DALLAS, Oct. 26 /PRNewswire/ -- Reata Pharmaceuticals, Inc. (“Reata”) today announced that it has received notification from the FDA granting Reata’s request for orphan drug designation for RTA 744 in the treatment of malignant gliomas.
“Reata is extremely pleased to have received orphan drug status for our lead program, RTA 744. This indicates that the FDA recognizes the tremendous unmet need for new brain tumor treatments, as well as the potential for RTA 744 to provide a meaningful benefit to brain tumor patients,” said Warren Huff, President and Chief Executive Officer of Reata.
About RTA 744
RTA 744 is a novel anthracycline derivative that crosses the blood-brain barrier and shows significant potential for the treatment of primary and metastatic brain cancers. Anthracyclines such as doxorubicin are some of the most broadly used and effective classes of cancer therapies; however, previous agents have not been used to treat brain cancers because they do not cross the blood-brain barrier.
RTA 744 is currently being tested in a Phase 1 clinical trial in patients with advanced primary brain cancers at three leading U.S. neuro-oncology centers. Encouraging early results from this trial were reported at the American Society of Clinical Oncology (ASCO) meeting in June, 2006. Updated trial results are scheduled for presentation at the Society of Neuro-Oncology meeting in November, 2006. Advanced clinical trials of this agent in primary brain tumors are planned to begin in 2007.
Due to the promising early results seen in patients with primary brain cancer, Reata has begun clinical trials of RTA 744 in patients who have other types of tumors (for example, lung or breast cancer) that have spread to the central nervous system (CNS). The lack of treatment options for metastatic CNS tumors represents a substantial unmet medical need in a patient population that is approximately 10-fold higher than the population with primary brain tumors. Data from two clinical trials of RTA 744 in metastatic CNS tumors are expected to be available in 2007.
About Reata
Reata Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel treatments for cancer, inflammation, and neurodegenerative diseases. Founded in 2002, Reata is developing five distinct classes of cancer drugs licensed from leading academic institutions. The company has three drugs in Phase 1 clinical development: RTA 744 for primary brain cancers; RTA 401 for leukemias and solid tumors; and RTA 402 for solid tumors and lymphoid malignancies. Reata is matching its clinical and preclinical drug development programs with a best-of-class drug discovery platform to identify small molecule chaperones that can induce proper folding of p53, SOD, and Tau, misfolded proteins that are involved in cancer and neurodegenerative disease.
Reata Pharmaceuticals, Inc.
CONTACT: press, Melissa Krauth of Reata Pharmaceuticals, Inc.,+1-972-865-2205, or melissa.krauth@reatapharma.com
