US-Australian drug discovery company, Novogen, today announced that its subsidiary joint venture company with Yale University, CanTx, Inc, has today received notification from the U.S. 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 U.S, 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 U.S. 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% tumor reduction) anti-tumor 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 U.S. 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.
"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. The funds we hope to raise in the current Placement and Rights Issue offerings are intended to take the Company to that next key inflection point."
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