San Diego, CA, October 7, 2003 - Advanced Targeting Systems, Inc. announced today that it has received a Small Business Innovative Research (SBIR) grant from the National Institute of Mental Health (NIMH) under the program announcement for pharmacologic agents and drugs to combat mental disorders. The three-year, $2.4 million award is a continuation of Phase II funding for the development of a drug for the treatment of chronic pain and will allow Advanced Targeting Systems to complete toxicology studies and to prepare clinical-grade material for use in human trials.
While the development of new drugs to treat disease represents both a major public health need and a commercially significant research area, the architecture of the SBIR Program did not allow for drug development projects to be pursued very far. In response to this need, the Public Health Service SBIR Coordinator worked with the Small Business Administration to allow the National Institutes of Health (NIH) to offer Phase II SBIR Competitive Continuation Awards. NIMH was the first Institute of the NIH to take advantage of this new opportunity by issuing the Program Announcement entitled "Competing Continuation Awards of SBIR Phase II Grants for Pharmacologic Agents and Drugs for Mental Disorders." The Advanced Targeting Systems award is among the first of this new funding.
The SBIR program was established in 1982 to promote efforts of small business in developing and commercializing innovative technologies. SBIR Phase I awards are generally funded up to $100,000, Phase II awards up to $750,000, but there was previously no mechanism for continuing funding for drug development. The NIMH program announcement specifically invites applications for the competing continuation of previously funded Phase II SBIR grants, to take existing, promising compounds through the next step of drug discovery and development. For small businesses like Advanced Targeting Systems, this latest expansion of the SBIR program provides important support at a time when alternative funding is expensive and difficult to find.
The Principal Investigator for the project is Douglas Lappi, Ph.D., President and Chief Scientific Officer of Advanced Targeting Systems. The revolutionary chronic pain drug under development is a targeted toxin called SP-SAP - a patented chemical conjugate composed of the neuropeptide Substance P, and the ribosome-inactivating protein saporin. According to Dr. Lappi, SP-SAP targets delivery of a toxic compound to only those few and specialized nerve cells that transmit chronic pain messages up the spinal cord to the brain. This precise method allows chronic pain to be permanently stopped without affecting normal pain transmission.
Dr. Lappi explains the urgency and importance of the development of SP-SAP. Many people suffering from intractable chronic pain have exhausted all of their options. Their quality of life is diminished. We envision, in the not too distant future, offering a one-time injection that will end the pain. Chronic pain sufferers wont need to take a pill every day. Advanced Targeting Systems has excellent pre-clinical data that leads us to believe that SP-SAP will be safe and effective and compels us to develop SP-SAP for clinical use.
We are fortunate to have a talented and knowledgeable team of collaborators and advisors, said Denise Higgins, VP of Business Development. Its always good to have outside, expert input on projects of this magnitude, and in a small company of fewer than ten employees, its critical.
The collaborative team is as diverse in their backgrounds as their locations. The idea for SP-SAP was first proposed by Ronald G. Wiley, M.D., Ph.D., scientific advisor to Advanced Targeting Systems and Chief of Neurology at the Veterans Administration Medical Center, and Professor of Neurology and Pharmacology at Vanderbilt University, Nashville, TN. Initial pain model studies were performed in the laboratories of University of Minnesota pain expert, Dr. Patrick Mantyh, a subcontractor on Advanced Targeting Systems SBIR Phase II grant. Results of the use of SP-SAP in chronic pain models were reported in a 1997 Science issue. Mantyhs laboratory published a second Science article in 1999 to present results demonstrating the long-term elimination of chronic pain with SP-SAP. Dr. Tony Yaksh, Professor of Anesthesiology and Pharmacology at the University of California, San Diego, is a leading expert on the administration and pharmacology of drugs in the spinal cord and spinal fluid. His associate, Dr. Jeff Allen, completed preliminary toxicology studies with SP-SAP in one of the FDA-required large animal models. UCSD will carry out the full toxicology studies with funding from the grant awarded to Advanced Targeting Systems.
Advanced Targeting Systems is the leading worldwide provider of research reagents for molecular targeting and elimination. The current product line includes targeted toxins, antibodies, and custom conjugation services designed to assist scientists in the study of nervous system function, brain-related disorders, and a variety of molecular-based disorders. The targeting technology has a broad spectrum of applications, not only in medical and pharmaceutical research, but also as the basis for innovative therapeutics. Advanced Targeting Systems continues to develop and expand the existing product line through strategic scientific collaborations with top scientists throughout the world.