US-Australian drug discovery company, Novogen Limited has engaged Novotech as the Contract Research Organization (CRO) to conduct its Phase 1 clinical study for the drug candidate, Cantrixil, which will commence in 2016.
This first-in-human study will investigate the safety and feasibility of Cantrixil administered via the intraperitoneal route for patients with refractory /recurrent peritoneal malignancies with malignant ascites.
According to Novogen's Clinical and Regulatory Affairs Manager, Kimberley Lilischkis, PhD, the Cantrixil Phase 1 study will be weighted towards ovarian cancer patients with the selection of a gynecological oncology site.
"However, patients with other cancer types will also be eligible to enrol in this first study since early preclinical data suggests the drug candidate may benefit patients with a range of cancer types," Dr Lilischkis said.
"Patients with malignant ascites have been chosen because ethically this patient group stands to receive the most benefit and face the least risk from the insertion of a peritoneal port or catheter, which can be used for drug administration but also for the on-going drainage of malignant ascites."
Dr Lilischkis said Novogen was continuing to progress Cantrixil through the necessary preclinical regulatory requirements and safety evaluations and was on track to complete the 'in-life' phase of the toxicity studies by the end of 2015. The Company expected to receive the final report in early 2016 once a comprehensive pathology review was completed.
Acting CEO, Iain Ross said the appointment of Novotech was a key milestone in progressing Novogen's first oncology drug candidate, Cantrixil, to the clinic. "Novogen is confident that Novotech will add significant value to the clinical trial program bringing their standard of excellence to the development of this promising drug candidate," Mr Ross said.
Novotech is a prominent Australian-based CRO with extensive background in oncology drug development and a broad range of clinical trial outsourcing services. Novotech has well-established working relationships with the Australian sites and KOLs working with Novogen on this study. This CRO has world-class electronic data and trial management systems that will support the data management, monitoring and safety reporting activities for this study. Novotech is the only Australian-based CRO that has a Quality Assurance system with ISO9001:2008 accreditation and has a superb track record in managing early phase oncology studies.
"We're delighted to be working with Novogen on this important study. The development of Cantrixil has the potential to add an important new tool in the fight against cancer, and we are looking forward to leveraging our previous experience in all phases of oncology drug development to the management of this program," CEO of Novotech, Alek Safarian, said.