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BioSphere taps FDA for investigational exemption

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BioSphere Medical Inc. wants the Food & Drug Administration to OK a clinical trial of its QuadraSphere liver cancer treatment.

The Rockland, Mass.-based microsphere maker said it’s asked the federal watchdog agency for an investigational device exemption to study whether its microspheres can be combined with the chemotherapeutic agent doxorubicin to effectively treat liver cancer.

According to the proposed study’s protocols, the treatment, conventional transarterial chemoembolization, would take two stages. In the first, a concentrated dose of doxorubicin would be injected directly into the blood vessels feeding the tumor. The second stage would see the injection of the microsphere into the same vessel, to embolize or block the vessel. The second stage not only cuts off the blood supply to the tumor but, in theory, would leave the chemotherapeutic drug in longer and more targeted contact with the cancerous tissue.

BioSphere said the QuadraSphere product is essentially identical to its HepaSphere, which has already won CE Mark approval in the European Union for the doxorubicin embolization procedure. The proposed IDE trial, involving about 15 centers in the U.S., EU and Brazil would begin enrolling patients within 60 days of FDA approval; it would take about a year to complete enrollment. BioSphere said it plans to file for pre-market approval from the FDA 12 months after concluding the IDE study, should it win approval.

The company recently cited data from another trial showing that uterine artery embolization treatment outperforms laparoscopic occlusion of uterine arteries in treating fibroids.

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