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
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.
加利福尼亞州拉霍亞,2024年5月20日(GLOBE NEWSWIRE)——在納斯達克全球市場(納斯達克股票代碼:MNOV)和東京證券交易所標準市場(代碼編號:4875)上市的生物製藥公司MediciNova, Inc. 今天宣佈,它已收到美國專利商標局對一項涉及 MN-166(ibudilast)的待處理專利申請的許可通知)用於預防眼癌的轉移。
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.
該專利一旦頒發,預計將不早於2042年7月到期。允許的索賠涵蓋使用 MN-166(伊布地拉斯特)預防、改善或最大限度地減少眼癌的轉移。允許的索賠特別涵蓋使用 MN-166(ibudilast)預防、改善或最大限度地減少葡萄膜黑色素瘤的轉移。允許的索賠包括口服給藥、廣泛的劑量、一系列不同的給藥頻率和一系列不同的治療週期。
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. 首席醫學官、醫學博士、公共衛生碩士松田和子評論說:“我們的研究表明,在原位葡萄膜黑色素瘤轉移模型(1,2)中,MN-166(ibudilast)在預防癌症轉移方面的功效。MN-166(ibudilast)通過抑制巨噬細胞遷移抑制因子(MIF)(一種促炎細胞因子)來抑制外泌體細胞遷移活性,從而顯著阻礙葡萄膜黑色素瘤的遷移。此外,我們之前曾報道,MN-166(ibudilast)降低了腫瘤微環境中免疫抑制性髓系衍生抑制細胞(MDSC)的水平並增強了CD8 T細胞活性(3)。我們很高興這項新專利將提高 MN-166(伊布地拉斯特)在腫瘤學領域的潛在價值。”
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 公佈了在 CURE OM 全球科學會議上公佈的有關葡萄膜黑色素瘤中 MN-166(ibudilast)的新數據”
2: MedicinOVA 宣佈發佈有關在分子癌研究中預防葡萄膜黑色素瘤轉移的 MN-166(ibudilast)數據
3: MedicinoVA 宣佈在《免疫學前沿》上發表的有關膠質母細胞瘤(GBM)中 MN-166(ibudilast)的臨床前陽性結果
About MN-166 (ibudilast)
關於 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)是一種小分子化合物,可抑制4型磷酸二酯酶(PDE4)和炎性細胞因子,包括巨噬細胞遷移抑制因子(MIF)。它正處於治療神經退行性疾病(肌萎縮性側索硬化症)、進行性多發性硬化症(多發性硬化)和DCM(退行性宮頸脊髓病)等神經退行性疾病的後期臨床開發階段;同時也在開發膠質母細胞瘤、Long、COVID(化療誘發的周圍神經病變)和藥物使用障礙。此外,對有發生急性呼吸窘迫綜合徵(ARDS)風險的患者進行了 MN-166(伊布地拉斯特)評估。
About MediciNova
關於 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. 是一家臨床階段的生物製藥公司,正在開發針對炎症、纖維化和神經退行性疾病的新型小分子療法的廣泛後期產品線。MedicinOVA基於兩種化合物,即 MN-166(伊布地拉斯特)和 MN-001(tipelukast),具有多種作用機制和很強的安全性,有11個臨床開發項目。MedicinOVA的主要資產 MN-166(ibudilast)目前處於肌萎縮性側索硬化症(ALS)和退行性宮頸脊髓病(DCM)的第三階段,已爲進行性多發性硬化症(MS)的第三階段做好準備。MN-166(伊布地拉斯特)也在長期COVID和藥物依賴的2期試驗中接受評估。MN-001(tipelukast)在特發性肺纖維化(IPF)的2期試驗中進行了評估,第二項非酒精性脂肪肝病(NAFLD)的2期試驗正在進行中。MedicinOVA在確保由政府撥款資助的研究者贊助的臨床試驗方面有着良好的記錄。
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.
根據1995年《私人證券訴訟改革法》安全港條款的定義,本新聞稿中非歷史性質的陳述構成前瞻性陳述。這些前瞻性陳述包括但不限於有關 MN-166、MN-001、MN-221 和 MN-029 未來發展和功效的陳述。這些前瞻性陳述的開頭、後面可能是 “相信”、“期望”、“預期”、“打算”、“估計”、“項目”、“能”、“可能”、“可能”、“將”、“將”、“考慮”、“規劃” 或類似的表述。這些前瞻性陳述涉及許多風險和不確定性,可能導致實際結果或事件與此類前瞻性陳述所表達或暗示的結果或事件存在重大差異。可能導致實際結果或事件與這些前瞻性陳述所表達或暗示的結果或事件存在重大差異的因素包括但不限於爲開發 MN-166、MN-001、MN-221 和 MN-029 獲得未來合作伙伴或撥款的風險,以及在需要爲MediciNova的運營和臨床開發貢獻提供資金時籌集足夠資金的風險、臨床試驗固有的風險和不確定性,包括潛在成本、預期時機和與旨在滿足食品藥品管理局要求的臨床試驗相關的風險指導方針和考慮到這些因素的進一步開發的可行性、產品開發和商業化風險、臨床試驗結果能否預測產品開發後期階段結果的不確定性、延遲或未能獲得或維持監管部門批准的風險、與依賴第三方發起和資助臨床試驗相關的風險、候選產品的知識產權風險以及捍衛和執行此類知識產權的能力的風險、MediciNova賴以進行臨床試驗和生產候選產品的第三方未能達到預期的業績,由於臨床試驗的開始、註冊、完成或分析延遲或臨床試驗設計的充分性或臨床試驗執行方面的重大問題而導致成本增加和延誤的風險,以及預期向監管機構申報的時機,MedicinOVA與第三方的合作,完成產品開發的資金可用性計劃和MediciNova爲項目獲得第三方資金並在需要時籌集足夠資金的能力,以及MediciNova向美國證券交易委員會提交的文件中描述的其他風險和不確定性,包括其截至2023年12月31日的10-K表年度報告及其隨後的10-Q表定期報告和8-K表的最新報告。不應過分依賴這些前瞻性陳述,這些陳述僅代表截至本文發佈之日。MedicinOVA不承擔任何修改或更新這些前瞻性陳述的意圖或義務。
INVESTOR CONTACT:
投資者聯繫人:
David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com
大衛·克雷恩博士
首席商務官
MedicinOVA, Inc.
info@medicinova.com