Novogen, in conjunction with Yale University and their joint venture company CanTx Inc., announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to Cantrixil (TRXE-002) for ovarian cancer.

Cantrixil, a cyclodextrin envelope has been designed as an intra-cavity chemotherapy to be injected directly into the peritoneal and pleural cavities without causing local irritation or toxicity. Its purpose is to achieve high drug levels at the site where the cancer is spreading through the migration of the cancer stem cell.

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CanTx is investigating the use of Cantrixil as first-line therapy of early-stage cancers of the abdominal cavity (e.g. ovarian, uterine, colo-rectal and gastric carcinomas). It plans to enter the clinic in late-2015 or early 2016 in patients with malignant ascites, a condition associated with ovarian cancer.

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