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MediciNova, in Collaboration with the University of Sydney and the Australasian Gastro-Intestinal Trials Group, Announces Plans for a Multi-center, Phase 2b Study to Evaluate MN-166 (ibudilast) in Chemotherapy-Induced Peripheral Neuropathy
LA JOLLA, Calif., Oct. 22, 2020 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the
About this update from Medicinova, Inc.
[{"type":"text","content":"LA JOLLA, Calif., Oct. 22, 2020 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it plans to initiate a multi-center, placebo-controlled, randomized Phase 2b trial to evaluate MN-166 (ibudilast) in chemotherapy-induced peripheral neuropathy (CIPN).\n The clinical trial is a collaborative effort between MediciNova, the University of Sydney, and the Australasian Gastro-Intestinal Trials Group (AGITG). Dr. Janette Vardy, Professor of Cancer Medicine, University of Sydney in Australia, will be the lead principal investigator. The proposed clinical trial will evaluate MN-166 (ibudilast) as a potential treatment to reduce acute neurotoxicity severity and CIPN in patients with metastatic colorectal cancer. AGITG will provide funding for this study and MediciNova will provide study drug and regulatory support. Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, “We are excited to collaborate with Dr. Vardy on this grant-funded study to further explore the potential of MN-166 as a pharmacotherapy for CIPN. As we recently reported, our first clinical trial in CIPN showed that half of participants reported improved symptoms in the acute period and showed improved neurological parameters on clinical assessment with ibudilast treatment. There is a large unmet medical need for patients with this disorder.” Dr. Janette Vardy, the Principal Investigator for this study, commented, “The findings from our initial study were encouraging, and with the support of AGITG and MediciNova, we plan to explore further the potential clinical utility of ibudilast in a larger sample of patients who experience oxaliplatin-induced acute neurotoxicity and chronic CIPN.” About the Chemotherapy-induced Peripheral Neuropathy Trial This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial to determine whether MN-166 (ibudilast) can decrease acute neurotoxicity symptoms and CIPN, and to determine whether ibudilast treatment results in fewer neurotoxicity-induced dose reductions in patients with metastatic colorectal cancer receiving oxaliplatin up to six months. We plan to enroll a total 100 patients in a 1:1 (ibudilast:placebo) ratio. Treatm...