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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

漫威宣布成功完成毒理学研究,为第一阶段人体试验做准备
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.

艾伯塔省卡尔加里--(Newsfile Corp.,2023年8月22日)- 漫威生物科学公司(多伦多证券交易所股票代码:MRVL)(OTCQB:MBCOF) 及其全资子公司漫威生物技术公司(统称为“公司“要么“奇迹“),很高兴地宣布,它已成功完成了为期4周的良好实验室规范(GLP)、美国食品药品管理局的研究性新药(IND)、其主要候选药物 MB-204 的剂量范围研究,为1期人体试验的开始铺平了道路。

"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总裁马克·威廉姆斯博士说:“我们很高兴地宣布,我们的GLP研究结果已经确定了与大鼠和狗研究中无不良事件水平(NOAEL)相关的剂量和暴露范围。”“这些研究的成功结果将使我们能够正式进入第一阶段人体试验和美国食品药品管理局的IND申请。我们现在正在为澳大利亚的1期研究做准备,并将很快报告试验的时间安排。”

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."

威廉姆斯博士继续说:“在我们最近的临床前研究的支持下,MB-204 特别令人兴奋的是,它已显示出在单剂给药后具有活性的潜力。这一点意义重大,因为与需要多种剂量来建立基线数据的典型候选药物相比,我们将能够以更快的速度收集有关候选药物安全性和有效性的宝贵数据。重要的是,由于这一发现,我们可以大幅缩短第一阶段的时间表,为更快地与战略合作伙伴接触提供机会。”

"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."

漫威首席执行官罗德·马西森说:“我们的药物再开发方法采用一种现有的获批药物,并对其进行合乎逻辑的修改,以开发出针对一种新疾病的药物,已接近实现。”“我们认为,MB-204 有可能成为治疗阿尔茨海默氏病、抑郁症,可能还有注意力缺陷多动障碍的同类首选治疗选择。”

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 是美国食品药品管理局批准的腺苷 A2a 受体拮抗剂 Istradefyline 的氟化衍生物。Istradefyline 和 MB-204 都是咖啡因的高活性衍生物,咖啡因是世界上消费最广泛的精神活性药物。摄入咖啡因与降低患帕金森氏病和阿尔茨海默氏病的风险以及提高注意力有关。

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.

关于漫威生物科学公司
Marvel Biosciences Corp. 及其全资子公司漫威生物技术公司是一家总部位于卡尔加里的临床前阶段药物开发生物技术公司,采用 “药物再开发” 方法进行药物开发。从历史上看,当开发出一类新药物时,它会针对特定靶点进行优化,但通常只批准用于特定疾病。通常,会发现一种涉及相同靶标的新疾病,但是,在剩余的专利有效期之前,最初批准的药物可能没有足够的时间来开发出针对新疾病适应症的商业可行性。Marvel 开发了用于新疾病适应症的原始批准药物的新合成化学衍生物。由于新的潜在资产是由公司开发的,因此正在寻求专利保护。该公司认为,与传统的生物技术公司相比,这种商业模式可以显著降低开发资产的风险、成本和时间。

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. 目前已开发出几种新的化学实体,使用已知的非专利药物的合成化学衍生物,抑制A2a腺苷受体,适用于神经系统疾病(抑郁和焦虑、阿尔茨海默氏症、注意力缺陷多动障碍)以及癌症和非酒精性脂肪性肝炎的非神经系统疾病。漫威还在探索其他未公开的目标,以扩大其资产渠道。

Contact Information

联系信息

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

投资者关系:
Virtus 咨询小组
电话:416-646-6779
电子邮件: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

漫威生物科学公司
J. Roderick (Rod) Matheson,首席执行官或
总裁兼首席科学官马克·威廉姆斯博士
电话: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.

多伦多证券交易所风险交易所及其监管服务提供商(该术语在多伦多证券交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。

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.

本新闻稿中包含的与公司及其子公司(统称为 “双方”)有关的所有信息分别由Marvel提供,以供纳入此处,双方的董事和高级管理人员相互依赖,获取有关该方的任何信息。

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.

本新闻稿可能包含前瞻性陈述和其他非历史事实的陈述。前瞻性陈述通常由 “意愿”、“可能”、“应该”、“预期”、“期望” 等术语和类似表达方式来识别。除历史事实陈述外,本新闻稿中包含的所有陈述,包括但不限于有关公司未来计划和目标的陈述,均为涉及风险和不确定性的前瞻性陈述。无法保证此类陈述会被证明是准确的,实际结果和未来事件可能与此类陈述中的预期存在重大差异。可能导致实际业绩与公司预期存在重大差异的重要因素,包括公司根据证券监管提交的文件中不时详述的其他风险。

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.

提醒读者,在准备任何前瞻性信息时使用的假设可能被证明是不正确的。由于许多已知和未知的风险、不确定性和其他因素,事件或情况可能导致实际业绩与预测存在重大差异,其中许多因素是公司无法控制的。因此,本公司无法保证本条款中的上述事件将在本协议披露的时间内发生或根本无法保证。提醒读者不要过分依赖任何前瞻性信息。尽管管理层在编写时认为此类信息是合理的,但可能被证明是不正确的,实际结果可能与预期的结果存在重大差异。本警示声明明确限制了本新闻稿中包含的前瞻性陈述。本新闻稿中包含的前瞻性陈述自本新闻稿发布之日起作出,公司将根据加拿大证券法的明确要求公开更新或修改所包含的任何前瞻性陈述。

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要查看本新闻稿的源版本,请访问

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