Tags: diabetes | vaccine | type 1 | moving | forward

Diabetes Vaccine Entering a Second Phase of Trials After Finding Success

By    |   Tuesday, 09 Jun 2015 01:09 PM

A possible vaccine for type I diabetes is heading into a second phase of trials after it was approved by the U.S. Food and Drug Administration, according to a statement from Massachusetts General Hospital.

Researchers found that the new vaccine, called bacillus Calmette-Guérin (BCG), was successful in reversing type 1 diabetes symptoms in a trial among mice and in phase I human trials with 103 patients, reported Time magazine.

Scientists announced Sunday that the new phase II trial will test the effects of the vaccine over a five-year period on people ages 18 to 60. Researchers believe that the vaccine can help people who have a detectable level of insulin coming from the pancreas.

"In the phase I trial we demonstrated a statistically significant response to BCG, but our goal in (this trial) is to create a lasting therapeutic response," Dr. Denise Faustman, director of the Massachusetts General Hospital Immunobiology Laboratory in Boston and principal investigator of the study, told the New York Daily News.

"We will be working again with people who have had type 1 diabetes for many years. This is not a prevention trial; instead, we are trying to create a regimen that will treat even advanced disease," she said, according to the newspaper.

The BCG vaccine has been around since 1921 when it was first used against tuberculosis and now has been used for bladder cancer treatment.

"It's a drug with an impeccable safety record," Faustman told the Daily News.

Robert Sobel, an assistant professor of endocrinology at Northwestern University's Feinberg School of Medicine, told the Daily News, though, that he believes diabetes will likely be eradicated because of a cure and not a drug that just reverses the symptoms.

"I think it's a stretch to say this would have a huge impact on the millions plus type I diabetes patients in this country," Sobel said. "We would love to do something to preserve or repopulate their beta cell mass. Historically, we have watched it dwindle and have not been able to do something (in time)."

The Iacocca Foundation, according to a statement from Massachusetts General Hospital, has taken a leadership role in the phase II trial after donating to phase I trial. The statement said that more than $19 million of $25 million needed to conduct the phase II study has already been raised.

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A possible vaccine for type I diabetes is heading into a second phase of trials after it was approved by the U.S. Food and Drug Administration, according to a statement from Massachusetts General Hospital.
diabetes, vaccine, type 1, moving, forward
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2015-09-09
Tuesday, 09 Jun 2015 01:09 PM
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