SurVaxM Phase I Completed


Phase I clinical trial results of SurVaxM presented at AACR Annual Meeting 2015 in Philadelphia

BUFFALO, N.Y. — A first-of-its kind cancer vaccine, SurVaxM, has demonstrated safety and tolerability in patients with recurrent or progressive malignant brain tumors, according to results of a phase I study conducted by Roswell Park Cancer Institute (RPCI) researchers. The findings were presented at the American Association for Cancer Research Annual Meeting 2015, being held April 18-22 in Philadelphia.
The study title is “Phase I study of SurVaxM in patients with survivin-expressing recurrent malignant gliomas” (CT301; section 24, poster board 1). This immunotherapeutic vaccine will now be evaluated in a larger phase II clinical trial to assess its effectiveness for patients with advanced brain tumors and a new phase I clinical trial for multiple myeloma patients.
“This recently completed clinical trial was the critical first step for the survivin vaccine, to show its safety for use in humans,” says the study’s senior author, Robert Fenstermaker, MD, Chair of the Department of Neurosurgery and Director of the Neuro-Oncology Program. “Through this process we also confirmed that the vaccine produces a strong immune response and gave us a signal of potential clinical responses.”
Fenstermaker and colleagues entered nine patients with survivin-positive recurrent glioblastoma (brain tumors) who received a series of up to four injections of SurVaxM at two-week intervals. Most patients developed T cell and antibody responses to survivin, the vaccine target. The average expected survival time for recurrent glioblastoma patients is approximately only seven months when receiving standard therapy. In this trial of SurVaxM, six of the eight patients with recurrent glioblastoma have had progressive disease, although five of these survived from 12 to 20-plus months. Two of the eight patients were still progression-free at 20 and 31-plus months.
Survivin is associated with aggressive cancers and an indicator of poor prognosis and response to conventional therapy. The SurVaxM vaccine is designed to target cancer cells that use this protein.
“SurVaxM is on the forefront of the next generation of cancer therapy. By harnessing the body’s own immune system to fight cancer using immunotherapy, we believe we can give hope to patients diagnosed with malignant gliomas and other cancers,” adds the study’s first author, Michael Ciesielski, PhD, Assistant Professor of Oncology in the Department of Neurosurgery at Roswell Park.

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