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CanTx gets FDA orphan drug designation for Cantrixil to treat ovarian cancer

CanTx, the Novogen-Yale joint venture, has received orphan drug designation from the US Food and Drug Administration (FDA) for its chemotherapy candidate drug, Cantrixil, to treat ovarian cancer.

The drug was granted orphan drug status under the US Orphan drug Act following a review by the FDA of a package of pre-clinical data submitted by the company.

Novogen and CanTx CEO Graham Kelly said: "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.

"CanTx came out of a belief by Yale University and some long-term ovarian cancer researchers in the Yale Medical School that Cantrixil represented a potential breakthrough in the treatment of ovarian cancer."

The company said that Cantrixil is on track to enter the clinic in Australia in late-2015/early-2016 in patients with the condition, malignant ascites, a terminal condition associated with cancers such as ovarian cancer and for which no effective long-term therapies exist.

Kelly noted: "The capital-raise Novogen announced yesterday was intended to give the Company the financial runway to bring drugs such as Cantrixil through to the point where we hope to see objective evidence of clinical efficacy.

"For Cantrixil, as for all our other pipeline drugs, this is the next key inflection point for the Company in its quest to become a major global drug discovery company."