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Reata Announces RTA 401 Entering Clinical Development

Cooperative Research and Development Agreement Signed with NCI
 
DALLAS, TX -- October 12, 2005 -- Reata Pharmaceuticals, Inc. today announced that its second development candidate, RTA 401, has received FDA clearance to begin clinical testing in patients with relapsed and refractory leukemias.  Additionally, the company has announced the signing of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).

"We are very pleased to have our second drug enter clinical development," said Warren Huff, President and Chief Executive Officer of Reata. "Our synthetic triterpenoids are potential first-in-class targeted therapies that induce programmed cell death in cancer cells by activating redox-sensitive signaling pathways.  This drug has demonstrated very high selectivity for cancer cells, which are under intrinsic oxidative stress, and minimal toxicity in IND-directed preclinical studies."

About RTA 401

RTA 401 (also known as CDDO) is the lead molecule from a series of synthetic triterpenoids licensed by Reata from Dartmouth College and The University of Texas M. D. Anderson Cancer Center and developed in collaboration with these institutions and NCI.  These agents are potential first-in-class targeted cancer therapies with a unique mechanism of action. In rigorous preclinical studies, they have been shown to:

  •            inhibit growth (and cause regression) of tumors as single agents and in combination with radiation and chemotherapy
  •           suppress radiation-induced mucositis and chemotherapy-induced toxicity in normal tissues
  •            display minimal toxicity in IND-directed studies in higher mammals

This combination of potent anti-cancer effects and protective effects in non-cancerous tissue is highly unusual and, if confirmed in clinical studies, would afford RTA 401 and Reata's other synthetic triterpenoids a unique and highly valuable position in the clinical treatment of cancer.

A clinical trial of RTA 401 in patients with relapsed and refractory leukemias has been initiated at the M.D. Anderson Cancer Center.  This trial will set a safe human dose for RTA 401, and will provide additional information on efficacy and side effects of the drug.  Additionally, an orally bioavailable analog of RTA 401 (designated RTA 402) is completing final preclinical development with an IND filing slated for the end of 2005.

Collaboration with NCI

Reata has also announced the signing of a CRADA with the NCI, under which the two organizations will collaborate in the clinical development of RTA 401 to provide the best treatment options to cancer patients and ultimately to obtain approval of RTA 401 as a commercial anti-cancer agent. Previously, the NCI completed much of the preclinical development of RTA 401 under the RAID (Rapid Access to Intervention Development) program.  "The NCI has made significant contributions to the development of Reata’s synthetic triterpenoids, and we are delighted to continue working with NCI as these agents enter the clinic," said Warren Huff of Reata.


About Reata

Reata Pharmaceuticals, Inc. is a development-stage biopharmaceutical company focused on the development of 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's most advanced products, RTA 744 for primary brain cancer and RTA 401 for hematological cancers and solid tumors, are in phase 1 clinical development.  An IND for our third product, RTA 402, is slated for filing at the end of 2005.   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 reactivate p53, SOD, and Tau, misfolded proteins involved in cancer and neurodegenerative disease.

Reata will be presenting data on several of its programs, including the synthetic triterpenoids, at the upcoming BioEurope annual meeting and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.

For more information, please see www.reatapharma.com.

For more information, press only:

Warren Huff
(972) 865-2200

warren.huff@reatapharma.com


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