Immunicom Announces First Patient Enrollment in Multi-Center, Triple-Negative Breast Cancer Clinical Trial
SAN DIEGO – June 10, 2019 – Immunicom, Inc., a medical technology company awarded FDA Breakthrough Device Designation for Immunopheresis™, its non-pharmaceutical solution for treating stage IV metastatic cancer, began treating its first of 170 triple-negative breast cancer (TNBC) patients on Friday, May 31 at the Jagiellonian University Medical College - Hospital in Cracow, Poland.
Immunicom's Immunopheresis therapy is a revolutionary new non-drug, blood-filtering immunotherapy treatment, with the potential to effectively treat a wide variety of cancer types more effectively and with fewer side effects, including those that have failed response to other treatment approaches. Immunopheresis works by removing cancer-produced proteins that inhibit the body's natural immune defenses from recognizing and attacking tumors, potentially enabling a patient's own body to effectively battle the disease. To learn more about how Immunicom's technology works, see Immunopheresis Treatment Overview.
This randomized, multi-center, TNBC clinical study compares Immunopheresis alone and its use in combination with low-dose paclitaxel and carboplatin weekly chemotherapy, versus a control arm of low-dose chemotherapy. Clinical trial results, which include endpoints of progression free survival (PFS) and objective response rate (ORR), will be used by Immunicom to pursue global regulatory approvals and European CE marking.
The trial is being conducted under the direction of Principal Investigator, Piotr Wysocki, MD, PhD, who serves as Department Head of Oncology at the Jagiellonian University - Medical College Hospital in Krakow and President of the Polish Society of Clinical Oncology. Professor Wysocki is a renowned leader in immunotherapy and breast & genitourinary cancer research having authored more than 100 published textbook chapters and scientific articles.
"I am extremely pleased to serve as the Principal Investigator for this groundbreaking clinical study" said Professor Wysocki. "While I continue to see exciting advancements in the field of immuno-oncology, most involve expensive new drug therapies which are financially out of reach for many health systems and patient populations. Every week, patients from all over the Europe who have failed all available treatments are coming to my department looking for last chance therapies such as combinations of metronomic chemotherapy and molecularly targeted approaches, we have been developing for many years. In this context, we hope, Immunopheresis may become the ultimate and universal therapy of choice we have been all waiting for. I am really optimistic that the results of this trial will demonstrate Immunopheresis alone or in combination with existing, low-cost, low-toxic standard of care chemotherapy can be an effective, affordable treatment option for TNBC patients."
According to Amir Jafri, Founder and CEO of Immunicom, "Successfully completing the first patient treatment in this pivotal TNBC study is an incredible company milestone. And, with this trial being the first of multiple international clinical studies planned to begin enrollment in 2019, this achievement demonstrates the strong momentum our organization and outstanding team of partners and advisors have created."
Immunicom, Inc. is a privately held medical technology company located in San Diego, CA focused on developing innovative, non-pharmaceutical approaches for treating cancer, inflammatory diseases, and autoimmune diseases. Immunicom's revolutionary blood-filtering technology has the potential to effectively treat a wide variety of cancer types including those that have not responded to other treatment strategies including other drug and biological-based immunotherapy options with possibly fewer side effects. The company seeks to leverage its technology to address unmet medical needs and improve patient access and affordability of cancer and other inflammatory and autoimmune disease treatments around the world.
This press release contains certain forward-looking statements regarding Immunicom products, technological capabilities, and future business aspirations. All such statements are based upon current Immunicom expectations and involve a number of business and technical risks and uncertainties that could cause actual results to differ materially from anticipated results described, implied or projected in any forward-looking statement, including, without limitation, clinical trial results, regulatory approvals, unexpected changes in technologies, uncertainties inherent in product development and commercialization, intellectual property protection, and the ability of our products to gain market acceptance.