April 18 /PRNewswire/ -- Abgenix, Inc. (Nasdaq: ABGX - news) and Immunex Corporation (Nasdaq: IMNX - news) announced today that the companies will start a Phase 2 clinical trial of ABX-EGF in patients with kidney cancer. The Phase 2 trial will assess the tolerability and efficacy of ABX-EGF as monotherapy (without concomitant chemotherapy) in patients with kidney cancer. ABX-EGF is being developed jointly by Abgenix and Immunex. Initiation of this study triggers a milestone payment from Immunex to Abgenix.
This multi-center, multiple-dose study will enroll up to 80 patients across North America. Patients will receive eight weekly intravenous infusions at varying doses of ABX-EGF. Preliminary results from an ongoing Phase 1 study support the dose-escalating Phase 2 study protocol in kidney cancer.
``We are happy to be moving forward with the first of several Phase 2 trials for ABX-EGF, our lead oncology antibody therapy in development,'' stated R. Scott Greer, chairman and chief executive officer of Abgenix. ``In the coming months, Abgenix and Immunex will initiate a series of Phase 2 clinical trials to explore the tolerability and efficacy of ABX-EGF in additional cancer indications. Our hope is to provide effective, antibody-based therapeutic options for cancer patients.''
``We are encouraged by the preliminary results we are seeing in the Phase 1 trial for ABX-EGF,'' said Douglas Williams, Ph.D., Immunex executive vice president and chief technology officer. ``The potential ability of ABX-EGF to target the EGF receptor is an exciting approach in cancer research, making it a valuable addition to the Immunex arsenal of oncology molecules.''
Preliminary results of an ongoing Phase 1 clinical trial of ABX-EGF will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in May 2001.
About ABX-EGF
ABX-EGF is a fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), which is over-expressed on a variety of cancers including lung, breast, bladder, prostate, colorectal, kidney and head and neck cancer. It has been demonstrated that cancer cells can become dependent on growth signals mediated through the EGFr for their survival. In mouse models, ABX-EGF monotherapy has been shown to both eradicate established human tumors and block the growth of human tumors.
Overexpression of the EGFr has been reported to occur in 70-90% of kidney cancer tumors. In 2000, there were approximately 12,000 deaths associated with kidney cancer and approximately 31,000 new cases of kidney cancer in the United States. Renal cell carcinoma or kidney cancer is characterized by a lack of early warning signs, which results in a high proportion of patients being diagnosed with advanced disease. In cases where localized kidney tumors are detected at an early stage, surgery provides the only curative therapy. Metastatic kidney cancer is highly resistant to systemic therapies. Therapeutic options for patients with advanced kidney cancer are very limited.
``There is an unmet medical need for new treatment options for patients with kidney cancer,'' said Robert Figlin, M.D., Professor of Medicine and Urology of the Johnsson Comprehensive Cancer Center at the UCLA School of Medicine. ``ABX-EGF, as a fully human monoclonal antibody, represents a promising therapeutic approach to solid tumors, and I am encouraged by its potential application in kidney cancer.''... |
