DANBURY, Conn., July 14, 2008 (PRIME NEWSWIRE) -- Penwest Pharmaceuticals Co. (Nasdaq:PPCO) today announced that it has begun dosing in a Phase Ia clinical trial of A0001, a compound the Company is developing for the treatment of symptoms associated with mitochondrial diseases. Mitochondrial diseases are devastating illnesses that often occur during childhood and currently have no FDA approved treatments.
"We are excited to have clinical development of A0001 underway," said Jennifer Good, Penwest's President and CEO. "This compound is important to patients who suffer from mitochondrial diseases and currently have very limited treatment options. We are eager to complete the safety work for this compound so that we can take the important next step of beginning to evaluate clinical benefit in patients."
The Phase Ia trial is a placebo-controlled single ascending dose clinical trial. The trial is designed to evaluate the safety and tolerability of A0001 at various doses and to collect pharmacokinetic data. The trial is also designed to determine if there is a maximum tolerated dose of the drug. The Company plans to enroll a total of 60 healthy volunteers in the trial.
Penwest anticipates that further development of A0001 would involve a Phase Ib multiple ascending dose trial in healthy volunteers for which dosing could begin in early 2009, followed by a Phase IIa proof of concept trial in patients with mitochondrial diseases.
About A0001
Penwest is developing A0001 under a collaboration and licensing agreement with Edison Pharmaceuticals, a private biopharmaceutical company headquartered in San Jose, CA. A0001 is a coenzyme Q10 analog demonstrated to improve mitochondrial function. Relative to CoQ10, A0001 possesses improved drug-like properties. Penwest believes that impairment of mitochondrial function is a key component of the diseases that Penwest plans to target with A0001, and that enhancing mitochondrial function may provide substantial clinical benefit to patients. A0001 has received orphan drug designation from the FDA for the treatment of inherited mitochondrial respiratory chain diseases.
Penwest Pharmaceuticals
Penwest is a drug development pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients. The Company's goal is to identify, develop and commercialize prescription products that address unmet medical needs, primarily for disorders of the nervous system. Penwest is currently applying its drug development and drug delivery expertise to a pipeline of potential products that are in various stages of development and that it intends to commercialize independently or through third party alliances.
Penwest Forward-Looking Statement
The matters discussed herein contain forward-looking statements that involve risks and uncertainties, which may cause the actual results in future periods to be materially different from any future performance suggested herein. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "intends," "potential" and similar expressions are intended to identify forward-looking statements. Important factors that could cause results to differ materially include: risks relating to the commercial success of Opana ER, including our reliance on Endo for the commercial success of Opana ER and risks of generic competition; the need for capital; regulatory risks relating to drugs in development, including the timing and outcome of regulatory submissions and regulatory actions; uncertainty of success of collaborations; the timing of clinical trials; whether the results of clinical trials will warrant further clinical trials, warrant submission of an application for regulatory approval of, or warrant the regulatory approval of, the product that is the subject of the trial; whether the patents and patent applications owned by us will protect the Company's products and technology; actual and potential competition; and other risks as set forth under the caption Risk Factors in Penwest's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2008, which risk factors are incorporated herein by reference.
The forward-looking statements contained in this press release speak only as of the date of the statements made. Penwest disclaims any intention or obligation to update any forward-looking statements.
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