The generic BCG vaccine is already approved to treat bladder cancer as well as its original target: the prevention of tuberculosis. And another indication may be on the horizon as Massachusetts General Hospital got an OK from the FDA for a Phase II trial of the vaccine's ability to help patients with Type I diabetes.
The vaccine contains a live but weakened strain of Mycobacterium, which causes tuberculosis in cows. When used in bladder cancer patients, the vaccine mounts an immune response toward the tumor. It can treat diabetes because it elevates levels of the immune modulator tumor necrosis factor (TNF), Massachusetts General said in a statement.
"We have learned a lot since the early studies in mice--not just about how BCG works but also about its potential therapeutic benefits, similar to what are being seen in trials against other autoimmune diseases," Dr. Denise Faustman, director of the hospital's immunobiology lab and the principal investigator of the study, said in a statement.
Faustman's team found that TNF can temporarily eliminate the abnormal white blood cells that cause autoimmune Type I diabetes in humans and in mice. In a Phase I trial, researchers found evidence of a "small, transient return of insulin secretion." The Phase II trial will up dosage over a longer period of time: Patients will receive 6 doses over 5 years.
"In the Phase I clinical trial, we demonstrated a statistically significant response to BCG, but our goal in Phase II is to create a lasting therapeutic response," Faustman said.
If it succeeds as a treatment for diabetes, it would be good news for vaccine behemoths Merck ($MRK) and Sanofi ($SNY). But the Big Pharmas have had their fair share of manufacturing problems, resulting in recalls of both BCG tuberculosis vaccine and ImmuCyst. Sanofi's Toronto plant got a green light from Health Canada in October 2014 to resume production of BCG vaccine and ImmuCyst, and product will be progressively made available starting in the second half of this year.
- read the release
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