Clinipace’s technology-driven service model and global oncology experience drive efficiencies for pivotal colon cancer phase 3b trial
MORRISVILLE, N.C. (Business Wire) May 5, 2010 — 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.
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.”
About OncoVAX® OncoVAX® immunotherapy is based on a decades-long attempt by scientists to transform the body’s immune response and its long-term memory to prevent the return of disease years after surgery. Such an approach has already been successful in preventing a number of infectious diseases.
Vaccinogen’s scientists prepare a vaccine from the patient’s own tumor and then administer the vaccine to the patient by three weekly injections one month after surgery. A fourth “booster” is administered six months later. In a previous phase 3 study, OncoVAX® reduced tumor recurrence or death due to disease progression by over 50%. The treatment has been shown to be safe and well tolerated in three randomized, multicenter studies.
Vaccinogen is a biopharmaceutical company that develops and commercializes cancer vaccines and other immunotherapeutic products – Turning Cancer on Itself™. Based in Frederick, MD, the Company has a portfolio of product candidates for the treatment of cancer, infectious disease, autoimmune, antiinflammatory diseases and fully human monoclonal antibodies in various stages of clinical development. The Company maintains a European subsidiary in Emmen, The Netherlands that operates a fully functioning cGMP manufacturing center for producing OncoVAX® vaccines. For more information visit our website at vaccinogeninc.com.
About Clinipace Worldwide
Clinipace Worldwide, a global digital clinical research organization (dCRO), specializes in fully-integrated clinical research services for biopharmaceutical and medical device firms. Optimized by TEMPO™, its proprietary eClinical platform, the Clinipace team of experts brings extensive knowledge and insight into site selection, patient recruitment, clinical operations, data management, medical monitoring, biostatistics, and regulatory affairs to ensure a successful clinical development program through proactive clinical trial management. With specific expertise in oncology, among other therapeutic areas, Clinipace Worldwide has managed over 90 contract research projects conducted at almost 3,000 sites with 100,000 patients. Clinipace Worldwide is headquartered in Research Triangle Park, NC with additional domestic operations in Overland Park, KS, and South American operations based in Brazil, Argentina, and Peru.