FDA Okays IsoRay's GliaSite

IsoRay Inc (ISR), which makes the Cesium-131 internal radiation therapy (brachytherapy) isotope, has secured the green signal of the U.S. Food and Drug Administration (“FDA”) for its GliaSite radiation therapy system, a balloon catheter used in treating brain cancer. The Washington-based company’s shares spiked 21% following the news on September 12.

IsoRay had acquired the exclusive global distribution rights to GliaSite from Hologic Inc (HOLX - Analyst Report) in June 2010. The company, in June 2011, secured the exclusive global licensing rights to Iotrex, a key component in the GliaSite system, from Dr. Reddy’s Laboratories (RDY - Snapshot Report). Iotrex is a radioactive liquid solution used in the treatment of brain cancer and is approved by the FDA for use with GliaSite.

Brain cancer is among the fastest growing cancers with more than 575 people being diagnosed with this condition in the U.S. each day. Treatment of brain tumors is challenging as they are very difficult to remove completely given the risk of damaging the brain.

Typically, surgeons remove most of the tumor followed by treatment of the surrounding areas with radiation therapy. However, brain tumors often recur shortly following the surgery.

The GliaSite balloon catheter is used to perform brachytherapy following the removal of the brain tumor. It is inserted into the brain (within the resection cavity of the removed tumor) and is inflated with a pre-specified amount of radioactive solution (such as Iotrex) followed by the delivery of radiation to the surrounding tissues.

GliaSite offers a number of advantages including a more targeted dose delivery of liquid radiation which lowers the impact on brain tissues surrounding the tumor. Moreover, the targeted therapy also reduces the chance of recurrence of the tumor, thereby extending patient survival.

The approval of GliaSite paves the way for IsoRay to seek FDA approval for a liquid form of Cesium-131 for treating brain cancer that will be delivered using the GliaSite system. The company expects GliaSite to be a major contributor to its top-line over the next 2-3 years.

IsoRay develops and markets isotope-based medical products and devices for the treatment of cancer and other malignant diseases. It competes with Theragenics (TGX) and C.R. Bard (BCR - Analyst Report), among others. IsoRay is optimistic that expanded market traction of Cesium-131 coupled with ongoing clinical developments would spur growth moving forward.