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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.
News For MNOV From The Last 14 Days
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October 22, 2014
19:01 EDTMNOVMediciNova confirmsFDA granted orphan drug designation to MN-001
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07:28 EDTMNOVNortheast Amyotrophic Lateral Sclerosis Consortium to hold annual meeting
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October 21, 2014
18:05 EDTMNOVMediciNova granted orphan status for idiopathic pulmonary fibrosis drug
The FDA posted on its website that MediciNova has been granted orphan status for its treatment of idiopathic pulmonary fibrosis. Reference Link
October 8, 2014
19:02 EDTMNOVMedicNova receives feedback from FDA regarding study protocol for MN-001 trial
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