RespiteMatch.com Health Blog

Data suggest Bristol-Myers Squibb’s new drug to prevent rejection of transplanted kidneys is better than current options.
August 25, 2005

The results of a mid-stage clinical trial announced Thursday suggest that Bristol-Myers Squibb’s experimental drug belatacept is as effective as a standard anti-rejection drug used in kidney transplant patients, but is less toxic.

Details of the study funded by Bristol-Myers Squibb were published in the August 25 issue of The New England Journal of Medicine.

Although mid-stage clinical trials do not fully prove a drug’s efficacy, the data from 218 transplant patients suggest that those taking belatacept also had kidneys better able to filter waste.

Because the experimental drug is less toxic than the approved drug, cyclosporine, the patients’ kidney damage, high blood pressure, and high cholesterol were less severe problems.

“This trial indicates that belatacept should be able to protect transplanted organs from rejection without the toxicities associated with today’s standard drugs,” said Flavio Vincenti, a principal author of the study and clinical professor of medicine and surgery at the University of California, San Francisco.

‘They will usher in a new paradigm for organ transplantation.’

-Flavio Vincenti,

UCSF

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Cyclosporine was discovered as far back as 1972 by Sandoz (now Novartis) in Basel, Switzerland. Approved in 1983, cyclosporine is used to prevent rejection of bone marrow and several organs, including heart and liver, and is sold by Novartis under the brand names Sandimmune and Neoral.

However, cyclosporine contributes to cardiovascular disease, the leading cause of death for kidney transplant patients.

New Science

Belatacept is a new type of anti-rejection treatment because it selectively knocks out parts of the immune system. While it blocks the body’s reaction to a transplanted organ, it leaves intact the ability to fight diseases, according to Dr. Vincenti.

When a patient has a transplant, the body’s immune system produces T-cells, which need a chemical signal before they can attack the new organ. Belatacept works by blocking this chemical signal, but leaves the T-cells intact.

“This is the first clinical trial of a treatment for transplant recipients based on this new principle of inducing immune tolerance of the transplanted organ,” said Dr. Vincenti. “If belatacept and similar drugs live up to their promise, they will usher in a new paradigm for organ transplantation.”

The drug is expected to go down well with transplant patients because it might mean they undergo an injection just a few times a year and can do away with the collection of pills they currently must take every day.

Because belatacept appears to damage the kidneys less than cyclosporine, it is also expected to reduce the number of patients who require a second transplant.

More than 16,000 Americans had a kidney transplant in 2004, according to the United Network for Organ Sharing.