Lixte, NCI collaborate for clinical evaluation of LB-100 compound

Lixte Biotechnology HoldingsOct 6 2010

Lixte Biotechnology Holdings (OTC: LIXT.PK) announced today that the National Cancer Institute Experimental Therapeutics (NExT) Program Senior Advisory Committee (SAC), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), National Institutes of Health (NIH), signed a NExT Material Transfer Agreement formalizing a collaboration with Lixte Biotechnology Holdings, Inc. for clinical evaluation of LB-100, one of Lixte's lead anti-cancer compounds.

This collaboration is a milestone-based approach in which NCI will first confirm the anti-cancer activity of LB-100 in an animal model of glioblastoma multiforme, the most common brain tumor of adults, and conduct an initial exploratory toxicology study in an animal model.  At milestone intervals, the SAC will re-evaluate project progress before considering assignment of additional support and resources to this project.  

The mission of the NCI NExT Program is to advance clinical practice and bring improved therapies to patients with cancer by supporting the most promising new drug discovery and development projects. NCI partners with successful applicants to facilitate the milestone-driven progression of new anticancer drugs (small molecules, biologics) and imaging agents towards clinical evaluation and registration."

"We are extremely pleased to be accepted into the NExT Program" said Dr. John Kovach, founder and president of Lixte. "The need for more effective cancer therapies is great. At the same time, the drug development process is long and arduous. The advice and practical assistance of the NCI and their collaborators are expected to significantly expedite evaluation of the clinical potential of LB-100. LB-100 was discovered by Lixte and initially evaluated for potential anti-cancer activity against brain tumors under an ongoing Cooperative Research Agreement with the NIH's Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke (NINDS). The research under the NExT program will focus on the pre-clinical evaluation of LB-100 that is needed for submission of an application to the FDA for approval to assess LB-100 in a Phase I clinical trial".