In April of this year ATS applied for funding from National Institute for Mental Health (NIMH) for the toxicology studies of Substance P-Saporin (SP-SAP). This $674,000 supplement to a previous NIMH Small Business Innovative Research grant will cover one of the FDA-required safety and toxicology studies and will bring us closer to clinical trials in humans. On August 14, ATS received notice of the reviewers’ score of these studies. ATS is pleased with the reviewers’ assessment and is optimistic about funding. Collaborating with ATS on this grant are two scientists who are experts in their fields: Dr. Tony Yaksh (UCSD, Dept. of Anesthesiology) who will be heading the toxicology/safety experiments in animals, and Dr. Patrick Mantyh (Univ. Minnesota), who will provide analysis and imaging of tissue samples from the study. Dr. Douglas Lappi (President and Senior Scientist at ATS) is Principal Investigator for this project and plans to begin synthesis of SP-SAP for use in these studies early in October.
The toxicology/safety studies will provide important information about the way SP-SAP may be used to treat intractable pain in humans. First, these experiments should tell us whether SP-SAP has toxic side effects. Second, they should give indications of how safe the drug will be at various doses. Finally, this will be the first time we will study the way the body reacts to the drug: how quickly it is absorbed, how it is broken down in the body, whether any of these breakdown products are toxic, and how quickly the drug and its breakdown products are eliminated from the body. If, after this intensive series of experiments, SP-SAP is determined to be safe to use in humans, ATS will initiate the first clinical trials.
The FDA has advised us that SP-SAP may best be developed as an orphan drug for treatment of pain in patients with terminal cancer. ATS will interact closely with the FDA during the drug development process and will publish updates in our quarterly newsletter and on our website at ATSbio.com.