Lobe Sciences Announces the Completion of CGMP Production of Clinical Supplies For Upcoming Clinical Trials
Lobe Sciences Announces the Completion of CGMP Production of Clinical Supplies For Upcoming Clinical Trials
Appointment of Philip J. Young, CEO, as Board Chairman
任命首席執行官菲利普·J·楊為董事會主席
Vancouver, British Columbia--(Newsfile Corp. - October 13, 2022) - Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a Canadian Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced that it has completed the synthesis of bulk L-130, a proprietary form of psilocin, and of the clinical supplies to be used in upcoming trials. The L-130 was manufactured in compliance with U.S. cGMPs (Current Good Manufacturing Practices).
温哥華，不列顛哥倫比亞省-(Newsfile Corp.-2022年10月13日)-致力於發現和開發治療神經和腦部疾病的迷幻衍生藥物的加拿大生物製藥公司LOPE Sciences Ltd.(CSE：LOPE)(場外交易市場代碼：LOBEF)今天宣佈，它已經完成了原裝L-130的合成，這是一種psiLocin的專利形式，以及即將進行的試驗中使用的臨牀用品。L-130是按照美國cGMP(現行良好製造規範)製造的。
Philip J. Young, Chairman and Chief Executive Officer of the Company stated, "This is an important step and validation of our approach to developing novel psilocin analogues to treat severe forms of anxiety, including a pediatric orphan indication. Our manufacturing partner has produced sufficient quantities of L-130 to dose subjects and patients in our first two Phase 1 programs. Ongoing stability and quality programs are in place to allow the use of all of the data generated in these studies to support our Investigational New Drug Application (IND) planned for early next year."
該公司董事長兼首席執行官菲利普·J·楊説：“這是我們為治療嚴重形式的焦慮症(包括兒科孤兒症狀)而開發新型裸鼠蛋白類似物方法的重要一步和驗證。我們的製造夥伴已經生產了足夠數量的L-130，可以在我們的頭兩個第一階段計劃中給受試者和患者服用。正在進行的穩定性和高質量計劃允許使用這些研究中產生的所有數據來支持我們計劃在明年初進行的研究性新藥應用(IND)。”
Dr. Fred Sancilio, Chief Executive Officer of Clearway Global, LLC and Head of Product Development stated, "Lobe Sciences is utilizing a team of global experts and has moved to the forefront in the development of therapeutics based on psychedelics. Our team is following a traditional drug development approach, and has solved many problems that have hindered others trying to develop similar therapeutics."
Clearway全球有限責任公司首席執行官兼產品開發主管弗雷德·桑西里奧博士説：“洛普科學公司正在利用一支全球專家團隊，在開發基於迷幻藥物的療法方面走在了前列。我們的團隊正在遵循傳統的藥物開發方法，已經解決了許多阻礙其他試圖開發類似療法的人的問題。”
Phase 1 clinical trials have been contracted with two contract research organizations who will conduct pharmacokinetics, single ascending dose and multiple ascending dose trials. The Company will soon announce the commencement of the first of this series of human studies.
第一階段臨牀試驗已經與兩個合同研究機構簽訂了合同，他們將進行藥代動力學、單劑量上升劑量試驗和多劑量上升劑量試驗。該公司不久將宣佈開始這一系列人體研究中的第一項。
Appointment of Philip J. Young as Board Chairman
委任菲利普·J·楊為董事會主席
On October 10, 2022, Philip J. Young was appointed as Executive Chairman of the board of directors of the Company, effective immediately.
2022年10月10日，菲利普·J·楊被任命為公司董事會執行主席，立即生效。
About Lobe Sciences Ltd.
關於波爾科學有限公司
Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.
Lobe Sciences是一家專注於迷幻藥物的生命科學公司。該公司通過與業界領先的合作伙伴合作，致力於使用迷幻化合物進行藥物研究和開發，並開發創新的設備和遞送機制，以改善精神健康和健康。
For further information please contact:
欲瞭解更多信息，請聯繫：
Lobe Sciences Ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623
洛普科學有限公司。
首席執行官菲利普·J·楊
郵箱：Info@lobesciences.com
電話：(949)505-5623
NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.
CSE及其監管服務提供商均未對本新聞稿的準確性或充分性進行審查或承擔責任。
This does not constitute an offer to sell or a solicitation of offers to buy any securities.
這不構成出售要約或邀請買入任何證券的要約。
Forward-Looking Statements
前瞻性陳述
This news release contains forward-looking statements relating to the future operations of the Company 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 news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) 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. Readers are cautioned that assumptions used in the preparation of the forward-looking statements 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, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at . As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. 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 only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.
本新聞稿包含與公司未來業務有關的前瞻性陳述，以及其他非歷史事實的陳述。前瞻性陳述通常用“將”、“可能”、“應該”、“預期”、“預期”和類似的表達方式來識別。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、使用迷幻化合物的研究和開發，以及改善精神健康和健康的創新設備和交付機制的開發)均為前瞻性陳述，涉及風險和不確定性。不能保證這樣的陳述將被證明是準確的，實際結果和未來事件可能與此類陳述中預期的大不相同。請讀者注意，在編制前瞻性陳述時使用的假設可能被證明是不正確的。事件或情況可能會導致實際結果與預期大不相同，原因是許多已知和未知的風險、不確定性和其他因素，其中許多是公司無法控制的，包括監管環境的變化；公司的藥物研發活動可能不成功；公司生產的或代表公司生產的藥品和醫療器械可能不以預期的方式或根本不起作用，並可能使公司承擔產品責任或其他責任索賠；公司可能無法實現公司的公司目標和目的；以及在公司不時提交的持續披露文件中詳細説明的其他風險因素，可在公司簡介中查閲，網址為。因此，公司不能保證任何前瞻性陳述都會成為現實，並告誡讀者不要過度依賴任何前瞻性信息。本新聞稿中包含的前瞻性陳述明確地受到本警示性聲明的限制。本新聞稿中包含的前瞻性陳述僅在本新聞稿發佈之日作出，公司不打算更新任何包含的前瞻性陳述，除非適用的加拿大證券法明確要求。
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