UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 12, 2009
MEDICINOVA, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-33185 | 33-0927979 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
4350 La Jolla Village Drive, Suite 950
San Diego, CA 92122
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (858) 373-1500
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01 | Regulation FD Disclosure. |
Representatives of MediciNova, Inc. (the “Registrant”) will be attending the 27th Annual JPMorgan Healthcare Conference commencing January 12, 2009. A copy of the slide presentation to be used by the Registrant at investor meetings during this conference is attached hereto as Exhibit 99.1 to this Current Report.
The information in this Current Report, including Exhibit 99.1 furnished herewith, is being furnished and shall not be deemed “filed” for any purpose, including for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing to this Current Report.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit |
Description | |
| 99.1 | Slide presentation of the Registrant | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MEDICINOVA, INC. | ||||||||
| Dated: January 12, 2009 | By: | /s/ Shintaro Asako | ||||||
| Shintaro Asako Vice President and Chief Financial Officer | ||||||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Slide presentation of the Registrant | |
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MediciNova, Inc. 2009 Accelerating the global development and commercialization of innovative pharmaceuticals Exhibit 99.1 |
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MediciNova, Inc. 2009 Statements in this presentation 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 clinical trials and product
development, strategies, future performance, 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. Actual results or events may differ materially from those expressed or implied in any forward-looking statements due to various factors, including, without
limitation, 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 MediciNova’s annual report on Form 10-K for the year ended December 31, 2007 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. Forward-Looking Statements Forward-Looking Statements |
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MediciNova, Inc. 2009 3 Development Company Focused on Differentiated Product Candidates • Unique access to differentiated, potentially high-value assets primarily from Japanese alliances New Approaches to Treat Serious Medical Conditions: • MN-221: IV Acute Exacerbations of Asthma candidate • Potential $500 M US opportunity for MediciNova • MN-166: Oral Multiple Sclerosis candidate • In 2007, over $8.2B in worldwide MS therapeutic sales* Corporate Overview: Corporate Overview: MediciNova, Inc. MediciNova, Inc. *Source: MedAdNews, July 2008 MNOV Headquarters: San Diego, CA Key Financials: • Dual listed company on NasdaqGM and Osaka Securities Exchange – Hercules • ~$19M Market Cap as of 12/31/08 • ~$47.5M Cash, Cash Equivalents and Marketable Securities as of 9/30/08
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MediciNova, Inc. 2009 4 In-License: • Product candidates with significant clinical or preclinical data Conduct Proof-of-Concept Clinical Trials: • Conduct Phase I and Phase II clinical trials to demonstrate
efficacy of compound Two Pathways Towards ROI After Phase II: 1. Continue internal development of compound towards commercialization 2. Seek partnership for further development of compound MediciNova has focused its resources on its two prioritized product candidates, MN-221 and MN-166. Following completion of the Phase II trial of MN-166, MediciNova will not pursue further significant clinical development of MN-166 until a partnership is
secured. In addition, MediciNova will pursue a variety of initiatives to monetize its remaining product candidates. Business Model:
Business
Model: Return On Investment Return On Investment |
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MediciNova, Inc. 2009 5 Definition: • Long-lasting and severe asthma episode that is not responsive to initial bronchodilator
or corticosteroid therapy Market Opportunity: • Approximately 2 million emergency room visits in the US each year* • 500,000 hospitalizations in the US • Approximately 4,000 deaths annually in the US* • Potential $500 M market opportunity for MediciNova Current Standard of Care (SOC): • Beta agonists (all patients) - Inhaled or nebulized • Corticosteroids (66-77% of patients) - IV or oral *Source: National Center for Health Statistics / CDC Acute Exacerbations of Asthma Acute Exacerbations of Asthma |
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MediciNova, Inc. 2009 6 MN-221: A novel, highly selective 2- adrenergic receptor agonist Three Potential Advantages over current therapy 1. Better delivery system (IV) = Better Bioavailability 2. Greater selectivity for 2 receptors in the lungs (better binding) 3. Partial agonist for 1 receptor in the heart MN-221: A New Approach to Treating MN-221: A New Approach to Treating Acute Exacerbations of Asthma Acute Exacerbations of Asthma |
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MediciNova, Inc. 2009 7 Human Human -Adrenergic Receptor -Adrenergic Receptor Selectivity Selectivity Test Drug 1 IC 50 (M) 2 IC 50 (M) 2 -Adrenoceptor Selectivity (IC 50 for 1 / IC 50 for 2 ) Levalbuterol 7.40E-06 1.40E-06 5.3 Albuterol 9.40E-06 1.60E-06 5.9 Terbutaline 6.00E-05 6.50E-06 9.2 MN-221 5.90E-06 1.40E-07 42.4 |
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MediciNova, Inc. 2009 Effect on Heart
rate: Effect on Heart
rate: Combination of MN-221 & Albuterol Combination of MN-221 & Albuterol in Dogs in Dogs 8 |
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MediciNova, Inc. 2009 9 MN-221-CL-004 Study Design • Randomized, placebo-controlled, double- blind, dose escalation • 23 subjects with mild-to-moderate stable asthma (FEV 1 60% predicted) • Doses tested (all for 15 minutes): • 0.35 µg
/min • 1.0 µg
/min • 3.5 µg
/min • 10 µg
/min MN-221: Positive Phase IIa MN-221: Positive Phase IIa Data Data MN-221-CL-005 Study Design • Randomized, single-blind, placebo-controlled, dose rate escalation • 17 subjects with moderate-to-severe stable asthma (40% FEV 1 75% predicted) • Two doses tested: • 16 µg/min for 15 minutes followed by 8 µg/min for 105 minutes (2-hour infusion with toal dose of 1,080 µg) or placebo • 30 µg/min for 15 minutes followed by 15 µg/min for 45 minutes (1-hour infusion with a
total dose of 1,125 µg) or placebo MN-221-CL-004 and MN-221-CL-005 Safety Data: No clinically significant cardiovascular, ECG or vital sign changes, or other safety
concerns observed at any dose tested • 16 µg/min • 30 µg/min • 60 µg/min |
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MediciNova, Inc. 2009 Mean Change in FEV Mean Change in FEV 1 1 Study: MN-221-CL-004 Study: MN-221-CL-004 10 Mean Baseline: 77.83% 77.67% 76.78% 81.60% 74.66% 75.78% 78.07% 79.78% At 15 Minutes: 77.54% 79.45% 80.06% 85.74% 82.02% 83.90% 89.65% 88.04% % Predicted: -0.29% 1.78% 3.28% 4.14% 7.36% 8.12% 11.58% 8.26% P = 0.0106 P = 0.0006 P < 0.0001 P < 0.0001 P < 0.0001 P = 0.11 P = 0.07 Placebo 0.35µg/min 1.0
µg/min 3.5µg/min 10µg/min 16µg/min 30µg/min 60µg/min |
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MediciNova, Inc. 2009 Mean Change in FEV Mean Change in FEV 1 1 Study: MN-221-CL-005 Study: MN-221-CL-005 11 Mean Baseline: 69.4% Mean Baseline: 64.6% Mean: 81.5% Mean: 82.0% Placebo Mean Baseline: 68.6% |
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MediciNova, Inc. 2009 Phase II Interim
Data Phase II Interim
Data Study: MN-221-CL-006 Study: MN-221-CL-006 12 • These reviews included data from a total of 18 of 36 planned patients with severe, acute exacerbations of asthma treated in emergency departments. • Decrease in the hospitalization rate from 50% to 10% with the addition of MN-221 (in10 subjects) to standardized care (in 8 subjects) • Improvement in FEV 1 values generally appeared to be greater for patients receiving MN-221 in addition to standardized treatment • No safety concerns with adding MN-221 to standardized care were identified in these reviews |
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MediciNova, Inc. 2009 MN-221-CL-007: A randomized, double-blind, placebo-controlled Phase II clinical trial designed
to evaluate the safety and efficacy of MN-221 in patients with severe, acute
exacerbations of asthma • Approximately 35 clinical sites in North America, Australia and New Zealand • Enroll approximately 200 patients • Enrollment anticipated to begin in March 2009 for North American clinical sites (enrollment expected to complete after nine to twelve months) • Doses: 1.2mg of MN-221 over one hour + Standardized Care Placebo + Standardized Care • Primary efficacy endpoint will be improvement in FEV 1 (% predicted) at 5 hours MN-221: Next Steps MN-221: Next Steps 13 |
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MediciNova, Inc. 2009 14 MN-221 Development Plan MN-221 Development Plan Note: Development plans / timelines for MN-221 are subject to change *Anticipated commencement and completion dates based on current projections If we are successful in completing the double-blind Phase IIb clinical trial, we plan to conduct a Phase III program. If we are successful in completing the Phase III program, we would then plan to file an NDA with the FDA to seek regulatory approval for MN-221. |
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MediciNova, Inc. 2009 15 Definition: Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system (CNS), affecting approximately 500,000 people in the United States and 2 million
people worldwide. There is no cure for the disease. Multiple Sclerosis Market: Over $8.2 B worldwide sales in 2007* Current Standard of Care: • Beta interferons (Rebif, Avonex, Betaserone), Copaxone ® , Tysabri ® • Administered either by intramuscular or subcutaneous injection or infusion Multiple Sclerosis Multiple Sclerosis *Source: MedAdNews, July 2008 |
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MediciNova, Inc. 2009 16 MN-166: • Anti-inflammatory and neuroprotective properties in vitro and in vivo • Demonstrated effects on brain volume and lesion evolution to axonal damage • Targets primarily chronic aspects of multiple sclerosis • Oral administration Mechanisms of Action: Stimulates Neurotrophic Growth Factor Release Inhibits nitric oxide and reactive oxygen species production Inhibits Th1 cytokine production (IFN- , TNF- , IL-1 , IL-6) Pilot studies found reduced relapse rate and Th1 Th2 cytokine shift Phosphodiesterase IV and Leukotriene inhibitor MN-166: A New Approach to MN-166: A New Approach to Treating Multiple Sclerosis Treating Multiple Sclerosis |
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MediciNova, Inc. 2009 Placebo-controlled, randomized, double-blind Phase II study: • Year 1 - 0, 10 mg tid, 20 mg tid • Year 2 - 10 mg tid, 20 mg tid • n ~ 100 MS patients/group @ 25 sites in Serbia, Ukraine, Belarus, Bulgaria and
Romania Key inclusion criteria: • Males or females aged 18 to 55 years, with relapsing remitting (RR) and/or secondary progressive (SP) Multiple Sclerosis with continued relapses; • A definite diagnosis of relapsing MS using the new International Committee recommendations (MacDonald Criteria); • One MRI scan taken two weeks prior to treatment start using a standardized MRI protocol with at least one Gd-enhancing lesion; • An EDSS score of 5.5 or less at the screening and baseline visits. Current Clinical Studies: Current Clinical Studies: MN-166-CL-001 MN-166-CL-001 17 |
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MediciNova, Inc. 2009 MN-166 Effects Outcomes Related to Disease Progression in RRMS Patients Clinical and MRI Outcomes: Indicative of Potential Neuroprotective Effect: 1. Reduced Brain Volume Loss 2. Reduced Conversion of Acute Lesions to Persistent Black Holes 3. Sustained disability progression was significantly less likely (~50%)
Acute Clinical Benefit: • Prolong time to relapse (by 127 days.) MN-166 was very well tolerated in Phase II study: 89% (264 of 297) of subjects completed the first 12 months of the study 82.5% (245 of 297) of subjects completed the full 24 months of the study GI adverse effects as a group and depression were the only adverse events to occur
more frequently in MN-166-treated than in placebo-treated subjects
18 P-Value: 0.044 P-Value: 0.030 MN-166 Targets Primarily MN-166 Targets Primarily Chronic Aspects of MS Chronic Aspects of MS P-Value: 0.026 P-Value: 0.011 |
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MediciNova, Inc. 2009 N=71
1.59 Chronic Efficacy
Demonstrated: Chronic Efficacy Demonstrated: Effects on Brain Volume Effects on Brain Volume N=70
1.79 N=34
2.08 N=45
2.12 Percent Brain Volume Reduction Percent Brain Volume Reduction (0 - 24 months) Brain volume loss was significantly less (p=0.030) in patients receiving 60 mg per day of MN-166 for 24 months compared to the other treatment groups 19 |
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MediciNova, Inc. 2009 Parameter Treatment Groups Placebo 30 mg/day 60 mg/day Number Patients w. New Lesions at Month 2 72 64 56 Total Number New Lesions in all Patients 426 338 315 Total Number of Persistent Black Holes 98 58 47 Proportion of Lesions Evolving to PBH 0.23 0.17 0.14 p Value - 0.036 0.004 New T1 gadolinium-enhancing or new T2 lesions were defined as NL in the first
on-study MRI at month 2 Lesions that were hypointense and inactive at month 10 were PBH Relative Risk (RR) of NL evolution to PBH was analyzed using a general linear model with the error term from the Poisson distribution Reduction of Persistent Black Hole Reduction of Persistent Black Hole (PBH) Formation (PBH) Formation 20 |
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MediciNova, Inc. 2009 TREATMENT Time Period Placebo to Active (N=100) Active Drug [30 mg (N=94), 60 mg (N=98)] 2 Years 21/100 (21%) 20/194 (10.4%) 21 Disability Progression is defined as a sustained increase in EDSS (increase in EDSS 1 maintained for four consecutive months) Sustained Disability Progression Sustained Disability Progression P-Value: 0.026 21 |
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MediciNova, Inc. 2009 22 Acute Efficacy Demonstrated: Acute Efficacy Demonstrated: Time to First Relapse Time to First Relapse Median 401 days Median 244 days P-Value: 0.044 |
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MediciNova, Inc. 2009 23 MN-166: NEXT STEPS MN-166: NEXT STEPS Seek Partnership for Further Development: MediciNova’s strategic objective for MN-166 is to secure a partner to advance the clinical development of MN-166, and MediciNova is actively pursuing that objective |
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MediciNova, Inc. 2009 24 Commercially-Attractive Commercially-Attractive Diversified Portfolio Diversified Portfolio |
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MediciNova, Inc. 2009 25 Dual Listing: • MNOV (NasdaqGM), December 2006 • 4875 (Osaka – Hercules), February 2005 Cash, Cash Equivalents and Marketable Securities as of 6/30/08 : ~$47.5 M as of 9/30/08 Market cap as of 12/31/08: ~$19M Shares outstanding: 11.9 M Key Financials Key Financials |
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MediciNova, Inc. 2009 26 Leadership Years Experience Background Yuichi Iwaki, MD, PhD CEO & President 33 Prof. USC, Formerly Prof. Pitt; Advisor to JAFCO, Tanabe Richard Gammans, PhD, MBA Chief Development Officer 31 Incara, Indevus, BMS Shintaro Asako, CPA Chief Financial Officer 10 KPMG USA (Audit), Arthur Andersen USA Michael Kalafer, MD Chief Medical Officer 25 Board Certified in Pulmonary Medicine, Critical Care Medicine and Internal Medicine. Associate Clinical Professorship of Medicine at UCSD School of Medicine since 1985 Masatsune Okajima, CMA VP, Head of Japanese Office 17 Daiwa Securities SMBC, Sumitomo Capital Securities, Sumitomo Bank Management Team with Global Management Team with Global Experience Experience |
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MediciNova, Inc. 2009 27 MN-221 (Acute Exacerbations of Asthma): • Proven mechanism of action • Highly selective with improved safety profile vs. standard of care • Positive Phase IIa efficacy data • Phase IIb study initiated by holding an Investigator’s meeting in January 2009 MN-166 (Multiple Sclerosis): • Both chronic and acute efficacy have been demonstrated in clinical studies completed
to date • MediciNova seeking a partner to advance the clinical development of MN-166 Minimized Burn Rate: • Annual burn rate reduced compared to previous years as a result of focus on MN-166
and MN-221 development programs • ~$47.5M Cash, Cash Equivalents and Marketable Securities as of 9/30/08 Investment Highlights Investment Highlights |
 Addendum:
Addendum: Additional Data |
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MediciNova, Inc. 2009 MN-221-Study 6 Design MN-221-Study 6 Design • Randomized, modified single-blind, dose escalation, placebo-controlled
Phase II Study in acute asthma patients in EDs • Approx. 36 patients in 3 dose cohorts at 8 ED clinical sites • Doses: 16µg/min x15 (240µg) 30µg/min x15 (450µg) 16µg/min x15;8µg/min x105 (1,080µg) • Patients will receive Standard of Care (SOC) treatment in addition to adjunctive treatment with MN-221 or placebo • Safety and efficacy (FEV1 and other) data will be summarized • No inferential statistical analysis • Help inform design of future, larger Phase III clinical trials A.1 |
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MediciNova, Inc. 2009 MN-221: Safety MN-221: Safety Phase IIa Study Safety Findings: • No clinically significant cardiovascular, ECG, or vital sign changes, or other safety
concerns, observed at doses up to 30 micrograms/minute for 15 minutes or any
time point thereafter • 60 micrograms/minute infusion improved FEV1 significantly (p< 0.0001) without
clinically significant cardiovascular, ECG or vital sign changes Safety Database: • MN-221 has been tested in over 300 subjects in the US and Europe to date • Subjects have had infusions with no clinically significant adverse events at: • 16 micrograms/minute for up to 4 hours and at lower doses for up to 24 hours A.2 |
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MediciNova, Inc. 2009 31 Description Efficacy (relapse rate) Current agents offer only 30-50% relapse reduction Neutralizing antibodies can diminish efficacy over time Progression (RRMS) –neurodegeneration leads to permanent functional disability No approved treatment for PPMS, SPMS AEs—including flu-like symptoms SAEs –Rare, fatal PML and heptotoxicity with Tysabri Reports of significant FTY side effects (e.g. hepatotoxicity), serious or fatal opportunistic infections, skin cancer Safety/ tolerability Injections – daily up to weekly Infusions -- monthly Administration Increasing interest in combination therapies given incomplete efficacy with current “core” agents Black box on combination with Tysabri, REMS program Combination Historically, anti-inflammatory agents have shown little impact on disease progression Demonstrated neuroprotection, that is, reduction in disease progression, would be groundbreaking Neuroprotection There are substantial unmet There are substantial unmet needs in MS needs in MS A.3 |
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MediciNova, Inc. 2009 Approx. Sales 2007** Compound Sponsor Side Effects $3.3 Billion Copaxone® Teva & Sanofi-Aventis Pain, redness, swelling, itching, chest pain, weakness, infection, nausea, anxiety are most common, also heart palpitations and trouble breathing after injection $1.9 Billion Avonex® Biogen-Idec Depression and Flu-like symptoms most common, also liver injury, severe allergic reactions, drop in red/white blood cell count $1.7 Billion Rebif® Serono & Pfizer Depression and Flu-like symptoms most common, also liver problems, injection site problems, severe allergic reactions, trouble breathing/loss of consciousness $1.4 Billion Betaseron® Bayer Lymphopenia, injection site reaction, asthenia, flu-like symptoms are most common, also necrosis at injection site $343 Million Tysabri® Biogen-Idec Infections, depression, pneumonia, acute hypersensitivity reactions, appendicitis most common, also liver damage, PML Multiple Sclerosis Market* Multiple Sclerosis Market* *All these top selling drugs for MS are immunomodulators **Source: MedAdNews, July 2008 and BIIB annual report 2007 A.4 |
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MediciNova, Inc. 2009 Brain volume changes are linked to axonal loss Chronic Efficacy Demonstrated: Chronic Efficacy Demonstrated: Effects on Brain Volume Effects on Brain Volume 1.20 A.5 |
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MediciNova, Inc. 2009 Reduction of Persistent Black Hole (PBH) Formation Parameter Treatment Groups Placebo 30 mg/day 60 mg/day # Patients w. New Lesions at Month 2 72 64 56 # Patients w. 1 PBH (% of Pts. w. New Lesions) 41 (56.9%) 33 (51.6%) 28 (50%) Mean Proportion of Lesions Evolving to PBH 0.24 0.20 0.16 Median Proportion of Lesions Evolving to PBH 0.17 0.08 0.04 Relative Risk (for Evolution to PBH) vs. placebo - 0.74 0.63 p Value - 0.074 0.011 New T1 gadolinium-enhancing or new T2 lesions were defined as NL in the first
on-study MRI at month 2 Lesions that were hypointense and inactive at month 10 were PBH Relative Risk (RR) of NL evolution to PBH was analyzed using a general linear model with the error term from the Poisson distribution Reduction of Persistent Black Hole (PBH) Reduction of Persistent Black Hole (PBH) Formation, a Sign of Axonal Loss Formation, a Sign of Axonal Loss A.6 |
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MediciNova, Inc. 2009 •MN-166 was very well tolerated in Phase II study: 89% (264 of 297) of subjects completed the first 12 months of the study 82.5% (245 of 297) of subjects completed the full 24 months of the study •Discontinuation
due to adverse effects was infrequent (5.1% in 60 mg/day for 24 months, 2.1% in 30 mg/day for 24 months, 2.0% in placebo to 60 mg/day, 1.9% in placebo to 30
mg/day) •Adverse effects
were generally mild and self-limiting •GI adverse effects as a group and
depression were the only adverse events to occur more frequently in MN-166-treated than in placebo-treated subjects •Tolerance to the GI side effects
occurred rapidly (2-4 days) and tended to occur early in treatment whether MN-166 treatment was initiated in Year 1 or Year 2 •Mild-to-moderate depression
was reported in 8 subjects; depression is common in MS patients and was reported only towards the end of the study •No significant increase in adverse
laboratory or ECG findings was observed •20 serious adverse events were
reported; all were not or unlikely to be attributable to treatment •No deaths occurred in the study
MN-166 Overview-Safety MN-166 Overview-Safety A.7 |
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MediciNova, Inc. 2009 Compound Sponsor Current Phase Safety Profile from Phase II trials MN-166 MediciNova Phase II Mild, transient GI upset FTY 720 Novartis Phase III Blood pressure Heart rate Dyspnea Liver enzymes Lymphopenia Cladribine Merck Serono Phase III Fever Nausea, Vomiting Leucopenia BG-12 Biogen-Idec Phase III H/A, Nasopharyngitis GI disorders Liver enzymes Laquinimod Teva Phase III Liver enzymes Arthralgia Fibrinogen Hemoglobin Safety Comparison with Other Safety Comparison with Other Oral Agents Oral Agents A.8 |