Medical technology firm Immunicom has recruited first patient in multi-center and triple-negative breast cancer (TNBC) clinical trial of Immunopheresis.
Immunopheresis, which already secured breakthrough device designation from the US Food and Drug Administration (FDA), is a non-pharmaceutical solution to treat treating stage IV metastatic cancer.
The company has commenced treating its first of 170 TNBC patients at the Jagiellonian University Medical College – Hospital in Cracow, Poland.
Immunopheresis therapy is an advanced non-drug and blood-filtering immunotherapy treatment, which holds capacity to treat a range of cancer types more efficiently and with fewer side effects.
The blood-filtering immunotherapy is said to work by eliminating cancer-produced proteins, which restrict the natural immune defences of the body from recognizing and attacking tumours, helping patient’s own body to efficiently battle the disease.
Immunicom has started the randomized, multi-center and TNBC clinical study to compare Immunopheresis alone and in combination with low-dose paclitaxel and carboplatin weekly chemotherapy against a control arm of low-dose chemotherapy.
The company will use the results from the trial, including endpoints of progression free survival (PFS) and objective response rate (ORR), to secure global regulatory approvals and European CE marking.
The trial is being carried out under the leadership of principal investigator Dr Piotr Wysocki, 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.
Wysocki said: “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.”
Immunicom, founder and CEO Amir Jafri said: “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.”
Based in San Diego, Immunicom is involved in the development of advanced non-pharmaceutical approaches to treat cancer, inflammatory diseases and autoimmune diseases.