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Novogen Ltd, an oncology-focused, Australian-US drug development company, announced that a patent for the ATM-3500 series had been granted in Australia. The ATM-3500 series includes the investigational agent known as Anisina (ATM-3507).
Novogen North America CEO, Dr Andrew Heaton, commented: "This patent provides full protection for Anisina in Australia through to 2035. Together with the SBP patent that was granted in February, today's news means that all three of Novogen's development candidates Cantrixil, Anisina and Trilexium are fully covered in Australia. With our strategy of utilizing the extensive global patent superhighway convention we anticipate a very smooth roll out of these patents globally."
Anisina is the first of a novel class of investigational anti-cancer agents known as anti-tropomyosins (ATMs), which selectively target an essential structural component of the cancer cell, causing cell death and tumor reduction in experimental models.
Dr Justine Stehn, Program Director for the ATM programme, added: "The granting of this patent reflects the innovation inherent in the ATM technology, and gives us confidence to continue moving forward towards clinical trials."
IND-enabling activities for Anisina are currently underway, with the intent of initiating clinical trials in 2017. Manufacture of API (active pharmaceutical ingredient) in accordance with GMP (good manufacturing practice) is in progress, and a battery of tests, including stability, sterility, and other parameters, will be undertaken after this is complete, in accordance with regulatory requirements.
In parallel, the company is performing a standard range of mandated GLP (good laboratory practice) toxicology studies so as to establish the safe dosing range for clinical studies. Preclinical work remains ongoing to fully characterize the effects of the drug and to establish the most appropriate population for a phase I clinical trial.
Anisina (ATM-3507) is the first drug candidate in the company's anti-tropomyosin (ATM) programme. Based on initial research at the University of New South Wales (UNSW), the ATM family have been developed through a rational drug design program to target the Tpm3.1 protein, a critical structural component of cancer cells. Anisina has been shown to be effective in vitro and in vivo against a broad range of cancer types, including neuroblastoma and prostate cancer. The drug is currently undergoing IND-enabling toxicology studies in preparation for the initiation of clinical trials.
Cantrixil is a cyclodextrin-based formulation of the active ingredient, TRXE-002-1, which has shown in vitro and in vivo anti-cancer activity in a range of tumor types. The company anticipates that, if approved, the drug would be used as an intra-peritoneal chemotherapy, either alone or in combination with other agents, and in one or more cancers of the abdominal cavity (e.g. ovarian, uterine, colorectal and gastric carcinomas). A first-in-human clinical study is planned to commence in the second half of 2016. Trilexium (TRXE-009) is the company's second SBP drug candidate.
