UCLA Initiates a NIDA-Supported Phase 1b Study With Ibudilast in Methamphetamine-Dependent Volunteers
First Clinical Study of Ibudilast in Methamphetamine Addicts
SAN DIEGO, Sep 27, 2010 (GlobeNewswire via COMTEX) -- MediciNova Inc, a biopharmaceutical company publicly traded on the NASDAQ Global Market and the Hercules Market of the Osaka Securities Exchange (code number:4875), today reported FDA's approval to proceed with an initial trial of the company's neurological drug candidate, ibudilast (MN-166/AV411), as a potential new pharmacotherapy for methamphetamine addiction. The study is largely funded by the National Institute on Drug Abuse (NIDA). The study will be led by Steven Shoptaw Ph.D., Principal Investigator and Professor of Family Medicine and Psychiatry and Biobehavioral Sciences, and colleagues at UCLA who are established clinical research investigators in the treatment of drug addiction.
"We are excited to participate in a study of this nature, for this unmet medical need, in partnership with NIDA and UCLA," said Yuichi Iwaki, M.D. Ph.D., MediciNova's Chief Executive Officer. "The initiation of this trial represents a model of translational medicine and institutional collaboration," added Kirk Johnson, Ph.D, MediciNova's Chief Scientific Officer. Consideration by NIDA of ibudilast for certain drug addiction syndromes began a few years ago founded upon its unique glial cell-attenuating mode of action, supportive pre-clinical data, and ibudilast's clinical profile. Ibudilast has been used in asthma and post-stroke disorders in Japan for nearly 20 yrs and has also been utilized at higher doses with encouraging outcomes in company-sponsored clinical trials in multiple sclerosis and neuropathic pain. Collaborative planning between the organizations led to NIDA support of both pre-clinical and clinical investigations: a clinical trial for opioid withdrawal with addiction experts at Columbia University-New York State Psychiatric Institute that is nearly completed and pre-clinical studies testing ibudilast's use in methamphetamine addiction with Dr. Patrick Beardsley at the Medicial College of Virginia. The animal pharmacology studies, wherein ibudilast demonstrated efficacy in reducing methamphetamine relapse, were published in June in the European Journal of Pharmacology.
The UCLA Phase Ib clinical study will involve 12 methamphetamine-dependent volunteers admitted into a hospital unit for approximately two-week phases wherein they receive low or high dosage-strength oral capsules (AV411), or placebo control, and are not allowed methamphetamine except for controlled periods wherein saline or methamphetamine are infused in a blinded fashion. Each subject will cross-over onto each oral treatment option (placebo or low- or high-dose). Primary study outcomes are safety and tolerability with secondary endpoints including the monitoring of drug levels in the blood and assessment of craving or other psychological symptoms.
Methamphetamine abuse is a significant public health concern. Dr. Shoptaw notes that "there is an urgent need for discovery of new medications for this terrible medical disorder in order to reduce suffering and improve the health of our communities." Worldwide prevalence of use of amphetamine-type stimulants, including methamphetamine (MA), is estimated to be greater than that for opioid use and cocaine use combined (UNODC, 2010). While overall methamphetamine use in the U.S. has dropped in the last couple years, it remains a significant issue particularly in the Western states. In Los Angeles, methamphetamine remains a leading primary drug of abuse mentioned at entry to publicly funded treatment centers accounting for nearly 20% of admissions in 2009 (LA County Participant Reporting System).
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of serious diseases with a commercial 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, chronic obstructive pulmonary disease exacerbations, multiple sclerosis and other neurologic conditions, 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 on its two prioritized product candidates, MN-221 for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations and Ibudilast (MN-166/AV411) for the treatment of multiple sclerosis, chronic pain, spinal cord injury, or drug addiction. Each drug candidate is involved in clinical trials under U.S. and Investigator INDs and MediciNova is engaged in strategic partnering discussions to support further development of the MN-221 and Ibudilast programs. Additionally, MediciNova will seek to monetize its other pipeline candidates. For more information on MediciNova, Inc., please visit www.medicinova.com.
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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," "will," "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, MediciNova's ability to realize the anticipated strategic and financial benefits from its acquisition of Avigen, Inc., to integrate the two ibudilast development programs and to pursue discussions with potential partners to secure a strategic collaboration to advance the clinical development of the combined development program, 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, 2009 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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SOURCE: MediciNova, Inc.
CONTACT: MediciNova, Inc.
Shintaro Asako, Chief Financial Officer