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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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July 27, 2015
08:12 EDTMNOVMediciNova announces FDA approval of second Phase 2 protocol for MN-001 in NASH
MediciNova announced that FDA has approved a second protocol for a clinical trial evaluating MN-001 for a NASH indication. This study targets NASH patients with hypertriglyceridemia to evaluate the ability of MN-001 to improve cardiovascular risk by assessing cholesterol-efflux capacity and serum triglyceride levels as well as reduction of percent fat in the liver, as assessed by MRI.
July 21, 2015
08:08 EDTMNOVMediciNova announces update on development plans for MN-001 in IPF
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