Tuesday, Oct 1, 2002
South San Francisco, Calif. -- October 1, 2002 --Genentech (NYSE:DNA) today announced positive preliminary data from a Phase Ib/II randomized, single-agent study with the investigational anti-VEGF (vascular endothelial growth factor) product, rhuFab V2 (ranibizumab), for patients with the wet form of age-related macular degeneration (AMD). Data from these studies will be presented today during two oral presentations at The Vitreous Society's 20th Annual Meeting and The Retina Society's 35th Annual Meeting in San Francisco. Based on these results, and pending discussions with the U.S. Food and Drug Administration (FDA), Genentech plans to move forward with Phase III randomized trials to begin during the first quarter of 2003.
"These data validate VEGF as an important target in the pathogenesis of wet AMD," said Hal Barron, M.D., FACC, Genentech's vice president, Medical Affairs. "We are encouraged with the data from this clinical trial and look forward to studying rhuFab V2 in a larger patient population in Phase III clinical trials to fully assess rhuFab V2's safety and efficacy for the potential treatment of wet AMD. Genentech's decision to move forward with Phase III demonstrates our commitment to developing potential anti-VEGF products for various diseases with high unmet medical needs."
Sixty-four patients were enrolled in a single-agent, multi-center trial. Patients were treated in one eye every four weeks for four doses (either 300 or 500 micrograms) of rhuFab V2 (n=53) or were treated with standard of care (no rhuFab V2) (n=11). Three different groups of subjects were enrolled in the study based on disease pattern and prior treatment: minimally classic, predominantly classic (both refer to particular patterns of leakiness and lesion characteristics seen on an angiogram), and patients previously treated with photodynamic therapy (PDT).
Patients were monitored for safety and visual acuity. Visual acuity is defined as change from baseline in total number of letters read correctly (gained or lost) on the Early Diabetic Retinopathy Study (ETDRS) chart. Of the 53 patients treated with rhuFab V2, 50 patients (94 percent) had stable or improved vision, of which 14 patients (26 percent) improved 15 letters or more on the ETDRS chart, and 36 patients (68 percent) had stable vision at day 98. Stable vision is defined as losing or gaining less than 15 letters on the ETDRS chart.
On average, patients treated with rhuFab V2 gained 9.0 letters at day 98 compared to patients treated with standard of care who lost 4.9 letters. The most common side effects from treatment with rhuFab V2 injection were mild transient, reversible inflammation.
About rhuFab V2
RhuFab V2 is a humanized, therapeutic antibody fragment developed at Genentech designed to bind and inhibit VEGF, a protein that plays a critical role in ocular angiogenesis (the formation of new blood vessels) thus blocking new blood vessel leakiness and growth, which is thought to lead to wet AMD disease progression.
AMD (age-related macular degeneration) is a major cause of gradual or sudden, painless, central visual loss and is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.
Macular degeneration is diagnosed as either dry (nonexudative) or wet (exudative). In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating blind spots in central vision and can account for blindness in wet AMD patients.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Fifteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes ten biotechnology products directly in the United States. The company has headquarters in South San Francisco, California.
The statement made in this press release relating to the initiation of rhuFab V2 Phase III clinical trials in the first quarter of 2003 is forward-looking and the actual time frame could differ materially. Among other things, the start of Phase III trials could be delayed by the outcome of discussions with the FDA, or by unexpected safety, manufacturing or patient enrollment issues.
For more information on clinical trials, please call 1-888-662-6728.