Phase 3 Trial for Promising Melanoma Vaccine

Rush University Medical Center in Chicago is leading a nationwide phase 3 clinical trial to determine whether a promising vaccine for advanced melanoma can effectively treat the deadly skin cancer. An earlier phase 2 trial of the experimental drug involving 50 patients with metastatic melanoma had what were referred to as “stunning results.” Eight patients recovered completely and four partially responded to the vaccine, according to the researchers. "Very few treatment options exist for patients with advanced melanoma, none of them satisfactory, which is why oncologists are so excited about the results we found in our phase 2 study," said Dr. Howard Kaufman, associate dean of Rush Medical College and director of the Rush Cancer Program. Dr. Kaufman is leading the phase 3 study. The vaccine being tested is called OncoVEX, initially developed to combat herpes virus. Researchers discovered accidentally that the vaccine attacked cancerous tissue when it was inadvertently placed in a Petri dish of tumor cells. The vaccine includes an oncolytic virus, a reprogrammed virus that has been converted into a cancer-fighting agent that attacks tumor cells while leaving healthy cells undamaged. OncoVEX also carries biological agents that boost the immune response to melanoma. The vaccine is injected directly into lesions that can be felt or seen, with or without ultrasound. The procedure is generally done in a physician's office. "What really surprised, and encouraged, us was that the vaccine worked not just on the cells we injected, but on lesions in other parts of the body that we couldn't reach," Dr. Kaufman said in commenting on the phase 2 results. "In other words, the vaccine prompted an immune response that was circulated through the bloodstream to distant sites.
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