CD40L Moved Forward Based On Outcomes Of Multi-Dose Safety Trial
SEATTLE - Immunex Corporation (Nasdaq: IMNX) announced today that it has launched a Phase II trial of the investigational agent CD40 Ligand (CD40L) in the most common form of kidney cancer, renal cell carcinoma. The company is continuing the development of CD40L based on results of a multi-dose Phase I trial of the drug in advanced cancer patients.
The Phase I study, which evaluated escalating doses of CD40L in patients with recurrent solid tumors and lymphoma, has been completed and the objectives of the study were met. The results of this multi-dose study will be presented at a future medical meeting. Several pre-clinical studies on the anti-tumor effect of CD40L will be presented next week at the 35th Annual Meeting of the American Society of Clinical Oncology (ASCO). In these studies, conducted in both mice and fresh human tumor samples, CD40L inhibited tumor growth in multiple solid tumor types, such as breast, lung, ovarian and colon.
"Based on the results of these safety trials, Immunex is moving forward with a Phase II trial of CD40L in metastatic renal cell carcinoma," said Ann Hayes, M.D., senior vice president, medical development, Immunex. "Patients with this disease currently have limited treatment options. Treatment with CD40L represents a novel approach to treating cancer, by potentially having a direct effect on tumor cells and by stimulating the immune system to recognize and seek out cancer cells for destruction."
The study, being conducted in three cancer treatment centers across the United States, will evaluate the safety and efficacy of the drug in metastatic renal cell carcinoma.
Approximately 30,000 new cases of kidney cancer will be diagnosed this
year in the United States and about 11,900 people will die from this disease.
It is the 8th most common cancer in men and the 10th most common in women.
Contact: Lisa Crisera