The Center for Cancer and Blood Disorders in Bethesda is participating in a worldwide trial of a preventative treatment, NeuVax, which, the drug company that hopes to bring it to market claims, could teach the immune system to target certain cancer cells.
The treatment, which underwent a previous trial at the Walter Reed National Military Medical Center in Bethesda, is being tested in preparartion for a U.S. Food and Drug Adminsitration application by drug company, Galena Biopharma.
The Center for Cancer and Blood Disorders is a private hematology and oncology practice. Breast cancer survivors from the Washington, D.C., metro are invited to participate in the trial.
“This is a very exciting vaccine,” said Dr. Ralph Boccia, medical director at the Center for Cancer and Blood Disorders. “Obviously we are trying to cure breast cancer, and in order to do that we've got to be able to eradicate the very last cell.”
It is too early to say whether NeuVax works, but preliminary resutls are promising, said Dr. James Gulley, senior investigator at the National Institutes of Health’s National Cancer Institute in Bethesda.
He said the side effects of immune system-boosting drugs, which include tiredness, tend to be more mild and transitory than treatments such as chemotherapy, he said.
About 19 immune system-boosting drugs are being tested in phase III clinical trials, such as those for lung and prostate cancers, he said.
The area of research is a promising one, in which the infectous disease community also is participating, he added.
“I’m guessting that, within the next five years, there will be additional vaccines that will likely be approved, based on clinical studies now,” he said. “Each of these will potentially be for different kinds of cancers.”
Women participating in the NeuVax trial will receive 11 injections during the span of three years: one per month for six months, plus boosters every six months.
Participants will be tracked for 10 years, said Natalie Bongiorno, nurse administrator at the Center for Cancer and Blood Disorders.
The only side effect of NeuVax has been reactions at the injection site, said Dr. Mark Ahn, president and chief executive officer of Galena, in Lake Oswego, Ore.
Diane Altenburg, 64, a breast cancer survivor from Springfield, Va., participated in a previous NeuVax trial at Walter Reed.
After recieving injections she felt more tired than usual, and developed a red welt at the injection site, she said.
“It is so easy to do this and to continue your life and all you are involved in,” Altenburg said. “For me, the hardest thing was driving to Walter Reed from Springfield, [Va.].”
In a previous trial of 187 women, 53 received at least one booster shot, according to the Galena website.
At a five year follow-up, the recurrence rate for the booster group was 3.8 percent versus 18.9 percent in the control group, women who were unsuitable for the trial and were followed . Final analysis is expected in the fourth quarter of this year.
To be accepted in the current trial, women must be within six weeks of completing primary treatment for breast cancer, node positive, HER2 1+ or 2+, HLA A2 or HLA A3 Positive, and have no evidence of disease following Standard of Care, according to the Galena website.
Boccia said the trial will remain open for at least 18 months. Women who recently were diagnosed or currently undergoing treatment are invited to inquire.
About 230,000 women in the U.S. are diagnosed with breast cancer every year, Ahn said. Of those, about 55 percent are node positive, a more advanced phase of the disease in which cancer spreads to lymph nodes in the armpits.
Such women have about a 50/50 chance that the cancer will recur, Boccia said. Systemic chemotherapy cuts the that number down to about 30 percent.
“That's unacceptable for everyone, doctors and patients,” he said.
Ahn said NeuVax teaches the immune system to attack cancer cells throughout the body that overproduce the protein HER2. The technology also could be useful for bladder and gastric cancer, he said.
If the current three-year trial is successful, the company will submit an application to the FDA, which must make a decision within six to 10 months, he said.
By the time the company submits an application to the FDA, it will have spent $40 million on development of the drug.
Ahn declined to say how much NeuVax could cost, but pointed to Herceptin.
The drug also targets HER2 producing cancer cells, according to the Herceptin website. Treatment can result in heart and lung problems, including congestive heart failure and swelling of the lungs.
It costs $60,000 to $70,000 per treatment cycle and generates $6 billion per year in revenue, Ahn said.
For more information about the clinical trial, contact Natalie Bongiorno at firstname.lastname@example.org, or call her at 301-571-2016. Appointments will last about an hour.