Novogen Reports Studies Confirm Trxe-009 Crosses The Blood-Brain Barrier

Novogen Limited

confirms that a lipid formulation of TRXE-009 dosed intravenously to animals was able to deliver therapeutic concentrations of TRXE-009 to brain tissue. This confirms that the drug is able to cross the blood brain barrier. The blood-brain barrier is a defence mechanism intended to protect the brain from the unwanted toxic effects of drugs and food chemicals. It serves to prevent some 98% of all drugs used in humans from reaching the brain. This, plus the inherent resistance of primary brain cancers to chemotherapies, is the reason behind the poor survival prospects of adults and children with brain cancer. Eleanor Ager PhD, Novogen GBM Program Manager, said, "TRXE-009 shows remarkably potent killing in the test tube against a wide range of cancer types, but it has been its particularly potent activity against brain cancers including glioblastoma and DIPG that has marked it as a potential treatment of primary brain cancers in both adults in children. These are tumors that show high levels of resistance to standard of care drugs, so even if it was possible to get those drugs into the brain, they may not offer clinical benefit." "We know TRXE-009 kills these highly resistant cancer cells in vitro, with toxic effects on normal brain cells only occurring at very high doses of the drug. So a vital step forward for us was to see whether we could get the drug to cross the blood-brain barrier. Today's data shows that it does. The next key step is to confirm that the drug is effective against brain cancer cells growing in the brain." Graham Kelly, Novogen Group CEO, said, "TRXE-009 is already on its way into the clinic early next year in the form of Trilexium, a proprietary dosage form of TRXE-009 utilising the compound's potent general anti-cancer activity. What marks this agent as particularly exciting is its particular ability to kill the full range of cells within a tumor, including the tumor-initiating or cancer stem cells. Cancers such as malignant melanoma and metastatic castrate-resistant prostate cancer are in our sights." "Today's data is important in showing that the compound now will also be able to proceed into the clinic for testing as a therapeutic for brain cancer, and where others in this field are focusing on the development of treatments just for cancers that arise in the brain, the much larger problem is cancers that arise elsewhere in the body and spread to the brain, so-called secondary brain cancers. About 25% of all malignant cancers that spread within the body, metastasize to the brain. This includes cancers such as cancers of the lung, breast, kidney and bladder, and melanoma, leukaemia, lymphoma and sarcomas. This is a significant problem that is not currently addressed with currently used therapeutics." "When you consider the broad anti-cancer activity of TRXE-009, combined its ability to kill cancer stem cells, and now combined with its confirmed ability to get it across the blood-brain barrier, TRXE-009 in our view represents an exciting drug prospect and a breakthrough in the search for an avenue of treatment for the large unmet clinical need of both primary and secondary brain cancer," Kelly added.