Novogen Ltd Optimistic on Cantrixil as Study Continues

KEY TAKEAWAYS:

• Novogen Ltd has continued with Phase 1 of the clinical trial for Cantrixil a drug for ovarian cancer.
• Novogen is set to link with a Contract Manufacturing Organisation that will help produce more clinical materials to supply the participating sites during the study.
• Cantrixil has been granted two new patents, one in the United States and another one in the European Union. Novogen has applied for a pa-tent for the drug in up to 25 jurisdictions around the world.

The executives of Australian company Novogen Ltd are confident about the future of the drug Cantrixil as a possible treatment for ovarian cancer even as the Phase 1 clinical trial for the drug is currently occurring.

“We are pleased with progress to date in the phase I study of Cantrixil. Novogen is fortunate to be working with highly-experienced clinicians at leading trial centres. We remain excited by the potential for Cantrixil to become an important addition to the treatment landscape in ovarian cancer and are grateful to those patients who are participating in the study,” Novogen CEO, Dr James Garner said.

Phase 1 of the clinical trial for Novogen started in December 2016. The study aims to understand the drug’s safety profile among the human subjects participating in the trial. It also aims to establish Cantrixil’s Maximum Tolerated Dose (MTD).

Phase 1 studies usually involve the administration of very low doses of the drug involved and then increased later on. In this case, Cantrixil was administered to patients in low doses during the early stage of the trial. The patients are carefully monitored as the dose increased to ensure they are within the tolerable safety criteria. With the establishment of the MTD, additional patients will be recruited into the trials to determine Cantrixil’s clinical efficacy.

Among the five hospitals participating in Novogen’s clinical trials for Cantrixil are Westmead Hospital in New South Wales, Australia; Flinders Medical Centre in South Australia; ICON Cancer Care in Queensland, Australia; Peggy & Charles Stephenson Cancer Center in Oklahoma, USA and Mary Crowley Cancer Research Center in Texas, USA.

Novogen expects to establish the MTD by the first quarter of next year based on the progress of the present study. The study could take longer if a higher MTD is established but it could mean that the drug has better tolerance.

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