A SERVICE
OF 
Repligen to Start
Phase II Study of CTLA4-Ig
NEEDHAM, Mass.- November 1, 2000· by TNN Medical Reporter
Virginia Baskerville
- Repligen Corporation has received approval from the Food and Drug
Administration to start a phase II clinical trial to evaluate the safety and
efficacy of CTLA4-Ig in patients receiving a stem cells transplant for leukemia
or other malignancies. The primary objective of the study is to determine if
CTLA4-Ig, in combination with T-cell depletion, can reduce the incidence or
severity of graft-versus-host disease (GVHD) in patients receiving a stem cell
transplant from a genetically mismatched donor. The trial is expected begin at
the bone marrow transplantation unit of the Comprehensive Cancer Center at the
University of Alabama, Birmingham. "Initial clinical studies indicate that
CTLA4-Ig may prevent or reduce the development of GVHD in this patient
population," said Repligen president Walter C. Herlihy, PhD. "Expansion of the
donor pool to 'mismatched' family members would substantially reduce the cost
of a stem cell transplant and eliminate treatment delays inherent in the search
for a 'matched donor.'" CTLA4 is a T-cell regulatory protein that is thought to
have potential for use as an immunosuppressive drug and, possibly, the ability
to maintain suppression after the drug is withdrawn. "CTLA4-Ig has been shown
by numerous research groups to have activity in animal models of solid organ
transplantation (heart and kidney), bone marrow transplantation, and autoimmune
diseases such as lupus and multiple sclerosis," Repligen said. In May, Repligen
announced that it had acquired rights to a U.S. patent application "broadly
claiming the use of CTLA4-Ig in immune-based diseases and organ
transplantation." For Your Information: See Repligen's website at
www.repligen.com.
-
This site developed and maintained by
SLACK Incorporated
Questions or
comments? E-mail the Webmaster
Please be aware that medical advice, diagnoses and
physician references cannot be obtained from this site.