Press Release: Athenagen Initiates Phase II Clinical Trial in Alzheimer's Disease
Athenagen Initiates Phase II Clinical Trial in Alzheimer's Disease Dec 13, 2006 SOUTH SAN FRANCISCO, CA -- Athenagen, Inc., a privately held biopharmaceutical company focused in the area of neurovascular diseases, announced today the commencement of a Phase II clinical study of the company's lead compound, GTS-21, in patients with Alzheimer's disease. GTS-21, a novel, orally active alpha-7 nicotinic acetylcholine (nACh) receptor agonist, was previously demonstrated to improve cognition in a proof-of-concept study in patients with schizophrenia and in healthy volunteers. "In preclinical and clinical studies, GTS-21 has shown positive benefits in the ability to improve attention, learning and memory impairment, all of which are debilitating cognitive deficiencies associated with numerous medical conditions," said W. Scott Harkonen, M.D., Athenagen President and Chief Executive Officer. "We are excited to advance GTS-21 in Alzheimer's disease as part of our broader strategy to establish efficacy of this product in multiple cognitive deficiencies; initially Alzheimer's disease, ADHD and schizophrenia." The current Phase II clinical trial is a placebo-controlled, double-blind, randomized dose-ranging study designed to evaluate both safety and cognitive effects in patients with early Alzheimer's disease. More than 4.5 million older Americans have Alzheimer's disease, a condition of aging that affects both memory and learning abilities. The 60-patient study is being conducted by Sheldon H. Preskorn, M.D., Professor and Chair for the Department of Psychiatry and Behavioral Sciences at the University of Kansas School of Medicine, Wichita. Athenagen expects to complete this trial in the second quarter of 2007. Initial results from a proof-of-concept study in patients with schizophrenia were published in the June issue of the Archives of General Psychiatry (2006; 63:630-638), a peer-reviewed publication of the American Medical Association. The NIH-funded study was conducted by Dr. Robert Freedman, Professor and Chairman of the Department of Psychiatry at the University of Colorado Health Sciences Center. About GTS-21 GTS-21 (also known as DMBX-A) is a novel, small-molecule, orally active and selective alpha-7 nicotinic acetylcholine (nACh) receptor agonist that has demonstrated memory and cognition enhancement activity in human clinical trials. GTS-21 has been studied in multiple Phase I studies in healthy volunteers and one Phase I/II study in schizophrenic patients. In all studies, the compound was well tolerated. In a Phase I multi-dose, double-blind, placebo-controlled study in healthy adults, GTS-21 also demonstrated cognitive enhancement across all doses, with a statistically significant improvement in attention- and memory-related tasks (Kitagawa, et al. Neuropsychopharmacology (2003), 28, 542-551). About Athenagen Athenagen, Inc., located in South San Francisco, is engaged in the discovery and development of small-molecule drugs to treat neurovascular disease indications, such as Alzheimer's disease, AMD and cognitive disorders. The company has two fundamental technology platforms: (i) beta-secretase inhibitors for the treatment of Alzheimer's disease; and (ii) nACh receptor agonists and antagonists for the treatment of angiogenesis mediated diseases and cognitive disorders. Athenagen currently has four product development programs based on these two technologies: ATG003, a topical (eye drop) anti-angiogenesis compound for neovascular AMD in a Phase I study; GTS-21, an oral agonist of the alpha-7 nACh receptor pathway for cognition enhancement currently in a Phase II study; ATG002, a topical (gel) pro-angiogenesis compound for diabetic foot ulcers currently in a Phase I/II study; and multiple clinical candidates from the beta-secretase inhibitor program approaching Phase I/II study for Alzheimer's disease in 2007. For more information: www.athenagen.com.