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August 5, 2014
07:52 EDTMNOVMedicNova announces positive results of MN-001 in advanced NASH mouse model
MediciNova announced positive results from a second preclinical study that examined the potential clinical efficacy of MN-001 for the treatment of advanced NASH, or nonalcoholic steatohepatitis with fibrosis. This study used mice in more advanced stages of NASH as compared to the first study of MN-001 in a NASH mouse model. MN-001 administered orally once daily for 4 weeks, was evaluated in the STAM mouse model of advanced NASH, as measured by histopathology, NAFLD activity score, or NAS, and percent of fibrosis. MN-001 showed anti-NASH and anti-fibrotic effects in the advanced NASH mouse model. NAFLD activity score was significantly reduced in the MN-001 treated group compared to the non-treated group. The reduction was observed consistently in all NAS components including hepatocyte ballooning score, lobular inflammation score, and steatosis score. Percent fibrosis area was also reduced in the MN-001 treated group. In addition, alpha-SMA-positive staining area was significantly reduced in the MN-001 treated group. Based on these results in addition to the results of the first NASH mouse model study reported on January 14, MediciNova requested a meeting with FDA to finalize the trial design for a clinical study of MN-001 in NASH patients.
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September 7, 2014
19:53 EDTMNOVMedicNova announces new NIDA grant for MN-166 in opioid dependence
MediciNova announced that Columbia University and the New York State Psychiatric Institute was awarded new grant funding from the National Institute on Drug Abuse, NIDA, to continue clinical research on MN-166, ibudilast, in opioid dependence. The new grant will support the completion of a Phase 2a clinical trial of MN-166, ibudilast, in opioid dependence, for which positive interim results were previously reported by MediciNova on August 18. The principal investigator, Dr. Sandra Comer, PhD, Professor of Neurobiology at Columbia University and the New York State Psychiatric Institute commented, "We are honored to receive this grant from NIDA with more than $2.66 MM for the next nine months and to be notified of a potential award of more than $11 MM for the next four years." Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased with NIDA's continued support of clinical research on MN-166 (ibudilast) in opioid dependence. We look forward to additional data as the study advances."

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