The clinical trials follow previous work using an animal model in 2009, which showed the concept worked. In the approach, researchers place a fingernail-sized sponge beneath the skin to reprogram immune cells to hunt and kill deadly cancers.
“It is rare to get a new technology tested in the laboratory and moved into human clinical trials so quickly,” Dr. Glenn Dranoff, a medical professor on the project, told reporters.
Dranoff and his colleagues intend to test the safety of the implant in a small number of patients in this early clinical trial, before moving to a phase II study to test the treatment’s effectiveness. If successful, the researchers plan to move to a larger phase III trial to win regulatory approval for a treatment that might save thousands of lives every year.
Composed of biodegradable plastic, the highly permeable devices contain antigens corresponding to the patient’s type of tumor. Once implanted, the device releases a protein that effectively recruits immune cells in the fight against cancerous cells. Whereas conventional vaccines take immune cells removed from a patient for reprogramming, the device works within the body.
Other researchers also continue efforts to develop and refine drugs that fight melanoma by reprogramming immune cells, with one being Bristol Myers Squibb’s Yervoy approved by the U.S. Food and Drug Administration in 2011. Meanwhile, pharmaceutical companies Merck and Roche report they’re experimenting in clinical trials with similar drugs.
In a setback, the United Kingdom’s GlaxoSmithKline failed in third-phase clinical trial with their MAGE-A3 vaccine. In those experiments, patients given the drug after surgical removal of their tumors did not live longer than their counterparts who did not receive the drug.
As many as 10,000 Americans die from melanoma every year.
Source: Medical Daily