Pink Sheet is part of the Business Intelligence Division 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

Xcyte leukemia protocol withdrawal

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA requests withdrawal of a Phase II/III trial protocol of Xcyte's Xcellerated T Cells oncologic for use in chronic lymphocytic leukemia "to allow additional discussion of the design of the trial," Xcyte says Feb. 2. The firm now anticipates "a delay in the initiation of the trial beyond the second quarter of 2005." The firm is meeting with FDA in mid-February to discuss the chemistry, manufacturing & controls submission related to the trial. Xcellerated T Cells are also in development for multiple myeloma and non-Hodgkin's lymphoma...
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS002808

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