Baxter Healthcare Corp. and Cantab Pharmaceuticals plc saidWednesday they are discontinuing development of an anti-CD45antibody designed to prevent kidney rejection episodes. Productrights were owned by Nextran, a partnership between Baxter andDNX Corp.
Baxter, of Deerfield, Ill., and Cantab, of Cambridge, England, saidPhase II results of LM-CD45 showed it had no clinical advantageover placebo. While follow-up will continue, the companies don'texpect to continue development of the monoclonal antibody.
"We have not yet had the opportunity to look at the data in detail,"Nick Hart, Cantab's finance director, told BioWorld. "We're going tofollow the patients for up to three months, but we believe a fullreview of the data will not change the outcome of the study."
The Phase II trial involved 80 patients at 10 centers in the U.S. Thedrug, a pair of monoclonal antibodies that bind to the donor kidney'swhite cells, was injected into donor kidneys before transplantation.Half the patients received treated kidneys, and half received kidneystreated with placebo.
Baxter and Cantab entered into a partnership in 1991, and "we had allour work in the trial funded by Baxter," said Hart, who added thatCantab received 3.7 million in license fees and 1 million inmilestones. "So we substantially offset the risk."
Last August, DNX, of Princeton, N.J., and Baxter formed apartnership called Nextran (also located in Princeton) that focused onorgan transplantation. (See BioWorld Today, Aug. 30, 1994, p. 1.)LM-CD45 was one product contributed to the partnership. Baxterowns 70 percent of Nextran.
Paul Schmitt, chairman, president and CEO of DNX, and acting CEOof Nextran, told BioWorld the results were disappointing, but notdevastating.
"We put this company [Nextran] together with a broad productportfolio," Schmitt said. "That portfolio remains strong. You fullyexpect that when you're putting a company together with sixproducts, something like this will occur. The other programs aregoing very well."
The bright side of the failed trial, Schmitt said, was "the fact that wedid a very good Phase II allowed us to avoid wasting a lot of moneyin Phase III. Our xenograft program is the only thing burningsignificant money [$4 million to $5 million annually]. The financingrequirements for Nextran have gone down substantially."
An earlier Phase I/II study of LM-CD45, results of which werepresented at a medical meeting in 1993, suggested that there mayhave been a correlation between the drug and reduced rejectionepisodes.
Cantab also said the trial results were not a major setback, in partbecause the monoclonal antibody technology on which LM-CD45 isbased differs from the approach being taken with the rest of itsportfolio.
"Our focus is on the immune system, either up-regulating or down-regulating the system for clinical advantage," Hart said. "The resultswill not effect our other programs."
Hart said Cantab had 15.3 million in cash and short-terminvestments as of Dec. 31, and burned 5.3 million. Cantab reporteda net loss of 4.1 million in 1994. n
-- Jim Shrine
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