Clinical trials on a global scale
The ongoing trials for Stimuvax are being conducted as a major global clinical program. As is often the case in clinical trials, the subprojects have catchy names: INSPIRE, for example, is the acronym that was given to a lung cancer study launched in Asia in 2010, while START is a worldwide Phase III study that began before INSPIRE. The clever meanings behind the acronyms are also typical: START, for example, stands for “Stimulating Targeted Antigenic Responses to NSCLC.” NSCLC itself is a “normal” set of initials that stands for “Non-Small Cell Lung Carcinoma,” which accounts for 80 percent of all cases of lung cancer.
The anticipated study results are a source of both hope and tension for the Stimuvax team, as they are for every research group working to make sure an innovative product becomes successful. As early as the Phase II study, the mean survival time of a subgroup of trial participants who were already severely ill was raised from 13.3 to 30 months. The goal now is to justify the expected effectiveness of the cancer immunotherapy with a solid and broad-based statistical foundation. There is still a great need for new tumor treatments: “In 2004 the U.S. Food and Drug Administration (FDA) chose Stimuvax for an accelerated approval procedure,” says Dr. Bernd Schneider-Lowitz, the international manager for the Stimuvax brand. This fast-track process speeds up FDA testing of a therapeutic substance without sacrificing trial thoroughness in any way.
There are many challenges to overcome here, a huge amount of data to process and analyze, thousands of doctor-patient discussions that have to be held, and a team of clinical researchers on several continents whose activities need to be coordinated. Still, every inch of progress made can represent a great leap for humanity. After all, there was a time when no one could even hope that infections like smallpox might be completely eliminated. Of course, every scientist knows that achieving the same feat with cancer is a much bolder objective, but that’s just one more reason to pursue innovative approaches — like vaccinations against tumors.
The ongoing trials for Stimuvax are being conducted as a major global clinical program. As is often the case in clinical trials, the subprojects have catchy names: INSPIRE, for example, is the acronym that was given to a lung cancer study launched in Asia in 2010, while START is a worldwide Phase III study that began before INSPIRE. The clever meanings behind the acronyms are also typical: START, for example, stands for “Stimulating Targeted Antigenic Responses to NSCLC.” NSCLC itself is a “normal” set of initials that stands for “Non-Small Cell Lung Carcinoma,” which accounts for 80 percent of all cases of lung cancer.
The anticipated study results are a source of both hope and tension for the Stimuvax team, as they are for every research group working to make sure an innovative product becomes successful. As early as the Phase II study, the mean survival time of a subgroup of trial participants who were already severely ill was raised from 13.3 to 30 months. The goal now is to justify the expected effectiveness of the cancer immunotherapy with a solid and broad-based statistical foundation. There is still a great need for new tumor treatments: “In 2004 the U.S. Food and Drug Administration (FDA) chose Stimuvax for an accelerated approval procedure,” says Dr. Bernd Schneider-Lowitz, the international manager for the Stimuvax brand. This fast-track process speeds up FDA testing of a therapeutic substance without sacrificing trial thoroughness in any way.
There are many challenges to overcome here, a huge amount of data to process and analyze, thousands of doctor-patient discussions that have to be held, and a team of clinical researchers on several continents whose activities need to be coordinated. Still, every inch of progress made can represent a great leap for humanity. After all, there was a time when no one could even hope that infections like smallpox might be completely eliminated. Of course, every scientist knows that achieving the same feat with cancer is a much bolder objective, but that’s just one more reason to pursue innovative approaches — like vaccinations against tumors.
