HDCN-- News Alert -- Renal Cell Cancer Treatment

September 26, 1995

FDA expands access to experimental treatment for advanced renal cell cancer

FDA has allowed expanded access to a new technology involving autologous somatic cell therapy for metastatic (stage IV) renal cell cancer. This is the first somatic cell therapy administered under FDA's treatment IND regulations. The following can be used to answer questions.

Somatic cell therapies use living cells, processed outside the source, for the prevention, diagnosis or treatment of diseases or injuries. In this case, the manufacturer, Cellcor Inc., Newton, Mass., extracts white blood cells from patients with advanced renal (kidney) cancer, stimulates the cells, and reintroduces them into the patients in order to help augment their immune systems. The manufacturer calls the treatment "autolymphocyte therapy," or ALT.

FDA has established a process called the treatment IND for patients suffering from serious or life-threatening conditions who have exhausted established treatments or for whom no satisfactory treatment exists. This process allows them to obtain promising experimental drugs that have undergone sufficient clinical testing to show that they may be safe and effective. In this case, FDA has granted expanded access to ALT based on clinical data that indicated that the activated somatic cells may decrease tumor size with few serious side-effects in a small percentage of patients.

Currently, the only other approved treatment for metastatic kidney cancer is interleukin-2 (Proleukin), manufactured by Chiron Corp. However, some patients cannot tolerate interleukin-2's side effects or do not respond favorably to the drug. This newly approved treatment protocol offers seriously ill patients another alternative.

Cellcor Inc. will begin accepting patients for autolymphocyte therapy in a few months. The company is permitted to recoup costs for the treatment. Patients and health care professionals can obtain more information about the treatment IND and its enrollment criteria by calling Cellcor at 1-800-441-7901.

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