SOURCE: Athenagen

January 31, 2007 08:00 ET

Athenagen's Eye Drop Therapy for AMD Is Safe and Well Tolerated in Phase I Study

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- January 31, 2007 --Athenagen, Inc., a privately held biopharmaceutical company focused in the area of neurovascular diseases, announced today the completion of a Phase I clinical study of ATG3, the company's topical eye drop therapy for neovascular age-related macular degeneration (AMD). ATG3, a proprietary ophthalmic formulation of mecamylamine, is an antagonist of the nicotinic acetylcholine (nACh) receptor pathway that mediates angiogenesis. Inhibition of this pathway, which was discovered at Stanford by Athenagen's founding scientists, also down regulates vascular endothelial-derived growth factor (VEGF) dependent angiogenesis. Studies in animal models have demonstrated excellent penetration of the proprietary ATG3 formulation to the retina and choroid following eye drop application.

ATG3 was evaluated in a randomized, double-masked, placebo-controlled Phase I study which enrolled 80 healthy volunteers in single and multiple dose ascending regimens for up to 14 days of therapy. Subjects received study medication by eye drop twice daily. The primary endpoint was ocular and systemic safety and included detailed ocular slit lamp examination.

"ATG3 is the first non-invasive eye drop therapy for AMD that has entered the clinic and we are extremely pleased with the safety data from this study," commented Henry Hsu, M.D., Athenagen's Chief Medical Officer. "The eye drop therapy showed excellent ocular tolerability. There were no study medication-related systemic side effects, consistent with the very low levels of the compound found in the blood following eye drop application. The safety profile observed allows us to advance into a large Phase II study in patients with neovascular AMD."

Athenagen's Phase II clinical trial, which is expected to begin this quarter, is a placebo-controlled, double-masked, randomized dose-ranging study designed to evaluate both safety and efficacy in patients with neovascular AMD (also known as "wet AMD"). The 330-patient study will be conducted at multiple centers worldwide. Athenagen expects to have interim (six month) efficacy data by mid-2008.

About AMD

AMD occurs when abnormal blood vessels behind the retina start to grow under the macula, the light-sensitive tissue at the back of the eye. These new blood vessels tend to be very fragile and often leak blood and fluid. The blood and fluid raise the macula from its normal place at the back of the eye and lead to loss of central vision, often quite rapidly. Although it rarely causes total blindness, AMD robs those affected of their sharp central vision required for most daily visual activities. It destroys the clear, "straight ahead" central vision necessary for reading, driving, identifying faces, watching television, doing fine detailed work, safely navigating stairs and performing other daily tasks. Approximately two million patients in the U.S. suffer from neovascular AMD and this number is expected to grow with an aging population.

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) nACh receptor agonists and antagonists for the treatment of angiogenesis mediated diseases and cognitive disorders; and (ii). beta-secretase inhibitors for the treatment of Alzheimer's disease. Athenagen currently has four product development programs based on these two technologies: ATG3, a topical (eye drop) anti-angiogenesis compound for neovascular AMD; GTS-21, an oral agonist of the alpha-7 nACh receptor pathway for cognition enhancement currently in Phase II studies for schizophrenia and Alzheimer's disease; several advanced clinical leads from the beta-secretase inhibitor program entering into the clinic for Alzheimer's disease in 2007; and ATG2, a topical (gel) pro-angiogenesis compound for diabetic foot ulcers currently in a Phase I/II study. For more information:

Contact Information

    W. Scott Harkonen, M.D.
    President and CEO
    (650) 869-7600
    Email Contact