Vaccinogen, Fredrick, Md., selected Clinipace Worldwide, Morrisville, N.C. to manage a Phase 3b confirmatory trial for OncoVAX in the treatment of Stage II Colon Cancer.
OncoVAX is an autologous immunotherapy vaccine [EMA classified Advanced Therapeutic Medicinal Product (ATMP)] for the adjuvant treatment of Stage II colon cancer. Having successfully completed a randomized, 254-patient Phase 3a clinical trial for OncoVAX at 12 sites in The Netherlands, OncoVAX has been granted SPA and Fast Track status by the US Food and Drug Administration (FDA).
The Phase 3b study is a randomized, controlled trial in Stage II colon carcinoma in which OncoVAX-treated patients will be compared with control patients having surgical resection alone (the standard of care). A total of 550 patients will be enrolled in at least 47 centers in the United States, South America, and Europe.
“Vaccinogen selected Clinipace Worldwide for its global clinical trial due to its strength and experience managing Phase 3 international oncology trials,” said Michael G. Hanna, Jr., PhD, founder, chairman, and CEO of Vaccinogen. “We are confident Clinipace’s therapeutic and operations experts, along with its technology platform, will enable us to centrally manage a very complex protocol with some very unique requirements.”
“We are pleased to be selected to run this pivotal trial for such a remarkable therapy. Our team of therapeutic experts brings extensive experience and insight into successfully managing oncology clinical trials,” said Christopher Porter, chief operating officer, Clinipace.
This article was published in Drug Discovery & Development magazine: Vol. 13, No. 4, May 2010, p. 24.