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

IMMUNEX' GM-CSF CLEARS INITIAL HURDLE OF MANUFACTURING FACILITY INSPECTION

Executive Summary

IMMUNEX' GM-CSF CLEARS INITIAL HURDLE OF MANUFACTURING FACILITY INSPECTION, which resulted in only "minor" and "basic" observations, according to Immunex Chief Operating Officer Michael Kranda. He said the company already has corrected most of the items noted by FDA. The inspection of the production facility was conducted the week of Aug. 20. Immunex has filed a Treatment IND application and product license application for its granulocyte macrophage-colony stimulating factor in treating engraftment failure following bone marrow transplants. The PLA was filed Feb. 21. The Treatment IND application was filed July 23, but FDA asked for a 30-day extension of its consideration deadline so that the agency could compile results of the inspection, Kranda said. GM-CSF was recommended for Treatment IND status by FDA's Biological Response Modifiers Advisory Committee at its July 31 meeting ("The Pink Sheet" Aug. 6, p. 8). Immunex is conducting an additional analysis of its historical control data in response to suggestions the advisory committee made following review of the PLA data. The company is also collecting data on additional patients enrolled in its multi-center trial. At a late August meeting of the International Society for Experimental Hematology, Immunex reported that it had genetically engineered a fusion molecule, called PIXY-321, made of GM-CSF and Interleukin-3. In a press release on the presentation, Immunex said that "in vitro studies have shown the fusion molecule to be 10 times more active than combinations of GM-CSF and IL-3 in its ability to promote bone marrow cell growth." Immunex stated that "clinical studies of PIXY-321 are planned for 1991." GM-CSF is currently in Phase III trials to reverse neutropenia caused by radiation or chemotherapy. Phase I/II studies of IL-3 in treating neutropenia and platelet deficiencies are ongoing. Combination studies of GM-CSF and IL-3 "are planned to begin" in the U.S., the firm advised. At the 13th International Congress of the Transplantation Society in San Francisco, Immunex presented results of preclinical studies that show that a soluble IL-4 receptor may prevent organ transplant rejection at doses 2,000 times lower than doses of monoclonal antibodies used to achieve similar results. Immunex noted in a release that the research could lead to a treatment for organ transplant rejection, graft-versus-host disease, allergy and other autoimmune diseases.

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

OM014079

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