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GenVec’s new AMD drug safe so far in phase 1 study

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GAITHERSBURG, Md. — With enrollment in a phase 1 trial almost complete, a new drug for wet age-related macular degeneration has been well tolerated by patients, according to the drug’s developer, GenVec.

Enrollment in the open-label, dose-escalating study of GenVec’s drug AdPEDF is expected to be complete in the first quarter of 2004, said Peter A. Campochiaro, MD, the study’s principal investigator, last week at the American Academy of Ophthalmology meeting.

In the trial, AdPEDF, which produces the pigment epithelium-derived factor (PEDF) protein, a natural antiangiogenic inhibitor, is administered locally to the eye. In the 18 patients enrolled to date, the drug has been well tolerated with no dose-limiting toxicities or severe adverse events, Dr. Campochiaro said.

“These data are promising and substantiate further advancement of the program,” said Lisa Wei, PhD, GenVec’s director of pharmacology and PEDF team leader. “We expect to present detailed data on the trial at the Association for Research in Vision and Ophthalmology [meeting] in April 2004.”