Biomarck Pharmaceuticals, Ltd today announced that a Phase 2 clinical study in advanced NSCLC has commenced. This study at 10 sites in India compares standard of care therapy (SOC; pemetrexed and carboplatin) alone to SOC plus BIO-11006. This trial will evaluate the safety and efficacy of Biomarck’s novel, patented, MARCKS protein inhibitor in a controlled trial.
“Although advances have been made recently in the treatment of advanced NSCLC especially with immunotherapy, the five-year survival rate remains disappointingly low. These immunotherapeutic agents have significant side effects and quality of life remains a critical issue to both patients and their treating oncologists. Animal studies have shown the ability of BIO-11006 to reduce primary tumor size, prevent the development of secondary tumors and act synergistically with other chemotherapeutic agents. The side effect profile in over 200 patients in previous clinical studies has demonstrated an encouraging safety database where only cough and headache were more common than placebo. Furthermore, animals with NSCLC treated with BIO-11006 did not lose weight whereas those untreated lost 30% bodyweight within 3 weeks. The initiation of this clinical study represents a significant milestone for Biomarck as we progress to clinically develop our patented portfolio in diseases, such as non-small cell lung cancer (NSCLC) that cause significant morbidity and mortality. This represents a first in class therapy,” said Dr. Brian Dickson, Biomarck’s Chief Executive Officer.
About the Phase 2 Study
This is a controlled randomized clinical study evaluating BIO-11006 with SOC compared to SOC alone in the treatment of advanced NSCLC. The primary endpoint is progression free survival (PFS) at 3 months. Overall survival (OS), and body weight are secondary endpoints. This study will be listed on https://clinicaltrials.gov
BIO-11006 is a novel patented peptide that inhibits the MARCKS protein. Phosphorylation of the MARCKS protein has been shown to stimulate cell division and movement. In the case of NSCLC this refers to inhibition of cancer cell division and movement. It is important to know that this is a targeted effect as normal cells are not affected. BIO-11006 is part of a portfolio of over 100 patented compounds owned by Biomarck.
Biomarck Pharmaceuticals, Ltd., is a clinical stage biotechnology company focused on treating patients with inflammatory and immunological diseases, using our platform of patent-protected peptides that have been developed to inhibit MARCKS. As a critical component of the inflammatory process, MARCKS is responsible for neutrophil aggregation at the site of inflammation and cytokine release. Inhibiting MARCKS with our peptides reduces the adverse effects of inflammation, including acute respiratory distress syndrome (ARDS) and cytokine storm. Phase 2 trials have been completed with our lead peptide, BIO-11006, in ARDS, COPD and NSCLC, confirming safety and efficacy in these three potential indications. In vivo data demonstrate that BIO-11006 and other peptides in the Biomarck pipeline inhibit inflammation in dermatology and ophthalmology models. Potential indications include uveitis, dry eye, atopic dermatitis and psoriasis.
This press release may contain forward-looking statements. Forward-looking statements are not guarantees, and they involve risks, uncertainties, and assumptions. The information in the press release should be considered accurate only as of the date of the document or presentation. We disclaim any obligation to supplement or update the information in these documents or presentations.