SYDNEY, June 14, 2016 /PRNewswire/ -- US-Australian drug discovery company Novogen Ltd (ASX: NRT; NASDAQ: NVGN) today 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 program, 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.
About the Anisina (ATM-3507) drug candidate
Anisina (ATM-3507) is the first drug candidate in the Company's anti-tropomyosin (ATM) program. 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.
About the Cantrixil (TRXE-002-1) drug candidate
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.
About the Trilexium (TRXE-009) drug candidate
Trilexium (TRXE-009) is the Company's second SBP drug candidate. It has shown evidence of potent anti-cancer activity across a wide range of tumor types, and additional preclinical work is underway to further characterize the drug's activity, and to identify potential indication(s) for clinical development.
About Novogen Limited
Novogen is an oncology-focused, Australian-US drug development company, traded on both the Australian Securities Exchange (NRT) and on NASDAQ (NVGN). Novogen has two proprietary drug discovery platforms (superbenzopyrans and anti-tropomyosins) with the potential to yield first-in-class agents across a range of oncology indications. The three lead molecules Cantrixil, Anisina, and Trilexium are in preclinical development for various cancer types, with the most advanced molecule, Cantrixil, slated to enter clinical trials in late 2016. For more information, please visit www.novogen.com.
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Forward Looking Statement
This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "appear," "intends," "hopes," "anticipates," "believes," "could," "should," "would," "may," "target," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to Cantrixil, Anisina, Trilexium, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company's drug components, including, but not limited to, Cantrixil, Anisina, Trilexium, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, Cantrixil, Anisina, Trilexium, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, the intellectual property relating to Cantrixil, Anisina, Trilexium, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management's current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.