SYDNEY, Australia--(BUSINESS WIRE)--Dec. 9, 2003--Novotech announced today that it has begun a cardiovascular drug trial on behalf of U.S.-based Angiogenix, Inc. Novotech, a Sydney-based clinical research organization (CRO), will be responsible for conducting the trial in Australia and New Zealand, working as part of an international team that also includes research organizations in North America and Europe.
The Phase II trial will study Angiogenix's ACCLAIM(TM) (organic nitrate combined with L-arginine) for the treatment of chronic angina. Nitrates are commonly used in cardiac patients but the drug's usefulness is limited by the development of tolerance, which occurs due to the cellular depletion of L-arginine. The study seeks to show that ACCLAIM, by combining L-arginine with a long acting nitrate, can eliminate drug tolerance and provide patients with an improved cardiovascular health benefit compared to standard nitrate products.
"We have included Australian and New Zealand investigational sites in our study for several reasons," said William Spickler, MD, PhD, vice president of pharmaceutical development at Angiogenix. "First, the population of patients is similar to those in the United States in terms of lifestyle and disease characteristics. In addition, a common language and similar health care systems mean that the patient populations are comparable. This population provides an additional source of patients for inclusion in the study, which will help shorten the time that it takes to complete the trial.
"Finally, the clinical investigators are well trained and are experienced in conducting clinical trials of this type. This capability will help support our efforts in the U.S. and elsewhere around the world."
Unsurpassed Local Knowledge and Network
Increasingly, U.S. companies are turning to Australia to expedite the pace, and reduce the cost, of clinical trials, while maintaining the high standard of research that U.S. experts demand. A 2001 Ernst and Young benchmarking study found that clinical research costs may be as much as 20-30 percent lower in Australia than in the United States and Europe. In addition, Australian regulatory procedures often enable a trial to begin in as little as 2-3 months from the initiation of the approval process. This compares favorably to the usual timeline in major Western countries.
As one of the largest independent CROs in Australia, Novotech offers a level of flexibility and local knowledge that is virtually unmatched among other contract research organizations in the region. This has helped Novotech develop a strong client base in the United States and Europe. In the past three years, Novotech has worked with more than 15 U.S.-based pharmaceutical and biotech companies as well as most major European pharmas.
"In contrast to multinational CROs that merely operate an office in Australia, we know this market inside and out," said Alek Safarian, Novotech's chief executive officer. "We have the network, relationships and expertise to quickly get a study up and rolling in this area of the world."
About Novotech (www.novotech-cro.com)
Novotech is a leading independent Australian clinical research organization (CRO) providing a comprehensive range of drug development services to the pharmaceutical and biotechnology industries. Headquartered in Sydney, Novotech is focused on the Australian and New Zealand markets but has worldwide reach through the company's subsidiary in the United Kingdom and through key external partnerships and strategic alliances in North America and other regions.
About Angiogenix (www.angiogenix.com)
Angiogenix, Inc. is a biopharmaceutical company focused on the research and development of novel drugs for the treatment of cardiovascular disease, with particular emphasis on disease caused by underlying ischemia. Angiogenix is currently developing two product candidates, ACCLAIM(TM) and Vasotrophin(TM), targeting several of the largest cardiovascular markets.
Dateline Media Susan Scher, MD, 415-339-9404