Posted: 7 February 2023
Imagion Biosystems Limited, a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to announce that an independent blinded review by a panel of expert breast cancer radiologists has corroborated the Company’s previously reported positive findings.
Each radiologist ascertained that the MagSense HER2 imaging agent produces a change in image contrast and that the contrast in nodes highly suspicious for tumour is distinctly different from the MR image contrast seen in non-involved nodes. The independent reviews are consistent with the Company’s previous assertion that the MagSense imaging agent provides new information for the radiologist not available through conventional methods, like ultrasound, and has the potential to aid in the clinical assessment of nodal metastasis in HER2 positive breast cancer.
The confirmation by the panel of the Company’s assessment that cancer detection can be achieved when using the MagSense imaging agent with MRI has significant implications for the Company.
“The outcome of the independent review is welcome news, indeed,” stated Bob Proulx, CEO. “We now have a clear indication that our MagSense® magnetic nanoparticle technology could work with the existing medical imaging infrastructure to provide the clinical benefit to breast cancer patients we have been aiming for. This takes a lot of the technical risk out of the future and will significantly facilitate market entry by eliminating the need to design, make, sell, and support new machinery.”
Adding, “We will continue to refine our proprietary relaxometry technology but can now confidently shift our resources to developing our nanoparticles for use with MRI, a ubiquitous imaging modality used in hospitals and radiology clinics throughout the world. We believe this will be more attractive for strategic partners and more likely for us to achieve commercial success sooner.”
Since all MagSense targeted imaging agents use the same underlying magnetic nanoparticle technology, the Company now plans to prioritize the development of its MagSense nanoparticle technology for use with mainstream clinical MRI scanners.
The Company has already initiated the regulatory process with the US Food and Drug Administration (FDA) regarding bringing the HER2 Breast Cancer clinical studies to the US where there will be access to a larger number of sites and a more substantial patient population.
Whereas previously the FDA had designated the MagSense® relaxometry technology as a medical device, recent US legislation has stipulated that any MRI contrast agent be regulated as drugs through the imaging group within the Center for Drug Evaluation and Research (CDER). The Company does not expect the change to seek approval for its imaging agents for use with commercially available MRI scanners to significantly impact the time or cost associated with obtaining regulatory approvals.