Athenagen Inc. Advances Angiogenesis Drug To Clinical Testing

SOUTH SAN FRANCISCO, Calif., June 21 /PRNewswire/ -- Athenagen, Inc., a privately held biopharmaceutical company, said today that it has an active Investigational New Drug Application (IND) and has completed preparation for a Phase I/II clinical trial of its pro-angiogenesis topical wound healing agent ATG002. Earlier this year the company filed an IND with the U.S. Food and Drug Administration for ATG002, a topical nicotinic acetylcholine (nACh) receptor agonist, to study the drug in patients with diabetic foot ulcers. The Phase I/II safety and proof of concept study will be conducted at leading wound care clinical sites in the U.S.

"Diabetics have decreased circulation in their lower extremities and are at great risk of suffering from chronic poorly healing foot ulcers that can lead to infections and ultimately, amputations," stated Henry Hsu, M.D., Chief Medical Officer of Athenagen. "ATG002 is a completely new approach to treating chronic wounds such as diabetic foot ulcers, which is based upon stimulation of angiogenesis in the wound bed to help drive the wound-healing process. Unlike protein-derived growth factors, ATG002 is a small molecule that, applied topically, effectively penetrates through the wound and into surrounding tissues."

"Advancing the ATG002 program to Phase I/II readiness is an important milestone for Athenagen," commented Scott Harkonen, M.D., President and Chief Executive Officer. "Going forward, we plan to pursue partnering opportunities for this program while we focus our internal resources on our programs in the therapeutic areas of CNS and ophthalmology. These include topical therapy for age-related macular degeneration (AMD), which is nearing the clinic; and our Phase II compound, GTS-21, targeting Alzheimer's disease and schizophrenia."

Agonists of the nACh receptor pathway (pro-angiogenic drugs)

Drugs that stimulate the nACh receptor pathway, such as nicotine and related compounds, could be useful in promoting angiogenesis in disease conditions where there is an insufficient supply of blood. These disease conditions include chronic wounds, such as diabetic foot ulcers, venous stasis ulcers and pressure sores. Attempts to promote wound healing using protein growth factors, such as FGF, VEGF and EGF, have met with limited success because of poor tissue penetration and rapid enzymatic degradation at the site of application. Small molecule agonists of the nACh receptor pathway are resistant to proteases and penetrate effectively though the surface of the wound, and have been shown to be effective wound- healing agents in animal models. Athenagen's wound-healing program is based on pioneering discoveries and intellectual property licensed exclusively to Athenagen from Stanford University.

About Athenagen

Athenagen, Inc., located in South San Francisco, is engaged in the development of small-molecule drugs that act on the nicotinic acetylcholine (nACh) receptor pathway. The company's lead nACh receptor agonists and antagonists are being developed to treat diseases associated with enhanced or impaired angiogenesis and in diseases where cognitive deficit plays a significant role. Athenagen currently has three product development programs acting on this pathway: ATG003, a topical (eye drop) anti-angiogenesis compound for neovascular AMD; ATG002, a topical (gel) pro-angiogenesis compound for diabetic foot ulcers; and GTS-21, an oral nACh receptor agonist for cognition enhancement. For more information: www.athenagen.com.

CONTACT: W. Scott Harkonen, M.D., President and CEO of Athenagen,+1-650-869-7600, or press@athenagen.com

Web site: http://www.athenagen.com//