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Marvel Announces Successful Completion of Toxicology Study in Preparation for Phase 1 Human Trials

Marvel Announces Successful Completion of Toxicology Study in Preparation for Phase 1 Human Trials

漫威宣佈成功完成毒理學研究,爲第一階段人體試驗做準備
newsfile ·  2023/08/22 09:00

Calgary, Alberta--(Newsfile Corp. - August 22, 2023) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), is pleased to announce that it has successfully completed its 4-week good laboratory practice (GLP), FDA investigational new drug (IND), dose-ranging dog and rat studies for its lead drug candidate MB-204 paving the way for Phase 1 human trials to begin.

艾伯塔省卡爾加里--(Newsfile Corp.,2023年8月22日)- 漫威生物科學公司(多倫多證券交易所股票代碼:MRVL)(OTCQB:MBCOF) 及其全資子公司漫威生物技術公司(統稱爲“公司“要麼“奇蹟“),很高興地宣佈,它已成功完成了爲期4周的良好實驗室規範(GLP)、美國食品藥品管理局的研究性新藥(IND)、其主要候選藥物 MB-204 的劑量範圍研究,爲1期人體試驗的開始鋪平了道路。

"We are very pleased to announce that the findings from our GLP studies have established the dosing and exposure ranges associated with No Adverse Event Levels (NOAEL's) in both the rat and dog studies," said Dr. Mark Williams, President of Marvel Biosciences. "The successful results of these studies will officially enable us to advance into Phase 1 human trials and an FDA IND submission. We are now preparing for a Phase 1 study in Australia and will report on the timing of the trial shortly."

Marvel Biosciences總裁馬克·威廉姆斯博士說:“我們很高興地宣佈,我們的GLP研究結果已經確定了與大鼠和狗研究中無不良事件水平(NOAEL)相關的劑量和暴露範圍。”“這些研究的成功結果將使我們能夠正式進入第一階段人體試驗和美國食品藥品管理局的IND申請。我們現在正在爲澳大利亞的1期研究做準備,並將很快報告試驗的時間安排。”

Dr. Williams continued, "What is particularly exciting about MB-204, supported by our recent pre-clinical work, is that it has shown the potential to be active after a single administered dose. This is significant, as we would be able to harvest valuable data about the safety and efficacy of our drug candidate at a much faster rate relative to typical drug candidates requiring multiple dosages to establish baseline data. Importantly, as a result of this discovery, we could be in a position to materially shorten the Phase 1 timeline providing an opening to engage with strategic partners sooner."

威廉姆斯博士繼續說:“在我們最近的臨床前研究的支持下,MB-204 特別令人興奮的是,它已顯示出在單劑給藥後具有活性的潛力。這一點意義重大,因爲與需要多種劑量來建立基線數據的典型候選藥物相比,我們將能夠以更快的速度收集有關候選藥物安全性和有效性的寶貴數據。重要的是,由於這一發現,我們可以大幅縮短第一階段的時間表,爲更快地與戰略合作伙伴接觸提供機會。”

"Our drug re-development approach, which takes an existing approved drug, and makes the logical modifications to develop it for a new disease is nearing its fruition," said Rod Matheson, Chief executive officer of Marvel. "We believe MB-204 has the potential to be a first-in-class treatment option for Alzheimer's disease, depression, and possibly ADHD."

漫威首席執行官羅德·馬西森說:“我們的藥物再開發方法採用一種現有的獲批藥物,並對其進行合乎邏輯的修改,以開發出針對一種新疾病的藥物,已接近實現。”“我們認爲,MB-204 有可能成爲治療阿爾茨海默氏病、抑鬱症,可能還有注意力缺陷多動障礙的同類首選治療選擇。”

MB-204 is a fluorinated derivative of the U.S. FDA-approved adenosine A2a receptor antagonist, Istradefylline. Both Istradefylline and MB-204 are highly active derivatives of caffeine, the most widely consumed psychoactive drug in the world. Caffeine consumption has been associated with a reduced risk of developing Parkinson's disease, and Alzheimer's disease and improved concentration.

MB-204 是美國食品藥品管理局批准的腺苷 A2a 受體拮抗劑 Istradefyline 的氟化衍生物。Istradefyline 和 MB-204 都是咖啡因的高活性衍生物,咖啡因是世界上消費最廣泛的精神活性藥物。攝入咖啡因與降低患帕金森氏病和阿爾茨海默氏病的風險以及提高注意力有關。

About Marvel Biosciences Corp.
Marvel Biosciences Corp., and its wholly owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based pre-clinical stage pharmaceutical development biotechnology company that utilizes a "drug redevelopment" approach to drug development. Historically, when a new class of drug is developed, it is optimized for a particular target, but typically only approved for a specific disease. Often, a new disease is identified which involves the same target, however, pending the remaining patent life, the originally approved drug may not have sufficient time left for it to be commercially viable to be developed for the new disease indication. Marvel develops new synthetic chemical derivatives of the original approved drug for the new disease indication. Patent protection is sought, as the new potential asset is developed by the Company. The Company believes the business model results in significantly less risk, cost and time to develop its assets compared to traditional biotechnology companies.

關於漫威生物科學公司
Marvel Biosciences Corp. 及其全資子公司漫威生物技術公司是一家總部位於卡爾加里的臨床前階段藥物開發生物技術公司,採用 “藥物再開發” 方法進行藥物開發。從歷史上看,當開發出一類新藥物時,它會針對特定靶點進行優化,但通常只批准用於特定疾病。通常,會發現一種涉及相同靶標的新疾病,但是,在剩餘的專利有效期之前,最初批准的藥物可能沒有足夠的時間來開發出針對新疾病適應症的商業可行性。Marvel 開發了用於新疾病適應症的原始批准藥物的新合成化學衍生物。由於新的潛在資產是由公司開發的,因此正在尋求專利保護。該公司認爲,與傳統的生物技術公司相比,這種商業模式可以顯著降低開發資產的風險、成本和時間。

Marvel Biotechnology Inc. has currently developed several new chemical entities, using synthetic chemical derivatives of known, off-patent drugs, that inhibit the A2a adenosine receptor with application to neurological diseases (depression & anxiety, Alzheimer's, ADHD), and the non-neurological conditions of cancer and non-alcoholic steatohepatitis. Marvel is also exploring additional undisclosed targets to expand its asset pipeline.

Marvel Biotechnology Inc. 目前已開發出幾種新的化學實體,使用已知的非專利藥物的合成化學衍生物,抑制A2a腺苷受體,適用於神經系統疾病(抑鬱和焦慮、阿爾茨海默氏症、注意力缺陷多動障礙)以及癌症和非酒精性脂肪性肝炎的非神經系統疾病。漫威還在探索其他未公開的目標,以擴大其資產渠道。

Contact Information

聯繫信息

Investor Relations:
Virtus Advisory Group
Tel: 416-646-6779
Email: info@virtusadvisory.com

投資者關係:
Virtus 諮詢小組
電話:416-646-6779
電子郵件:info@virtusadvisory.com

Marvel Biosciences Corp.
J. Roderick (Rod) Matheson, Chief Executive Officer or
Dr. Mark Williams, President and Chief Science Officer
Tel: 403 770 2469

漫威生物科學公司
J. Roderick (Rod) Matheson,首席執行官或
總裁兼首席科學官馬克·威廉姆斯博士
電話:403 770 2469

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.

多倫多證券交易所風險交易所及其監管服務提供商(該術語在多倫多證券交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。

All information contained in this news release with respect to the Company and its subsidiary, (collectively, the "Parties") were supplied by Marvel, respectively, for inclusion herein and each parties' directors and officers have relied on each other for any information concerning such Party.

本新聞稿中包含的與公司及其子公司(統稱爲 “雙方”)有關的所有信息分別由Marvel提供,以供納入此處,雙方的董事和高級管理人員相互依賴,獲取有關該方的任何信息。

This news release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of the Company are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the expectations of the Company and include other risks detailed from time to time in the filings made by the Company under securities regulations.

本新聞稿可能包含前瞻性陳述和其他非歷史事實的陳述。前瞻性陳述通常由 “意願”、“可能”、“應該”、“預期”、“期望” 等術語和類似表達方式來識別。除歷史事實陳述外,本新聞稿中包含的所有陳述,包括但不限於有關公司未來計劃和目標的陳述,均爲涉及風險和不確定性的前瞻性陳述。無法保證此類陳述會被證明是準確的,實際結果和未來事件可能與此類陳述中的預期存在重大差異。可能導致實際業績與公司預期存在重大差異的重要因素,包括公司根據證券監管提交的文件中不時詳述的其他風險。

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. As a result, the Company cannot guarantee that the above events on the terms will occur and within the time disclosed herein or at all. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by Canadian securities law.

提醒讀者,在準備任何前瞻性信息時使用的假設可能被證明是不正確的。由於許多已知和未知的風險、不確定性和其他因素,事件或情況可能導致實際業績與預測存在重大差異,其中許多因素是公司無法控制的。因此,本公司無法保證本條款中的上述事件將在本協議披露的時間內發生或根本無法保證。提醒讀者不要過分依賴任何前瞻性信息。儘管管理層在編寫時認爲此類信息是合理的,但可能被證明是不正確的,實際結果可能與預期的結果存在重大差異。本警示聲明明確限制了本新聞稿中包含的前瞻性陳述。本新聞稿中包含的前瞻性陳述自本新聞稿發佈之日起作出,公司將根據加拿大證券法的明確要求公開更新或修改所包含的任何前瞻性陳述。

To view the source version of this press release, please visit

要查看本新聞稿的源版本,請訪問

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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