MediciNova Announces Proposed Final Protocol for Its Phase II Placebo-Controlled...

MediciNova Announces Proposed Final Protocol for Its Phase II Placebo-Controlled
Clinical Trial Evaluating MN-221 in Patients With Severe, Acute Exacerbations of
Asthma

SAN DIEGO, July 13, 2009 (GLOBE NEWSWIRE) -- MediciNova, Inc., a
biopharmaceutical company that is publicly traded on the Nasdaq Global Market
(Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code
Number: 4875), today 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.

"After completing the more comprehensive PK/PD analysis, we concluded that the
dose of 1,200 micrograms of MN-221 given over one hour had the best chance of
proving the effectiveness of this promising new potential product for acute
exacerbations of asthma. Most importantly, by going to this dose, we do not
believe we are conferring additional risks to patients. Our safety analysis also
included, in a blinded fashion, the safety data from the limited number of
patients who already completed dosing in MN-221-CL-007 at the proposed dosing
regimen," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer
of MediciNova, Inc. "We look forward to resuming the study and anticipate that
patient enrollment will accelerate as we approach the peak asthma season in
North America."

About the MN-221-CL-007 Phase II Clinical Trial

MN-221-CL-007 is a randomized, double-blind, placebo-controlled Phase II
clinical trial. A total of approximately 35 clinical sites, including the
clinical sites rolled-over from the MN-221-CL-006 clinical trial, in North
America, Australia and New Zealand will enroll approximately 200 patients into
the MN-221-CL-007 clinical trial. Once a patient has received the initial
standardized care treatment regimen (consistent with the National Asthma
Education and Prevention Program and the Global Initiative for Asthma (GINA)
guidelines), the patient will be assessed for response to that treatment. If the
patient's forced expiratory volume in one second (FEV1) is less than or equal to
50 percent of predicted and the patient meets all other study entry criteria,
the patient will be randomized to receive either MN-221 or placebo. Patients
enrolled in the study will continue to receive standardized care as needed while
receiving an intravenous infusion of MN-221 or placebo. The primary efficacy
endpoint will be improvement in FEV1.

About MN-221

MN-221 is a highly-selective beta2-adrenergic receptor agonist. Preclinical
testing in vitro and in vivo shows MN-221 to be more selective for the
beta2-adrenergic receptor than other beta2-adrenergic receptor agonists commonly
used for these asthma attacks. This improved selectivity, coupled with its
partial agonist activity at beta1-adrenergic receptors, may result in fewer
cardiovascular side effects than are commonly observed with these other agents.
MediciNova has developed an intravenous formulation of MN-221 that bypasses the
constricted airways to deliver the drug to the lungs. In addition to the data
described above MN-221 has been shown to produce significant improvements in
mean change in post-infusion (15 minute) FEV1 from baseline (objective measure
of lung function) at doses of 3.5 micrograms/min (p=0.011), and at 10, 16, 30
and 60 micrograms/min (p less than or equal to 0.0001), compared to placebo in
stable mild-to-moderate asthma patients (MN-221-CL-004). Administration of
MN-221 at a dose of approximately 1,100 micrograms over intervals of one or two
hours also produced marked improvement in FEV1 in patients with
moderate-to-severe stable asthma (MN-221-CL-005). In addition, administration of
1,100 micrograms of MN-221 over one hour produced the greatest FEV1 improvement
in patients with stable asthma of the regimens tested in these two studies.
Based on an analysis of the data from the recently completed Phase II clinical
trial (MN-221-CL-006), doses of 240 micrograms to over 1,100 micrograms of
MN-221 administered to subjects with an acute exacerbation of asthma in
combination with standard care was associated with improvement in FEV1 compared
to standard care alone and was well tolerated. In addition, a recently completed
drug interaction study in dogs found that adding MN-221 by intravenous
administration in combination with inhaled albuterol does not add to the heart
rate increase associated with inhaled albuterol alone.

MediciNova acquired an exclusive, worldwide (excluding Japan), sublicensable
license to MN-221 from Kissei Pharmaceutical Co., Ltd. The intellectual property
acquired from Kissei included extensive preclinical and clinical safety data.

About MediciNova

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
holds rights to 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 acute exacerbations
of asthma, 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 its two prioritized
product candidates, MN-221 for the treatment of acute exacerbations of asthma
and MN-166 for the treatment of multiple sclerosis, and either pursue
development independently, in the case of MN-221, or establish a strategic
collaboration to support further development, in the case of MN-166. MediciNova
will seek to monetize its other product candidates at key value inflection
points. For more information on MediciNova, Inc., please visit
www.medicinova.com.

The MediciNova, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3135

Statements in this press release that are not historical in nature, including
those related to the progress of the product development program for MN-221 for
the treatment of acute exacerbations of asthma, 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, 2008 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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CONTACT: MediciNova, Inc.
Shintaro Asako, Chief Financial Officer
858-373-1500
info@medicinova.com

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