Exton, Pennsylvania based Morphotek, Inc., the U.S. biopharmaceutical subsidiary of Tokyo-based global health care pharmaceutical company Eisai Co.,Ltd. — specializing in development of protein and antibody products through use of novel and proprietary gene evolution technology — reports the first patient enrollment in the ARTEMIS (Amatuximab – Research – in – Treatment-naive – Epithelial – Mesothelioma: Impact on Survival) trial. This multicenter, double-blind, randomized, parallel-group study using a placebo control or amatuximab 5 mg/kg, administered weekly is designed to evaluate the safety and efficacy of amatuximab, a monoclonal antibody (mAb) that targets mesothelin, in combination with the standard chemotherapy regimen of pemetrexed plus cisplatin in subjects with unresectable Malignant Pleural Mesothelioma who have not received prior systemic therapy.
The Morphotek-sponsored clinical trial is officially entitled “Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM) (ARTEMIS)“ — ClinicalTrials.gov Identifier: NCT02357147 — and is currently recruiting participants.
Another Morphotek-sponsored trial, the MORAb-009-201 study (full title: “An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma“ – ClinicalTrials.gov Identifier: NCT00738582) is a randomized, double-blind, placebo-controlled trial to determine if amatuximab improves the overall survival of MPM patients based and designed on exposure response results of the completed 89-patient MORAb-009-003 Phase 2 study. All patients will receive the standard-of-care chemotherapy regimen for four to six cycles combined with either amatuximab or placebo, followed by maintenance therapy with either amatuximab or placebo. Secondary objectives of the trial include evaluating progression-free survival, objective response rate, duration of response, disease control and performance status maintenance, disease control rate, health-related quality of life, and safety. Morphotek says it expects to enroll 560 patients in this study, which will be conducted in sites across Australia, Europe and the United States.
“We are excited to initiate this global study of amatuximab. The exposure-response modeling in the MORAb-009-003 trial indicates a potential role for amatuximab in this disease where the current standard of care provides a median overall survival of approximately 13.3 months,” says Nicholas Nicolaides, Ph.D., President and CEO of Morphotek in a release. “Mesothelioma is a rare and aggressive cancer with poor prognosis; therefore, further investigation of amatuximab in this area of unmet need is warranted.”
Morphotek describes Amatuximab’s action as triggering antibody-dependent cellular cytotoxicity against tumor cells expressing mesothelin and blocks the ability of mesothelin to bind to its cognate receptor on adjacent cells. Mesothelin is a cell-surface glycoprotein believed to be involved in tumor metastasis that is expressed in mesothelioma and other solid tumors, such as epithelial ovarian cancer, lung adenocarcinoma and pancreatic ductal adenocarcinoma.
The MORAb-009-003 Phase 2 Study
Morphotek previously conducted a global, single-arm, open-label, Phase 2 study testing whether amatuximab plus standard of care could improve progression-free survival in patients with newly diagnosed, unresectable, epithelioid or biphasic, malignant pleural mesothelioma. Secondary endpoints included overall response, overall survival and safety. The company reports that results of this MORAb-009-003 study showed that amatuximab failed to statistically improve progression-free survival in the intent to treat population compared to historic controls; however, the 14.8-month median overall survival compared favorably to the historical control of 13.3 months. These results, along with dose modeling, suggested an opportunity to improve median overall survival in the majority of patients using a modified dosing schema than what was used in the MORAb-009-003 study. Based on these findings, further study of amatuximab using a more frequent dosing schedule is being pursued.
Since its founding in 2000, Morphotek has been focused on discovering and developing monoclonal antibodies to treat diseases. Post-graduate research executed by Morphotek’s President and CEO, Dr. Nicholas Nicolaides, during his studies at Johns Hopkins Medical School was the basis for the company’s inception. It was at Johns Hopkins that Dr. Nicolaides co-invented the company’s legacy technology called morphogenics. Along with the honed applications for applying morphogenics for product development refined by the company’s other co-founders, Dr. Philip Sass and Dr. Luigi Grasso, morphogenics has enabled Morphotek to gain considerable ground in the advancement of novel pharmaceutical products and targets. In the spring of 2007, Morphotek was acquired by Eisai Co. Ltd. Morphotek’s propriety technologies and promising antibodies, combined with Eisai’s existing research programs and infrastructure, enables the companies to work toward addressing unmet medical needs of patients, especially those with cancer and inflammatory diseases, all around the world.
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