On May 14, 2018 Immunicom, Inc., a medical technology company developing revolutionary non-pharmaceutical approaches for treating cancer and autoimmune diseases, reported the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Immunopheresis therapy, which is based on a proprietary technology that selectively removes immune inhibitors from a patient’s bloodstream potentially enabling their natural immune system to more-effectively attack cancer tumors (Press release, Immunicom, MAY 14, 2018, View Source [SID1234637423]).
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To achieve Breakthrough Device designation, a technology must demonstrate compelling potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.
The FDA’s intent in granting this specific designation to qualified devices is to collaboratively facilitate expediting the device’s assessment and review processes through more interactive communication and planning with the FDA; ensuring proper data collection, efficient clinical study design, senior management engagement of Agency personnel, and priority review of applicable filings.
In contrast to immunotherapy pharmaceuticals and biologicals that introduce foreign compounds and material into a patient’s body, and which are often accompanied by negative side effects, Immunicom’s patented technology is based on a "subtractive" approach that is intended to potentially limit treatment-associated adverse effects. By removing immune system inhibitors from the blood without introducing new substances, Immunicom’s therapeutic approach has been shown in preliminary preclinical studies to enhance anti-cancer immune system response without causing unwanted side effects.
Immunicom’s blood-filtering device technology is the first step in execution of a broader corporate strategic vision. "We are very pleased with FDA’s granting of Breakthrough Device designation for Immunopheresis, our initial immunotherapy product for treating late/end stage IV cancer patients with metastatic solid tumors," said Amir Jafri, CEO of Immunicom, "This significant milestone will enable us to more efficiently pursue device regulatory approval and address critical unmet patient needs sooner, while also continuing our commitment to invest in other exciting treatment options in our product pipeline."