DURHAM, N.C., Jan. 23, 2018 /PRNewswire/ -- 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 is a Durham, N.C. based biopharmaceutical company focused on the clinical development of its lead and back up compounds for the treatment of significant disease states such as ARDS and NSCLC. For additional information on Biomarck, please visit the Company's website at www.biomarck.com
Forward Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company's plans and expectations for BIO-11006, contain predictions, estimates and other forward looking statements. These forward looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments and the risk related to the efficacy or safety of the Company's development pipeline, the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic factors and competitive and technological advances; and other risks.
Mike Enright, Chief Financial Officer
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.
SOURCE Biomarck Pharmaceuticals