News & Events

2016-11-18
A Statement From Gradalis

 

At Gradalis, we are committed to bringing new and innovative therapies to patients for whom new treatment options are most urgently needed. Our investigational Vigil engineered autologous tumor cell (EATC) therapy is in the final stages of clinical trials required to seek U.S. Food and Drug Administration (FDA) review and approval of the treatment for advanced Ewing’s sarcoma.  Recently, there has been a social media campaign on behalf of a young patient asking us to supply Vigil EATC therapy after the patient had been randomized and treated on the chemotherapy control arm of this important study.

The trial in question randomly assigns patients with Ewing’s sarcoma to receive either the investigational cancer immunotherapy, Vigil EATC, or a currently available treatment combination where published clinical results have shown activity in patients with recurrent Ewing’s sarcoma.  We closely follow each patient’s case in partnership with the team of treating physicians and evaluate outcomes to ensure the best care throughout the clinical trial.

 Our clinical trials are carefully designed in consultation with the FDA, to ensure we achieve the data quality required for validation and approval of Vigil EATC. Any deviation from trial design, such as switching therapeutic arms, impacts the integrity of the data and can void the entire trial – significantly delaying availability of any new treatment.

While we are encouraged by early results with Vigil EATC in certain patients with Ewing’s sarcoma, we need the results from this trial to provide more definitive proof of clinical benefit.  All of Gradalis is working hard to see this study completed as quickly as possible so that ultimately, through the FDA review and approval process, we might provide access to Vigil EATC to a broader group of Ewing’s patients.

To that end, we appeal to the Ewing’s sarcoma community to help us raise the awareness of this trial so that we may finish accrual as soon as possible.  A list of the sites where the trial is open is published on our clinical trials website www.vigilclinicaltrials.com.  We cannot express the depth of our gratitude to the patients and families who agree to be part of our clinical trial program.  Your contributions are nothing short of heroid, and together we will advance the care of Ewing's Sarcoma.