Penwest initiates second Phase IIa Melas syndrome trial; PPS $2.41
Thursday February 11, 2010 09:53:23 EST
Feb 11, 2010 (Datamonitor via COMTEX News Network) --
Penwest Pharmaceuticals, a drug development company, has initiated a Phase IIa clinical trial for A0001 in patients with the A3243G mitochondrial DNA point mutation and evidence of impaired mitochondrial function. This point mutation is commonly associated with MELAS syndrome.
The study is being conducted at the Newcastle upon Tyne Hospitals in Newcastle, England. The primary objective of this study is to investigate whether treatment with A0001 has a discernible impact in the treatment of these patients using metabolic imaging, a number of functional assessments, biochemical measures and patient/clinician-rated scales as compared to placebo.
The Phase IIa clinical trial is a double-blind, randomized, placebo-controlled trial. Penwest plans to enroll approximately 30 patients who meet the eligibility criteria with a 2:1 randomization of drug to placebo. The patients will be dosed for 28 days. The company expects data from this trial in the third quarter of 2010.
Jennifer Good, president and CEO of Penwest, said: "We are very pleased to commence the second proof of concept trial for A0001 in patients. We look forward to evaluating the clinical data from the two on-going Phase IIa trials to determine if there are meaningful signs of efficacy from the drug. There is a significant unmet medical need in these mitochondrial diseases, including Melas, and we are hopeful that A0001 can provide an important treatment option for these patients."
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