Patients

Prior to commencement of clinical studies involving patients, preclinical testing of new pharmaceutical products is generally conducted on animals in the laboratory to evaluate the potential efficacy and safety of the product candidate. The results of these studies are submitted to the Food and Drug Administration (FDA) as a part of an Initial New Drug (IND) application, which must become effective before clinical testing in humans can begin. Typically, human clinical evaluation involves a time-consuming and costly three-phase process. In Phase I, clinical trials are conducted with a small number of people to assess safety and to evaluate the pattern of drug distribution and metabolism within the body. In Phase II, clinical trials are conducted with groups of patients afflicted with a specific disease in order to determine preliminary efficacy, optimal dosages and expanded evidence of safety. (In some cases, an initial trial is conducted in diseased patients to assess both preliminary efficacy and preliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II trial.) In Phase III, large-scale, multi-center, comparative trials are conducted with patients afflicted with a target disease in order to provide enough data to demonstrate the efficacy and safety required by the FDA. The FDA closely monitors the progress of each of the three phases of clinical testing and may, at its discretion, re-evaluate, alter, suspend, or terminate the testing based upon the data which have been accumulated to that point and its assessment of the risk/benefit ratio to the patient. All adverse events must be reported to the FDA. Monitoring of all aspects of the study to minimize risks is a continuing process.

The results of the preclinical and clinical testing on non-biologic drugs and certain diagnostic drugs are submitted to the FDA in the form of a New Drug Application (NDA) for approval prior to commencement of commercial sales. In the case of vaccines or gene and cell therapies, the results of clinical trials are submitted as a Biologics License Application (BLA). In responding to a NDA or BLA, the FDA may grant marketing approval, request additional information or refuse to approve if the FDA determines that the application does not satisfy its regulatory approval criteria.

The following chart provides information on the status of the products we are currently developing.

We recognize the importance of communicating information about our current and future clinical trials. Information about enrollment in our current clinical trials is available on this website at the links on the left. Information about future clinical trials will be made available on this website when the protocols have been accepted by the individual clinical trial sites. For patient inquiries, please call 650-473-7730.

Related Links

For general information about clinical trials, visit the links below.

For a diagram and explanation of all phases of a clinical trial, visit the CBER website (Center for Biologics Evaluation and Research at FDA)

For basic questions and articles about clinical trials, visit the U.S. Food and Drug Administration

For general information about clinical trials that specifically address cancer, visit the American Cancer Society

For detailed information about clinical trials that specifically address cancer, visit the National Cancer Institute Web site at the U.S. National Institutes of Health (NIH)