CNS to help plan pancreatic cancer trial

Australian CRO Clinical Network Services (CNS) has been contracted by Nuvilex to help plan a trial of a prospective new treatment for inoperable pancreatic cancer.

Under the agreement, CNS will provide Australian clinical and global regulatory services in support of a treatment built from Nuvilex’s Cell in a Box technology.

Cell in a Box is a cellulose-based, live-cell encapsulation technology which Nuvilex is using as a platform to develop treatments for multiple types of cancer, as well as diabetes.

The pancreatic cancer treatment involves combining anticancer drug ifosfamide with encapsulated live cells to convert the drug into its active form.

CNS will provide clinical trial planning and management services to support an Australian phase IIb trial of the treatment.

The CRO’s BioDesk unit will also provide consultancy and management services to support Nuvilex's regulatory strategy for the product, including orphan drug applications with the TGA, FDA and EMA.

CNS was the CRO in charge of phase I and early phase II trials of the drug. Nuvilex CEO Kenneth L Waggoner said CNS’s history and familiarity with the product “will greatly facilitate preparations for the Australian trials and bring us closer to a potential solution [for treating] pancreatic cancer”.