PharmaDrug's Sairiyo Successfully Demonstrates Ability to Manufacture Cepharanthine (PD-001) for Human Clinical Studies
PharmaDrug's Sairiyo Successfully Demonstrates Ability to Manufacture Cepharanthine (PD-001) for Human Clinical Studies
Company to pursue regulatory filing for Phase I/II clinical study
公司將爲I/II期臨床研究提交監管申請
Toronto, Ontario--(Newsfile Corp. - February 14, 2024) - PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) ("PharmaDrug" or the "Company"), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs, is pleased to provide an update on the development activities of Sairiyo Therapeutics Inc. ("Sairiyo"), a 51% owned subsidiary of the Company. The update relates to Sairiyo's patented reformulated enteric coated version of orally bioavailable cepharanthine (PD-001) as a potential treatment for oncology and infectious diseases. The technical transfer and development activities with Genvion Corporation are completed and successfully demonstrated the ability to manufacture clinical GMP manufacturing batches of PD-001 to support future filings to Australia's Therapeutic Goods Administration (TGA) and the Food and Drug Administration (FDA) in the United States. This announcement is made in conjunction with PharmaTher Holdings Ltd, a 49% shareholder of Sairiyo.
安大略省多倫多--（Newsfile Corp.，2024年2月14日）——PharmaDrug Inc.（CSE：PHRX）（場外交易鏈接：LMLF）（”PharmaDr“或者”公司“）是一家專注於受控物質和天然藥物（例如迷幻藥和先前批准的藥物）的研究、開發和商業化的專業製藥公司，很高興向大家介紹Sairiyo Therapeutics Inc.的最新開發活動（”Sairiyo“），是該公司持股51％的子公司。該更新涉及Sairiyo獲得專利的重新配方的口服生物可利用頭孢黃鹼（PD-001）的腸溶包衣版本，可作爲腫瘤和傳染病的潛在治療方法。與Genvion Corporation的技術轉讓和開發活動已經完成，併成功證明了生產臨床GMP製造批次的 PD-001 的能力，以支持未來向澳大利亞治療產品管理局（TGA）和美國食品藥品監督管理局（FDA）申報。本公告是與Sairiyo的49％股東PharmAther Holdings Ltd聯合發佈的。
Robert Steen, CEO and Chairman of PharmaDrug commented, "We are extremely excited to reach this milestone in the development of PD-001. We will immediately begin taking the steps required to set up the appropriate infrastructure and partner relationships in Australia for the purposes of a potential human clinical trial. We have already begun to work on an application and expect to be able to submit it to the proper channels in the next quarter."
PharmaDrug首席執行官兼董事長羅伯特·斯蒂恩評論說：“我們非常高興在 PD-001 的開發中達到這個里程碑。我們將立即開始採取必要措施，在澳大利亞建立適當的基礎設施和合作夥伴關係，以進行潛在的人體臨床試驗。我們已經開始處理申請，預計能夠在下個季度將其提交給適當的渠道。”
The successful completion of analytical method establishment, manufacturing protocol development and materials handling strategies for PD-001 API and Drug Product enabled the manufacturing of a feasibility batch. Successful completion of the feasibility batch demonstrated appropriateness of the manufacturing process and material evaluation approaches in support of scale up activities for future clinical research needs. On going stability studies are being conducted to support product performance and shelf-life determination.
PD-001 原料藥和藥物產品的分析方法建立、製造協議開發和材料處理策略的成功完成使可行性批次的製造成爲可行性批次的製造提供了條件。可行性批次的成功完成表明，製造過程和材料評估方法在支持擴大活動以滿足未來臨床研究需求方面是適當的。正在進行穩定性研究，以支持產品性能和保質期的確定。
Manufacturing of product for clinical studies is scheduled for the second quarter of 2024. These materials are intended to support potential Phase 1 and 2 clinical trials of PD-001 for oncology and infectious diseases. The Company has commenced working on a regulatory application to the TGA for an in human safety trial in Australia.
計劃於2024年第二季度生產用於臨床研究的產品。這些材料旨在支持潛在的 PD-001 腫瘤學和傳染病的 1 期和 2 期臨床試驗。該公司已開始向TGA提交監管申請，要求在澳大利亞進行人體安全試驗。
About PD-001 (Enteric-coated Oral Cepharanthine)
關於 PD-001（腸溶包衣口服頭孢黃鹼）
Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases. In clinical research, cepharanthine has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects1,2. However, historically cepharanthine's low oral bioavailability has represented a major obstacle to realizing its full clinical potential.
Cepharanthine是一種天然產物，是一種經批准的藥物，在日本使用了70多年，可以成功治療各種急性和慢性疾病。在臨床研究中，頭孢黃鹼已被證明具有多種藥理特性，包括抗氧化、抗炎、免疫調節、抗癌、抗病毒和抗寄生蟲作用1,2。但是，從歷史上看，頭孢黃鹼的低口服生物利用度一直是充分發揮其臨床潛力的主要障礙。
Sairiyo is focused on advancing the clinical development of an improved and patented enteric-coated oral formulation of cepharanthine (PD-001) to treat responsive cancers and COVID-19. Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly improved oral bioavailability (more easily absorbed). These findings support the development of an orally administered formulation, and in so doing, removes the undesirable requirement for frequent intravenous dosing to maintain therapeutic levels of drug in circulation. Sairiyo endeavours to develop an efficacious oral therapeutic to potentially improve outcomes for infectious disease and oncology applications.
Sairiyo專注於推進一種經過改進且獲得專利的頭孢黃鹼口服制劑（PD-001）的臨床開發，該製劑用於治療反應性癌症和 COVID-19。與仿製頭孢黃鹼相比，在齧齒動物和非齧齒動物模型中，PD-001 的口服生物利用度顯著提高（更容易吸收）。這些發現支持了口服給藥製劑的開發，從而消除了爲維持流通中藥物治療水平而經常靜脈給藥的不良要求。Sairiyo致力於開發一種有效的口服療法，以潛在地改善傳染病和腫瘤學應用的療效。
About PharmaDrug Inc.
關於 PharmaDrug Inc.
PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs. PharmaDrug owns 51% of Sairiyo Therapeutics ("Sairiyo"), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of infectious disease and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. PharmaDrug also owns 100% of SecureDose Synthetics Inc. ("SecureDose"), a pharmaceutical research and development company focused on the development of synthetic formulations of currently existing drugs for potential commercialization and distribution.
PharmaDrug是一家專業製藥公司，專注於受控物質和天然藥物（例如迷幻藥和先前批准的藥物）的研究、開發和商業化。PharmaDrug擁有Sairiyo Therapeutics（“Sairiyo”）51％的股份，Sairiyo Therapeutics（“Sairiyo”）是一家專門研究和重建成熟天然藥物的生物技術公司，其目標是在美國和歐洲通過臨床試驗和相關的監管批准程序。Sairiyo目前正在開發頭孢黃鹼的專利重組配方，該藥物已顯示出相當大的經第三方驗證的治療傳染病和罕見癌症的潛力。Sairiyo還在迷幻藥領域進行研發，用於治療非神經精神疾病。PharmaDrug還擁有SecureDose Synthetics Inc.（“SecureDose”）的100％股份，該公司是一家藥物研發公司，專注於開發當前現有藥物的合成配方，以進行潛在的商業化和分銷。
For further information, please contact:
欲了解更多信息，請聯繫：
Robert J. Steen, Chairman and CEO
rob@pharmadrug.ca
(416) 400-7086
羅伯特·斯蒂恩，董事長兼首席執行官
rob@pharmadrug.ca
(416) 400-7086
Caution Regarding Forward-Looking Information:
關於前瞻性信息的注意事項：
THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
加拿大證券交易所尚未審查本新聞稿的充分性或準確性，也不承擔任何責任。
This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results of the Company. Forward looking statements in this press release relate setting up the appropriate infrastructure and partner relationships in Australia for the purposes of a potential human clinical trial, the timing of the application to be made to the Australian authorities, the completion of ongoing stability studies, the timing of the manufacturing of product for clinical studies and the development of the Company's business. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements.
本新聞稿可能包含基於當前預期的前瞻性陳述和信息。這些陳述不應被視爲對公司未來業績或業績的保證。本新聞稿中的前瞻性聲明涉及在澳大利亞建立適當的基礎設施和合作夥伴關係，以進行潛在的人體臨床試驗、向澳大利亞當局提出申請的時機、正在進行的穩定性研究的完成、臨床研究產品的生產時間以及公司業務的發展。此類陳述涉及已知和未知的風險、不確定性和其他因素，這些因素可能導致實際結果、業績或成就與此類陳述所暗示的有重大差異。
Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company's future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals..
前瞻性信息受已知和未知的風險、不確定性和其他因素的影響，這些因素可能導致公司的實際業績、活動水平、業績或成就與此類前瞻性信息所表達或暗示的結果存在重大差異。此類風險和其他因素可能包括但不限於：一般業務、經濟、競爭、政治和社會的不確定性；一般資本市場狀況和證券市場價格；公司未來經營的實際業績；競爭；影響公司的立法變化；獲得和維持所需許可證和批准的能力、以可接受的條件獲得外部融資的時間和可用性；缺乏合格的熟練勞動力或關鍵人物的流失。
A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company's disclosure documents on the SEDAR+ website at . Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. 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.
可能導致實際業績與前瞻性信息存在重大差異的其他風險因素的描述可在SEDAR+網站上公司的披露文件中找到，網址爲。儘管公司試圖確定可能導致實際業績與前瞻性信息中包含的結果存在重大差異的重要因素，但可能還有其他因素導致業績與預期、估計或預期的結果不符。因此，讀者不應過分依賴前瞻性信息。提醒讀者，上述因素清單並不詳盡。進一步提醒讀者不要過分依賴前瞻性信息，因爲無法保證前瞻性信息所依據的計劃、意圖或期望會實現。儘管管理層在編制時認爲此類信息是合理的，但可能被證明是不正確的，實際結果可能與預期結果存在重大差異。
The Company's securities have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or "U.S. Persons", as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.
公司的證券未根據經修訂的1933年《美國證券法》（“美國證券法”）或適用的州證券法進行註冊，未經註冊或未獲得此類註冊要求的適用豁免，不得向美國個人或 “美國個人”（該術語的定義見《美國證券法案》）或適用的州證券法進行發行或出售，或爲其賬戶或利益。本新聞稿不構成出售要約或徵求買入要約，也不得在美國或任何將此類要約、招攬或出售爲非法的司法管轄區出售證券。
Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.
本警示聲明明確限制了本新聞稿中包含的前瞻性信息。本新聞稿中包含的前瞻性信息代表了公司截至本新聞稿發佈之日的預期，因此，在該日期之後可能會發生變化。但是，除非適用的證券法明確要求，否則公司明確否認任何更新或修改任何前瞻性信息的意圖或義務，無論是由於新信息、未來事件還是其他原因。
譯文內容由第三人軟體翻譯。