BUFFALO, N.Y. -- Doctors Robert Fenstermaker and Michael Ciesielski have spent the last 20 years at Roswell Park, looking for ways to combat brain cancers.
"About 12 years ago, we started looking at a protein target called Survivin. It's expressed on tumor cells, it looked interesting, that this might be something we'd want to develop a vaccine to,” Ciesielski said.
Ciesielski says Survivin is essentially a flag on tumor cells that the immune system can attack when it's been properly stimulated, and kills them.
After doing well in pre-clinical studies 6 years ago, they began clinical trials for their drug, SurVaxM, to treat the deadliest and most common brain cancer, glioblastoma.
"This is a very serious disease where patients may only live six months or so. In that particular trial, several patients lived longer than a year and we have four- and five-year survivors coming from it, which is really an exciting observation for us," Ciesielski said.
Following that success, a phase 2 clinical trial is underway, with 50 patients in a partnership with four other hospitals, and in more good news for Roswell, the FDA has approved SurVaxM for orphan status.
"Orphan status allows us to potentially get this to patients much faster by doing a smaller phase 3 clinical trial that's still randomized with control groups, but has a smaller number of patients," Fenstermaker said.
Fenstermaker says phase 3 puts the drug head-to-head with the current standard of care to see which is better.
"My practice is devoted to treating patients with malignant brain tumors like glioblastoma, and I know that surgery by itself is not going to cure this disease for most patients, so it's particularly important for me to have this opportunity to do research in the field and do the vaccine with the hope that we can prolong survival for patients with this very terrible illness," Fenstermaker said.
A good result in the final clinical trial would allow them to apply for FDA approval. Fenstermaker says that is about 3-5 years away.