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Theralase(R) Successfully Completes Non-GLP Toxicity Analysis for Brain Cancer

Theralase(R) Successfully Completes Non-GLP Toxicity Analysis for Brain Cancer

Theralase (R) 成功完成腦癌的非GLP毒性分析
Accesswire ·  2023/09/27 19:00

TORONTO, ON / ACCESSWIRE / September 27, 2023 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF) is a clinical stage pharmaceutical company that is dedicated to the research and development of light and radiation activatedPhoto Dynamic Compounds ("PDCs"), their associated drug formulations and the light systems that activate them. These PDCs are intended to safely and effectively destroy various cancers, bacteria and viruses when light or radiation activated.

多倫多,2023年9月27日/ACCESSWIRETheralase Technologies Inc.(“Theralase“或”公司“)(TSXV:TLT)(OTCQB:TLTFF)是一家臨床階段的製藥公司,致力於光和輻射激活的光動態化合物的研究和開發。PDC“),它們的相關藥物配方和激活它們的光系統。這些PDCs旨在當光或輻射激活時安全有效地摧毀各種癌症、細菌和病毒。

Theralase announced that it has successfully completed its non-Good Laboratory Practices ("GLP") preclinical toxicology analysis of Rutherrin for Glio Blastoma Multiforme ("GBM"). GBM is the most aggressive and most common type of brain cancer.

Theralase宣佈,它已經成功地完成了其非良好實驗室操作規範(“普洛斯“)盧瑟林治療多形性膠質母細胞瘤的臨床前毒理學分析(”GBMGBM是最具侵襲性和最常見的腦癌類型。

The preclinical toxicology data collected to date has demonstrated that Theralase's Rutherrin (RuvidarTM + human transferrin) PDC is able to be safely administered Intra Venously ("IV") into brain cancer animal models and then successfully hunt, target and significantly accumulate inside GBM cells versus healthy brain cells. When the PDC is activated by radiation therapy, such as X-ray radiation, it effectively destroys GBM tumour cells. In addition, to providing a strong cancer killing effect the technology is able to induce Immunogenic Cell Death ("ICD") and certain anti-tumour protective responses, preventing further growth of the GBM tumour cells.

迄今為止收集的臨床前毒理學數據表明,Theralase的Rutherrin(Ruvidar)TM+人轉鐵蛋白)PDC能夠安全地靜脈注射(“IV)進入腦癌動物模型,然後與健康的腦細胞相比,成功地尋找、靶向並顯著積累在GBM細胞內。當PDC被放射治療(如X射線輻射)激活時,它有效地摧毀GBM腫瘤細胞。此外,該技術能夠誘導免疫原性細胞死亡(ICD)和某些抗腫瘤保護反應,防止GBM腫瘤細胞進一步生長。

Theralase is forwarding a summary of the preclinical data to Health Canada for review and response on a GLP toxicology program to be completed by the Company by 1Q2024.

Theralase正在將臨床前數據的摘要提交給加拿大衛生部,以供對公司將於2024年第一季度完成的GLP毒理學計劃進行審查和回應。

Based on the successful completion of the GLP toxicology program, Theralase intends to commence a Phase Ia/Ib dose escalating clinical study in 2024 in patients diagnosed with GBM to determine the appropriate clinical dose of the drug from both a toxicity and tumour localization perspective. This phase will also look at radiation activation of a single IV dose of Rutherrin.

在成功完成GLP毒理學計劃的基礎上,Theralase打算在2024年開始對被診斷為GBM的患者進行Ia/Ib期劑量遞增臨床研究,以從毒性和腫瘤定位的角度確定該藥物的適當臨床劑量。這一階段還將研究單次靜脈注射盧瑟林的輻射激活情況。

Following the successful completion of the Phase Ia/Ib clinical study, Theralase plans to commence a Phase IIa/IIb clinical study in Canada and the United States focused on enrolling and treating patients diagnosed with recurrent GBM, with multiple radiation activated doses of Rutherrin.

在成功完成Ia/Ib期臨床研究後,Theralase計劃在加拿大和美國開始一項IIa/IIb期臨床研究,重點是招募和治療被診斷為復發性GBM的患者,使用多次放射激活的Rutherrin劑量。

Dr. Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase stated, "Theralase's scientific team has worked tirelessly to research and develop Rutherrin as an IV PDC that post administration is able to be activated by radiation therapy to hunt, target and destroy GBM. The GLP toxicology program that Theralase is completing will lay the groundwork for Rutherrin to be IV administered for numerous other cancers; including: Non-Small Cell Lung Cancer ("NSCLC"), pancreatic cancer, prostate cancer, kidney cancer and colorectal cancer. I look forward to commencing the clinical study program evaluation of this versatile and effective drug in 2024."

Theralase的首席科學官Arkady Mandel博士,醫學博士,博士,DSC說:“Theralase的科學團隊不知疲倦地研究和開發Rutherrin作為一種靜脈注射的PDC,這種藥物可以通過放射治療激活,以尋找、靶向和摧毀GBM。Theralase正在完成的GLP毒理學計劃將為Rutherrin用於許多其他癌症的靜脈注射奠定基礎;包括:非小細胞肺癌(非小細胞肺癌)、胰腺癌、前列腺癌、腎癌和結直腸癌。我期待著在2024年開始對這種多功能和有效的藥物進行臨床研究計劃評估。

Mr. Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase stated, "Dr. Mandel and his scientific team have conducted numerous in-vitro and in-vivo experiments to compile this body of preclinical work to be able to bring Rutherrin to the GLP toxicology analysis stage and then pending successful completion onto clinical development. The use of human transferrin in animal models has proven difficult to overcome, but the hard work and dedication of the Theralase team have successfully completed this work to bring Theralase to the next step."

羅傑·杜穆林-懷特先生,BSC,P.Eng,Pro.Dir,總裁先生和Theralase首席執行官表示:“曼德爾博士和他的科學團隊進行了無數次體外培養體內實驗匯編了這一系列的臨床前工作,以便能夠將Rutherrin帶入GLP毒理學分析階段,然後等待成功完成臨床開發。事實證明,在動物模型中使用人類轉鐵蛋白很難克服,但Theralase團隊的辛勤工作和奉獻精神成功地完成了這項工作,將Theralase帶入下一步。

About Theralase Technologies Inc.:

關於Theralase技術公司:

Theralase is a clinical stage pharmaceutical company dedicated to the research and development of light and radiation activated compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.

Theralase是一家臨床階段的製藥公司,致力於研究和開發光和輻射激活的化合物、它們的相關藥物配方和激活它們的光系統,主要目標是療效,次要目標是銷毀各種癌症、細菌和病毒的安全性。

Additional information is available at and

欲瞭解更多資訊,請訪問和

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


Forward Looking Statements


前瞻性陳述

This news release contains Forward-Looking Statements ("FLS") within the meaning of applicable Canadian securities laws. Such statements include, but are not limited to, statements regarding the Company's proposed development plans with respect to Photo Dynamic Compounds ("PDCs") and their drug formulations. FLS may be identified by the use of the words "may, "should", "will", "anticipates", "believes", "plans", "expects", "estimate", "potential for" and similar expressions; including, statements related to the current expectations of the Company's management for future research, development and commercialization of the Company's PDCs and their drug formulations; including: preclinical research, clinical studies and development and regulatory approvals.

本新聞稿包含前瞻性陳述(“FLS)適用的加拿大證券法所指的範圍內。此類陳述包括但不限於,關於本公司關於照片動態化合物的擬議發展計劃的陳述(PDC“)和他們的藥物配方。FLS可以通過使用單字”可能,“應該“,”將要“,”預期“,”vbl.相信,相信“,”平面圖“,”期望“,”估算“,”潛在的以及類似的表述;包括與公司管理層目前對公司PDC及其藥物配方的未來研究、開發和商業化的期望有關的陳述;包括:臨床前研究、臨床研究和開發以及監管批准。

These statements involve significant risks, uncertainties and assumptions; including, whether the Company is able to: adequately fund and secure the requisite regulatory approvals to successfully complete preclinical and clinical studies in a timely fashion to implement its development plan; successfully commercialize its drug formulations; access sufficient capital to fund the Company's operations, which may not be available on terms that are commercially favorable to the Company or at all; provide preclinical and clinical support that the Company's drug formulations are effective against the conditions tested in its preclinical and clinical studies; comply with the term of license agreements with third parties, not to lose the right to use key intellectual property in its business; protect its intellectual property and the timing and success of this intellectual property and achieve acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict.

這些陳述涉及重大風險、不確定因素和假設,包括公司是否能夠:提供足夠的資金並獲得必要的監管批准,以及時成功完成臨床前和臨床研究,以實施其開發計劃;成功地將其藥物配方商業化;獲得足夠的資本為公司的運營提供資金,而這些資金可能無法以對公司有利或根本不利於商業的條款提供;提供臨床前和臨床支持,以確保公司的藥物配方對其臨床前和臨床研究中測試的條件有效;遵守與第三方的許可協定條款,不會失去在其業務中使用關鍵知識產權的權利;保護其知識產權和這一知識產權的時機和成功,並實現對監管備案的接受和批准。其中許多將決定實際結果的因素超出了公司的控制或預測能力。

Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will successfully come to fruition, and as such, FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS.

讀者不應過度依賴這些FL,它們不能保證未來的表現。不能保證自由貿易協定將成功實現,因此,自由貿易協定涉及已知和未知的風險、不確定因素和其他可能導致實際結果或未來事件與自由貿易協定大不相同的因素。

Although the FLS contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these FLS.

儘管新聞稿中包含的財務會計準則是基於管理層目前認為合理的假設,但公司不能向潛在投資者保證實際結果、業績或成就將與這些財務會計準則一致。

All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such statements.

所有FLS均自本合同生效之日起生效,並可隨時更改。除法律另有規定外,本公司不承擔更新此類聲明的義務。

For More Information:

有關詳細資訊,請訪問:

1.866.THE.LASE (843.5273)
416.699.LASE (5273)

1.866.THE.LASE(843.5273)
416.699.LASE(5273)

Kristina Hachey, CPA
Chief Financial Officer
khachey@theralase.com
416.699.LASE (5273) x 224

克裡斯蒂娜·哈奇,註冊會計師
首席財務官
郵箱:khaceh@theralase.com
416.699.LASE(5273)x 224

SOURCE: Theralase Technologies Inc.

資料來源:Theralase Technologies Inc.


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