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MediciNova Receives Notice of Allowance For New Patent Covering MN-166 (Ibudilast) for the Prevention of Metastasis of Eye Cancer

MediciNova Receives Notice of Allowance For New Patent Covering MN-166 (Ibudilast) for the Prevention of Metastasis of Eye Cancer

MedicinOVA 收到批准新专利的通知,该专利涵盖用于预防眼癌转移的 MN-166(Ibudilast)
GlobeNewswire ·  05/20 06:00

LA JOLLA, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the prevention of metastasis of eye cancer.

加利福尼亚州拉霍亚,2024年5月20日(GLOBE NEWSWIRE)——在纳斯达克全球市场(纳斯达克股票代码:MNOV)和东京证券交易所标准市场(代码编号:4875)上市的生物制药公司MediciNova, Inc. 今天宣布,它已收到美国专利商标局对一项涉及 MN-166(ibudilast)的待处理专利申请的许可通知)用于预防眼癌的转移。

Once issued, this patent is expected to expire no earlier than July 2042. The allowed claims cover the use of MN-166 (ibudilast) for preventing, ameliorating, or minimizing metastasis of eye cancer. The allowed claims specifically cover the use of MN-166 (ibudilast) for preventing, ameliorating, or minimizing metastasis of uveal melanoma. The allowed claims cover oral administration, a wide range of doses, a range of different dosing frequencies, and a range of different treatment periods.

该专利一旦颁发,预计将不早于2042年7月到期。允许的索赔涵盖使用 MN-166(伊布地拉斯特)预防、改善或最大限度地减少眼癌的转移。允许的索赔特别涵盖使用 MN-166(ibudilast)预防、改善或最大限度地减少葡萄膜黑色素瘤的转移。允许的索赔包括口服给药、广泛的剂量、一系列不同的给药频率和一系列不同的治疗周期。

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "Our research efforts demonstrated the efficacy of MN-166 (ibudilast) in preventing cancer metastasis in an orthotopic uveal melanoma metastasis model (1,2). MN-166 (ibudilast) significantly impeded uveal melanoma migration through the inhibition of macrophage migration inhibitory factor (MIF), a proinflammatory cytokine, to suppress exosomal cell migration activity. Also, we previously reported that MN-166 (ibudilast) reduced levels of immune suppressive myeloid-derived suppressor cells (MDSCs) and enhanced CD8 T cell activity in the tumor microenvironment (3). We are gratified that this new patent will enhance potential value of MN-166 (ibudilast) in the oncology field."

MedicinOVA, Inc. 首席医学官、医学博士、公共卫生硕士松田和子评论说:“我们的研究表明,在原位葡萄膜黑色素瘤转移模型(1,2)中,MN-166(ibudilast)在预防癌症转移方面的功效。MN-166(ibudilast)通过抑制巨噬细胞迁移抑制因子(MIF)(一种促炎细胞因子)来抑制外泌体细胞迁移活性,从而显著阻碍葡萄膜黑色素瘤的迁移。此外,我们之前曾报道,MN-166(ibudilast)降低了肿瘤微环境中免疫抑制性髓系衍生抑制细胞(MDSC)的水平并增强了CD8 T细胞活性(3)。我们很高兴这项新专利将提高 MN-166(伊布地拉斯特)在肿瘤学领域的潜在价值。”

1: MediciNova Announces New Data regarding MN-166 (ibudilast) in Uveal Melanoma Presented at the CURE OM Global Science Meeting"

2: MediciNova Announces Publication of MN-166 (ibudilast) Data regarding Prevention of Metastasis in Uveal Melanoma in Molecular Cancer Research
3: MediciNova Announces Positive Preclinical Results Regarding MN-166 (ibudilast) in Glioblastoma (GBM) Published in Frontiers in Immunology

1: MedicinOVA 公布了在 CURE OM 全球科学会议上公布的有关葡萄膜黑色素瘤中 MN-166(ibudilast)的新数据”

2: MedicinOVA 宣布发布有关在分子癌研究中预防葡萄膜黑色素瘤转移的 MN-166(ibudilast)数据
3: MedicinoVA 宣布在《免疫学前沿》上发表的有关胶质母细胞瘤(GBM)中 MN-166(ibudilast)的临床前阳性结果

About MN-166 (ibudilast)

关于 MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

MN-166(ibudilast)是一种小分子化合物,可抑制4型磷酸二酯酶(PDE4)和炎性细胞因子,包括巨噬细胞迁移抑制因子(MIF)。它正处于治疗神经退行性疾病(肌萎缩性侧索硬化症)、进行性多发性硬化症(多发性硬化)和DCM(退行性宫颈脊髓病)等神经退行性疾病的后期临床开发阶段;同时也在开发胶质母细胞瘤、Long、COVID(化疗诱发的周围神经病变)和药物使用障碍。此外,对有发生急性呼吸窘迫综合征(ARDS)风险的患者进行了 MN-166(伊布地拉斯特)评估。

About MediciNova

关于 MedicinOVA

MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova's lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

MedicinOVA, Inc. 是一家临床阶段的生物制药公司,正在开发针对炎症、纤维化和神经退行性疾病的新型小分子疗法的广泛后期产品线。MedicinOVA基于两种化合物,即 MN-166(伊布地拉斯特)和 MN-001(tipelukast),具有多种作用机制和很强的安全性,有11个临床开发项目。MedicinOVA的主要资产 MN-166(ibudilast)目前处于肌萎缩性侧索硬化症(ALS)和退行性宫颈脊髓病(DCM)的第三阶段,已为进行性多发性硬化症(MS)的第三阶段做好准备。MN-166(伊布地拉斯特)也在长期COVID和药物依赖的2期试验中接受评估。MN-001(tipelukast)在特发性肺纤维化(IPF)的2期试验中进行了评估,第二项非酒精性脂肪肝病(NAFLD)的2期试验正在进行中。MedicinOVA在确保由政府拨款资助的研究者赞助的临床试验方面有着良好的记录。

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 the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. 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," "considering," "planning" 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, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, 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, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, 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 of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, 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, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 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.

根据1995年《私人证券诉讼改革法》安全港条款的定义,本新闻稿中非历史性质的陈述构成前瞻性陈述。这些前瞻性陈述包括但不限于有关 MN-166、MN-001、MN-221 和 MN-029 未来发展和功效的陈述。这些前瞻性陈述的开头、后面可能是 “相信”、“期望”、“预期”、“打算”、“估计”、“项目”、“能”、“可能”、“可能”、“将”、“将”、“考虑”、“规划” 或类似的表述。这些前瞻性陈述涉及许多风险和不确定性,可能导致实际结果或事件与此类前瞻性陈述所表达或暗示的结果或事件存在重大差异。可能导致实际结果或事件与这些前瞻性陈述所表达或暗示的结果或事件存在重大差异的因素包括但不限于为开发 MN-166、MN-001、MN-221 和 MN-029 获得未来合作伙伴或拨款的风险,以及在需要为MediciNova的运营和临床开发贡献提供资金时筹集足够资金的风险、临床试验固有的风险和不确定性,包括潜在成本、预期时机和与旨在满足食品药品管理局要求的临床试验相关的风险指导方针和考虑到这些因素的进一步开发的可行性、产品开发和商业化风险、临床试验结果能否预测产品开发后期阶段结果的不确定性、延迟或未能获得或维持监管部门批准的风险、与依赖第三方发起和资助临床试验相关的风险、候选产品的知识产权风险以及捍卫和执行此类知识产权的能力的风险、MediciNova赖以进行临床试验和生产候选产品的第三方未能达到预期的业绩,由于临床试验的开始、注册、完成或分析延迟或临床试验设计的充分性或临床试验执行方面的重大问题而导致成本增加和延误的风险,以及预期向监管机构申报的时机,MedicinOVA与第三方的合作,完成产品开发的资金可用性计划和MediciNova为项目获得第三方资金并在需要时筹集足够资金的能力,以及MediciNova向美国证券交易委员会提交的文件中描述的其他风险和不确定性,包括其截至2023年12月31日的10-K表年度报告及其随后的10-Q表定期报告和8-K表的最新报告。不应过分依赖这些前瞻性陈述,这些陈述仅代表截至本文发布之日。MedicinOVA不承担任何修改或更新这些前瞻性陈述的意图或义务。

INVESTOR CONTACT:

投资者联系人:

David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com

大卫·克雷恩博士
首席商务官
MedicinOVA, Inc.
info@medicinova.com


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