Clinical Trials

Clinical trials are the first stage of testing in humans — required prior to any approval for sale of the potential drug product.

Phase I trials are the first-stage of testing in humans. The number of patients is generally small — less than 80 patients, and may be in either healthy volunteers, or individuals who have failed previous therapies. Phase I trials are designed to determine drug safety and the appropriate effective dose.

Phase II trials are designed to demonstrate drug activity, as well as continue to monitor drug safety. The number of patients can vary in Phase II trials, but generally is no greater than 300 patients.

Phase III trials are randomized controlled trials in a large number of patients. These trials are designed to confirm the safety and efficacy of the drug using definitive end-points. Phase III trials generally run longer than Phase I and Phase II trials.

Phase IV trials are conducted post FDA (or international regulatory agency) approval. Their purpose is to continue to monitor safety and determine if the drug has any long-term adverse effects. Phase IV trials may be mandated by regulatory agencies, or conducted by the Company for competitive reasons.

Additional information on clinical trials may be found at: http://www.clinicaltrials.gov and http://www.cancer.gov/clinicaltrials