From the S-1:
Our lead mAb-drug conjugate, SGN-15, is composed of the mAb BR96 that binds to a carbohydrate found on many different cancer types, chemically linked to the cytotoxic drug doxorubicin. SGN-15 binds to cancer cells and kills them by delivering doxorubicin inside the cell. SGN-15 is currently in three phase II clinical trials in combination with Taxotere to treat patients with breast, colon or prostate cancer. Aventis, the manufacturer and marketer of Taxotere, is co-funding the studies in breast and colon cancer. >>snip<<
Development Status and Clinical Data. SGN-15 has been tested as a single agent in three phase I trials and two phase II trials. Based on data from these initial phase I and phase II trials that included 153 patients, SGN-15, as a single agent, localized to human tumors and has antitumor activity. However, the infrequency of this antitumor activity did not support further development as a single agent. Rather, our strategy with SGN-15 is to utilize it in combination with a chemotherapeutic agent. >>snip<<
In September 2000, we completed the phase I component of the phase I/II SGN-15 trial and established a well-tolerated dose of SGN-15 in combination with Taxotere. We safely treated 16 patients and antitumor responses were observed. We initiated separate phase II trials in breast and colon cancer in October 2000 with 6 patients being placed in the trial during the first month. This trial is presently accruing patients at the University of Alabama, Birmingham Cancer Center, Georgetown University Medical Center in Washington, D.C., and the Georgia Cancer Specialists in Atlanta, Georgia. We plan to accrue a total of 30 patients in our phase II colon cancer trial and 45 patients in our phase II breast cancer trial. In order to achieve rapid marketing approval, our phase III development strategy is focused on designing trials for second-line therapy, or those therapies that are available after the front-line therapies have failed. |
