Novogen, a US-Australian drug discovery company, announced that its subsidiary joint venture company with Yale University, CanTx, Inc, has received notification from the US Food and Drug Administration (FDA) that its chemotherapy candidate drug, Cantrixil, has been granted Orphan Drug Designation for ovarian cancer.

Orphan Drug Designation is an important development for any experimental drug and has been instigated in a number of territories including the US, Europe and Australia to encourage the development of drugs for clinical indications that do not have a high incidence.

Orphan Drug Designation can provide the following benefits to a drug developer: Financial subsidization for clinical research; Tax incentives; Extended patent protection; Enhanced marketing rights.

Cantrixil was granted Orphan Drug Designation 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," Kelly added.

Key Cantrixil pre-clinical data was presented by Yale researchers two days ago at the American Association of Cancer Research annual conference. That data represented the final stringent challenge that CanTx and Yale clinicians had set Cantrixil in order to justify bringing it into patients. That data related to an animal model believed to be highly representative of late-stage chemo-resistant ovarian cancer. Cantrixil in that highly stringent model delivered a very potent (>95% tumour reduction) anti-tumour effect.

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. The company sees this as a logical entry point into the clinic for the Cantrixil as being a clinical indication without any approved therapies in the US and Australia, and as a prelude to the ultimate objective of using Cantrixil much earlier in the cancer process as a first-line therapy following diagnosis of ovarian cancer.

Cantrixil is a cyclodextrin envelope containing the active ingredient, TRXE-002. The construct 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 in the environment in which the cancer is spreading through the migration of the cancer stem cell. The ultimate primary indication of Cantrixil to be sought is first-line therapy of early-stage cancers of the abdominal cavity (e.g. ovarian, uterine, colo-rectal and gastric carcinomas). Cantrixil will enter the clinic in later-stage cancers where the abdominal carcinomatosis has resulted in the terminal condition of malignant ascites.

CanTx is a joint venture company between Novogen and Yale University. Novogen owns 85% of the joint venture. Novogen has licensed the drug candidate, TRXE-002, to CanTx for use in Cantrixil. CanTx is based in New Haven, CT.