FDA grants orphan drug status to Reata’s pancreatic cancer drug
A study published by Elsevier this month in Clinical Immunology, the official journal of the Clinical Immunology Society (CIS), describes a new method that facilitates the induction of a specific type of immune suppressive cells, called ‘regulatory T cells’ for therapeutic use. These immune suppressive cells show great potential for the treatment of autoimmune diseases
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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.
The Burzynski Research Institute, Inc. (BRI) has announced that its antineoplaston A10 and antineoplaston AS2-1 therapy (ANP) has been granted orphan drug designation by the U.S. Food and Drug Administration (”FDA”) for the treatment of gliomas. It is estimated that in 2008 more than 21,000 men and women in the U.S. will be diagnosed with
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Kiadis Pharma has announced that the U.S. Food and Drug Administration (FDA) has granted its product Reviroc Orphan Drug Designations (ODD) for the treatment of two types of Non-Hodgkin Lymphoma (NHL). One ODD has been granted for diffuse large B-cell lymphoma and the other one for the treatment of follicular lymphoma. Reviroc(TM) is under development
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Dyax Corp. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) and has designated the application for Priority Review. Based on this designation, the FDA Prescription Drug User Fee Act (PDUFA)
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Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today that SQ109, its lead drug candidate for the treatment of tuberculosis (TB), was the first drug approved for evaluation in a newly awarded clinical program contract to Dynport Vaccine Company LLC and Quintiles Transnational. The contract, awarded by the National Institute
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The Cure Our Children Foundation, a nonprofit charitable foundation dedicated to children, announced today that the U.S. Food and Drug Administration (FDA) has approved the Orphan Drug Designation of the foundation’s unique drug product for children with Ewing’s Sarcoma cancer. The efforts to develop this drug were made possible by the generous volunteers and researchers
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