Gene Therapy Clinical Trial for Mesothelioma Moving Forward

This study will compare the effectiveness of the drug against a control group receiving only the gemcitabine and celecoxib. Patients have a one-in-two chance of being randomly assigned to either the adenovirus treatment or the control group. Adenovirus-delivered interferon Alpha-2b is designed as a second- or third-line treatment for patients who have failed in earlier regimens. Patients who previously had aggressive mesothelioma surgery but whose tumors have since progressed would be eligible to enroll. Success at the phase III level would mark the culmination of 20 years of researching and fine tuning gene therapy for use with mesothelioma cancer. Success also could lead to FDA approval. “The hope is, we may have a new treatment option,” said Sterman, a longtime gene therapy researcher. Sterman previously served at the University of Pennsylvania’s School of Medicine, working closely with Dr. Steven M. Albelda, an early pioneer in the gene therapy field. “We’re hoping the triple drug combination will demonstrate significant improvement in survival,” Sterman said. In the earlier phase II clinical trial, the treatment regimen showed a median survival of 17 months, compared to historical study controls of just nine months. The three-year survival rate was 20%. “Over the years, gene-based therapy has had its ups and downs. It often was viewed as high-risk, high-reward,” Tanvetyanon said. “This one has been fully proven safe and effective in delivering what i...
Source: Asbestos and Mesothelioma News - Category: Environmental Health Authors: Source Type: news