Clinipace

This morning we announced 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.

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.

Read the full announcement

did you read today’s Wall Street Journal? There is a great article entitled Lilly Taps Contractors to Revive Pipeline about Eli Lilly & Co positive relationship with its CRO partners.

While the article highlights big pharma and their relationship with big CROs, these strategic partnerships are no longer the exclusive domain of large biotechnology and pharmaceutical firms with multi-millions to spend on clinical trials (as our recent white paper on the subject points out).

As the face of the biopharma world is being altered by smaller firms, these strategic relationships have taken a new form. Now, growing companies are working with more synergistic and more specialized CROs for new gains in efficiency and cost-effectiveness.

Rather than being the small fish in a big pond, emerging firms are actively elevating their status by testing the waters of strategic partnerships with their CRO. Many of the benefits of working with a CRO that accrue to larger organizations are even more important for the smaller research sponsor that likely has limited resources, such as:

• Capitalizing on the capabilities of a CRO allows sponsors to focus on their own core strengths rather than organize, create and administer a complete clinical trial themselves.
• Optimally designed trials that are conducted correctly the first time are crucial for success. CROs have the breadth of expertise to design trials that achieve stated clinical, regulatory, and commercial objectives in a focused and efficient manner.

We’re expanding to enhance our global clinical operations capabilities and oncology therapeutic practice

On October 26th, 2009, Clinipace closed its acquisition of Worldwide Clinical Research, Inc. (WWCR), a Midwest-based CRO specializing in the management of clinical studies for biotechnology and pharmaceutical companies. With the acquisition, Clinipace has changed its name to Clinipace Worldwide.

“Vaccinogen selected Clinipace Worldwide for its upcoming global clinical trial due, in part, to the combined strength of both companies and experience managing phase 3 international oncology trials,” said Michael G. Hanna,” Jr., Ph.D., Founder, Chairman & CEO of Vaccinogen. We are confident their therapeutic and operations experts, along with their technology platform, will enable us to centrally manage a very complex protocol with some very unique requirements.”

Combined, the companies have managed over 70 contract research projects conducted globally at almost 3,000 sites with 100,000 patients. With specific expertise in oncology, among other therapeutic areas, the company will offer fully-integrated technology-based clinical research solutions and services to growth-oriented and mid-tier biopharmaceutical and medical device firms.

We welcome more than 30 employees to the company and our headquarters will remain in Research Triangle Park, NC with additional domestic operations in Overland Park, KS, and South American operations based in Sao Paulo, Brazil, Buenos Aires, Argentina, and Lima, Peru.

Barbara Geiger, president and CEO of WWCR, will transition to Executive Vice President of Clinical Operations and will be responsible for directing all clinical operations for Clinipace Worldwide, Inc. from the Overland Park, KS office.

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