Novogen to launch Cantrixil clinical trials in second half of 2016

US-Australian drug discovery company, Novogen Limited (ASX:NRT; NASDAQ:NVGN) today provided an update on progress regarding the development of Cantrixil (TRXE-002-1), its lead superbenzopyran (SBP) molecule, which is intended for the treatment of ovarian cancer.

The company say Cantrixil remains on track to commence clinical trials in the second half of 2016, as the Company has previously indicated.

The proposed design of the phase I study has been amended in light of emerging data to focus more specifically on patients with ovarian cancer in order to better understand its effects in the target population, and it is no longer anticipated to be restricted to patients with malignant ascites.

It is envisaged that the study will be conducted at centres in Australia and the United States, and discussions are ongoing with potential clinical investigators in both countries.

Given the international scope of the study, Quintiles (NYSE: Q), a global clinical research organisation (CRO), has been engaged to support execution of the study.

Novogen plans to submit an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) in August 2016, and expects to achieve First Patient In (FPI) to the study in the fourth quarter of 2016. In preparation for transition of Cantrixil into the clinic, Novogen has concluded funding to the CanTx joint venture with Yale University, and the CanTx entity will be wound-up in an appropriate manner.

All intellectual property licensed from Novogen to CanTx will be returned to Novogen, in accordance with the terms of the agreement between the two companies. CanTx was formed in November 2013 as a joint venture between Novogen, Yale University, and certain of its faculty, with Novogen owning 85% of the company.

The primary purpose of the joint venture was to facilitate the application of Yale’s experimental models and preclinical test systems to Novogen’s molecules.

Novogen licensed components of its intellectual property to CanTx for investigation in the laboratories of Professor Gil Mor, and this work has provided useful data to guide further development of Cantrixil, Novogen’s lead superbenzopyran molecule, in the field of ovarian cancer.

A scientific review by Novogen’s Board in August 2015 resolved to advance Cantrixil into clinical development in this indication, and the Company’s R&D team have since been focused on designing and implementing an appropriate first-in-human study.

Dr James Garner, CEO of Novogen, said “CanTx has been a helpful vehicle for performing some of the supportive experiments that have informed our development of Cantrixil.

As we move into clinical trials, a simpler arrangement will be advantageous and we will be returning the licensed intellectual property to Novogen’s stewardship. We believe this represents the most appropriate use of shareholder funds, and the most effective way to move Cantrixil forward.”

As part of the wind-up process, Novogen may be required to recognise an impairment to certain intercompany loans between Novogen and CanTx, and these impairments will be appropriately reported once they have been fully determined.

Dr Garner added, “we believe there is a strong basis to move Cantrixil into the clinic and the team has been working assiduously for some months on the necessary preparations. We have completed most of the INDenabling work, and are finalising protocol design in collaboration with external advisors and potential investigators, while also completing manufacture of the investigational product.

Our goal is to offer a meaningful new treatment option for patients with ovarian cancer, and we plan to give Cantrixil the best opportunity possible to demonstrate its potential in a clinical setting.”

Cantrixil is a cyclodextrin-based formulation of the active ingredient, TRXE-002-1, which has shown in vitro and in vivo anti-cancer activity in a range of tumor 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 cavity (eg ovarian, uterine, colorectal and gastric carcinomas). A first-in-human clinical study is planned to commence in the second half of 2016.