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

NIH RECOMBINANT DNA ADVISORY CMTE. WILL REVIEW SEVEN GENE THERAPY PROTOCOLS

Executive Summary

NIH RECOMBINANT DNA ADVISORY CMTE. WILL REVIEW SEVEN GENE THERAPY PROTOCOLS at its Sept. 9-10 meeting on the National Institutes of Health campus in Bethesda, Md. None of the seven protocols slated for review by RAC at the upcoming meeting are company-sponsored, although companies are likely to be involved through the supply of materials or cell separation systems. The committee last met June 7-8 ("The Pink Sheet" June 14, p. 6). The first protocol for review is "genetically engineered autologous tumor vaccines producing interleukin-2 for the treatment of metastatic melanoma." The researchers are James Economou and John Glaspy from the University of California-Los Angeles. A mini-trend of Interleukin-2 is apparent in the RAC agenda for the September meeting. Two other protocols relate to IL-2. RAC will examine a protocol deferred from review at the June 1993 meeting pending additional information. The protocol, "immunization of malignant melanoma patients with interleukin-2 secreting melanoma cells expressing defined allogeneic histocompatability antigens," has as its investigators Tapas Gas Gupta and Edward Cohen, University of Illinois College of Medicine, and Jon Richards, University of Chicago. Their revised protocol is entitled: "pilot study of toxicity of immunization of patients with unresetable melanoma with IL-2 secreting allogeneic human melanoma cells." The other IL-2 protocol, also resubmitted, first came before RAC last March. The protocol is for a "Phase I study of transfected cancer cells expressing the interleukin-2 gene product in limited stage small-cell lung cancer." The investigators are Peter Cassileth, Eckhard Podack, Kasi Sridhar and Niramol Savaraj from the University of Miami School of Medicine. The committee will consider a protocol from NIH researcher Joyce O'shaughnessy previously submitted for review at RAC's December 1992 meeting: "retroviral mediated transfer of the human multi-drug resistance gene (MDR-1) into hematopoietic stem cells during autologous transplantation after intensive chemotherapy for breast cancer." The committee deferred approval of the protocol at its December 1992 meeting pending additional information. The committee will also consider the protocol for "a Phase I clinical trial to evaluate the safety and effects in HIV-1 infected humans of autologous lumphocytes transduced with a ribozyme that cleaves HIV-1 RNA." The researchers are Flossie Wong-Staal, Eric Peschla and David Looney from the University of California-San Diego. Additionally, RAC will review for approval "a Phase I study to evaluate the safety of cellular adoptive immunotherapy using genetically modified CD8+ HIV-specific T cells in HIV-seropositive individuals." The researchers submitted a "major modification" to their previous protocol, which would have involved HIV-positive patients undergoing allogeneic bone marrow transplant. RAC's agenda includes discussions on changing the biosafety level of a Semliki Forest Virus vector expression system; amendments to the review process for experiments involving the cloning of toxin molecules; a working group report on gene therapy transfer experiments that will be proposed exempt from RAC review; changes to the "Points to Consider" document concerning submission of protocols to RAC; and updating of the classification of microorganisms on the basis of hazard. Notice of the upcoming RAC meeting appears in the Aug. 18 Federal Register.

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

PS023189

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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