FDA News

FDA grants orphan drug designation to pancreatic cancer treatment

The FDA granted orphan drug designation to a pancreatic cancer treatment in development by Nuvilex Inc., the company announced today.

The targeted chemotherapy treatment combines Cell-in-a-Box — Nuvilex’s patented and proprietary cellulose-based encapsulation technology — with the cancer prodrug ifosfamide and encapsulated live cells that convert the prodrug into its cancer-killing form.

The capsules are placed as closely as possible to the tumor in order to deliver the highest levels of the drug possible to the source of the cancer.

“Receiving orphan drug designation by the FDA represents a significant milestone in the development of our pancreatic cancer treatment,” Kenneth L. Waggoner, CEO of Nuvilex, said in a press release. “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 technology.”

Nuvilex intends to begin a phase 2b clinical trial of the treatment in 2015.

The FDA Office of Orphan Products grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

The FDA granted orphan drug designation to a pancreatic cancer treatment in development by Nuvilex Inc., the company announced today.

The targeted chemotherapy treatment combines Cell-in-a-Box — Nuvilex’s patented and proprietary cellulose-based encapsulation technology — with the cancer prodrug ifosfamide and encapsulated live cells that convert the prodrug into its cancer-killing form.

The capsules are placed as closely as possible to the tumor in order to deliver the highest levels of the drug possible to the source of the cancer.

“Receiving orphan drug designation by the FDA represents a significant milestone in the development of our pancreatic cancer treatment,” Kenneth L. Waggoner, CEO of Nuvilex, said in a press release. “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 technology.”

Nuvilex intends to begin a phase 2b clinical trial of the treatment in 2015.

The FDA Office of Orphan Products grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.