Provided that the FDA accepts the planned clinical protocol, Biosphere plans to begin enrolling patients into the study within 60 days of FDA approval.
The proposed investigation will be a prospective, randomised, double-blinded clinical trial conducted at approximately 15 sites in the US, European Union and Brazil. The clinical trial will focus on treating patients with advanced hepatocellular carcinoma (HCC), also known as primary liver cancer, and will compare QuadraSphere with doxorubicin against conventional transarterial chemoembolization (cTACE) with doxorubicin. BioSphere anticipates that patient enrollment will take approximately 12 months, and that it will file a premarket approval application (PMA) with the FDA approximately 12 months after the final patient is enrolled. The company expects to fund trial costs from current working capital and cash flow from operations.
Richard Faleschini, chief executive officer of BioSphere Medical, said, “Only a small percentage, about 25%, of the more than 600,000 patients diagnosed each year with hepatocellular cancer worldwide can be treated with surgery or transplant. For the majority of patients with hepatocellular cancer, conventional transarterial chemoembolization (cTACE) is the standard of care. At the present time, there is not an embolic in the United States with FDA market clearance for the treatment of hepatocellular cancer.”
Faleschini added, “Independent studies in Europe of our embolic loaded with doxorubicin have generated positive results, and the pivotal study is designed to further evaluate clinical performance. The QuadraSphere with doxorubicin clinical trial is an important milestone for BioSphere, and if the trial is successful and the PMA is approved by the FDA, it is expected to be the first FDA approval for hepatocellular carcinoma using chemoembolization, providing further demonstration of our leadership position in embolotherapy.”
About QuadraSphere Microspheres
QuadraSphere’s technical attributes are designed to provide a unique and versatile embolization platform. Its spherical shape is designed to allow for a predictable, flow-directed occlusion. The product has been demonstrated to expand to four times its dry-state diameter. Also, QuadraSphere is designed to afford atraumatic conformability to the vessel architecture, leading to a more complete vessel occlusion. QuadraSphere is technically identical to BioSphere’s HepaSphere microspheres, an embolic currently CE marked in the European Union for delivery of doxorubicin for embolization of HCC and hepatic metastases.
