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Marvel Successfully Completes the Dog and Rat GLP Toxicology Studies Required to Enter Human Trials

Marvel Successfully Completes the Dog and Rat GLP Toxicology Studies Required to Enter Human Trials

Marvel 成功完成了进入人体试验所需的狗和老鼠 GLP 毒理学研究
newsfile ·  2023/04/20 09:06

Calgary, Alberta--(Newsfile Corp. - April 20, 2023) - Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), is pleased to announce that it has completed the dosing portion of the 4-week good laboratory practice (GLP) FDA investigational new drug (IND) enabling dose-ranging dog and rat studies for its lead drug candidate MB-204.

艾伯塔省卡尔加里--(Newsfile Corp.——2023年4月20日)- 漫威生物科学公司(TSXV:MRVL) 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,它已经完成了为期4周的良好实验室规范(GLP)的剂量部分,美国食品药品管理局的研究新药(IND)允许对其主要候选药物 MB-204 进行剂量范围的狗和老鼠研究。

"We are pleased to report we have now completed treating both rats and dogs with multiple doses of MB-204 for this pivotal study and we have now entered the 4 week recovery period before we begin harvesting results from this study," said Dr. Mark Williams, Chief Science Officer of Marvel Biosciences. "We expect full data from this study to be ready within three months following the completion of the recovery period, which if positive, will allow us to initiate our Phase 1 human trials."

漫威生物科学首席科学官马克·威廉姆斯博士说:“我们很高兴地报告,在这项关键研究中,我们现在已经完成了用多剂量 MB-204 对老鼠和狗的治疗,在开始收集这项研究的结果之前,我们已经进入了为期 4 周的恢复期。”“我们预计,这项研究的完整数据将在恢复期结束后的三个月内准备就绪,如果恢复期为阳性,将使我们能够启动第一阶段的人体试验。”

"We look forward to receiving the toxicological data for MB-204 as we continue preparing for human trials targeting the third quarter of this year," said Rod Matheson, CEO of Marvel Biosciences. "We believe the chemical changes we made to Istradefylline will enable our lead drug candidate MB-204 to retain the safety and efficacy that we have observed in Istradefylline, however MB-204 has already shown in a number of our studies to play an effective role in addressing symptoms associated with depression, in addition to targeting a receptor that has shown to play a pivotal role in Alzheimer's disease."

漫威生物科学首席执行官罗德·马西森表示:“我们期待收到 MB-204 的毒理学数据,因为我们将继续为针对今年第三季度的人体试验做准备。”“我们认为,我们对伊曲德林所做的化学改变将使我们的主要候选药物 MB-204 能够保持我们在伊曲德菲林中观察到的安全性和有效性,但是 MB-204 在我们的许多研究中已经表明,除了靶向一种在阿尔茨海默氏病中起着关键作用的受体外,在治疗抑郁症相关症状方面也起着有效作用。”

In the United States, it is estimated that one in ten senior citizens over the age of 65 suffer from dementia. MB-204 is a novel solution to Alzheimer's that has similar properties to the Food and Drug Administration-approved drug, Istradefylline. MB-204 has, through the Company's studies, proven to be more effective and longer lasting than Istradefylline in pre-clinical studies.

在美国,据估计,65岁以上的老年人中有十分之一患有痴呆症。MB-204 是一种治疗阿尔茨海默氏症的新型解决方案,其特性与美国食品药品监督管理局批准的药物依曲替林相似。通过该公司的研究,在临床前研究中,事实证明,MB-204 比依曲茶碱更有效,持续时间更长。

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。依曲茶碱和 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注意力的提高有关。

About Marvel Biosciences Corp.

关于漫威生物科学公司

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.

Marvel Biosciences Corp. 及其全资子公司Marvel Biotechnology Inc. 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,但通常仅获准用于特定疾病。通常,会发现一种涉及相同靶标的新疾病,但是,在剩余的专利寿命到期之前,最初批准的药物可能没有足够的时间为新的疾病适应症开发具有商业可行性。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,与传统生物技术公司相比,这种商业模式可以大大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 Biotechnologine 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,这些药物抑制A2a腺苷受体,应用于神经系统疾病(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等非神经系统疾病。漫威还在探索其他未公开的目标,以扩大其资产管道。

Contact Information

联系信息

Investor Relations:
Virtus Advisory Group
Tel: 416-646-6779

投资者关系:
Virtus 咨询小组
电话:416-646-6779

Email: info@virtusadvisory.com

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
马克·威廉姆斯博士,总裁兼首席科学官
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,供纳入本新闻稿中,双方的董事和高级管理人员相互依靠对方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。前瞻性陈述通常用 “意愿”、“可能”、“应该”、“预期”、“期望” 等术语和类似表达方式来识别。本新闻稿中除历史事实陈述以外的所有陈述,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,包括公司根据证券法规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都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,其中许多因素是公司无法控制的,事件或情况可能导致实际结果与预期结果存在重大差异。因此,公司无法保证上述条款中的事件将在本文披露的时间内发生,也无法保证根本不会发生。提醒读者不要过分依赖任何前瞻性信息。此类信息虽然在准备时被管理层认为是合理的,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。本警告声明明确限定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。

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

要查看本新闻稿的源版本,请访问

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