Vincent Michael Fulginiti still remembers what his life was like before the diagnosis.
The 57-year-old Aston, Pennsylvania resident started his own insurance company 30 years ago and planned to retire in 2013. It was right before that planned retirement however when his life changed forever.
“I went to bed one night,” Fulginiti said. “I was fine. I woke up the next morning and my speech was slurred.”
Fulginiti underwent extensive treatment for the next 12 months and was tested for everything from stroke, to Lyme disease to a blood disorder. It wasn’t until August, 2014 when he found out the truth.
“I was diagnosed with Bulbar Onset ALS,” Fulginiti said.
Amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease, is a disorder that involves the death of neurons. It causes muscle weakness throughout the body and those affected are at risk of losing their ability to initiate and control movement. Some people eventually lose their ability to speak, swallow food and walk. The Bulbar Onset impacts breathing and eating.
There is currently no cure for ALS though a medication known as Riluzole may extend life expectancy for two to three months. Many people with ALS die within three to five years from when the symptoms began. Fulginiti’s family says he was only given six months to two years to live after the diagnosis.
Always a fighter, Fulginiti underwent treatment at several hospitals and clinics but to no avail.
“I’m now at a dead end,” he said. “It is not in my DNA to do nothing.”
Yet a year and a half after his diagnosis, Fulginiti and his family say they have a new reason for hope. It’s called GM604, a new ALS drug that the family believes will save Fulginiti’s life.
The drug was created by Genervon, a biotech company based in Pasadena, California. The company released a report stating the drug was used on 12 patients in a 12-week trial and that it slowed down the disease dramatically in at least one of the patients. The company stated the drug showed promise.
Genervon has urged the Food and Drug Administration (FDA) to grant accelerated approval for the drug. Accelerated approval is a program which allows for earlier approval of drugs that treat serious conditions. Drugs that have been fast-tracked include an Ebola-related drug as well as an AIDS treatment drug.
“FDA approval processes take years,” said Michael Fulginiti, Vincent’s son. “So when you have increased breathing problems, it’s not something that can wait. The accelerated approval program could allow it to be fast-tracked.”
Fulginiti’s family supported the move and joined hundreds of thousands of people across the nation pushing for the drug to be approved. Fulginiti’s daughter Kerri traveled to Washington to lobby Congress. The family also posted videos on Vimeo as well as EllenTube urging the FDA to approve it.
“We spent a week in Georgia and the music video was a family idea,” Michael Fulginiti said. “I rewrote the lyrics and Kerri sang lead vocals and we used a cousin’s recording studio in the basement. It was all done over the course of a week.”
The petition needs to reach 100,000 by April 24 in order for President Obama to respond. So far it has over 21,000.
The FDA has not made an official decision on GM604 and must determine whether the drug is safe enough to fast-track. The drug has also had its fair share of critics, even in the ALS community, with some stating that the 12-week trial on 12-patients was too small a sample size to determine if the drug actually works. There have also been disputes and conflicting reports regarding whether or not Genervon has actually filed a formal application for FDA approval.
While the future remains uncertain, the Fulginiti family is confident that Vincent will continue to battle through.
“My dad’s a fighter,” Kerri Fulginiti said. “He never gives up.”