CLEVELAND, Aug. 10 /PRNewswire/ -- Athersys, Inc., announced today that it has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom to initiate a phase I study to test ATHX- 105, its lead obesity drug candidate, in humans. Athersys intends to begin enrollment for the phase I study shortly.
Obesity represents a serious condition with substantial health consequences and growing prevalence globally. In the United States, more than thirty percent of adults are clinically obese and another thirty percent are overweight according to the Centers for Disease Control and Prevention. Obesity impairs overall quality of health and is associated with an increased risk for diabetes, hypertension, coronary artery disease, osteoarthritis and sleep apnea, among other conditions. The increasing prevalence of obesity among children and teens suggests that the problem will continue to grow. Athersys has multiple programs for the development of drug candidates for the treatment of obesity.
“Our novel and proprietary drug candidate, ATHX-105, is a highly selective agonist of the serotonin receptor 5HT2c, a validated molecular target located in the region of the brain that regulates appetite and food intake,” noted Kurt Brunden, Senior Vice President of Biopharmaceuticals. Compounds acting on this target have been shown to reduce appetite and result in weight loss in animal models and humans.
In pre-clinical studies conducted by Athersys, ATHX-105 has demonstrated a significant reduction of food intake and weight loss in established obesity models and a good safety profile across multiple animal species. “Based on extensive preclinical studies, we believe that ATHX-105 has the potential to be a highly effective and safe pharmaceutical treatment option for obesity patients,” said John Harrington, executive vice president and chief scientific officer. “The compound displays industry leading selectivity relative to other serotonergic receptors, resulting in a targeted effect of the compound and a strong pre-clinical safety profile.”
Athersys plans to undertake a phase I trial in healthy volunteers to assess the safety, tolerability and pharmacokinetics of ATHX-105. The Phase I study will be conducted in the United Kingdom at a site chosen for its substantial experience in obesity and conducting early stage clinical studies.
“While Athersys has successfully applied our proprietary drug discovery capabilities to assist other companies, such as Bristol-Myers Squibb, in their drug development activities, this represents an important milestone since it represents the first product candidate developed by Athersys researchers to enter clinical studies,” said William Lehmann, President and Chief Operating Officer of Athersys. “In addition to ATHX-105, we have a portfolio of therapeutic development programs in other high value areas, such as cardiovascular disease, oncology support, stroke, and central nervous system disorders, that we intend to advance into the clinic in the near term.”
Athersys is a biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. Through the application of its proprietary technologies, it has established a pipeline of therapeutic product development programs in multiple disease areas scheduled to advance into clinical trials in 2006 and 2007. In addition to Athersys’ lead product candidate, ATHX-105, the company is developing novel pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders, utilizing proprietary capabilities and technologies including Random Activation of Gene Expression (RAGE). Athersys is also developing MultiStem(TM) to treat patients for certain cardiovascular disorders, stroke, bone marrow transplantation and oncology support, as well as other disease indications. MultiStem is a patented stem cell product that is based on a special class of adult-derived stem cells known as Multi-Potent Adult Progenitor Cells (MAPC). Unlike most other adult stem cell types, MAPC have a demonstrated ability to form a broad range of cell types, contributing to a range of tissues. In addition, MAPC may be isolated from the bone marrow and other non-embryonic tissue sources, can be routinely expanded to create large product inventories, and are being developed for off-the-shelf treatment of patients. Athersys is a founding member of the Center for Stem Cell and Regenerative Medicine based in Cleveland, Ohio, with the Cleveland Clinic, University Hospitals and Case Western Reserve University, and is working in partnership with Angiotech Pharmaceuticals to develop cell-based products for treating cardiovascular disease.
Athersys, Inc.
CONTACT: William (B.J.) Lehmann, J.D., President and Chief OperatingOfficer of Athersys, Inc., +1-216-431-9900, or bjlehmann@athersys.com
Web site: http://www.athersys.com/
