FDA Fast-Track Granted to Cancer Therapy Side-Effects Drug

(National Institutes of Health)

BioAlliance Pharma SA in Paris says its drug candidate to treat inflammation of the mucus membranes in the mouth, resulting from chemo- or radiation therapy to treat cancer, received fast-track status from the U.S. Food and Drug Administration. Validive, the drug’s brand name, is designed for patients with head and neck cancers.

Oral mucositis is an adverse effect of chemo- and radiation therapy, which can become severe and take up to eight weeks to heal, depending on the length of time exposed to radiation. The condition can result in pain, bleeding, or infection.

Valdive works by stimulating the alpha-2 adrenergic receptors that decrease the release of proteins encouraging inflammation of mucus membranes in the mouth. The company says its technology also increases the concentration of Valdive’s active ingredients in mucus and saliva.

BioAlliance Pharma says Valdive is currently in intermediate-stage clinical trials, with 180 head and neck cancer patients in the U.S. and Europe who received chemotherapy or radiation therapy, and who suffer from oral mucositis. In the trial, the drug is being tested against a placebo.

FDA’s fast track process expedites the review of drugs designed to address unmet medical needs. Fast track status provides new drug developers with more frequent meetings and correspondence with FDA officials. The company says Valdive also received orphan drug designation in Europe.

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