Healthcare Industry News: diabetic foot ulcers
News Release - April 10, 2007
CoMentis Initiates Phase II Clinical Trial for AMD Eye Drop TherapySOUTH SAN FRANCISCO, CA--(Healthcare Sales & Marketing Network)--Apr 10, 2007 -- CoMentis, Inc. (formerly Athenagen), a privately held biopharmaceutical company, announced today the initiation of a Phase II clinical study of ATG3, the company's topical eye drop therapy for neovascular age-related macular degeneration (NV-AMD). A proprietary ophthalmic formulation of mecamylamine, ATG3 is an antagonist of the nicotinic acetylcholine (nACh) receptor pathway that mediates angiogenesis. The drug was developed to effectively penetrate into the retina and choroid following topical eye drop administration.
This Phase II study is a double-masked, randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of ATG3 in patients with NV-AMD (also known as "wet" AMD). Approximately 330 patients will be randomized to one of three treatment groups, administered by eye drop twice daily: two different doses of ATG3 or placebo. One eye per patient will receive the study treatment. All patients will be treated for up to 48 weeks, during which time they will be monitored for safety, tolerability and efficacy assessments. Patients will be assessed for change in visual acuity and macular thickness using ocular coherence tomography.
"In January we completed our Phase I study of ATG3 in healthy volunteers and found excellent ocular safety following eye drop administration," said Henry Hsu, M.D., Chief Medical Officer of CoMentis. "We are very pleased to begin this international Phase II study as planned, and expect to have interim (six month) efficacy data by mid-2008. ATG3 could be the first topical angiogenic treatment for AMD and if approved, would compliment current therapies which require injection directly into the eye."
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. In addition to demonstrating excellent ocular tolerability, the study confirmed that systemic exposure following eye drop administration is minimal, resulting in no systemic side effects
Inhibition of the nicotinic acetylcholine (nACh) receptor pathway, which was discovered at Stanford by two of CoMentis'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 as well as reduction of new blood vessel growth in the eye.
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.
CoMentis, Inc. (formerly Athenagen), has its headquarters in South San Francisco, with research operations in both South San Francisco and Oklahoma City. The company is engaged in the discovery and development of small-molecule drugs to treat diseases 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.
CoMentis 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; ATG2, a topical (gel) containing a pro-angiogenesis compound for diabetic foot ulcers; and ATG-Z1, an orally active beta-secretase inhibitor entering the clinic in 2007. For more information: www.comentis.com.
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