The FDA has also cleared the use of the drug for emergency use. The study showing that 13 would have died based on the over exposure sound pretty conclusive and perhaps a good reason for Oncologists and Chemotherapy treatment centers to perhaps keep some of the antidote around. Wellstat is active in molecular research and development and the CEO was one of the founders of Amgen. BD
NEW YORK (Reuters Health) – 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.
From the Website:
Vistonuridine and 5-FU Overexposure5-fluorouracil (5-FU), in use as a cancer drug for decades, is an important mainstay of various treatment regimens for solid tumors including those of the colon, stomach, esophagus, head and neck, and breast. The drug is most commonly administered by infusion pump at or near what is considered the maximum tolerated dose. Still, many patients do not receive optimally effective treatment with 5-FU because of concerns about dose-limiting toxicity and individual variation in 5-FU metabolism.
Vistonuridine (PN401) is converted to uridine in the body. Uridine is a specific pharmocologic antidote for 5-FU toxicity. Once converted, it reduces the incorporation of 5-FU metabolites into the genetic material of non-cancerous cells. Due to the poor bioavailability of oral uridine and because of complications associated with infusion of uridine, uridine itself is not a clinically viable treatment for 5-FU overexposure. Vistonuridine delivers about eight-fold more uridine into the bloodstream than does oral administration of uridine.
Vistonuridine has been provided to patients overdosed with 5-FU under emergency use INDs from the FDA. These patients fully recovered from the overdose even in cases where a lethal outcome otherwise would have been expected.
Orphan-drug designation of vistonuridine as an antidote in the treatment of 5-FU poisoning was granted by the FDA. A similar designation, which provides incentives to bring to market drugs for rare medical conditions, was recommended to the European Commission by a committee of the European Medicines Agency (EMEA).