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FDA grants orphan drug designation to Cantrixil for ovarian cancer
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The FDA granted orphan drug designation to TRXE-002 for the treatment of patients with ovarian cancer, according to a press release from Novogen.
TRXE-002 (Cantrixil) — a chemotherapy candidate drug developed by CanTx Inc., Novogen’s subsidiary joint venture company with Yale University — is designed as an intra-cavity chemotherapy to be injected into the peritoneal and pleural cavities directly to avoid local irritation and toxicity.
The FDA based its decision in part on preclinical data of TRXE-002 in ovarian cancer presented earlier this week at the American Association of Cancer Research Annual Meeting in Philadelphia. The data demonstrated that TRXE-002 was associated with more than 95% tumor reduction in models highly representative of late-stage, chemotherapy-resistant ovarian cancer.
"Receiving this designation is one more step in our objective of bringing Cantrixil to market as a drug that we hope will provide meaningful clinical benefit to patients with ovarian cancer and deliver that long-sought breakthrough for patients with a cancer that has shown only slight improvement in 5-year survival rates over the last 30 years,” Graham Kelly, BSc, BVSc, PhD, chief executive officer of Novogen and CanTx, Inc., said in a press release.
TRXE-002 is expected to enter the clinic in Australia by early 2016 for patients with malignant ascites, a terminal condition associated with ovarian cancer. Currently, no effective long-term therapies exist for this condition, according to the release.
The FDA’s Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.