The US-Australian drug discovery company, Novogen Limited announced that a patent for the superbenzopyran (SBP) family, covering the lead candidates Cantrixil and Trilexium, has been granted in Australia. This patent provides full protection of Novogen's intellectual property (IP) for the SBP family until 2035.
In addition, the key patent application covering the first lead anti-tropomyosin (ATM) compound, Anisina, has been examined and accepted by the Australian Patent Office. The application has now entered the standard three-month opposition window prior to being granted.
According to Novogen North America CEO, Dr Andrew Heaton, these milestones help validate the company's discovery platforms and represent critical milestones in IP protection.
"The SBP patent covers a wide range of new chemical entities, including Cantrixil and Trilexium. Critically, the patent covers composition of matter, a new abridged method of manufacture, and treatment for a wide variety of cancer types," Dr Heaton said.
"Our key SBP assets are now fully covered in Australia. Furthermore, passing scrutiny in Australia will aid the ongoing global roll-out of this patent."
"The availability of the Global Patent Prosecution Highway will permit accelerated examination in overseas jurisdictions, based on acceptance of an Australian application. This provides an opportunity to expedite examination and subsequent patent grant of SBP and ATM applications in a number of key overseas jurisdictions, such as the United States, Japan and Korea," he said.
"The API for the lead SBP, Cantrixil, has completed large-scale GMP manufacture and production of sterile drug product for clinical studies is well underway. Cantrixil has completed the necessary GLP toxicology assessments for a first-in-human study, with final reports now being collated for inclusion in our clinical trials application package," Dr Heaton concluded.
The ATM Program director, Dr Justine Stehn, commented, "Our lead ATM, Anisina, is covered in this first ATM patent application. The application has been examined by the Australian Patent Office and formally accepted. It has now entered the standard three-month period for opposition. Novogen is committed to building a robust suite of patents around the ATM technology."
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 tumour types. The company anticipates that, if approved, the drug product 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 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.
Anisina 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.