DURHAM, N.C., July 10, 2019 /PRNewswire/ -- Biomarck Pharmaceuticals, Ltd today announced that statistical significance (p=0.02) was achieved in improvement of Overall Response Rate (ORR) in the BIO-11006/SOC group compared to standard of care alone at 3 months in the Phase 2 study in NSCLC. This study compares standard of care alone, (pemetrexed/carboplatin; SOC) to SOC plus BIO-11006 in 60 patients with stage 4, NSCLC.
BIO-11006/SOC also showed less Disease Progression (DP) than SOC alone (7% to 17% respectively) and more Partial Response (PR) than SOC (40% to 30%).
BIO-11006 was well tolerated with cough, dyspnea and headache being most commonly (5%) related adverse events. This compares favorably to the myelosuppression, liver and renal toxicity of other commonly used agents.
In Vivo studies have shown BIO-11006 can inhibit NSCLC metastases and reduce tumor size in several animal species. Those treated with BIO-11006 also did not lose weight over the treatment period. This study is intended to give confirmation of these findings in a clinical setting.
About the Phase 2 study
This is a SOC controlled randomized, parallel group, clinical study evaluating BIO-11006 in addition to SOC in patients who have end stage NSCLC. The primary endpoint is progression free survival (PFS) at three months with secondary endpoints of response rate (RR), overall survival (OS) at 3 and 12 months. Body weight is also a clinical endpoint. For more information please visit https://clinicaltrials.gov ID number NCT 03472053
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. BIO-11006 has, in InVitro studies, shown activity against all solid tumors tested including lung, breast, colon and sarcoma. It 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 compound 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 Pharmaceutical, LTD