SYDNEY, Sept. 12, 2016 /PRNewswire/ --
- Cantrixil (TRX-E-002-1) is Novogen's lead development candidate, and is being developed as an intraperitoneal therapy
for patients with ovarian cancer
- Investigational New Drug (IND) application is the key regulatory filing to initiate clinical trials in the United States
- First-in-human (FIH) phase I study remains on track for initiation in 4Q 2016, as per previous guidance
Australian oncology-focused biotechnology company Novogen Ltd (ASX: NRT; NASDAQ: NVGN) today announced that it had received
confirmation from the United States Food and Drug Administration (FDA) that the Investigational New Drug (IND) application for
Cantrixil (TRX-E-002-1) had been successfully opened, and the phase I study of Cantrixil in patients with ovarian cancer may
therefore proceed as planned.
Dr James Garner, CEO of Novogen, commented, "We are grateful to the FDA for their thorough and
comprehensive review of our submission, and we are pleased to have their approval to move forward with the study. The team is
already working alongside Quintiles, our contract research organisation, to make the necessary submissions to human research
ethics committees at each of the participating sites, and we continue to anticipate initiation of the phase I study in the fourth
quarter of 2016, as previously indicated."
About the Cantrixil (TRXE-E-002-1) development candidate
Cantrixil is a cyclodextrin-based formulation of the active ingredient, TRX-E-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 or pelvic cavity (e.g. ovarian, uterine, colorectal or gastric carcinomas). A first-in-human clinical study is planned
to commence in the fourth quarter of 2016.
About Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an oncology-focused biotechnology company based in Sydney, Australia. 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, with the most advanced molecule, Cantrixil, slated to
enter clinical trials in late 2016. For more information, please visit: www.novogen.com