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, 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.
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