GENELABS GLQ223 TO ENTER PHASE I TRIALS IN MAY
GENELABS GLQ223 TO ENTER PHASE I TRIALS IN MAY at San Francisco General Hospital, the company said in a press release announcing the April 26 FDA approval of its IND for the AIDS drug. Preclinical studies with the drug, a purified plant protein called trichosanthin derived from the Chinese cucumber, have been conducted by Genelabs, University of California San Francisco and The Chinese University of Hong Kong. The trial will begin in three or four weeks and last about six months, according to San Francisco General Hospital. A total of about 20 patients with advanced AIDS are expected to be enrolled. GLQ223 is administered by injection. The agent is being codeveloped by Sandoz and Redwood, California-based Genelabs. Sandoz will have worldwide exclusive marketing rights to the final product. In vitro, GLQ223 has been shown to "selectively block HIV expression in acutely infected T-cells and to kill HIV-infected macrophages," the release states. Results of pre-clinical studies were recently published in the April Proceedings of the National Academy of Sciences. In an April 12 release on the pre-clinical studies, San Francisco General reported that "the scientists found in a study of blood samples from eight participants infected with HIV that their macrophages showed no evidence of virus production five days after being treated with a single dose of the compound in tissue culture." The hospital noted that "in a concurrent UCSF/Genelabs test comparing GLQ223 and AZT in culture, GLQ223 was shown to apparently kill chronically infected macrophages while AZT showed no effect." San Francisco General added that "the exact mechanism(s) by which trichosanthin exerts its apparent selective anti-HIV effect is unknown." "Compounds related to trichosanthin have been shown to cut a portion of the ribosomes . . . One possible explanation is that in the case of HIV-infected cells, inactivated ribosomes would make no protein, causing cell death and stopping spread of the infection," the release adds. UCSF and Genelabs were issued a U.S. patent in January 1989 for use of GLQ223 as an anti-HIV compound, the release says. San Francisco General noted that trichosanthin has been used in China for the past 20 years to induce abortions and to treat malignant tumors of the reproductive organs.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth