The breast cancer shot? Cleveland doctor develops a vaccine

Cancer survivor Judy Fitzgerald couldn’t believe what she was seeing.

After enduring a double mastectomy and hysterectomy for breast cancer in 2010, she began researching preventative measures for the recurrence of the disease. She discovered an online video by a doctor in Cleveland who claimed to have developed a vaccine against cancer cells in adults.

“I kept thinking, ‘how is this possible?’” the Del Ray Beach, Fla., woman recalled. “I had no idea that someone had developed a vaccine for cancer.”

It turns out that there was substance to the claim. Vincent Tuohy, an immunologist at the Cleveland Clinic, has a vaccine. But even now, three years later, there remains a big catch: It’s so far been tested only on mice, and it isn't likely to be available to women for another 10 years. And that’s only if it passes a rigorous Food and Drug Administration approval process.

There is promise, though. In September, an investor ponied up an undisclosed sum to cover the cost of an FDA Phase 1 clinical trial to test the drug on humans. The Cleveland Clinic also formed a company called Shield Biotech, a key step to commercializing the drug.

The vaccine has proved to be both safe and effective in preventing breast cancer in mice, including mice bred to have a genetic predisposition for breast cancer. The research was originally published in Nature Medicine in May 2010.

The vaccine activates the immune system against proteins, including the prototypic protein alpha-lactalbumin, expressed only in breast tumors. This leads to the destruction of the tumor before it has a chance to grow and take root, Tuohy told Yahoo News.

“What I’m proposing is that we create a shield,” Tuohy said. “In the end, we want to reduce the occurrence of this disease. We’re approaching it from a defensive perspective. … It’s a very different approach.”

Indeed it is, says Dr. Kathleen Ruddy, a breast cancer surgeon and one of Tuohy’s vocal proponents. Like Fitzgerald, Ruddy discovered Tuohy’s research while researching possible breast cancer vaccines online. She moderated a panel with him at the Clinton Global Initiative in New York City on Sept. 25 to discuss the vaccine.

The fight against cancer has been until now about finding a cure for the disease, not preventing it, Ruddy said. That’s what sets Tuohy’s vaccine apart — he wants to stop women from getting breast cancer in the first place.

And, while other organizations are also looking for a vaccine, Tuohy and his research team are the only ones to have developed a vaccine that’s proved to prevent breast cancer in mice.

“He certainly has something here,” Ruddy said. “It’s a 100 percent effective in animal models. … It doesn’t get any better than that in animal studies. The only question now is: Is it going to be safe and effective in women? The only way to answer that is with a clinical trial where the vaccine is tested.”

But there are skeptics. The challenge, as Tuohy sees it, is getting people to rethink “cancer prevention,” which to most people means education, screening and early diagnosis. He wants to go way beyond that, and actually introduce a vaccination that will be administered to post-menopausal women.

Jill O’Donnell-Tormey, the CEO and director of scientific affairs at the nonprofit Cancer Research Institute in New York City, said that the area of cancer vaccines is a promising field.

The drug appears to be in very early stages, O’Donnell-Tormey said. She said she had not heard of the vaccine prior to Yahoo News asking her about it.

“At this point, it’s entirely a mouse study,” O’Donnell-Tormey said of Tuohy’s research. “Can they show the same results in humans? We have to be cautious.”

A great deal of effort has gone into trying to attract investment in this program, Cleveland Clinic officials said. Supporters including Dr. Ruddy and Fitzgerald, the cancer survivor, have raised more than $1 million for Tuohy’s research through their blogs. A passionate bunch, they’ve written numerous posts about his research and the possibility of a vaccine.

While grants from the government have helped cover development of the drug so far, forming the company, Shield Biotech, was a step to attract the private investment to get the vaccine into clinical trials.

Shield Biotech plans to test dosage levels and conditions under which the drug would be administered on a total of about 100 women within two years, Tuohy said. The clinical trial would take another three years to complete.

The trials will involve two groups of women. The first will be women who have undergone chemotherapy, radiation or surgery for breast cancer, to determine if the drug prevents the cancer from returning. The second group will involve healthy, cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomies to lower their risks (the same procedure actress Angelina Jolie underwent in May.) The test would determine dosage sizes, how best to administer the vaccine and the safety of the vaccine on the women.

More advanced clinical testing, if permitted by the FDA, would determine the overall effectiveness of the vaccine in preventing breast cancer and involve a much larger cohort of women.

“This is going to take a long time,” Tuohy cautioned, estimating at least 10 years before the vaccine could be available for most people.

For those like Fitzgerald, who survived the disease but live in fear of its return to their bodies, the time is right to push for a vaccine. A cure for cancer would be great, but preventing other women from getting it in the first place would be even better.

“If I can prevent my grandchildren from getting this, why can’t we at least try it,” Fitzgerald said.