Monday, Aug 18, 2003
New York -- August 18, 2003 --Genentech (NYSE:DNA) today announced preliminary data from the extension phase of an open-label Phase Ib/II randomized, single-agent study with the investigational anti-angiogenesis product, Lucentis (ranibizumab), formerly known as rhuFab V2, for patients with the wet form of age-related macular degeneration (AMD). Lucentis is a humanized, therapeutic antibody fragment that is designed to bind to and inhibit VEGF (vascular endothelial growth factor), a protein that is believed to play a critical role in angiogenesis, the formation of new blood vessels and in regulating vascular permeability. Data from this study is being presented today at The 21st Annual Meeting of the American Society of Retina Specialists in New York City.
"The data from this study appear to indicate that most patients not only continued to maintain vision, but improved their vision when Lucentis therapy was extended to six months and beyond," said Hal Barron, M.D., FACC, Genentech's vice president, Medical Affairs. "Furthermore, patients initially showing a decline in visual acuity in the usual care group experienced an improvement in visual acuity upon crossing over to receive Lucentis. The fact that visual acuity continued to improve during extended Lucentis treatment suggests that a patient's response can be durable, an important potential benefit for patients with this normally progressive disease."
In the first treatment period (98 days), 64 patients with minimally classic and predominantly classic wet AMD were entered into the single-agent, multi-center trial. Patients were treated every four weeks for four doses (either 300 or 500 micrograms) of Lucentis (n=53) or with usual care of observation or photodynamic therapy (n=11). After Day 98, patients in the usual care group were permitted to cross over to receive Lucentis. All patients were monitored for safety and visual acuity, which is defined as the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. Stable vision is defined as losing or gaining fewer than 15 letters on the ETDRS chart compared with the baseline.
Of the 53 patients who received Lucentis during the first treatment period, 42 patients continued with Lucentis for the second treatment period with 40 patients completing the study through Day 210. The visual acuity at Day 98 in patients who continued with treatment improved by an average of 7.4 letters (n=20) in the 300 microgram group and 12.6 letters (n=22) in the 500 microgram group. At Day 210, their visual acuity improved further to an average gain of 12.8 letters (n=19) in the 300 microgram group and 15.0 letters (n=21) in the 500 microgram group compared with the baseline.
While patients receiving usual care demonstrated an average loss in visual acuity of 5.1 letters (n=11) at Day 98, those who crossed over to Lucentis improved on the average by 7.3 letters (n=4) and 3.2 letters (n=5) at Day 210 compared with the baseline in the 300 and 500 microgram groups, respectively. Of the 40 patients who were treated with Lucentis for six months and completed the study through Day 210, 97.5 percent (n=39) of patients had stable or improved vision at Day 210, of which 45 percent (n=18) improved 15 letters or more on the ETDRS chart.
The most common side effects from treatment with Lucentis were mild transient, reversible inflammation. Adverse events were similar in the first and extended treatment periods. There were three serious adverse events of endophthalmitis (infection), recurrent uveitis (inflammation) and central retinal vein occlusion, all of which were successfully treated or resolved.
Phase III Clinical Trials Currently Enrolling
Genentech is currently enrolling patients into two Phase III clinical trials for Lucentis. The first trial, called MARINA, is a randomized, multi-center, double-masked, sham-injection controlled study evaluating the safety and efficacy of two different doses of Lucentis in approximately 720 patients with minimally classic or occult wet AMD. The second trial, called ANCHOR, is a randomized, multi-center, double-masked, active treatment-controlled, Phase III study comparing two different doses of Lucentis to verteporfin photodynamic therapy in approximately 426 patients with predominantly classic wet AMD. For more information on these clinical trials, please call 1-888-662-6728.
Lucentis is a humanized, therapeutic antibody fragment developed at Genentech to bind and inhibit VEGF, a protein that plays a critical role in angiogenesis (the formation of new blood vessels). Lucentis is designed to block new blood vessel growth and leakiness, which are thought to lead to wet AMD disease progression.
AMD (age-related macular degeneration) is a major cause of painless, central visual loss and is the leading cause of blindness for people over the age of 60. Awareness of the condition and treatment in the initial stages of the disease are essential for patients to take the necessary steps that lead to diagnosis and early treatment to potentially halt progression of AMD.
AMD occurs in two forms: dry and wet. The dry form is associated with atrophic cell death of the central retina. The wet form is caused by growth of abnormal blood vessels (CNV) under the central part of the retina or macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This results in a deterioration of sight over a period of months to years.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Sixteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 11 biotechnology products in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.