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Innocan Pharma Submits Investigational New Animal Drug Application to FDA's Veterinary Center

Innocan Pharma Submits Investigational New Animal Drug Application to FDA's Veterinary Center

Innocan Pharma向FDA獸醫中心提交了新的動物藥物申請
PR Newswire ·  07/26 16:00

HERZLIYA, Israel and CALGARY, AB, July 26, 2024 /PRNewswire/ -- Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) ("Innocan" or the "Company"), a pioneer in the pharmaceutical and biotechnology industries, is pleased to announce that the FDA's Center for Veterinary Medicine (CVM) has granted the Company a sponsor fee waiver and assigned an Investigational New Animal Drug (INAD) number for its LPT-CBD (Liposome Platform Technology-Cannabidiol) product. This represents a significant step for the Company, as an INAD designation facilitates correspondence and data exchange with CVM to support LPT-CBD development as a new veterinary drug.

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The Company further announced that following the assessment of LPT-CBD's scientific package, the CVM recognized Innocan's contribution to pursuing innovative animal drug products and technology and granted the company a sponsor fee waiver for fiscal year 2024.

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Innocan's LPT-CBD is a proprietary drug delivery platform designed to provide prolonged-release CBD for chronic pain and well-being management in animals. Over the past year, repeated administration of LPT-CBD in dogs and other animals has demonstrated both efficacy and tolerability, providing sufficient evidence for the INAD application.

Innocan Pharma公司(CSE: INNO)(FSE: IP4)(OTCQB: INNPF)是藥品和生物技術行業的先鋒,總部位於以色列赫茲利亞和加拿大卡爾加里地區。該公司很高興地宣佈,FDA的獸藥中心(CVM)免除了公司的贊助費併爲其LPt-CBD(卡那比利脂質體平台技術)產品指定了一種新動物研究藥物(INAD)編號。這代表了該公司邁出的重要一步,因爲INAD的指定有助於與CVM進行通信和數據交流,以支持LPt-CBD作爲新的獸藥的開發。

"We are thrilled by CVM's response," said Prof. Chezy Barenholz, CSO of Innocan Pharma. "The granted INAD will allow us to advance the investigational studies of LPT-CBD and share knowledge to support future discussions with CVM on LPT-CBD's development plan. Moreover, the fee waiver, granted by CVM, supports our development and pursuit of innovative animal drug products and technology, further validating our approach and potential impact in veterinary medicine."

公司進一步宣佈,在評估了LPt-CBD的科學計劃後,CVM認識到Innocan爲追求創新的獸藥產品和技術作出的貢獻,併爲2024財年免除了公司的贊助費。

Dr. Eyal Kalo, R&D Director at Innocan, added, "LPT-CBD is a unique technology that has proven itself worthy of the INAD fee waiver granted by CVM. This will streamline our efforts to deliver a unique solution for chronic pain management to the animal market."

Innocan的LPt-CBD是一種專有的藥物輸送平台,旨在爲動物提供緩釋性的CBD,用於慢性疼痛和健康管理。在過去一年中,對狗和其他動物反覆施用LPt-CBD已經證明了其療效和耐受性,爲INAD的申請提供了充分的證據。

About Innocan Pharma:
Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies comprises with cannabinoids science, to treat various conditions to improve patients' quality of life. This segment involves two drug delivery technologies: (i) LPT CBD-loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for two indications: Epilepsy and Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment Innocan has established a Joint Venture by the name of BI Sky Global Ltd. that focuses developing on advanced targeted online sales.

關於Innocan Pharma:
Innocan是一家制藥技術公司,掌握兩個主要業務領域:製藥和消費者保健。 在製藥領域,Innocan專注於開發創新的藥物遞送平台技術,包括大麻素科學,以治療各種疾病從而提高患者的生活質量。 此領域涉及兩種藥物遞送技術:(i)LPT CBD負載的脂質體平台,有助於準確用量和CBD進入血液流的持久和受控釋放。 LPT遞送平台研究正在進行爲兩種適應症的臨床前試驗:癲癇和疼痛管理。 在消費者保健領域,Innocan開發和銷售廣泛的創新和高性能自護產品組合,以推廣更健康的生活方式。 在這個領域,Innocan成立了一家名爲BI Sky Global Ltd的合資企業,其專注於開發先進的定向在線銷售。

Contact Information:

聯繫方式:

For Innocan Pharma Corporation:
Iris Bincovich, CEO
+1 5162104025
+972-54-3012842
+442037699377
[email protected]

對於Innocan Pharma公司:
Iris Bincovich,首席執行官
+1 5162104025
+972-54-3012842
+442037699377
[email protected]

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

加拿大證券交易所及其監管服務提供方對本發佈的信息的充分性或準確性未經審查或承擔任何責任。

Caution Regarding Forward-Looking Information

關於前瞻性信息的注意事項

Certain information set forth in this news release, including, without limitation, the Company's plans for human trials of its LPT-CBD platform, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan's control. . The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of production and distribution arrangements.

Innocan Pharma公司的CSO Chezy Barenholz教授表示:“我們對CVM的回覆感到非常高興。這份INAD的授權將使我們推進LPt-CBD的調查研究,以及與CVM分享知識,進一步支持LPt-CBD的開發計劃。此外,由CVM授權的贊助費減免支持我們開發和追求創新的獸藥產品和技術,進一步驗證了我們在獸醫藥品領域的研究方法和潛在影響。”同時Innocan的R&D總監Eyal Kalo博士補充道:“LPt-CBD是一項獨特的技術,已經證明自己值得CVM免除INAD費用的授權。這將簡化我們的工作,爲動物市場提供解決慢性疼痛管理的獨特解決方案。”該新聞稿中的某些信息,包括但不限於公司對其LPt-CBD平台進行人體試驗的計劃,都是適用證券法律的前瞻性信息。由於前瞻性信息的特性,它受到無數風險和不確定性的影響,其中一些是Innocan Pharma無法控制的。本新聞稿中的前瞻性信息基於Innocan的某些關鍵預期和假設,包括與產品有關的預期和假設,在各個管轄區滿足監管要求以及生產和分銷安排的順利完成。

Forward-looking information is subject to various risks and uncertainties that could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: global and local (national) economic, political, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and potential disruption of relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import/export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner). The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release. A comprehensive discussion of other risks that impact Innocan can be found in Innocan's public reports and filings which are available under Innocan's profile at .

前瞻性信息會受到各種風險和不確定因素的影響,這會使實際結果和體驗與本新聞稿中表達的預期結果或期望結果產生實質性差異。主要的風險和不確定性包括但不限於:全球和當地(國家)的經濟、政治、市場和商業狀況;政府和監管機構的要求和行動;可能破壞與供應商、製造商、客戶、商業夥伴和競爭對手之間關係的風險。產品分銷的性質本身也存在風險,包括進口/出口事項和未獲得任何必要的監管和其他批准(或未能及時獲得)。預計的進入市場時間表可能會因多種原因而改變,包括未能確保必要的監管要求或需要額外時間來完成和/或滿足製造和分銷安排。因此,讀者不應對本新聞稿中所包含的前瞻性信息過於依賴。影響Innocan的其他風險的全面討論可在Innocan在其個人檔案下提供的公開報告和文件中找到。

Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward-looking information as a result of any new information, future events or otherwise, except as may be required by applicable law.

讀者應該注意到,不應過度依賴前瞻性信息,因爲實際結果可能與前瞻性信息產生實質性差異。Innocan不會更新、糾正或修訂任何前瞻性信息,除非適用法律要求或出於任何新信息、未來事件或其他原因。

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SOURCE Innocan Pharma Corporation

消息來源:Innocan Pharma公司

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