Novogen, CanTx Secure CMOs For Clinical Batches Of Cantrixil Cancer Therapy
By Suzanne Hodsden
Novogen, an Australian drug-development company, announced that contract manufacturing organizations (CMOs) Regis Technologies and Pharmaceutics International will produce Cantrixil for stage IV ovarian cancer patients in clinical trials.The companies hope that this agreement will enable them to produce a sufficient amount of the drug to complete the Investigational New Drug (IND) application process and launch phase 1 trials by mid-2015.
Cantrixil was developed by CanTx, a joint-venture company between Novogen and researchers at Yale University that is devoted exclusively to developing treatments for ovarian cancer. Cantrixil contains two components: an active pharmaceutical ingredient (API) Trx-1 and a cyclodextrin carrier. The Trx-1 targets ovarian cancer stem-cells, thus eliminating the tumors and drastically reducing the chances of their recurrence. The result of this combination is a formula intended for injection directly into the peritoneal cavity.
Intra-peritoneal therapies have been used before in the treatment of abdominal cancers, but at considerable risk of toxicity. However, according to Graham Kelly, PhD, Novogen Group CEO, Cantrixil “has proven to be well tolerated in animals at doses delivering a significant anti-cancer effect.”
Per their agreement with Novogen and CanTx, Regis Technologies will produce the API Trx-1 and Pharmaceutics International, a Maryland-based company, will manufacture the finished dosage form of Trx-1 in cyclodextrin and its intended injectable formulation.
Both companies have undergone recent expansions and are equipped to deal with the scale of this project and its long term goals. Regis Technologies announced in June its commitment to building out its facilities and expanding its range of services to accommodate the production of high potency APIs. Pharmaceutics International doubled the size of its manufacturing facility in late 2012 to allow for batch sizes as large as 100,000 plus units.
Andrew Heaton, Novogen Group VP, Drug Discovery and Manufacture, said: “Having relationships with such companies meets our long term corporate goal of seeing Cantrixil progress from an experimental to a commercial product.”
If the clinical trials prove successful, Cantrixil would be the first FDA approved intra-peritoneal treatment for ovarian cancer — currently the deadliest of gynecological cancers and the 11th most common cancer affecting women.