Healthcare Industry News: MediciNova
News Release - February 1, 2008
MediciNova's MN-166 Reduces Persistent Black Hole Formation in Multiple Sclerosis PatientsSAN DIEGO, Feb. 1, 2008 (Healthcare Sales & Marketing Network) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (NasdaqGM:MNOV ) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced additional data from a double-blind analysis of the first year of treatment from its two-year Phase II clinical trial of MN-166 in multiple sclerosis (MS). The second year of the Phase II clinical trial is on-going with results expected in April 2008. The analysis showed that MN-166 decreased the formation of black holes (permanent brain lesions believed to indicate the death of nerves in the brain) on magnetic resonance imaging (MRI) in MS patients, adding support to MediciNova's belief that MN-166 may provide neuroprotection in relapsing MS.
Data demonstrated that a 60 mg/day dosing regimen of MN-166 significantly reduced the proportion of new T1 gadolinium-enhancing or new T2 lesions identified at month two of the study that evolved into persistent black holes at month 10 compared to placebo (RR 0.63, p=0.011). Treatment with a 30 mg/day dosing regimen of MN-166 showed a trend toward reduced risk of new lesion evolution to persistent black holes compared to placebo (RR 0.735, p=0.074).
``The results of this new analysis provide further evidence of a potential neuroprotective effect of MN-166 in MS patients and are consistent with the previously announced results showing that 60 mg/day of MN-166 significantly attenuated percent brain volume loss compared to placebo treatment during the first year of this study,'' said Dr. Frederik Barkhof, Professor of Neuroradiology, Vrije Universiteit Medical Centre (VUMC), Amsterdam, The Netherlands.
The evaluation was performed using MRI data collected from 292 patients with relapsing forms of MS who were randomly assigned to receive daily oral treatment with placebo or 30 or 60 mg/day of MN-166 during year one of this two year study. MediciNova's Scientific Advisory Board suggested this evaluation to further elucidate the mechanism by which MN-166 significantly reduced the percent of brain volume loss observed in year one. MRIs were collected bimonthly during the one year treatment period and were re-evaluated in a double-blind manner for this new analysis. Predefined endpoints for this evaluation were the rate of evolution of new lesions to persistent black holes and remyelinated lesions. New T1 gadolinium-enhancing or new T2 lesions were defined as new lesions in the first on-study MRI at month two and tracked in the month four and month 10 MRIs. Lesions were classified at month 10 as persistent black holes or remyelinated lesions according to predefined criteria. The relative risk (RR) of new lesion evolution to persistent black holes and remyelinated lesions per patient was analyzed using a generalized linear statistical model.
Of the 292 patients who received either placebo (n=100), 30 mg/day of MN-166 (n=94) or 60 mg/day of MN-166 (n=98), 72 of the placebo-treated patients, 64 of the patients receiving 30 mg/day of MN-166 and 56 of the patients receiving 60 mg/day of MN-166 had new lesions in month two. The proportions of new lesions evolving to persistent black holes were 0.24, 0.20 and 0.16 in the placebo, 30 mg/day of MN-166 and 60 mg/day of MN-166 treatment groups, respectively. The RR for new lesion evolution to persistent black holes was significantly lower (RR 0.63, p=0.011) in MS patients treated with 60 mg/day of MN-166 and tended to be lower (RR 0.735, p=0.074) in patients treated with 30 mg/day of MN-166 compared to placebo-treated patients. The proportion of new lesions that evolved to remyelinated lesions did not differ significantly among treatments.
About Multiple Sclerosis and MN-166
Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system (CNS), affecting approximately 250,000 - 350,000 people in the United States. The most obvious effect of MS is the progressive loss of muscle control, but multiple brain and CNS functions are also affected. There is no cure for the disease. Relapsing-remitting MS (RRMS), which is the most common type of the disease, affects approximately 65% of MS patients according to a Cognos study published by Decision Resources, Inc. Most patients with RRMS eventually progress to the secondary progressive (SPMS) form of the disease.
MN-166 is a novel, orally administered compound being evaluated for the treatment of MS. MN-166 inhibits leukotriene activity, phosphodiesterases and nitric oxide synthase, all inflammatory mechanisms known to be involved in MS. MN-166 may also suppress the production of pro-inflammatory cytokines (IL-1?, TNF-?) and may enhance the production of the anti-inflammatory cytokines (IL-4, IL-10). Clinical results showing positive clinical benefits and the drug to be well tolerated after one year of treatment in this two-year randomized, double-blind, placebo-controlled Phase II clinical trial in 297 relapsing multiple sclerosis patients were reported in March 2007. The second year of this clinical trial is ongoing with results expected in April 2008.
MediciNova acquired an exclusive, worldwide (excluding Japan, China, Taiwan and South Korea), sublicensable license to MN-166 for the treatment of MS, excluding ophthalmic solution formulations, from Kyorin Pharmaceutical Co. Ltd. For the past 18 years, MN-166 has been marketed in Japan and South Korea as Ketas(r) for the treatment of asthma and cerebrovascular disorders. Data from the existing clinical trial and post-marketing surveillance databases, which includes treatment of an estimated 3.2 million patients with these disorders, indicate that Ketas(r) is well tolerated.
MediciNova, Inc. is a publicly-traded biopharmaceutical company focused on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a specific focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova is developing a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential and patent assets having claims of commercially adequate scope. MediciNova's pipeline includes six clinical-stage compounds for the treatment of status asthmaticus, multiple sclerosis, asthma, interstitial cystitis, solid tumor cancers, Generalized Anxiety Disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova's current strategy is to focus its resources on the development and commercialization of two prioritized assets in its development pipeline: MN-221 for the treatment of status asthmaticus, an acute, severe asthma attack, and MN-166 for the treatment of multiple sclerosis. MediciNova will seek to monetize its other product candidates at key value inflection points. For more information on MediciNova, Inc., please visit http://www.MediciNova.com.
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding MediciNova's clinical trials supporting safety and efficacy of product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for present and future clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements may be preceded by, followed by or otherwise include the words ``believes,'' ``expects,'' ``anticipates,'' ``intends,'' ``estimates,'' ``projects,'' ``can,'' ``could,'' ``may,'' ``would,'' or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements, include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA, MediciNova's failure to execute strategic plans or strategies successfully, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to raise sufficient capital when needed, intellectual property or contract rights, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2006 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.
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