Nuvilex Files For EU Orphan Status For Cell-in-a-Box Treatment
Clinical-stage biotech Nuvilex announced that it has filed an application to the European Medicines Agency (EMA) seeking Orphan Drug status for its Cell-in-a-Box treatment for pancreatic cancer.
Cell-in-a-Box for pancreatic cancer is comprised of low doses of anticancer drug ifosfamide and live cells which convert the drug into its cancer killing form. Both the drug and the cells are contained within a protective capsule the size of a pin-head and made of bio-inert cellulose. The capsules can be used to provide treatments for up to two years inside the patients’ body, where they stay bio-inert and incite no immune or inflammatory response. Nuvilex’s cell encapsulation technology is currently being developed both for cancers and diabetes.
Kenneth L. Waggoner, Nuvilex's CEO and President, said, “Since the cellulose-based encapsulation of live, ifosfamide-activating cells for their use in treating pancreatic cancer has been previously approved in principle for the Orphan Drug Designation in Europe, we are encouraged that this will be the case once again, particularly given that additional data have been submitted to support the new application and the fact that the Cell-in-a-Box technology has matured significantly since the previous application.”
If the EMA grants Nuvilex’s application for Orphan status, the company could enjoy reductions or exemption in regulatory fees as well as marketing exclusivity of ten years once the treatment is approved for the indication.
The company acquired rights to the technology which was used to produce Cell-in-a-Box from SG Austria Pte. Last year, analysts declared that the “one size fits all” technology of cell encapsulation, particularly Cell-in-a-Box, could become the “gold standard” for treating late-stage, inoperable pancreatic cancer. Last month ViaCyte also unveiled a similar encapsulated cell replacement therapy that will soon be assessed in a clinical trial for patients with Type 1 diabetes.
Nuvilex has set its sights on several target markets for Cell-in-a-Box aside from Europe. These markets include the U.S. and Australia, where Nuvilex plans to apply for similar orphan drug status for the novel treatment.