Q. What is UNLEASH™ and why is it important?
A. UNLEASH™ is a proprietary columnar filter that selectively removes specific immune-system regulating molecules from the plasma of cancer patients, molecules which inhibit the action of cancer-killing proteins. The column mounts to an apheresis platform, similar to a kidney dialysis machine. Treatments may last for an hour or so, during which the patient’s natural immune response is significantly boosted to aggressively attack tumor cells. Repeated treatments over a few weeks will initiate destruction of malignant cells wherever they occur in the body.
Q. How is the therapy different from other cancer treatments?
A. UNLEASH™ is a device, not a drug. It operates as a filter, outside of the body, and only reduces the concentration of one specific cytokine (signaling protein) circulating in the patient’s bloodstream. It is expected to be effective across a wide-spectrum of different cancer indications including metastatic diseases.
Q. What are the side effects?
A. During and following treatment, a general systemic inflammatory response is expected. Patients may experience flu-like symptoms including fever. They may also experience pain at tumor sites. The symptoms are temporary. No lasting side effects are expected.
Q. Can this therapy be used before, during, or after other modes of treatment, such as chemotherapy or radiation?
A. UNLEASH™ should, in theory, work both as a stand-alone therapy and as an adjunctive or additional therapy alongside other modes of treatment. In addition to directly acting upon cancer cells, the UNLEASH™ device may conceivably work to enhance the effectiveness of certain chemotherapy drugs.
Q. How many cancers, and at what stages of disease progression, is this therapy intended for?
A. Theoretically, the UNLEASH™ device, will be effective against solid tumors growing anywhere in the body. While early indications and related clinical work in Europe are promising, only clinical evidence from future human trials will actually prove its effectiveness.
Q. How much will it cost?
A. Because UNLEASH™ is a device, the development, testing, and regulatory approval process will be far less expensive than is typical for drugs. Once manufacturing scale is achieved, treatments should be competitive with other oncology modalities.