Clinipace Worldwide, a global full-service clinical research organization (CRO), announced today that Vaccinogen, a biotechnology company with more than three decades experience researching how to combat cancer using the body's own immune system, has selected the company to manage a pivotal phase 3b confirmatory trial for OncoVAX® in the treatment of Stage II Colon Cancer.
“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.”
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. Having successfully completed a randomized, 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.
With colon cancer being the third most common form of cancer and the second leading cause of cancer-related death, OncoVAX® has the potential to fulfill an unmet medical need. In the phase 3a study, OncoVAX® significantly 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 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 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.
"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., Ph.D., 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. "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."
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