Clinipace

While cancer vaccines seem straightforward in theory, numerous vaccines have shown promise in early phases of development only to have difficulties meeting endpoints in Phase III clinical trials. At this time, only one true cancer vaccine has been approved by the FDA; Sipuleucel-T (Provenge®) which is used to treat advanced prostate cancer.

Despite these shortcomings, many pharmaceutical companies have become increasingly invested in cancer immunotherapies. Currently, there are over 100 immunotherapy products in various stages of development, and many are specific active immunotherapies (vaccines) that have already entered into clinical development and several are currently in or have recently completed Phase III trials.

The discovery of several tumor-associated antigens is raising hopes for developers of cancer vaccines. As envisioned by researchers, cancer vaccines hold the potential to be specific, safe, and long-lasting while eliciting minimal associated toxicity.

As a follow-up our The High Stakes Of Running A Successful Oncology Trial featured in Life Science Leader last year, Clinipace Worldwide is currently working on another article looking at different facets of cancer vaccine development, including clinical research and studies, regulatory aspects, the clinical operations side, and technology’s role in running a vaccine trial.

We’ll also highlight some of our clients working in this space to gain some additional insight and industry perspective from the trenches.

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