Knobias ClipReport (8-22-2007)
Submitted from Knobias ClipReport
MediciNova, Inc. (MNOV) announced results from its Phase Ib clinical trial of MN-221 for the treatment of preterm labor. Target plasma concentrations were achieved with an intravenous priming followed by maintenance infusion dosing paradigm. No significant safety concerns with MN-221 were identified in this clinical trial. The primary objectives of this clinical trial were to determine the pharmacokinetics, safety and tolerability of this infusion regimen of MN-221 in pregnant women. The intravenous formulation of MN-221 is also appropriate for use in emergency facilities.
There are no FDA-approved and marketed treatments for preterm labor in the U.S. All medications in current use are being used “off-label." Brethine(R) and Bricanyl(R)(terbutaline) are FDA-approved for the treatment of asthma, but they are commonly used “off-label” to treat preterm labor.
Chief Scientific Officer of MediciNova, Kenneth W. Locke, Ph.D., told Knobias on Tuesday, "Because MN-221 is a much more selective beta2 adrenergic receptor agonist than terbutaline, We believe that it should produce fewer cardiovascular side effects (e.g., palpitations)."
"MN-221 is also currently in a Phase IIa clinical trial for status asthmaticus, an acute exacerbation of asthma that does not respond to standard treatments of bronchodilators and corticosteroids. We expect to announce results from this trial during the fourth quarter of this year."
The Company has a broad broad pipeline of therapeutic product candidates that address significant disease markets, including six compounds in clinical testing. In addition to MN-221, the Company's other lead commercial candidate is MN-166, currently in a Phase II clinical trial for multiple sclerosis. MN-166 is an oral therapy that showed both neuroprotective and anti-inflammatory benefits in the first year of the trial, signifying the potential to reduce relapses and to halt or slow disease progression. Results from the second year of this study are expected during the first half of 2008.
Dr. Locke explained, "We have a wholly-owned subsidiary in Japan to establish relationships with many mid-size Japanese pharmaceutical companies, through which MediciNova has licensed the rights to develop several current product candidates. Our unique relationships provide us with an untapped source of novel therapeutics."
As of June 30, 2007, MediciNova had $85.9 million in cash or equivalents and an accumulated deficit of $191.8 million.
CFO Shintaro Asako noted, "We believe that our current financial resources will be sufficient to fund anticipated operating requirements, including planned research and development programs, through December 31, 2008."
"Our current strategy is to focus investment on key assets, such as MN-221 and MN-166, in order to bring these assets substantially forward towards commercialization, while pursuing a variety of business development initiatives for other product candidates in the pipeline."
Dutton recently reiterated a Strong Speculative Buy for MNOV with an ambitious target price of $20 a share by year-end. Punk Ziegel initiated coverage of MNOV at Buy and a price target of $22. The analyst indicated that the Company is an attractive investment opportunity that has not been recognized by the investment community.
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Labels: Knobias, MedicNova, small cap stocks

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