PEAPACK, N.J., March 16 /PRNewswire/ -- Pharmacia Corporation (NYSE: PHA - news) announced today the launch of a multi-national Phase III clinical trial to evaluate the addition of semaxanib (SU5416), an investigational angiogenesis signaling inhibitor, to the combination of CAMPTOSAR® (irinotecan hydrochloride injection), fluorouracil (5-FU) and leucovorin (LV) -- a standard chemotherapy regimen against which future therapies should be compared to treat advanced colorectal cancer. This clinical trial brings together leading cancer researchers from more than 150 institutions worldwide to explore the ability of the semaxanib combination to delay tumor progression and ultimately extend survival among approximately 1300 patients. The initiation of this study follows clinical trial experience with semaxanib for the treatment of advanced colorectal cancer in approximately 350 patients.
``Angiogenesis inhibitors may offer us a new way to attack cancer. SU5416 is among the farthest along in clinical development,'' said Lee Rosen, M.D., Director of Cancer Therapy Development Program, UCLA's Jonsson Cancer Center. ``This trial evolved from the results of SU5416 and 5-FU/leucovorin, so the addition of current care with CPT-11 (CAMPTOSAR) may add promise. We are pleased to participate in a clinical trial that offers this investigational treatment option to patients.''
Semaxanib, a small molecule angiogenesis signaling inhibitor, hinders the development of new blood vessels thus depriving a tumor of nutrients needed for growth. In cancer, angiogenesis is the process by which tumors develop blood vessels allowing them to grow and spread to healthy organs. During angiogenesis, tumors send a signal (VEGF), which stimulates normal blood vessels to grow and create a blood supply to carry nutrients and oxygen to the tumor. Semaxanib binds to the vascular endothelial growth factor receptor (VEGF-R) in the blood vessels, intercepts the signal and therefore inhibits the formation of the blood supply to the tumor. Toxicities seen to date in patients treated with semaxanib include headaches and gastrointestinal events (nausea, vomiting and diarrhea).
``This study represents an important step in the development of semaxanib for the treatment of advanced colorectal cancer,'' said Laura K. Shawver, Ph.D., President of SUGEN, an innovative and leading molecular targeting research branch of Pharmacia. ``We are committed to exploring the full therapeutic potential of semaxanib and other novel angiogenesis signaling inhibitors in development at SUGEN.''
Colorectal cancer is the second leading cause of cancer deaths in the US, with approximately 130,200 diagnoses and 56,300 deaths in 2000. Nearly one in 18 Americans will develop colorectal cancer in their lifetime. Colorectal cancer research being led by Pharmacia Corporation encompasses care options from prevention to advanced stage treatments.
This Phase III clinical trial of semaxanib in combination with CAMPTOSAR and 5-FU/LV is currently enrolling patients with untreated, advanced colorectal cancer nationwide. For the latest information about participating centers, please call 1-877-439-0596 or access sugen.com for information about clinical trial sites.
In addition to the Phase III clinical trials in colorectal cancer, semaxanib is being studied in numerous solid tumors, hematologic (blood related) cancers and more than 28 National Cancer Institute trials for various tumor types, including breast cancer.
Pharmacia Corporation has an innovative, multi-faceted approach to attack colorectal cancer with an unmatched research program examining all stages of colorectal cancer from prevention to treatment of advanced disease. The National Cancer Institute's (NCI) Division of Cancer Prevention is currently studying, with the support of Pharmacia and Pfizer, the role of celecoxib (CELEBREX®) in preventing the recurrence of colorectal polyps. An NCI-sponsored intergroup study is also researching the efficacy of CAMPTOSAR as an adjuvant treatment in earlier-stage colorectal cancer following surgery... |
