Aphase III clinical trial conducted by researchers at Lehigh Valley
Hospital, Allentown, Pennsylvania, found that the OncoVAX colon
cancer vaccine reduced the 5-year recurrence rate of patients with
stage II colon cancer patients by 61% and improved their cancer-free
survival rate by 50%. The study, published in a recent issue of the Lancet,
compared patients who underwent surgery alone to patients who had
surgery plus the vaccine.
The vaccine was recently approved for use in The Netherlands, and the
Intracel Corporation has applied for FDA approval. Side effects
observed in patients treated with OncoVAX include mild flu-like
symptoms, redness, and/or ulceration at the injection site.
A New Postsurgical Option
According to the American Cancer Society, colon cancer is the second
leading cause of cancer death in both men and women. Of the
approximately 95,600 Americans diagnosed with colon cancer in 1998,
two-thirds had stage II disease.
Colon cancer patients have very few postsurgical treatment
options available, said Herbert C. Hoover, md, chairman of the
Department of Surgery, Lehigh Valley Hospital and professor of
surgery at Penn State University, School of Medicine. If
approved by FDA, the OncoVAX vaccine therapy will be a completely new
treatment approach that could become standard treatment for stage II
colon cancer, following surgical removal.
OncoVax is an active specific immunotherapeutic that is prepared for
each patient using the patients own surgically removed tumor.
The tumor is treated with enzymes to separate the tumor cells. The
cells are then frozen for vaccine preparation, and, beginning 4 weeks
after surgery, the patient receives four injections over a 6-month period.