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July 22, 2013
Doretta Royer 315 464-4833

Upstate enrolling newly diagnosed patients with advanced kidney cancer in phase three clinical trial

SYRACUSE, N.Y.— Newly diagnosed patients with metastatic renal cell carcinoma (mRCC) may be eligible to participate in a phase three clinical trial at Upstate Medical University to determine if investigational immunotherapy AGS-003 will improve survival when combined with standard treatment. Upstate is one of the first sites in the country to offer the clinical trial to patients. AGS-003 is the first fully personalized cancer immunotherapy being developed for the treatment of mRCC. It is designed to trigger the body’s natural immune response to help recognize and kill cancer cells.

Gennady Bratslavsky, M.D professor and chair of the Department of Urology, is principal investigator of the “Phase 3 ADAPT kidney cancer study for AGS-003” at Upstate. Upstate is one of 120 sites in the world to participate in this randomized study that is expected to enroll 450 newly diagnosed mRCC patients. Because of existing expertise in kidney cancer at Upstate, doctors expect to be successful in enrolling patients in the study. The ADAPT study is sponsored by Argos Therapeutics.

Metastatic renal cell carcinoma is generally resistant to conventional treatments, such as chemotherapy. “Despite recent advances in the area of targeted drug therapies, expected survival is still limited for most patients,” Bratslavsky said. “Combining targeted drug therapy with AGS-003, with standard treatment for mRCC, is an exciting new treatment approach. Previous AGS-003 studies for this type of kidney cancer have shown encouraging results and could provide an improved treatment option and new hope for patients.”

To create AGS-003, ribonucleic acid (RNA) or the tumor’s “code” is isolated from a small tumor sample obtained from a standard tumor removal surgery. The patient’s specialized white blood cells (that provide the body with immunity) are taken during a blood donation procedure a few weeks later. The tumor RNA is used to “program” the specialized white blood cells with all of the signals necessary to trigger an immune response against the patient’s specific cancer. These “programmed” specialized white blood cells are then formulated into a ready-to-use injection. In three previous clinical studies in mRCC, AGS-003 has been well tolerated by patients.

“Surgical removal of the tumor and sometimes the entire kidney remains the mainstay of initial treatment for newly diagnosed mRCC patients,” said Bratslavsky. “The tumor sample used to develop AGS-003 is easily obtained during this routine procedure and is, in fact, critical to personalizing the therapy so that the patient’s immune system can recognize and target their specific cancer cells.”

To be considered for the ADAPT study patients must be:

• 18 or older and newly diagnosed with clear cell metastatic renal cell carcinoma.

• Patients must be good candidates for standard tumor removal surgery and for treatment with standard targeted drug therapy, starting with sunitinib (Sutent®).

Renal cell carcinoma is the most common type of kidney cancer with more than 50,000 new patients diagnosed each year in the United States. As many as 20 percent are diagnosed when the disease has already spread to other organs or metastasized. For many who are identified with an aggressive form of metastatic renal cell carcinoma, meaning they present with unfavorable risk factors at diagnosis, there are limited treatment options and the average survival can drop to approximately six months to two years.

Individuals who are interested in participating in this investigational clinical trial may call Upstate’s Department of Urology at 315-464-1500.

Visit ADAPT to learn more about advanced kidney cancer, immunotherapy or the ADAPT study.

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