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A new chemotherapy drug for ovarian cancer has received United States Food and Drug Administration (FDA) Orphan Drug Designation. Cantrixil is now scheduled to enter Australia in late-2015/early-2016 for clinical treatment of 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.

Cantrixil was developed as a joint venture between drug discovery company Novogen and Yale University under the company name CanTx.

The Company sees this move 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 Orphan Drug Designation allows for the development of experimental drugs for clinical indications that do not have a high indication. Receiving this designation allows the US-Australian company access to patent protection, financial subsidisation and marketing incentives.

Novogen and CanTx CEO, Graham Kelly, said, "[This] 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

Approximately 1 in 70 women will develop ovarian cancer in their lifetime. In the U.S. this equates each year to approximately 22,000 new cases diagnosed and 15,000 deaths from ovarian cancer; the figures for Europe are 66,000 and 41,000 respectively. There are different forms of ovarian cancer with epithelial ovarian cancer accounting for 90% of cases.

Approximately 15% of women present with disease localised to the ovaries and with successful surgery, the 5-year survival rate is >90%.

For women with more advanced disease at the time of diagnosis, the 5-year survival rate is <30%.

Approximately 85% of advanced cases respond to first-line therapy (typically paclitaxel and carboplatin), but about 80% of these will relapse within several years