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The company submits an orphan drug application to FDA for its Cell-in-a-Box treatment for pancreatic cancer.
Nuvilex, a clinical-stage biotechnology company, announced that it has applied for Orphan Drug Designation in the United States for its Cell-in-a-Box treatment for pancreatic cancer. The US submission follows the application Nuvilex made to the European Medicines Agency in September 2014. Orphan Drug Designation in the US is given to drugs or treatments for rare, life-threatening diseases and provides special development and commercial assistance from FDA, including a seven-year period of marketing exclusivity.
According to the company, Nuvilex's pancreatic cancer treatment provides targeted chemotherapy by combining its the Cell-in-a-Box cellulose-based live cell encapsulation technology with low doses of the anticancer prodrug ifosfamide. Cells enclosed in pin-head-sized capsules during the Cell-in-a-Box encapsulation process convert ifosfamide into its cancer-killing form at or near the site of the tumor.
"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," commented Kenneth L. Waggoner, Nuvilex's CEO and president, in a press release.