SRI International, an independent nonprofit research and development organization, announced today that it has been awarded a $6.3 million contract by the National Institute of Mental Health (NIMH) to conduct preclinical safety studies of promising novel ligands that will be used for brain imaging research and clinical applications. Ligands are types of molecules that can be used to perform brain imaging through positron emission tomography (PET), single photon emission computed tomography (SPECT), and magnetic resonance imaging (MRI).
"SRI is pleased to be awarded this important contract to conduct the preclinical safety studies needed to understand whether a compound can eventually be administered to people," said Hanna Ng, Ph.D., director of preclinical safety, SRI International, and principal investigator for the program. "Our multidisciplinary team has experience in safety evaluation and regulatory compliance needed to effectively support the NIMH's preclinical development program for central nervous system imaging agents and therapeutics for various mental disorders."
The preclinical studies will help determine the safety, optimal dosage, and form for delivery of imaging agents and medications for the treatment of mental disorders. Toxicology and safety data generated from this program may be used to support investigational new drug (IND) applications to the U.S. Food and Drug Administration (FDA).
SRI has extensive experience working with the NIMH in the preclinical development of neuroimaging agents and potential drugs for mental disorders, and has held the contract for this evaluation program since its inception in 2002.
SRI previously performed toxicology and safety studies for 17 imaging ligands, at least 10 of which have gained approval from the FDA for human clinical trials.