treatment of PH associated with COPD.

About Predix Pharmaceuticals Holdings, Inc.

Predix, based in Lexington, MA, is a pharmaceutical company focused on the discovery and development of novel, highly selective, small-molecule drugs that target G-Protein Coupled Receptors (GPCRs) and ion channels. Using its proprietary drug discovery technology and approach, Predix has advanced four internally-discovered drug candidates into clinical trials and has five additional programs in preclinical development and discovery. Predix is expected to complete the first of at least two pivotal Phase III clinical trials for generalized anxiety disorder for its lead drug candidate, PRX-00023, in the second half of 2006. In addition to PRX-00023, Predix has three other clinical-stage drug candidates: PRX-03140 for the treatment of Alzheimer's disease, which is expected to enter Phase IIa later this year; PRX-08066 for the treatment of pulmonary hypertension (PH) and PH associated with chronic obstructive pulmonary disease, which recently entered a Phase II trial; and, PRX-07034, which recently entered a Phase I trial and is expected to be developed for the treatment of obesity and also cognitive impairment associated with Alzheimer's disease or schizophrenia. Additional information about Predix can be found on the company's website at www.predixpharm.com.

About EPIX Pharmaceuticals, Inc.

EPIX Pharmaceuticals, Inc., based in Cambridge, MA, discovers and develops innovative pharmaceuticals for imaging that are designed to transform the diagnosis, treatment and monitoring of disease. The Company uses its proprietary Target Visualization Technology(TM) to create imaging agents targeted at the molecular level, designed to enable physicians to use Magnetic Resonance Imaging (MRI) to obtain detailed information about specific disease processes. On April 3, 2006, EPIX announced a definitive agreement to merge with Predix Pharmaceuticals to create a specialty pharmaceutical company with capabilities in both therapeutics and imaging. To receive the latest EPIX news and other corporate developments, please visit the EPIX website at www.epixpharma.com.

Additional Information About the Merger And Where To Find It

EPIX has filed a registration statement on Form S-4 with the Securities and Exchange Commission containing a joint proxy statement/prospectus in connection with the proposed merger with Predix. Investors and security holders are advised to read the joint proxy statement/prospectus (including any amendments or supplements thereto) regarding the proposed merger because it contains important information about EPIX, Predix and the proposed transaction and other related matters. The joint proxy statement/prospectus has been mailed to stockholders of EPIX and Predix seeking their approval of the proposed transaction. Investors and security holders may obtain a free copy of the joint proxy statement/prospectus and any amendments or supplements thereto and other documents filed by EPIX at the Securities and Exchange Commission's web site at www.sec.gov. The joint proxy statement/prospectus and such other documents may also be obtained for free by directing such request to EPIX Pharmaceuticals, Inc. 161 First Street, Cambridge, Massachusetts, Attn: Investor Relations, tel: (617) 250-6000; e-mail: ahedison@epixpharma.com or Predix Pharmaceuticals Holdings, Inc., 4 Maguire Road, Lexington, Massachusetts 02421, Attn: Investor Relations, tel: (781) 372-3260; e-mail: investors@predixpharm.com.

EPIX and Predix and their respective directors, executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies with respect to the adoption of the merger agreement and the transactions associated with the merger. A description of any interests that EPIX and Predix directors and executive officers have in the merger is included in the registration statement containing the proxy statement/prospectus that has been filed with the Securities and Exchange Commission and is available free of charge as indicated above.

Safe Harbor Statement

Certain statements in this news release concerning Predix's business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to the timing and results of future clinical development of Predix's drug candidates, including PRX-08066, as well as the potential efficacy, safety and tolerability of such drug candidates. Any or all of the forward-looking statements in this press release can be affected by inaccurate assumptions Predix might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Predix undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

Source: Business Wire

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