Novogen US studies confirm drug’s cancer-kill capability
THE ROADHOUSE PHARMACY: Novogen Limited (ASX: NRT) has claimed to have confirmed one of its lead candidate products, TRXE-009, is showing potential to become a new therapy in the fight against adult and pediatric brain cancer.
The company said its latest study looked at the ability of TRXE-009 to kill a library of patient-derived cell cultures from subjects with glioblastoma multiform (GBM).
The cells were cultured under conditions that promote cancer stem cell growth.
Novogen explained these stem-like cancer cells are believed to be responsible for chemotherapy resistance and tumor recurrence and that being able to kill the highly-resistant GBM cancer stem cells is considered to be a fundamental requirement to treating this disease.
Novogen claimed all patient derived cancer cells represented in the library responded to TRXE-009 at clinically relevant doses, which it said suggests the drug hols therapeutic potential.
The studies were conducted by Drs John Boockvar and Marc Symons at the Feinstein Institute for Medical Research.
The company indicated its next step in the drug’s development would be to confirm its ability to cross the blood-brain barrier, a key filtering mechanism that effectively blocks the majority of chemotherapic drugs from reaching brain tissue.
TRXE-009 was designed to cross the blood-brain barrier and has been formulated as a proprietary drug product known as Trilexium.
Novogen declared Trilexium is anticipated to have application in the treatment of cancers both with and without brain involvement and is due to enter a Phase 1 study in early-2016.
Investigations being undertaken in conjunction with Feinstein are looking at alternative means of delivering TRXE-009 to the brain, including direct injection into the brain cancer by the process known as convection-enhanced delivery, and the use of lipid brain-targeting particles injected intravenously.
“TRXE-009 has been a drug development success story, thanks to a team led by Andrew Heaton PhD and Eleanor Ager, PhD,” Novogen Group CEO Dr Graham Kelly said in the company’s announcement to the Australian Securities Exchange.
“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 o 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.
“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.”
Website: www.novogen.com