SYDNEY, Australia — August 11, 2016 — Australian oncology-focused biotechnology company Novogen Ltd (ASX: NRT; NASDAQ: NVGN) today announced that it has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for Cantrixil (TRX-E-002-1) in ovarian cancer.
The IND is a detailed regulatory filing which is required to initiate clinical studies in the United States. It has been compiled over the past twelve months, following a decision to move Cantrixil into clinical development at the Company’s strategic pipeline review in August 2015.
The IND submission includes a comprehensive package of data, encompassing preclinical pharmacology and toxicity, manufacturing, quality control and clinical development plans. Novogen will be able to move forward to the next step of setting up the clinical trials program thirty days after submission, unless FDA reviewers have questions or concerns which cannot be resolved during that time.
Dr Kimberley Lilischkis, Director of Clinical & Regulatory Affairs at Novogen, commented, “The Cantrixil IND is a critical step on the path to the clinic. We will work closely with the FDA to resolve any queries they may have. Following that, we expect to initiate the study swiftly in the last quarter of 2016, with participation from centres in the US and Australia.”
Cantrixil is a first-in-class development candidate which is being studied as a therapy for ovarian cancer, administered directly into the abdominal cavity via the intra-peritoneal route. Preclinical data has shown broad-based evidence of anti-tumour activity in animal models of ovarian cancer, and a toxicology program conducted under GLP (Good Laboratory Practice (GLP) has demonstrated a toxicity profile that appears appropriate for use in humans at therapeutic doses.
Dr James Garner, CEO of Novogen, added, “This is an important milestone in Novogen’s transition to a clinical stage drug development company. I am delighted that the team has succeeded in delivering on schedule, in accordance with our prior guidance of an August 2016 submission. The Cantrixil trial has received strong interest from clinicians in Australia and the United States. The team is working with Quintiles, our contract research organisation, to select and initiate the most appropriate trial sites and prepare for the phase I study.”
About the Cantrixil (TRX-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.