ASX:NRT NASDAQ:NVGN
Novogen Ltd (Company)
ABN 37 063 259 754
Capital Structure
Ordinary Shares on issue:
429 M
Board of Directors
Mr John O'ConnorChairman
Non-Executive Director
Mr Bryce CarmineDeputy Chairman
Non-Executive Director
Dr James GarnerChief Executive Officer Managing Director
Mr Ian Phillips MNZMNon-Executive Director
Mr Iain RossNon-Executive Director
Mr Steven CoffeyNon-Executive Director
MARKET RELEASE12 September 2016
US FDA APPROVES INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR CANTRIXIL™ (TRX-E-002-1) IN OVARIAN CANCER- 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
Sydney, 12th September 2016 - 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."
[ENDS]
Media and Investor Relations | Investor Relations (US) |
Glen Zurcher E: glen.zurcher@irdepartment.com.au T: +61 420 249 299 | Robert Kennedy E: robert.kennedy@novogen.com T: +1 212 519 9832 / +1 646 662 3574 |
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 LimitedNovogen 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
Novogen Limited published this content on 12 September 2016 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 12 September 2016 01:20:03 UTC.
Original documenthttp://www.novogen.com/pdf/160912 - IND open announcement.pdf
Public permalinkhttp://www.publicnow.com/view/2E103FD8A49F1F22917FC1AD70C55B101F794914