DALLAS, April 6 /PRNewswire/ -- Reata Pharmaceuticals, Inc. today announced that its third development candidate, RTA 402, has received FDA clearance to begin clinical testing in patients with solid tumors, lymphoma, and myeloma. A clinical trial has been initiated with this agent at the M. D. Anderson Cancer Center.
“Reata is very excited to begin clinical development of RTA 402, based on its striking preclinical profile,” said Warren Huff, President and Chief Executive Officer of Reata. “In animal studies, this drug has shown excellent anti-cancer activity by itself, and when used in combination with traditional cancer therapies it enhances their anti-cancer effect while, remarkably, protecting normal tissues from harmful side effects. We believe this novel drug holds great promise for helping cancer patients, and look forward to the start of clinical testing.”
About RTA 402
RTA 402 (also known as CDDO-Me) is a novel targeted cancer therapy with a unique mechanism of action. It exploits fundamental physiological differences between cancerous and noncancerous cells by modulating oxidative stress response pathways. As a result, the drug is toxic to cancer cells but induces protective antioxidant and anti-inflammatory responses in normal cells. In rigorous preclinical studies, RTA 402 has been shown to:
* inhibit growth and cause regression of cancerous tumors as a single agent and in combination with radiation and chemotherapy * suppress radiation and chemotherapy-induced toxicities in normal tissues * cause minimal toxicity in non-human primates when dosed orally at very high doses for 28 consecutive days
This combination of potent anti-cancer effects and protective effects in non-cancerous tissue is unique, and confirmation of this activity in clinical studies would afford RTA 402 a uniquely valuable position in the clinical treatment of cancer.
Reata has initiated a clinical trial of RTA 402 capsules in patients with solid tumors, lymphoma, or myeloma at the M. D. Anderson Cancer Center. Initiation efforts are also underway at the Dana-Farber Cancer Institute. This trial will set a safe human dose for RTA 402, and will also provide insights into efficacy and side effects of the drug.
Reata’s Synthetic Triterpenoid Program
RTA 402 and a number of related drugs with the same mechanism of action were licensed by Reata from Dartmouth College and The University of Texas M. D. Anderson Cancer Center. RTA 402 is the second of Reata’s synthetic triterpenoids to enter clinical studies. RTA 401 (also known as CDDO) began clinical testing in patients with leukemia during 2005.
In addition to these two lead drugs, several other analogues have shown highly promising activity in preclinical studies. Recently, the imidazolide derivative of CDDO (CDDO-Im) was featured on the cover of Cancer Research. This agent demonstrated excellent activity in preventing liver cancer in mice exposed to aflatoxin, a toxic fungus known to cause liver cancer in humans.
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 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 prevent pathogenic misfolding of p53, SOD, and Tau, proteins involved in cancer and neurodegenerative disease.
Reata is scheduled to present its programs at the BIO Annual meeting held in Chicago from April 9-12, 2006. For more information, please see http://www.reatapharma.com .
Reata Pharmaceuticals, Inc.
CONTACT: Warren Huff of Reata Pharmaceuticals, Inc., +1-972-865-2200, orwarren.huff@reatapharma.com
