By Ed Susman SAN ANTONIO, TX -- December 15, 2006 -- A experimental breast cancer vaccine appeared to offer protection against recurrences but failed to achieve statistical significance after 2 years of treatment, doctors reported here at the 29th San Antonio Breast Cancer Symposium (SABCS).
"Recurrence rates reached 8.3% among the 101 women who received the vaccine and 16% among the 85 women who acted as controls in the trial," said Col. George Peoples, a surgeon at Brooke Army Medical Center, Fort Sam Houston, Texas.
Despite the nearly 50% reduction in recurrence, the small numbers of women in the trial resulted in a statistical value that is above the cutoff generally recognized as being significant.
Col. Peoples conducted the study while working at Walter Reed Army Medical Center in Washington, DC.
"We think the trial showed enough benefit to go before the US Food and Drug Administration to discuss a pivotal vaccine trial with the agency," he said December 14th in an oral presentation. Meetings with the FDA to write protocols for that trial will begin early next year. It's possible that we could begin recruitment for the trial in late summer of 2007."
The E75 vaccine targets the human epidermal growth factor 2 (HER2) gene, a molecule found in abundance in certain aggressive breast cancers, but also found to some degree in most breast cancers. A fragment of the HER2 gene is incorporated into the vaccine as an immune system stimulant.
Under an optimal schedule, women who were clinically free of breast cancer after undergoing surgery and post-surgery chemotherapy or radiation would receive an injection of the vaccine per month for 6 months.
Dr. Peoples said researchers were working to achieve the ideal dose of the vaccine -- 1000 mcg/mL per injection -- and the ideal schedule, so only one third of the women in the study received the optimal dose. This, he said, may have played against the vaccine's reaching statistical significance.
"These results are extremely preliminary," said Eric Winer, MD, director of the breast oncology program, Dana-Farber Cancer Institute, Boston, Massachusetts. "It certainly is worthwhile doing a clinical trial. Everyone wants a vaccine for breast cancer."
Despite numerous attempts to develop a breast cancer vaccine to treat or prevent breast cancer, these attempts have not been a successful. Col. Peoples said the vaccine is still years from commercial development even if it successfully hurdles regulatory obstacles.
He said the vaccine will be developed further by Apthera, Inc., Scottsdale, Arizona. The company has named the vaccine NeuVax. The initial trials were sponsored by grants from the US Department of Defense Congressionally-mandated breast cancer program.
source - Doc Guide