This excerpt taken from the ABII 8-K filed Apr 1, 2008.
Phase III Clinical Trials
The company expects to have five Phase III trials active or initiated in 2008. These trials are designed to expand the number of oncology indications in which ABRAXANE may be used. The Phase III trials are focused in the areas of non-small cell lung cancer (NSCLC), melanoma, first-line metastatic breast cancer (MBC) and pancreatic cancer. These are all expected to be superiority trials utilizing weekly dosing schedules of ABRAXANE.
Abraxis BioScience, Inc.
2007 Fourth Quarter/Full Year Financial Results
NSCLC: Special Protocol Assessments (SPAs) for the design of Phase III trials in first-line NSCLC, melanoma and first-line metastatic breast cancer were submitted to the FDA in 2007. In October 2007, the company reached a definitive agreement with the FDA under the SPA process regarding the design of the Phase III NSCLC trial. Patient enrollment in the Phase III NSCLC trial commenced in the fourth quarter of 2007.
Melanoma: The company and the FDA have agreed upon the design and endpoints for the Phase III melanoma trial, which is expected to begin in the second half of 2008.
MBC: Based on the compelling results of a randomized head-to-head Phase II clinical trial comparing ABRAXANE and Taxotere® in the first-line treatment of metastatic breast cancer (MBC), the company plans to initiate a multi-center Phase III registration trial comparing ABRAXANE to Taxotere® for the first-line treatment of MBC. The company has reached agreement with the FDA with regard to endpoints (progression free survival) for the Phase III trial in first-line MBC. The Phase III trial in first-line MBC is expected to begin during the second half of 2008.
Pancreatic Cancer: Based on encouraging Phase I/II clinical trial data of ABRAXANE in the treatment of first-line metastatic pancreatic cancer, the company plans to initiate two randomized Phase III trials of ABRAXANE for use in both first- and second-line pancreatic cancer. Presentation of the Phase I data on use of ABRAXANE in treatment of pancreatic cancer has been accepted by the American Society of Clinical Oncology (ASCO) at the ASCO conference in May 2008. The company plans to initiate the Phase III trials in pancreatic cancer by the end of 2008.