Merrion Pharmaceuticals plc Announces Preliminary Results On Phase II Orazol(tm) Study


DUBLIN, Ireland, May 15, 2009 (GLOBE NEWSWIRE) -- Dr. John Fox, of Merrion Pharmaceuticals ("Merrion" or the "Company"), will address the 7th International Cancer Conference in Dublin today, and will speak about the very positive preliminary results from a multi centre Phase II study on Merrion's Orazol(tm) drug (formerly known as MER 101). The study, conducted in hormone refractory prostate cancer patients with proven bone metastases, enrolled patients at sites in the U.S. and Europe.

The preliminary results show that weekly therapy with 20mg Orazol(tm) (tablet) appears to be as therapeutically effective as monthly treatment with the intravenous drug Zometa(r)(4mg) based on movements in observed levels of critical bone biomarkers. Changes in bone biomarkers, e.g. NTX, have been correlated with improvement in clinical outcomes such as skeletal related events (SRE) and death. This study examined the effects of treatment on four separate bone biomarkers, NTX, serum CTX, serum bone specific alkaline phosphatase and serum calcium. John Lynch, Merrion CEO said, "We are very pleased with these preliminary results. It is clear that Orazol has the potential to make an impact on patient care in the years ahead -- and we will now work on identifying a licensing partner to complete Phase III development and market the product."

Orazol(tm) is a once weekly tablet form of zoledronic acid, which is currently only available as an intravenous infusion (Zometa(r) and other trademarks, Novartis). Zoledronic acid is a very potent and thoroughly investigated bisphosphonate compound, which has been used to treat over 3 million patients worldwide. Orazol(tm), as a weekly tablet formulation, offers many new potential advantages to patients, physicians and healthcare providers.

The preliminary data show a rapid response to treatment on biomarkers of bone resorption in each of the study arms. These effects were noted at 7 days and were sustained throughout the study period.

The Company anticipates that the data will be fully analyzed and comprehensive results will be published on 31st May 2009 at the annual general meeting of the American Society of Clinical Oncology (ASCO) in Florida.


            

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