Arch Biopartners Announces GMP Manufacturing of Cilastatin Drug Product
Arch Biopartners Announces GMP Manufacturing of Cilastatin Drug Product
TORONTO, June 27, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., ("Arch" or the "Company") (TSX Venture: ARCH and OTCQB: ACHFF), announced that Dalton Pharma Services (Dalton) has completed the good manufacturing practice (GMP) glass vial filling stage for cilastatin, the Company's second drug candidate for preventing acute kidney injury (AKI).
加拿大多倫多,2024年6月27日 (環球新聞社) - Arch Biopartners公司(“Arch”或“公司”)(TSX Venture: ARCH,OTCQB: ACHFF)宣佈Dalton Pharma Services (Dalton)已完成公司的第二個防止急性腎損傷(AKI)藥物候選品cilastatin的GMP玻璃瓶灌裝階段。
Over the next six to eight weeks Dalton will be completing the quality control process which will culminate with the release of a first-ever, stand-alone cilastatin drug product to be used in a Phase II trial targeting drug toxin related AKI in hospitalized patients.
在接下來的六到八週內,Dalton將完成質量控制的過程,併發布第一個獨立的cilastatin藥物產品,用於針對醫院患者中藥物毒素相關的AKI的II期臨床試驗。
Arch has agreed to be an industry partner with a group of Canadian clinical researchers in a planned Phase II clinical trial targeting drug toxin-related AKI, which is expected to start in late 2024. The Company will be acting as a study partner for grant funding opportunities, providing cilastatin drug product and providing scientific and regulatory advice.
Arch已經同意與一組加拿大臨床研究人員合作,計劃在2024年底開始對藥物毒素相關的AKI進行II期臨床試驗。 該公司將作爲授予經費機會的研究合作方,提供cilastatin藥物產品並提供科學和監管建議。
Arch has method of use patents in several jurisdictions including North America and Europe for repurposing cilastatin as a treatment for AKI. The patents are proprietary and/or exclusively licensed to Arch. Today's announcement marks the completion of an important milestone in the Company's plans to repurpose cilastatin as a new treatment to prevent toxin related AKI.
Arch在多個司法轄區包括北美和歐洲擁有cilastatin重新定位作爲AKI治療的使用方法專利。 這些專利是專有的和/或專有許可給Arch。 今天的公告標誌着公司計劃將cilastatin作爲預防毒素相關AKI的新療法的重要里程碑的完成。
About Cilastatin
關於cilastatin
Cilastatin is an enzymatic dipeptidase-1 (DPEP1) inhibitor originally developed in the early 1980 ́s by Merck Sharp & Dohme Research Laboratories to limit the renal metabolism of imipenem, a β-lactam antibiotic used for the treatment of systemic infections. Cilastatin was approved for use as fixed combination with imipenem for IV administration to treat different types of bacterial infections. This fixed combination is currently marketed under different names, including Primaxin (USA, UK, Australia, Italy), Tienam (Spain, Belgium) or Zienam (Germany). The combination imipenem/cilastatin was approved by the FDA in 1985. Patents for imipenem and cilastatin have expired and the combination drug is currently in a generic phase. There is no commercial history of cilastatin as a stand-alone drug product.
Cilastatin是一種酶促二肽酶-1(DPEP1)抑制劑,最初由Merck Sharp&Dohme Research Laboratories於20世紀80年代初開發,用於限制β-內酰胺類抗生素imipenem的腎代謝。 Cilastatin已獲批批准與imipenem固定配方聯合使用,用於治療不同類型的細菌感染。該固定配方目前以不同的名稱在市場上銷售,包括Primaxin(美國,英國,澳大利亞,意大利),Tienam(西班牙,比利時)或Zienam(德國)。imipenem / cilastatin固定組合物在1985年獲得FDA批准。 imipenem和cilastatin的專利已經過期,該組合藥物目前處於通用階段。 cilastatin作爲獨立藥物產品沒有商業歷史。
Cilastatin has a slightly different mechanism of action compared with Arch's novel drug candidate, LSALT peptide (Metablok) a non-enzymatic DPEP1 inhibitor. Whereas LSALT peptide specifically blocks DPEP1-mediated inflammation in the kidney, lungs and liver, cilastatin also has off target-effects that prevent toxin uptake in the kidneys. Thus, cilastatin is particularly effective for toxin-related AKI, but not suitable for other forms of non-toxin related AKI targeted by LSALT peptide.
與Arch的新型藥物候選物LSALT肽(Metablok)非酶DPEP1抑制劑相比,Cilastatin具有略微不同的作用機制。 雖然LSALT肽特別阻止腎臟,肺和肝臟中的DPEP1介導的炎症,但cilastatin還具有預防腎臟中毒素攝取的非靶點效應。 因此,cilastatin尤其適用於毒素相關AKI,但不適用於LSALT肽針對的其他形式的非毒素相關AKI。
Cilastatin as a potential treatment for AKI
Cilastatin作爲預防AKI的潛在療法
AKI reflects a broad spectrum of clinical presentations ranging from mild injury to severe injury that may result in permanent and complete loss of renal function. Clinically, the causes of AKI include sepsis, ischemia-reperfusion injury, and various endogenous as well as exogenous (drug) toxins. There is no specific therapeutic treatment available in the market today that prevents AKI. In the worst cases, the kidneys fail, requiring kidney dialysis or kidney transplant for survival.
AKI反映了各種臨床表現的廣泛譜,從輕度損傷到嚴重損傷,可能導致腎功能的永久和完全喪失。 臨床上,AKI的原因包括敗血症,缺血再灌注損傷以及各種內源性以及外源性(藥物)毒素。 目前市面上沒有特定的治療方法可用於防止AKI。 在最嚴峻的情況下,腎臟衰竭,需要腎透析或腎移植才能生存。
Exogenous toxins include a wide range of pharmaceutical drugs such as antibiotics (vancomycin, aminoglycosides), chemotherapeutic agents and radiographic contrast. Drug toxin-induced AKI represent approximately 30% of all AKI in hospitalized patients.
外源毒素包括廣泛的藥物,如抗生素(萬古黴素,氨基糖苷類抗生素),化療藥物和造影劑。 藥物毒素引起的AKI約佔住院患者AKI的30%。
As stated above, cilastatin is particularly suited to preventing AKI caused by drug toxins due to a unique off-target effect that blocks their uptake into the kidney tissue. Several in vitro and in vivo studies indicate that cilastatin prevents AKI induced by multiple nephrotoxic drugs (exogenous toxins).
如上所述,由於具有阻斷腎組織中藥物毒素攝取的獨特非靶點效應,cilastatin特別適合預防由藥物毒素引起的AKI的治療。 幾項研究表明,cilastatin可以預防多種腎毒性藥物(外源毒素)引起的AKI。體外和體內研究表明,西拉斯汀可以預防多種腎毒性藥物(外源性毒素)誘導的急性腎損傷。
About Arch Biopartners
關於Arch Biopartners
Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The Company is developing a platform of new drugs to prevent inflammation in the kidneys, liver and lungs via the dipeptidase-1 (DPEP1) pathway and are relevant for many common injuries and diseases where organ inflammation is an unmet problem.
Arch Biopartners Inc.是一家專注於預防炎症和急性器官損傷的晚期臨床試驗公司。該公司正在開發一系列通過二肽酶-1(DPEP1)途徑防止腎臟、肝臟和肺部炎症的新藥物平台,並與許多常見損傷和疾病相關,其中器官炎症是一個未被滿足的問題。
For more information on Arch Biopartners' science and drug platform, please visit:
欲了解更多Arch Biopartners的科學和藥物平台信息,請訪問:
For investor information and other public documents the company has also filed on SEDAR+, please visit
欲了解有關Arch Biopartners的投資者信息和公司在SEDAR+上提交的其他公共文件,請訪問
The Company has 64,250,633 common shares outstanding.
該公司擁有64,250,633股普通股。
Forward-Looking Statements
前瞻性聲明
This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as the ongoing clinical development of our drug candidates targeting the dipeptidase-1 (DPEP1) pathway, including the outcome of our clinical trials relating to LSALT peptide (Metablok) or cilastatin, the successful commercialization and marketing of our drug candidates, whether we will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe and other countries, our ability to raise capital to fund our business plans, the efficacy of our drug candidates compared to the drug candidates developed by our competitors, our ability to retain and attract key management personnel, and the breadth of, and our ability to protect, our intellectual property portfolio. These statements are based on management's current expectations and beliefs, including certain factors and assumptions, as described in our most recent annual audited financial statements and related management discussion and analysis under the heading "Business Risks and Uncertainties". As a result of these risks and uncertainties, or other unknown risks and uncertainties, our actual results may differ materially from those contained in any forward-looking statements. The words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including our most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval ("SEDAR") website at .
本新聞稿包含根據適用的加拿大證券法的前瞻性聲明,涉及我們未來業績,流動性和資本資源的預期,以及針對二肽酶-1(DPEP1)途徑的我們藥物候選品的持續臨床開發,包括與LSALT肽(Metablok)或cilastatin相關的我們的臨床試驗的結果,我們藥物候選品的成功商業化和營銷,無論我們是否將在加拿大,美國,歐洲和其他國家獲得,以及獲得監管批准的時間和費用,我們籌集資金以資助我們的業務計劃,我們的藥物候選品與競爭對手開發的藥物候選品的功效相比,我們的關鍵管理人員保留和吸引的能力,以及我們知識產權組合的廣度和保護能力。 這些陳述基於管理層的當前期望和信念,包括某些因素和假設,如我們最近的年度審計財務報表以及相關管理討論和分析中在“業務風險和不確定性”標題下所述。 由於這些風險和不確定性,或其他未知的風險和不確定性,我們的實際結果可能與任何前瞻性聲明中所包含的結果有所不同。 雖然並非所有前瞻性聲明都包含這些識別詞,但“相信”,“可能”,“計劃”,“將”,“估計”,“繼續”,“預期”和類似用語旨在識別前瞻性聲明。 我們未承擔更新前瞻性聲明的義務,除非法律要求。 有關Arch Biopartners Inc.的其他信息,包括我們最近的年度審計財務報表,請訪問加拿大證券管理機構的電子文件分析和檢索系統(“SEDAR”)網站。
The science and medical contents of this release have been approved by the Company's Chief Science Officer
本發佈稿的科學和醫學內容已獲公司首席科學官批准
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
TSX Venture Exchange及其監管服務提供者(如TSX Venture Exchange的政策中所定義的)不接受對本發佈內容的充分性或準確性的責任。
CONTACT: For more information, please contact: Richard Muruve Chief Executive Officer Arch Biopartners, Inc. 647-428-7031 info@archbiopartners.com
聯繫方法:想了解更多信息,請聯繫:Richard Muruve 首席執行官Arch Biopartners,Inc. 647-428-7031 info@archbiopartners.com
譯文內容由第三人軟體翻譯。