Novogen’s Brain Cancer Drug Demonstrates Promising Results

Australian biotechnology company Novogen Limited’s lead candidate demonstrated promising results in patients with brain cancer.

The company announced that one of its lead candidate products, TRXE-009, is showing the potential to become an important new therapy in the fight against adult and pediatric brain cancer. The pre-clinical study has found that the drug can destroy brain cancer cells that are resistant to chemotherapy and cause tumors to return.

The news sent Novogen shares up 38 percent.

The study evaluated TRXE-009’s ability to kill a library of patient-derived cell cultures from individuals with glioblastoma multiform (GBM). The cells were cultured under conditions that promote cancer stem cell growth. Researchers believe that these stem-like cancer cells are responsible for chemotherapy resistance and tumor recurrence.

Findings from the study, carried out at the Feinstein Institute for Medical Research, join other recently announced pre-clinical studies showing that TRXE-009 is highly cytotoxic of chemo-resistant pediatric brain cancers such as Diffuse Intrinsic Pontine Glioma (DIPG) as well as other pediatric neural and neural crest-derived tumors.

According to the company, the next step in the drug’s development is to confirm its ability to cross the blood-brain barrier, a key filtering mechanism that effectively blocks the majority of chemotherapeutic drugs from reaching brain tissue. The drug was designed to cross the blood-brain barrier and has been formulated as a proprietary drug product known as Trilexium. The company anticipates that Trilexium will have application in treating cancers both with and without brain involvement. The drug is expected to enter a Phase I study early next year.

“TRXE-009 has been a drug development success story, thanks to a team led by Andrew Heaton PhD and Eleanor Ager, PhD. 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.”

Source: Novogen Limited

Last updated: 3/6/15; 9:55am EST

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