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news.Nuvilex, a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced that the US Food and Drug Administration (FDA) has granted Nuvilex orphan drug designation for its pancreatic cancer treatment.
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Nuvilex’s pancreatic cancer treatment combines Nuvilex’s patented and proprietary cellulose-based encapsulation technology, known as Cell-in-a-Box(R), with the cancer prodrug ifosfamide and encapsulated live cells that convert the prodrug into its cancer-killing form.
These capsules are placed as close to the cancerous tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the cancer. This "targeted chemotherapy" has proven remarkably effective in past clinical trials.
"Receiving orphan drug designation by the FDA represents a significant milestone in the development of our pancreatic cancer treatment. This achievement is a very important one, both for Nuvilex and our partner Austrianova. It not only facilitates the future development of Nuvilex’s pancreatic cancer treatment, but also serves to validate the Cell-in-a-Box(R) technology," stated Kenneth L. Waggoner, Chief Executive Officer of Nuvilex.
Nuvilex is currently preparing for a Phase 2b clinical trial in advanced pancreatic cancer (the orphan indication) in Australia to gain regulatory approval from agencies like the FDA for Nuvilex’s targeted chemotherapy of pancreatic cancer. Nuvilex’s clinical trial is planned to commence in 2015.
Orphan drug designation in the U.S. is given to drugs or treatments for "rare," life-threatening diseases. In the U.S., a rare disease is defined as one that is diagnosed in less than 200,000 people in the U.S.
In addition, in the U.S. pancreatic cancer can be classified as a life-threatening disease because, even with the best available chemotherapy, patients with advanced pancreatic cancer are destined to live less than one year on average and the 5-year survival rate is less than seven percent.
Receiving orphan drug designation for Nuvilex’s pancreatic cancer treatment carries with it up to 7 years of marketing exclusivity in the U.S. In addition, special assistance from the FDA in the development of Nuvilex’s treatment for pancreatic cancer and exemptions or reductions in regulatory fees and taxes can accompany the designation.