News Feature | December 22, 2014

Novogen's Brain Cancer Drug Also Active Against Melanoma

By C. Rajan, contributing writer

Australian biotech firm, Novogen, has announced a “breakthrough” discovery in melanoma treatment, as the company’s lead candidate, TRXE-009, was found to be highly active against melanoma in pre-clinical studies.

Novogen originally developed TRXE-009 for the treatment of brain cancers, and its activity against melanoma indicates that there is a link between brain cancer and melanoma. While this link has been hypothesized before, TRXE-009 is the first compound to provide evidence for this connection, says Novogen, as the drug identifies the two cancers arising in cells that share the neural crest as their common origin.

The pre-clinical results are also exciting because they show that TRXE-009 is an important new potential treatment for melanoma, and also for treatment of secondary brain cancers caused by melanoma. Metastatic melanoma spreads to several parts of the body, including the brain, and there are no available treatments for this currently.

In earlier clinical trials, TRXE-009 displayed its potential as a treatment option for both adult and paediatric neural cancers, as well as brain tumors that are highly resistant to available chemotherapies. The drug shows equally high potency against the melanoma cells, according to these recent results, without its activity being impacted by the tumor's BRAF gene status.

Dr. Graham Kelly, CEO of Novogen, said, "This finding completely changes the outlook for this drug candidate. From a drug that was due to come into the clinic specifically for the treatment of adult and childhood neural cancers, we now are presented with a prospective treatment for malignant melanoma, including the treatment of secondary brain cancers due to melanoma for which there currently is no effective therapy."

TRXE-009 is a super-benzopyran compound that is able to pass through the blood-brain barrier and has activity against brain cancer stem cells. TRXE-009 and similar super-benzopyran compounds are designed to kill the entire spectrum of cells within a tumor, including the cancer stem cells. The drug attacks the cancer cells’ electron-transfer pump mechanism oncogene and causes the cells to die by respiratory distress and mitochondrial disintegration.

Novogen is developing TRXE-009 as a special oil-based formulation (called Trilexium), which will maximize the bio-availability of the drug to cancer cells in the body and enable the drug to pass across the cancer cell plasma membrane. The efficacy of the Trilexium formulation has already been confirmed by animal xenograft studies of human cancer.

Novogen also announced this week that it has raised $4.1 million AUD in private placement to U.S. institutions. The funds will be used to fund the clinical trials of its lead compounds. The company also gave an update of its other experimental chemotherapy drug, Cantrixil, developed in collaboration with Yale University, which is due to enter its first clinical study next year.