With FDA calling for non-invasive new tracking systems to accompany cell therapies, Bell Biosystems Inc. wants its Magnelle trackers to become the technology of choice. While the magnetic organelles' longevity and strong signals lend the agents advantages for large animal and human studies, the company is hoping to make its mark in the preclinical space before tackling what will likely be a long road to the clinic.
Bell Biosystems believes its platform can address concerns identified by FDA in its guidances on preclinical and early-phase clinical trials for cell and gene therapies. For preclinical studies, FDA recommends that companies include imaging analyses to track the fate and survival of cell therapy products, their distribution, potential for differentiation, and tumorigenicity following administration in vivo.In its clinical guidance, issued in June, the agency outlined the need for imaging or other studies to address the potential of cell therapies to migrate from the target site, form ectopic tissue, or produce other abnormal cell activity.
According to Michael Alvarez, VP of business development at Bell Biosystems, that means companies will need to show in their preclinical packages that their cell therapies are targeting only the