"The commencement of this Phase I trial for SNS-595 is an important milestone for Sunesis. Based on the strong preclinical data demonstrating SNS-595's robust anti-tumor activity against a variety of cancers -- even in drug resistant tumor models -- we believe this product has significant potential as an innovative cytotoxic therapy," said Daniel Swisher, CEO of Sunesis Pharmaceuticals. "I am also pleased to announce that we have established a world-class clinical advisory board to assist our experienced internal development team."
Patients with advanced malignancies are being enrolled at four centers in the U.S. In the first trial, SNS-595 will be administered as a single dose followed by a 21-day observation period for up to six treatment cycles. In vivo animal studies of SNS-595 demonstrate robust activity, as well as marked potency, in comparison to marketed cytotoxic drugs such as paclitaxel and irinotecan. In addition, SNS-595 shows strong activity in drug-resistant tumor models. Sunesis intends to initiate a second, multi-dose Phase I clinical study in the third quarter. Phase II clinical studies in a variety of tumor types are expected to begin in 2005.
Dr. Daniel C. Adelman, Senior Vice President of Development at Sunesis stated, "SNS-595 has terrific preclinical activity and pharmaceutical properties. We are hopeful that SNS-595 will prove to be useful in the treatment of human cancers."
Prestigious Clinical Oncology Advisory Board Established
Sunesis has established a clinical oncology advisory board comprised of renowned experts in the field. The Clinical Oncology Advisory Board will help guide the oncology drug discovery and development programs at Sunesis. Members of the Clinical Advisory Board include: Stephen Carter, M.D., formerly Senior Vice President of Worldwide Research and Development at Bristol-Myers Squibb; Thomas Fleming, M.D., Professor and Chairman, Biostatistics, at the University of Washington; David Gandara, M.D., Professor of Medicine and Director of Clinical Research at the University of California, Davis Cancer Center; Michael Gordon, M.D., Associate Dean for Research at the University of Arizona and Associate Director of the Arizona Cancer Center; Daniel Hoth, M.D., Consultant Drug Development and Clinical Trials; Herbert Hurwitz, M.D., Associate Professor of Medical Oncology and Transplantation at Duke University; Branimir Sikic, M.D., Director, Clinical Trials Office, Clinical Cancer Center at Stanford University and Alan Venook, M.D., Professor of Medicine and Director of Cancer Research at the University of California, San Francisco.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on discovering and developing superior small molecule medicines for oncology and inflammatory disease. The company has established a rich pipeline using its proprietary fragment-based drug discovery engine, known as Tetheringsm, in-licensing a promising compound within its therapeutic areas of focus and forming partnerships for the development of certain Sunesis-discovered leads. To date, Sunesis has established partnerships with Johnson & Johnson PRD, Merck & Co., Biogen Idec and Dainippon Pharmaceuticals. For further information, visit www.sunesis.com
