CARROLLTON, Texas (CBSDFW.COM) – Tucked away in Carrollton, biotech company, Gradalis, could soon transform the way cancer is treated worldwide.
The cure could be about a simple as a flu vaccine.
The CBS 11 I-Team has been following the development of this clinical trial for more than a decade, and it’s now in the final stages of the Food and Drug Administration approval process, a place few drugs or clinical trials get to.
Nineteen-year-old Ella McKeirnan has been counting on its success for the last two years. Every month, the young woman travels from Spokane, Washington to Dallas.
Two years ago, the then-senior in high school was headed off on a spring break trip. A nagging cough sent her to the doctor for one last check before she headed out.
“Coughing was the only symptom I had. I thought, I guess we should make sure I am not sick before we go on this trip,” says McKeirnan.
The trip never happened. Instead, McKiernan spent the next week in the hospital and had surgery.
Doctors diagnosed her with Ewing’s Sarcoma – a rare pediatric cancer in the bone or soft tissue. Her body was filled with tumors.
“So they think it started in my toe. Two in my pelvis. One in my shoulder. And then like 20 in my lungs.”
It seemed as though traditional therapy was working but then McKiernan relapsed.
“It’s not like there’s no hope but it’s definitely… You got to try something because it doesn’t look good,’ explained McKiernan.
What McKiernan is trying is in North Dallas.
It’s a personalized vaccine developed at Gradalis in Carrollton.
Since 2009, the immunotherapy company has been harvesting cells from patients’ tumors, modifying them, and then re-injecting them into the patients’ bodies.
Dr. Maurizio Ghisoli heads up the team. “Any new cells or cancer cells that would appear would be targeted by the immune system of the patient.”
The I-Team first met the researchers several years ago in the early stages of the FDA approval process.
CBS 11 asked, “Will the day come where your cancer shot is just like your flu shot?“
Dr. John Neumunaitis said, “You know that’s our dream. It recognizes the cancer where before it could not and that’s really what a flu shot does.“
Since that interview, the team says dozens of patients have received hundreds of doses of the immunotherapy.
“It was well reviewed by the FDA, and now we have it open in ten centers all across the country from the East Coast, West Coast, New York. We have some centers in Florida.”
These North Texas researchers believe the treatment will receive FDA approval by 2020, and it will change the way many cancers are treated.
For now, Ella McKiernan is going many extra miles to prove it is successful with Ewing’s Sarcoma.
“I hope everything just goes away and I am done and I am cured and everything is fine.”
The immunotherapy is called, Vigil. The clinical trial is for Ewings sarcoma patients, but the Carrollton company says it has had success in ovarian and breast cancer as well.
For more information on the trial, click here.