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Nuvilex seeks FDA orphan drug designation for Cell-in-a-Box pancreatic cancer treatment

US-based biotechnology firm Nuvilex has submitted an application to the US Food and Drug Administration (FDA) seeking orphan drug designation for its Cell-in-a-Box treatment for pancreatic cancer.

If granted, the FDA orphan drug designation will provide the company special development and commercial assistance, including a seven year period of marketing exclusivity.

In September, the company had submitted an application to the European Medicines Agency (EMA) for this treatment.

The company’s pancreatic cancer treatment combines the Cell-in-a-Box cellulose-based live cell encapsulation technology with low doses of the anticancer prodrug ifosfamide to provide targeted chemotherapy to these patients.

During the Cell-in-a-Box encapsulation process, cells are enclosed in pin-head-sized capsules, which convert ifosfamide into its cancer-killing form at or near the site of the tumor to increase the efficiency and effectiveness of a patient’s treatment.

Nuvilex chief executive officer and president Kenneth Waggoner said, "Submission for Orphan Drug Designation in the US is the next logical step for the development of Nuvilex’s pancreatic cancer treatment, and we look forward to hearing back from the FDA regarding our application."