Key Developments For MediciNova, Inc.
MediciNova, Inc. (MNOV.O) (Consolidated Issue listed on NASDAQ Global Market)
MediciNova, Inc Receives Admission for Delaying Submission of Financial Report for Q3 of FY Ending December 2009
MediciNova, Inc announced that from the head of Kanto finance bureau, the Company has received the admission for delaying the submission of financial report for the third quarter of the fiscal year ending December 2009. The Company delayed submitting the financial report because it will take time to do the translation. The Company was supposed to submit the financial report by November 16, 2009. And caused by the delay, the Company will submit the financial report by December 14, 2009.
MediciNova, Inc Announces Initiation Of Phase Ib Clinical Trial For MN-221 In Patients With Stable, Moderate To Severe Chronic Obstructive Pulmonary Disease
MediciNova, Inc announced the initiation of a Phase Ib clinical trial, by holding the Investigator's Meeting, to evaluate the safety of MN-221 at planned escalating doses in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD). COPD exacerbations represents the second respiratory indication for which MediciNova is currently evaluating MN-221. This randomized, placebo-controlled, dose escalation Phase Ib clinical trial designed to evaluate the safety of MN-221 for the treatment of COPD exacerbations will involve approximately 48 stable, moderate to severe COPD patients. Each patient will receive a one hour intravenous infusion of MN-221 at one of three escalating dose levels or placebo. Safety and preliminary efficacy data will be collected and summarized, but will not be subjected to inferential statistical analysis.
MediciNova, Inc Appoints New Accounting Auditor
MediciNova, Inc announced that the Company appointed KPMG LLP as accounting auditor, to replace Ernst & Young LLP, effective October 15, 2009.
MediciNova, Inc. Announces Proposed Final Protocol for Phase II Placebo-Controlled Clinical Trial Evaluating MN-221 in Patients With Severe, Acute Exacerbations of Asthma
MediciNova, Inc. and the Hercules Market of the Osaka Securities Exchange announced the proposed final protocol for its Phase II clinical trial (MN-221-CL-007), which is evaluating the safety and efficacy of MN-221 in patients with severe, acute exacerbations of asthma. Following a more comprehensive pharmacokinetic/pharmacodynamic (PK/PD) analysis and model of data from previous Phase II clinical trials, it was determined that the dose of 1,200 micrograms of MN-221 administered over one hour may provide greater potential efficacy without conferring additional risk to patients. As such, dosing in the MN-221-CL-007 clinical trial will now compare standardized care only to standardized care plus MN-221 at a dose of 1,200 micrograms administered over one hour rather than at a dose of 250 micrograms administered over 15 minutes, as previously contemplated. MediciNova has submitted an amendment to the clinical trial protocol for MN-221-CL-007 to the U.S. Food and Drug Administration (FDA) which reflects this dosing regimen and plans to submit the same information to the relevant regulatory authorities outside of the United States. MediciNova has also communicated this modification to the participating study investigators and clinical sites. MediciNova anticipates patient enrollment to resume within approximately two months and expects to complete enrollment within nine to 12 months from such point in time.
MediciNova, Inc to Merge with Avigen, Inc.
MediciNova, Inc announced that it has signed a memorandum with Avigen, Inc. to merge with Avigen. The formal agreement has not been signed and the details regarding this needs further negotiation.
