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
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SOURCE Novogen Limited