Pharmaceutical Business review

FDA clears Reata’s leukemia drug for clinical trials

The company has also entered a cooperative R&D agreement with the National Cancer Institute, a collaborator in the development of the RTA 401 compound.

RTA 401 is the lead molecule from a series of synthetic triterpenoids licensed by Reata from Dartmouth College and The University of Texas MD Anderson Cancer Center, and developed in collaboration with these institutions and the National Cancer Institute. These agents are potential first-in-class targeted cancer therapies with a unique mechanism of action.

In preclinical studies, these agents have been shown to inhibit growth, and cause regression, of tumors as single agents and in combination with radiation and chemotherapy. They have also been shown to suppress radiation-induced mucositis and chemotherapy-induced toxicity in normal tissues, and have displayed minimal toxicity in IND-directed studies in higher mammals.

This combination of potent anticancer 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.

“We are very pleased to have our second drug enter clinical development,” said Warren Huff, president and CEO of Reata. “This drug has demonstrated very high selectivity for cancer cells, which are under intrinsic oxidative stress, and minimal toxicity in IND-directed preclinical studies.”

Under the agreement with the National Cancer Institute, 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 anticancer agent.