Dec. 13, 1999 (NEW HAVEN) -- A genetically engineered strain of the bacteria Salmonella has been administered to the first cancer patients enrolled in a Phase I intratumoral clinical trial. The patients were initially monitored in the hospital and subsequently discharged.
The concept, developed by Yale Cancer Center researchers and licensed to Vion Pharmaceuticals in New Haven, Conn., involves the use of engineered strains of the common Salmonella bacterium, the same bacterium that, in its unaltered or wild type form, can cause food poisoning and septic shock. The altered Salmonella, stripped of its pathogenicity, has been shown to target solid tumors and inhibit their growth in laboratory animals.
The key is that the safe versions are still able to target solid tumors in laboratory animals, much like the wild type parent, while at the same time have little or no adverse effects. "We have shown that we can significantly prolong the life of mice with melanoma by injecting them with our attenuated bacteria," said John M. Pawelek, Ph.D., senior research scientist in dermatology and a lecturer in pharmacology at the Yale University School of Medicine. "These preliminary results with animals are encouraging. We would now like to see the same outcome in people."
Collaborating with Pawelek on this novel approach to fighting cancer are K. Brooks Low, Ph.D., a bacterial geneticist and professor of research in therapeutic radiology at Yale, and former Yale colleague David Bermudes, Ph.D., now a senior scientist working on the Salmonella project at Vion.
Potential safety and efficacy will continue to be monitored according to the protocol. The study is designed to evaluate the safety, potential efficacy and optimum biological dose of the bacterial vector for patients with either cutaneous or subcutaneous solid tumors. Patient accrual for the trial is continuing.
The Yale Cancer Center is one of a select network of comprehensive cancer centers in the country designated by the National Cancer Institute and the only one in Southern New England. Bringing together the resources of Yale-New Haven Hospital and the Yale University School of Medicine, its mission encompasses patient care, research, cancer prevention and control, community outreach and education.
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