NEWS OF THE WEEK DRUG
DEVELOPMENT
VISION-LOSS DRUG EYES SUCCESS TREATMENT Lucentis succeeds in improving vision for patients with wet age-related macular degeneration.
Genentech's new drug yields positive results, moves markets
W
ITH ITS POSITIVE PHASE
III clinical trial results, Genentech's experimental drug Lucentis has grabbed the spotlight among treatments being developed for wet age-related macular degeneration, or wet AMD. This leading cause of straight-ahead, central vision loss in patients over age 50 can progress to blindness. According to Genentech, in a trial with 716 patients, 95% of patients treated with Lucentis "maintained or improved vision" and had significantly improved visual acuity PUBLIC
The news sent the stock of biotech company Eyetech Pharmaceuticals into a 46% plunge. In December 2004, Eyetech and its partner Pfizer received approval for wet AMD treatment Macugen, the much-celebrated first in a new class of ophthalmic drugs that target vascular endothelial growth factor (VEGF). In Eyetech's clinical trials, however, vision improvement or stabilization was found in only 70 % ofpatients. VEGF is a signaling protein crucial in abnormal blood vessel growth. The leakiness of these blood vessels is part of the progression of wet AMD to vision loss. Both drugs must be injected
HEALTH
RULES AIM TO CURB INFECTIOUS DISEASE World Health Organization requires immediate notification of outbreaks
W
zation (WHO) member states have adopted new rules to stem the spread of avian influenza, severe acute respiratory syndrome, smallpox, and polio. The rules were approved by WHO's governing body, the World Health Assembly, on May 23. They require states to immediately notify WHO of any outbreak of these diseases and of any other serious potential international public health concern. The previous guidelines, devised in 1969, required countries to report only six diseases—cholera,
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ORLD HEALTH ORGANI-
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plague, yellow fever, smallpox, relapsing fever, and typhus. The new rules are especially intended to help the world prepare for an influenza pandemic. At the assembly, delegates also discussed a recent WHO report on avian influenza. The report says the pattern of avian flu outbreaks in humans seems to have changed in a manner consistent with the possibility that human-to-human transmission is occurring. What's more, the bird flu viruses isolated in 2005 from infected humans in Vietnam are different from 2004 isolates. Changes near
direcdy into the eye, and both attack VEGF, although they differ in the forms of VEGF to which they bind. The Genentech trial results have the makings of a showdown between a biopharmaceutical and a chemically synthesized product. Macugen is based on an oligonucleotide developed at Eyetech and manufactured by Degussa's Raylo Chemicals unit. Lucentis is a humanized therapeutic antibody fragment developed and manufactured by Genentech. It is a cousin of the firm's colon cancer drug Avastin and, according to a spokeswoman, is based "on the same concept and the same science of angiogenesis," or blood vessel growth. Other companies are active in the wet AMD area with drugs based on other modes of action. They include QLT, which markets Visudyne, the veryfirsttreatment approved for wet AMD, and Alcon, whose steroid Retaane just received conditional FDA approval.—VIVIEN MARX a receptor-binding site on the virus could make it easier for the virus to attach to human cells, thus infecting humans more readily The report stresses, however, that firm conclusions cannot be drawn from the sparse data now available. 'The new rules are a major step forward for international health," said WHO Director-General Lee Jong-wook. "{They} recognize that diseases do not respect national boundaries." Under the revised regulations, countries have much broader obligations to build their capacity to take routine preventive measures and to detect and respond to public health emergencies. Ifa dispute arises between WT30 and a member state over the seriousness of a disease outbreak, the new rules allow WHO to summon a committee of experts to make recommendations, which could include bans on travel or transport of goods.-BETTE HILEMAN WWW.CEN-0NLINE.ORG
