Australian oncology-focused biotechnology company Novogen Ltd 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.
