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news.Vaccinogen, a biotechnology company, has selected Clinipace Worldwide, a full-service clinical research organisation (CRO), to manage a pivotal Phase 3b confirmatory trial for OncoVAX in the treatment of Stage II Colon Cancer.
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Vaccinogen is the producer of OncoVAX, an autologous immunotherapy vaccine [EMA classified Advanced Therapeutic Medicinal Product (ATMP)] for the adjuvant treatment of Stage II colon cancer.
Vaccinogen said that having successfully completed a randomised, 254-patient Phase 3a clinical trial for OncoVAX at twelve sites in The Netherlands, OncoVAX has been granted SPA and Fast Track status by the FDA.
In the Phase 3a study, OncoVAX reduced tumor recurrence following treatment in the earlier stage of colon cancer where the current standard of care is surgery plus observation, enrollment in a clinical trial, or consideration for chemotherapy in some.
The Phase 3b study is a randomised, 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 US, South America, and Europe.
Vaccinogen begins its study with Clinipace on the heels of recent news announcing the first autologous immunotherapy approved by the FDA to treat cancer Dendreon’s Provenge, a breakthrough cancer vaccine that promises to extend the lives of men with advanced prostate cancer.
Michael Hanna, founder, chairman and CEO of Vaccinogen, said: “Vaccinogen selected Clinipace Worldwide for its global clinical trial due to its strength and experience managing Phase 3 international oncology trials. 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.”
Christopher Porter, chief operating officer of Clinipace, said: “Our team of therapeutic experts brings extensive experience and insight into successfully managing oncology clinical trials. Additionally, it is in large, complex trials like this one that our technology platform, and the visibility and control it will provide Vaccinogen, becomes essential.”