ATS continues to make progress toward human clinical trials with SP-SAP. Thanks to the financial support of the National Institutes of Health, National Institute of Mental Health, preclinical studies have been completed, protocols for drug production have been written and the first of two toxicology studies is done. This first study is a GLP toxicology study done in rat. At the time of this printing, the reports are being finalized with the results. The important preclinical work that was published in the journal Science was done in rat, but the studies were not GLP, nor did they examine enough parameters to meet the standards set for a toxicology study. The FDA requires one additional toxicology study be completed in another animal model before tests can begin in humans.
Another important part of the drug development process is the careful formulation of the drug itself. ATS is fortunate to have established a relationship with Dr. Arthur Frankel and his team at Scott and White Memorial Hospital, Cancer Research Institute in Temple, Texas. Dr. Frankel has supervised the production of four drugs under GMP (Good Manufacturing Practices) conditions. He is an expert in the field of recombinant toxin drug development. His group is currently working with ATS to improve the production of recombinant saporin (the toxic component of SP-SAP).
For several years ATS has been discussing the possibility of using SP-SAP in veterinary applications, in particular for bone cancer in dogs. Within the next few weeks, the protocol should be completed and the trial set to begin. SP-SAP is expected to provide relief from the debilitating pain these pets endure. With that relief they should experience a greater freedom of movement and enjoyment of life. Check the next issue of Targeting Trends for more details on this exciting project.
And, finally, here is a follow up on the July 2005 article regarding a partnering opportunity for ATS. Meetings have been held with potential candidates, but no deals have been finalized to form a partnership to bring SP-SAP to market for patients in chronic pain. ATS is looking for an experienced pharmaceutical or biotechnology company that can quickly take SP-SAP through the regulatory and clinical phases of development. If you have a connection with such a company, please contact Denise Higgins, Vice President of Business Development. ATS will provide a business plan and other pertinent
information to potential partners.