On July 10, 2019 Biomarck Pharmaceuticals, Ltd reported 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 (Press release, BioMarck Pharmaceuticals, JUL 10, 2019, View Source [SID1234537469]). This study compares standard of care alone, (pemetrexed/carboplatin; SOC) to SOC plus BIO-11006 in 60 patients with stage 4, NSCLC.

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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 View Source ID number NCT 03472053