FDA’s Orphan Drug Designation to Cantrixil for Ovarian Cancer

Oncology Times

 FDA’s Orphan Drug Designation to Cantrixil for Ovarian Cancer 

The U.S. Food and Drug Administration has granted orphan drug designation to the chemotherapy drug Cantrixil for the treatment of patients with ovarian cancer. Cantrixil is a cyclodextrin envelope containing the active ingredient, TRXE-002.

The Orphan Drug designation—to encourage development of drugs in the diagnosis, prevention, or treatment of a medical condition affecting fewer than 200,000 people in the U.S.—grants a product market exclusivity for a seven-year period if the sponsor complies with certain FDA specifications, as well as tax credits and prescription drug user fee waivers. The designation does not, though, shorten the duration of the regulatory review and approval process.

Pre-clinical data were presented at the American Association of Cancer Research Annual Meeting in April. A Phase I study is currently enrolling patients and a Phase IIa study is being planned.

Cantrixil is being developed by Novogen and CanTx, Inc. 

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[PDF]Cantrixil - Novogen

www.novogen.com/pdf/cantrixil.pdf

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