Chemotherapy antidote may be lifesaving

In cancer patients accidentally overexposed with the chemotherapy drug 5-fluorouracil (5-FU), the drug vistonuridine (Wellstat Therapeutics Corp) may be lifesaving, according to research to be reported June 1 at the American Society of Clinical Oncology's annual meeting in Orlando.

The presentation at ASCO will report on 17 patients overdosed with 5-FU who received vistonuridine within 8 to 96 hours of overexposure. The drug was supplied under the US Food and Drug Administration's emergency-use Investigational New Drug provisions.

In a pre-meeting interview with Reuters Health, Michael Bamat, Wellstat's vice president for research and development, noted that all 17 of the vistonuridine-treated patients recovered fully. Without this antidote, at least 13 of these patients would have died, based on the dose of 5-FU they received.

"Vistonuridine performed very well and it also is, in itself, a very safe drug," Bamat said.

The National Institutes of Health estimates that 250,000 patients in the United States undergo 5-FU therapy annually and that 1,300 die from toxicities associated with 5-FU and another 8,000 have serious 5-FU-related toxicities.

5-FU overexposure can result from several factors, including infusion pump malfunction or misprogramming and dose calculation errors.

There is currently no approved antidote for 5-FU overexposure. "There really isn't much to do in these cases," Bamat said.

"Because no antidote for 5-FU overexposure is approved today, we have been responding to emergency requests for vistonuridine," Bamat said.

Vistonuridine was granted orphan drug status by the US FDA on May 1 and Wellstat is anticipating orphan drug status in Europe. The company plans to seek regulatory approval in the US and Europe.

Source : www.reuters.com