San Francisco, CA – January 2, 2017 – Bell Biosystems’ Magnelle® technology is a patented cell tracking solution that monitors cell therapies after administration using standard magnetic resonance imaging (MRI). Unlike alternatives, Magnelle-powering provides both anatomical location and viability data, which allows the cell therapy to be monitored in real-time. This is must have at every stage of development from bench to bedside. During early R&D, understanding biodistribution and cell survival guides the design of studies and accelerates identification of lead assets. During translational studies and clinical trials, Magnelle-powering enables cell therapy developers to meet and exceed regulatory requirements. In the clinic, Magnelle-powering gives practitioners the ability to monitor therapy progress and make informed decisions that can be personalized for each patient. In summary, Magnelle-powering has tremendous value to the field of regenerative medicine by enhancing clinical effectiveness and accelerating development timelines of cell therapies by months to years.
“I’ve been delighted with the Bell Bio team’s progress and am excited to see that Magnelle-powering is getting closer to human use,” says Tim Draper, founding partner of leading venture capital firms Draper Associates and DFJ, and early investor in Bell Biosystems. “These encouraging safety results show huge potential and I look forward to what’s next.”
The encouraging results of this safety study represent achievement of another major company milestone advancing their clinical program. Magnelle-powered and unlabeled therapeutic cells were administered to rats in varying doses and were followed for up to 20 days. Clinical examinations showed that all animals behaved normally. Across the 77 animal, 7-arm study, no mortalities related to Magnelle-powering were observed. Acute and chronic toxicity assessments were performed and the general lack of evidence for adverse events strongly supports that Magnelle-powering is well tolerated even at doses above what’s clinically relevant. Additionally, blood biomarkers showed Magnelle-powering did not cause sepsis or infection, further strengthening the safety conclusions.
"These results reinforce that Magnelle-powering is potentially suitable for human use. The viability tracking data our solution provides coupled with the non-invasive nature of MRI creates huge advantages over standard invasive practices for cell tracking, such as biopsy and autopsy,” said Caleb Bell, Ph.D., Founder and CEO of Bell Biosystems. “In addition to informing clinical progress, Magnelle-powering is well positioned to address regulatory guidance by providing data supporting ‘the viability and function of cells.’ With these exciting results, we are now focused on partnerships to bring Magnelle-powered cell therapies to the clinic.”