FDA grants orphan drug status to Reata's pancreatic cancer drug

Oct 16 2008

Reata Pharmaceuticals, Inc. has announced that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease.

"Pancreatic cancer is a devastating disease with few effective therapies," said Warren Huff, CEO of Reata. "We are encouraged by the initial results with RTA 402 in pancreatic cancer, and are pleased that the FDA has recognized this potential by granting Orphan Drug status."

FDA's Orphan Drug Act was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions affecting 200,000 persons or less in the United States. Orphan drug designation provides an important economic incentive for the development of new products in the cancer field. U.S. orphan drug designation provides for seven years of market exclusivity, reduction in regulatory fees, and additional regulatory support for R&D initiatives.

RTA 402 is an orally available, first-in-class Antioxidant Inflammation Modulator (AIM). RTA 402 and others AIMs work via a novel mechanism that promotes the resolution of inflammation and oxidative stress that underlie many intractable diseases, including cancer and renal/cardiovascular disease. Earlier this year, Phase 1 results with RTA 402 were presented at the Annual Meeting of the American Society of Clinical Oncology. The drug was shown to be well tolerated; to have single agent anti-cancer activity including multiple Objective Responses; to modulate target biological pathways including Nrf2, NF-kappaB, and STAT3; and to reduce levels of pro-inflammatory cytokines including TNF and VEGF. RTA 402 is currently in mid-stage clinical testing for pancreatic cancer and chronic kidney disease.