Dendritic Cell Immunotherapy Platform: DCVax®
DCVax® is a platform technology that can be applied to multiple cancers. It combines a patientís own dendritic cells (DC) with cancer related proteins, or antigens, with the aim of inducing immune responses against a patientís cancer cells. Our early-stage clinical trial data, and those of our collaborators, suggest that DCVax®-Prostate and DCVax®-L may have the ability to significantly delay disease progression, in addition to possibly prolonging patient survival, while maintaining a good quality of life. DCVax®-Prostate and DCVax®-L are designed to have the following characteristics, which would make them and other DCVax® product candidates attractive therapeutic additions to current treatments.
Activation of The Natural Immune System: Our DCVax® platform is designed to naturally elicit an immune response against a patientís cancer. We believe that this response can be effectively accomplished through the injection in the skin of DC that are "educated" to teach the immune system to recognize, and kill cancer cells. Our clinical trials to date, and those of our collaborators, suggest that this immune response may be effective in delaying time to disease progression in brain and prostate cancer, and may significantly prolong survival in brain cancer while maintaining good quality of life.
Targeting of serious cancers with no existing treatments: DCVax® is designed to treat multiple cancers, and to be used together with standard medical treatment such as surgery, radiation and/or chemotherapy. Our clinical protocol for DCVax®-Prostate targets men with rising PSA levels while on hormone therapy, but before metastases develop. There is currently no effective treatment for this growing population of patients that invariably go on to develop complications from the spread of their cancer to the bone and, eventually, succumb to their disease. Our clinical protocol for DCVax®-L targets patients with Glioblastoma multiforme, a highly lethal form of brain cancer. Data from two Phase I trials completed at UCLA, suggest that patients treated with DCVax®-L may survive considerably longer without relapse than historical controls not receiving DCVax®-L.
Low Incidence of Significant Adverse Side Effects or Toxicity: DCVax® Products are designed to induce a natural immune response. Expected side reactions are therefore those reactions that are also seen with other strong immune responses, suchs as pain or itching at the injection site, mild fevers and malaise, muscle pain and headaches. After more than 250 injections given during our previous clinical trials, the side effects related to receiving DCVax® were generally mild. Some patients had moderate injection site reactions, and we observed some sever injection site reactions that we believe to be a result of immune activation. We believe that our use of the patientís own DC to create DCVax® minimizes the potential for toxicity, especially when compared to other cancer treatments
Efficient and Cost Effective Manufacturing: We have developed a closed and automated device based on tangential flow filtration (TFF-Cell Separation System) for manufacturing DC from patient leukapheresis material. Disposable sets have been manufactured, and the system is ready for in-house production of DC for clinical use. This TFF-Cell Separation System is expected to be tested in Phase I trials beginning in late 2007.
Ease of Administration: We initially collect a patientís white blood cells in a single standard outpatient procedure called leukapheresis. After patient-specific manufacturing, freezing of the product followed by quality control testing, each small dose of a DCVax® product is administered by a simple injection into the skin in an outpatient setting.