�EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and development novel therapeutics through the use of its proprietary and highly efficient in silico dose discovery platform, announced that it has initiated its Phase 2b right-heart catheter study of PRX-08066 in patients with chronic obstructive pulmonary disease (COPD) and moderate-to-severe pulmonary hypertension (PH). PRX-08066 is a novel serotonin type 2B sense organ (5-HT2B) opposer that crataegus laevigata represent a new mechanics of action for treating PH.
"There are presently no sanctioned drugs to treat PH associated with COPD and it is estimated that this disease may affect up to six 1000000 people worldwide," said Elkan Gamzu, Ph.D., interim top dog executive ship's officer of EPIX. "These patients have a very poor prognosis and, consequently, in that respect is a significant unmet medical indigence for an effective treatment. We believe that PRX-08066 may be the only 5-HT2B opposer being highly-developed for pulmonic hypertension that has the potential to selectively and safely reduce pulmonary arteria blood pressure in these patients without affecting their systemic blood pressure."
"There is an undeniable need for safe and efficient treatments for patients with PH associated with COPD," said Aaron Waxman, M.D., Ph.D., helper professor of medicine, Harvard Medical School and Massachusetts General Hospital, Pulmonary and Critical Care Medicine and lead investigator of this Phase 2b study. "We believe this drug english hawthorn be an important advance toward effective treatment for patients with this progressive lung disease, and hope to see reductions in pulmonary artery blood atmospheric pressure and improvements in exercise capacity in this trial similar to those seen in previous trials with PRX-08066 victimisation more stringent techniques."
This single-arm, open-label, Phase 2b study is designed to evaluate the mean pulmonic artery ancestry pressure change from baseline as measured directly by right-heart catheterization and will also bar the change from baseline in the standard six-minute walk length test afterwards three months of handling. Patients volition be treated with 500 mg of PRX-08066 on day peerless of the trial followed by twice-daily dosing of 300 mg of PRX-08066 for ternion months. The trial is designed to enroll adult patients with COPD and moderate-to-severe PH.
PRX-08066 may represent a novel mechanism for selectively dilating pathologic pulmonary arteries without affecting systemic line of descent pressure. Expression of the 5-HT2B receptor is increased in the pulmonary arteries of patients with PH. Blocking the 5-HT2B receptor in patients with PH may reduce or forestall the acute rise in pulmonary blood pressures which occurs when patients increase their activity. This mechanics means that the tenderness would do less work for a given grade of activity, allowing for improvements in exercise tolerance. Moreover, by blocking the serotonin-dependent outgrowth of pneumonic vascular smooth muscle cells, which farther increases pulmonary blood pressures and increases workload need on the heart, PRX-08066 could potentially slow the progression of PH. Over time, this effect could translate into long-term improvements in exercise tolerance and slowing of the vascular and cardiac remodeling that leads to right heart failure. These kinds of effects have been seen with PRX-08066 in presymptomatic animal models of hypoxia-induced pulmonary hypertension.
COPD is a progressive lung disease that affects nearly 30 million people worldwide and is characterized by air flow obstruction which interferes with normal breathing and impairs the ability to example and perform daily activities. According to a December 2005 Datamonitor report, PH is estimated to be present in up to 20 percentage of patients with COPD. Despite the fact that patients with COPD and concomitant moderate-to-severe PH broadly speaking have poor prognoses, on that point are no agents presently approved to treat this patient population.
About PRX-08066Discovered and designed using EPIX's proprietary G-protein coupled receptor (GPCR) mould and optimisation technology, EPIX is developing PRX-08066 to provide both symptomatic improvement of PH, through selective dilation of diseased pulmonary arteries, and to likewise slow disease progression by inhibiting the serotonin-mediated node of the pulmonary arterial blood vessel vessels. EPIX believes PRX-08066 may be a first-in-class selective antagonist of the 5-HT2B sensory receptor for the treatment of PH.
In a Phase 2a, randomized, double-blind, placebo-controlled trial of 71 patients, 62 of whom were evaluable, treatment with PRX-08066 resulted in statistically important (p=0.043) reductions in median systolic pulmonary artery pressure (SPAP) compared with placebo subsequently two weeks of treatment. Responder (defined as greater than or equal to a 4mmHg drop in SPAP) rates were 45% on cd mg of PRX-08066 given once-daily vs. 14% on placebo. The company has also completed several Phase 1 trials with PRX-08066 in respectable volunteers, including a Phase 1b study that assessed the personal effects of PRX-08066 on pulmonary artery rakehell pressure in athletes whose pulmonary pressures were increased by picture to a reduced oxygen level (hypoxia). The results of this Phase 1b trial indicated that two hundred mg of PRX-08066 tending orally double daily importantly reduced the increase in pulmonary arterial blood vessel blood pressure during hypoxic exercise (by 3.6mmHg vs. placebo), without affecting systemic blood press. The half life of PRX-08066 is approximately 20 hours and the broker has shown good oral absorption. PRX-08066 was well-tolerated when given alone and when combined with standard medications for COPD patients as all of the patients in the Phase 2a test were on several concomitant medications. One patient in the four hundred mg dosage group world Health Organization continued into the six-week open-label extension experienced a modest addition in liver enzyme levels at the end of the filename extension that was believed to be drug-related. These values returned to normal within two weeks and the patient remained asymptomatic.
About EPIXEPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly effective in silico drug find platform. The company has a line of internally-discovered drug candidates currently in clinical development to handle diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics and Bayer Schering Pharma.
This news release contains extract or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on current expectations of direction. These statements relate to, among former things, our expectations regarding our Phase 2b study of PRX-08066 in patients with COPD and moderate-to-severe PH and the potency efficacy of PRX-08066. These statements are neither promises nor guarantees, but are subject to a sort of risks and uncertainties, many of which ar beyond our control, and which could cause existent results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things: risks that PRX-08066 may bomb in the clinic or may not be successfully marketed or manufactured; risks relating to our power to boost the ontogenesis of PRX-08066; failure to obtain the financial resources to complete development of PRX-08066; our inability to achieve commercial success for our products and technologies; our loser to follow with regulations relating to our products and cartesian product candidates, including FDA requirements; the risk that FDA may interpret the results of our studies differently than we hold; and risks of fresh, changing and competitive technologies and regulations in the U.S. and internationally. Existing and prospective investors are cautioned not to space undue reliance on these forward-looking statements, which speak only as of the date hereof. We take on no obligation to update or retool the information contained in this press release, whether as a result of new information, future events or fate or other than. For additional information regarding these and other risks that we face, attend the revelation contained in our filings with the Securities and Exchange Commission, including our most late Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.
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