Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

GENELABS GLQ223 WILL BE USED IN COMMUNITY-BASED AIDS TRIAL

Executive Summary

GENELABS GLQ223 WILL BE USED IN COMMUNITY-BASED AIDS TRIAL sponsored by Project Inform under an IND approved March 7 by FDA. The agency "has granted a separate, independent IND...license to Project Inform CRA [Community Research Alliance]," the AIDS activist group said in a March 9 press release. In a same-day release, Genelabs announced that it will supply GLQ223 free of charge to Project Inform and that the company's marketing partner, Sandoz, will donate $250,000 to the group "to defray the administrative costs of re-treating with GLQ223." Sandoz holds worldwide rights to the drug under a licensing agreement with Genelabs. Under the approved IND protocol, San Francisco-based Project Inform will treat about 100 patients with GLQ223, a purified derivative of the Chinese cucumber extract, tricosanthin. Patients were treated last year, without FDA consent, with an unpurified version of tricosanthin, commonly called Compound Q. Of the 60 patients in the unauthorized Project Inform trial, two died and three others suffered from severe dementia or seizures. The study protocol approved by FDA calls for randomization of patients into two groups, one receiving GLQ223 every three weeks and the other receiving the drug every six weeks. "Our goal is to evaluate the safety and effectiveness of the drug in long-term treatment use, under real-world conditions," Project Inform said. The group noted that patients will continue to receive other AIDS therapies concomitantly. Last August, FDA asked Project Inform to halt further study of Compound Q in HIV-infected patients until the group obtained an approved IND ("The Pink Sheet" Aug. 14 T&G-2). At that time, Center for Drug Evaluation and Research Director Carl Peck suggested that community-based clinical research might supplement drug research by corporate sponsors. Genelabs' GLQ223 clinical trials, begun in May 1989, are in Phase I/II at the University of California San Francisco-affiliated San Francisco General Hospital and other clinical centers. Preliminary findings from the Genelabs trials will be submitted to FDA for review in mid-1990, the press release states. Project Inform CRA will use a dosing regimen similar to that of the Genelabs GLQ223 trials. Genelabs said that it has no plans at this time to include the data from the Project Inform studies into the NDA for GLQ223, although they will review the data once the study is complete.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

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 Skin Infections Guidance Spurs Debate On Endpoint Relevance

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

Shire Hopes To Sow Future Deals With $50M Venture Fund

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

UsernamePublicRestriction

Register

ID005817

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel