PPD Completes First-in-Human Trial for Novel StatinEarly Clinical Study Shows Potential Safety Advantage
WILMINGTON, N.C., July 17, 2007 /PRNewswire-FirstCall/ -- PPD, Inc. today announced that it has completed a single ascending dose, first-in-human study with PPD's novel statin for the treatment of dyslipidemia. The compound was safe and well tolerated at all doses in this clinical trial.
The recently completed Phase I trial was a randomized, placebo-controlled evaluation in healthy subjects to investigate the safety, tolerability and pharmacokinetics of single rising oral doses of PPD's statin. The study enrolled 36 male subjects. The compound was studied across a broad range of doses in this trial and was safe and well tolerated at all dosage levels. In addition, blood levels of the compound measured during the trial suggest the potential to offer an improved safety profile over currently marketed statins.
"We are extremely pleased that our statin is advancing in human clinical studies in aggressive development time," said Fred Eshelman, chief executive officer of PPD. "We have commenced a randomized, double-blind, placebo- controlled, first-in-patient clinical trial in high cholesterol patients and then plan to proceed into a Phase II proof-of-concept study."
PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 28 countries and more than 9,700 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients. For more information, visit our Web site at http://www.ppdi.com.
Except for historical information, all of the statements, expectations and assumptions contained in this news release, including expectations and assumptions about the development and commercialization of this novel statin, are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward- looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause results to differ materially include the following: risks associated with and dependence on collaborative relationships; risks associated with the development and commercialization of drugs, including earnings dilution and obtaining regulatory approval; rapid technological advances that make our products and services less competitive; continued success in sales growth; loss of large contracts; increased cancellation rates; economic conditions and outsourcing trends in the pharmaceutical, biotechnology, medical device, academic and government industry segments; competition within the outsourcing industry; the ability to attract and retain key personnel; risks associated with acquisitions and investments, such as impairments; risks that we may not continue our dividend policy; and the other risk factors set forth from time to time in the SEC filings for PPD, copies of which are available free of charge upon request from the PPD investor relations department.
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Posted: July 2007