Novogen Limited (NASDAQ: NVGN) confirmed Wednesday morning that one of its lead candidate products, TRXE-009, has shown potential to become an important new therapy for both adult and pediatric brain cancer.

The most recent study focused on the ability of TRXE-009 to kill a library of patient-derived cell cultures which came from subjects with glioblastoma multiform (GBM). The cells were cultured under conditions that promote cancer stem cell growth, and these stem-like cancer cells are believed to be responsible for chemotherapy resistance and tumor recurrence.

In this study, all of the patient-derived cancer cells that were represented in the library responded to TRXE-009 at clinically relevant doses. Ultimately this suggested the strong potential for crafting this candidate into a therapy.

TRXE-009 was designed to cross the blood-brain barrier and has been formulated as a proprietary drug product known as Trilexium. It is anticipated that Trilexium will have an application in the treatment of cancers both with and without brain involvement. Trilexium is expected to enter a Phase 1 study in early-2016.

Dr. Graham Kelly, Novogen Group CEO, said:

The urgent need to find a successful treatment for devastating cancers such as primary and secondary brain cancers in adults and children is what is driving our collaboration with Feinstein to bring TRXE-009 into the clinic.

The CEO would go on to say:

The TRXE-009 story started with the discovery of a compound that was highly cytotoxic against GBM brain cells that came from patients who had failed to respond to Temozolomide, the only standard of care chemotherapy for GBM; it then showed itself to be an equally effective killer of GBM cancer stem cells; it also is highly active in vitro against a range of pediatric brain cancer cells that are notoriously resistant to chemotherapy; it has been designed to cross the blood-brain barrier; it shows little toxicity against normal human brain cells (astrocytes) in vitro; in its parenteral delivery form, the Trilexium drug-product is highly active in animal models of xenografted human tumors, including GBM, and is reasonably well tolerated. So far it has ticked every box asked of it.

Shares of Novogen were up 44% at $3.61 in the last two hours of trading on Wednesday. The stock has a 52-week trading range of $1.51 to $5.97. Novogen is a publicly traded, Australian drug-development company with a market cap of $35 million.

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