Sona Nanotech Updates on Dalhousie Efficacy Study and New NCL Results
Sona Nanotech Updates on Dalhousie Efficacy Study and New NCL Results
Halifax, Nova Scotia--(Newsfile Corp. - March 25, 2024) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company" or "Sona") announces positive interim results from its study with The Giacomantonio Immuno-Oncology Research Group at Dalhousie University (the "Study"). An update received by the Company indicates that all tumors treated within the Study to date with a single Targeted Hyperthermia Therapy ("THT") treatment shrunk within the first 24 hours, with an average reduction in size of 80% compared to matched controls.
新斯科舍省哈利法克斯--(Newsfile Corp.,2024年3月25日)——索納納米技術公司(CSE:SONA)(OTCQB:SNANF)(“公司” 或 “索納”)宣佈了其與達爾豪西大學賈科曼託尼奧免疫腫瘤學研究小組的研究(“研究”)的積極中期結果。該公司收到的最新報告表明,迄今爲止在研究中使用單一靶向熱療法(“THT”)治療的所有腫瘤在最初的24小時內縮小,與匹配的對照組相比,大小平均縮小了80%。
Study Principal Investigator, Dr. Carman Giacomantonio, comments, "Our initial assessment documented that in cohorts of seven animals, 7/7 of treated triple negative breast cancer mouse tumors bearing gold nanorods responded with an average reduction in tumor volume of 80% following a single treatment with near infrared light in comparison with untreated 'control' tumors. Interestingly, in all cases we observed responses (tumor shrinkage) in distant, untreated tumors supporting the hypothesis that our observations are consistent with systemic immunogenic responses. This observation will be a significant focus of our research going forward. While we are encouraged by these initial results, there is still significant work to be completed. The studies are designed to enable and identify statistical significance which will be achieved with the completion of the full Study."
研究首席研究員卡曼·賈科曼託尼奧博士評論說,”我們的初步評估表明,在七隻動物的隊列中,與未經治療的 “對照” 腫瘤相比,在接受過治療的三陰性乳腺癌小鼠腫瘤中,有7/7的帶有金納米棒的腫瘤在使用近紅外光進行單次治療後,腫瘤體積平均減少了80%。有趣的是,在所有病例中,我們在未經治療的遠處腫瘤中觀察到反應(腫瘤萎縮),這支持了我們的觀察結果與全身免疫原性反應一致的假設。這一觀察結果將成爲我們未來研究的重要重點。儘管這些初步結果令我們感到鼓舞,但仍有大量工作要做。這些研究旨在實現和確定統計意義,這將在完整研究完成後實現。”
The current study assesses the THT efficacy of using Sona's gold nanorods for their combined effect both in generating Targeted Hyperthermia in tumors exposed to near infrared light and as an immune modulator locally and in distant, untreated tumors. This portion of the study will continue to look for elevated immune activation and anti-tumor responses within the mouse models of breast cancer, melanoma and colorectal cancer, using THT alone and in combination with selected immunological agents commonly used in current cancer treatment protocols.
當前的研究評估了使用索納的金納米棒的THT功效,因爲它們在近紅外光照射下的腫瘤中產生靶向高溫以及作爲局部和遠距離未經治療的腫瘤中的免疫調節劑的綜合效應。該研究的這一部分將繼續單獨使用THT並與當前癌症治療方案中常用的特定免疫藥物聯合使用,在乳腺癌、黑色素瘤和結直腸癌的小鼠模型中尋找增強的免疫激活和抗腫瘤反應。
Also, the Company recently received its final report from the U.S. National Cancer Institute's ("NCI") Nanotechnology Characterization Laboratory ("NCL") of its polymer-coated gold nanorods, which included a third assessment of material from Sona, bringing the number of batches of Sona material validated by the NCL to a total of seven. The most recent assessment found improved physical uniformity (with all three batches measuring within 2.1 nanometers in length of each other) and greater purity when compared to past batches. These improvements have been achieved via certain manufacturing process improvements developed with the support of the NCL, and which, in addition to improving purity, may result in reduced costs of scaled manufacturing. This final report also confirmed that the data between all lots of the material that have been assessed are in general agreement.
此外,該公司最近收到了美國國家癌症研究所(“NCI”)納米技術表徵實驗室(“NCL”)關於其聚合物塗層金納米棒的最終報告,其中包括對Sona材料的第三次評估,使NCL驗證的Sona材料批次總數達到七批。最新的評估發現,與過去的批次相比,物理均勻性有所提高(所有三個批次的長度均在2.1納米以內),純度也更高。這些改進是通過在NCL的支持下開發的某些製造工藝改進實現的,這些改進除了提高純度外,還可能降低規模化製造的成本。這份最終報告還證實,已評估的所有批次材料之間的數據基本一致。
The studies conducted by NCL included endotoxin testing, hydrodynamic size by DLS, size and shape distribution by TEM, zeta potential, total gold concentration by inductively coupled plasma mass spectrometry (ICP-MS), total and free PEG and total surfactant concentration using RP-HPLC-CAD, and total gold concentration using ICP-MS.
NCL進行的研究包括內毒素測試、通過DLS測定的流體力學尺寸、透射電鏡的大小和形狀分佈、zeta電位、電感耦合等離子體質譜(ICP-MS)的總金濃度、使用RP-HPLC-CAD的總金濃度、使用RP-HPLC-CAD的總金濃度,以及使用ICP-MS的總金濃度。
The NCL was established by the National Cancer Institute ("NCI") to accelerate the progress of nanomedicine by providing preclinical characterization and safety testing of nanoparticles. The NCL is a collaborative effort between NCI, the U.S. Food and Drug Administration ("FDA"), and the National Institute of Standards and Technology ("NIST"). It is anticipated that the NCL report could be used in a future potential regulatory application for an investigational device exemption ("IDE") to support the biocompatibility of Sona's gold nanorods.
NCL由美國國家癌症研究所(“NCI”)設立,旨在通過提供納米顆粒的臨床前表徵和安全性測試來加快納米醫學的進展。NCL 是 NCL、美國食品藥品監督管理局(“FDA”)和國家標準與技術研究所(“NIST”)的合作項目。預計NCL報告可用於未來潛在的研究設備豁免(“IDE”)監管申請,以支持索納金納米棒的生物相容性。
Contact:
David Regan, CEO
+1-902-536-1932
david@sonanano.com
聯繫人:
首席執行官大衛·里根
+1-902-536-1932
david@sonanano.com
About Sona Nanotech Inc.
Sona Nanotech, a nanotechnology life sciences company, is developing Targeted Hyperthermia, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by Sona's gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (41-48°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion - thus enabling drugs to reach all tumor compartments more effectively. The size, shape, and surface chemistry of the nanorods target the leaky vasculature of solid tumors, and the selective thermal sensitivity of tumor tissue enables the therapy to deliver clean margins. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments.
關於 Sona Nanotech Inc.
納米技術生命科學公司Sona Nanotech正在開發靶向熱療,這是一種光熱癌症療法,它使用熱療來治療實體癌腫瘤。熱量通過紅外線傳遞到腫瘤,紅外光被腫瘤中的索納金納米棒吸收,並以熱量的形式重新發射。治療熱(41-48°C)刺激免疫系統,收縮腫瘤,使癌症幹細胞失活,並增加腫瘤灌注,從而使藥物能夠更有效地到達所有腫瘤隔室。納米棒的大小、形狀和表面化學成分靶向實體瘤滲漏的血管系統,而腫瘤組織的選擇性熱靈敏度使該療法能夠提供乾淨的邊緣。靶向熱療有望安全、有效、微創、具有競爭力的成本,是藥物治療和其他癌症治療的寶貴輔助手段。
Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles which it uses for the development of both cancer therapies and diagnostic testing platforms. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium ("CTAB") free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona's gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
Sona開發了多種製造金納米顆粒的專有方法,用於開發癌症療法和診斷測試平台。Sona Nanotech的金納米棒顆粒不含十六烷基三甲基銨(“CTAB”),消除了在醫療應用中使用其他金納米棒技術相關的毒性風險。預計Sona的金納米技術可能會被調整用於應用,作爲一種安全有效的多種藥物治療的輸送系統,但需要獲得包括加拿大衛生部和美國食品藥品管理局在內的各個監管委員會的批准。
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding the anticipated applications of Targeted Hyperthermia Therapy, the Dalhousie study, Sona's preclinical study plans, the potential impact of the planned studies and its product development plans. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
關於前瞻性信息的警示聲明:本新聞稿包括適用的加拿大證券立法規定的某些 “前瞻性陳述”,包括有關靶向高溫療法的預期應用、達爾豪西研究、索納的臨床前研究計劃、計劃研究及其產品開發計劃的潛在影響的聲明。前瞻性陳述必然基於許多假設或估計,這些假設或估計雖然被認爲是合理的,但受已知和未知的風險、不確定性和其他因素的影響,這些因素可能導致實際結果和未來事件與此類前瞻性陳述所表達或暗示的存在重大差異,包括索納可能無法成功獲得足夠的臨床和其他數據來提交監管文件、籌集足夠的額外資金、獲得專利或開發設想療法的風險,以及THT 可能無法證明具有目前預期的好處的風險。無法保證此類陳述會被證明是準確的,因爲實際結果和未來事件可能與此類陳述中的預期存在重大差異。因此,讀者不應過分依賴前瞻性陳述。除非法律要求,否則索納不打算或義務更新或修改任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。
Not for distribution to United States newswire services or for dissemination in the United States
不得分發給美國新聞通訊社或在美國傳播
譯文內容由第三人軟體翻譯。