UNLEASH®

More than 285,000 Americans will die of cancer in 2016. Present “standard of care” in oncology is focused on surgery, radiation, chemotherapy, and/or hormonal therapy, or combinations of these therapies. Although improvements in survival rates are dramatic for certain cancers, there are many patients for whom these methods provide no improvement or may extend life only by a few months. Recent gains seen in survival rates are mostly due to earlier detection.

The incidence of cancer is expected to rise in the U.S. as the baby boomer population ages into the peak cancer years (age 65+), and the need for better therapeutic methods is obvious. Immunotherapeutic drugs are beginning to appear and are showing very promising results for some cancers. UNLEASH® represents a non-drug line of immunotherapy research with potential advantages over drug therapies.

CytoLogic’s UNLEASH® immunotherapy device is a type of filter called an adsorption column. The column mounts on common plasmapheresis equipment and is used in a procedure similar to kidney dialysis. A patient’s plasma is separated from the whole blood and then filtered through the column, which contains engineered proteins that “adsorb” or bind to one specific targeted protein in the plasma. Treated plasma returns to the whole blood to be re-infused back into the patient’s vein.

CytoLogic’s proprietary “M4” protein is a highly-efficient binding partner for tumor necrosis factor receptors (TNFR). These receptors repress activity of TNF molecules which are hunting cancer cells. TNF cytokines bind to cancer cells and start a process (apoptosis) that kills them. UNLEASH® temporarily, but dramatically, lowers the circulating concentration of TNFR molecules which causes a temporary spike in the immune response. Tumor tissue becomes inflamed and individual cancer cells begin to die.

The benefits of removing TNFR from plasma are widely published. Over a century of research suggests that the UNLEASH® immunotherapy column will effectively improve survival rates for certain cancers. The action of UNLEASH® is not cancer indication-specific. It may potentially be useful for a variety of soft-tissue and epithelial cancers i.e. sarcomas and carcinomas.

The non-invasive, extracorporeal UNLEASH® therapy may be administered in established apheresis clinics by personnel already trained in the process. A course of treatment may include up to a dozen or more sessions. The therapy is expected to generate a pronounced tumor inflammation almost immediately, as soon as during the procedure itself. UNLEASH® is expected to be effective as a stand-alone therapy, but may ostensibly be used in combination with surgery, chemotherapy, and radiation therapy.

Side effects may included general inflammation and flu-like symptoms during and/or following each treatment session. Side effects are transitory and manageable. Nothing enters the patient’s body except for the patient’s own processed blood.

Research also suggests that UNLEASH®, used in combination with certain chemotherapeutic agents, may significantly improve response rates.

UNLEASH® is an FDA Class III Medical Device, single-use and disposable. Treatments may fall under existing CPT codes in use by Medicare, Medicaid, and private insurance companies.