Hemostemix Announces Updated Phase II Randomized Clinical Trial Results Published by the Journal of Biomedical Research and Environmental Sciences
Hemostemix Announces Updated Phase II Randomized Clinical Trial Results Published by the Journal of Biomedical Research and Environmental Sciences
Calgary, Alberta--(Newsfile Corp. - February 6, 2024) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is pleased to announce the Journal of Biomedical Research and Environmental Sciences published the Company's Phase II randomized clinical trial results today.
艾伯塔省卡爾加里--(Newsfile Corp.,2024年2月6日)——Hemostemix Inc.(多倫多證券交易所股票代碼:HEM)(OTCQB:HMTXF)(FSE:2VF0)(“Hemostemix” 或 “公司”)很高興地宣佈,《生物醫學研究與環境科學雜誌》今天公佈了該公司的二期隨機臨床試驗結果。
The publication highlights the results of no option critical limb ischemia patients who started the clinical trial with an ulcer, comparing wound healing, amputation, and mortality between the patients treated with ACP-01 and patients treated with a placebo, and stated the following:
該出版物重點介紹了以潰瘍開始臨床試驗的無選擇嚴重肢體缺血患者的結果,比較了接受 ACP-01 治療的患者和接受安慰劑治療的患者的傷口癒合、截肢和死亡率,並指出以下內容:
- 67 patients with no option Critical limb ischemia were allocated to treatment with ACP-01 (46/67) or placebo (21/67).
- From this data, only patients who presented with wound ulcers before administration of ACP-01 were reviewed (21 treatment, 8 placebo).
- Ulcer size in the treated group decreased from a mean of 1.46 cm2 to 0.48 mm2 (p = 0.01) by 3 months. There was no significant decrease in the size of the ulcers of the placebo group (p < 0.54).
- At one year there were no complications related to treatment.
- The treatment group had one amputation (4.8%) and one death (4.8%).
- The placebo group had 2 amputations (25%) and 1 death (12.5%).
- 67 名別無選擇嚴重肢體缺血的患者被分配接受 ACP-01(46/67)或安慰劑(21/67)的治療。
- 根據這些數據,僅對在給藥 ACP-01 之前出現傷口潰瘍的患者進行了審查(21 種治療,8 種安慰劑)。
- 治療組的潰瘍大小從平均值 1.46 cm2 下降到 0.48 mm2(p = 0.01)延長 3 個月。安慰劑組的潰瘍大小沒有顯著減少 (p )。
- 一年內沒有出現與治療相關的併發症。
- 該治療組有一次截肢(4.8%)和一例死亡(4.8%)。
- 安慰劑組有2次截肢(25%)和1例死亡(12.5%)。
"In evaluating the subgroup of patients who presented with ulcerous wounds, there was a significant decrease in ulcer size at 3 months, lower amputation rate at 12 months, and a lower mortality rate at 12 months in the ACP-01 treatment group. Moreover, the 1-year death rate in the patients treated with ACP-01 for CLI (4.8%) was substantially less than the death rate reported in the literature of 15%-20% within 6 months of a CLI diagnosis . Similarly, the amputation rate of 4.8% in this treatment subgrouop compares favorably with the literature, the latter variably reporting amputation rates of 10%-40% per year.," stated Dr. Fraser Henderson, CMO.
“在評估出現潰瘍傷口的患者亞組時,ACP-01 治療組在 3 個月時潰瘍大小顯著減少,12 個月時截肢率降低,12 個月時死亡率降低。此外,接受 ACP-01 治療的 CLI 患者 1 年死亡率(4.8%)遠低於文獻中報告的在 CLI 診斷後 6 個月內的 15%-20% 的死亡率。同樣,該治療亞組的截肢率爲4.8%,與文獻相比處於有利地位,後者報告的截肢率爲每年10%-40%。” 首席營銷官弗雷澤·亨德森博士說。
"I want to thank the authors for their scientific contributions, and bringing this clinical data to fruition. The growing body of evidence in eight peer reviewed publications covering 318 subjects suggests that ACP-01 is safe and efficacious in the treatment of various forms of ischemia," stated Thomas Smeenk, CEO. "We will have additional news of the production of ACP-01 for revenue and clinical trials in the near future, as we are selling ACP-01 as treatment for CLI under exemption," Smeenk said.
“我要感謝作者的科學貢獻,並使這些臨床數據得以實現。在涵蓋318個受試者的八份同行評審出版物中,越來越多的證據表明,ACP-01 在治療各種形式的缺血方面是安全有效的,” 首席執行官托馬斯·斯梅恩克說。斯梅恩克說:“在不久的將來,我們將獲得更多關於生產 ACP-01 用於收入和臨床試驗的消息,因爲我們將根據豁免出售 ACP-01 作爲 CLI 的治療方法。”
ABOUT HEMOSTEMIX
Hemostemix is an autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling a patient's blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. For more information, please visit .
關於 HEMOSTEMIX
Hemostemix 是一家自體幹細胞療法公司,成立於 2003 年。作爲世界經濟論壇技術先鋒獎的獲得者,該公司開發了包括血管生成細胞前體、神經元細胞前體和心肌細胞前體在內的患者血液基幹細胞治療平台,並正在擴大其專利。欲了解更多信息,請訪問 。
For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder
EM: tsmeenk@hemostemix.com PH: 905-580-4170
欲了解更多信息,請聯繫: Thomas Smeenk,總裁、首席執行官兼聯合創始人
EM: tsmeenk@hemostemix.com 電話:905-580-4170
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
多倫多證券交易所風險交易所及其監管服務提供商(該術語由多倫多證券交易所風險交易所的政策定義)均不對本新聞稿的充分性或準確性承擔責任。
Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to: the publication of its Phase II randomized clinical trial results of its lead product ACP-01, the sales of ACP-01 as an exempt compassionate treatment, the Trademark Know Your Health! and related results, including the commercialization of ACP-01. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of the litigation that Hemostemix is pursuing or defending (the "Litigation"); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix's services and products; competition and Hemostemix's competitive advantages; and Hemostemix obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies, and any Litigation. 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 Hemostemix 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: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemis mayface; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression;the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at . Although Hemostemix 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. 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. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix 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.
前瞻性信息:本新聞稿包含適用的加拿大證券立法所指的 “前瞻性信息”。除歷史事實陳述外,此處包含的所有陳述均爲前瞻性信息。特別是,本新聞稿包含與以下內容有關的前瞻性信息:其主要產品 ACP-01 的二期隨機臨床試驗結果的公佈、作爲豁免同情療法的 ACP-01 的銷售、“了解你的健康” 商標!及相關成果,包括 ACP-01 的商業化。There 無法保證此類前瞻性信息會被證明是準確的。實際結果和未來事件可能與此類前瞻性信息中的預期存在重大差異。這些前瞻性信息反映了Hemostemix當前的信念,基於Hemostemix目前獲得的信息以及Hemostemix認爲合理的假設。這些假設包括但不限於:Hemostemix及其普通股的基本價值;Hemostemix提起或辯護的訴訟的成功解決(”訴訟“);ACP-01 研究、試驗、研究和分析的結果,包括分析等同於或優於先前的研究、試驗或研究;研究、試驗或研究所需的所有監管approvals 的收據;醫療保健行業的活動水平、市場接受度和市場趨勢;一般economy;Hemostemix 中的消費者interest服務和產品;競爭和Hemostemix 的競爭優勢;以及Hemostemix獲得令人滿意的融資, 爲Hemostemix的業務(包括任何研究、試驗或研究以及任何訴訟)提供資金。前瞻性信息受已知和未知風險、不確定性和其他因素的影響,這些因素可能導致Hemostemix的實際結果、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:Hemostemix完成臨床試驗、完成令人滿意的分析並提交此類分析結果以獲得監管部門批准 ACP-01 的二期或三期臨床試驗的能力;Hemostemis可能面臨的潛在訴訟;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;延遲或未能獲得董事會或監管機構的批准;未來運營的實際結果,包括未來研究、試驗或研究的實際結果;競爭;立法變化affecting Hemostemix;在可接受條件下外部融資的時機和可用性;Hemostemix市場及其預期競爭市場的長期資本要求和未來發展; 缺乏合格熟練勞動力或關鍵人員流失;以及風險related 到 COVID-19 疫情,包括政府當局向try 提出的限制疫情的各種建議、命令和措施,包括旅行限制、邊境關閉、非必要企業關閉、服務中斷、隔離、自我隔離、就地避難和保持社交距離、市場中斷、經濟活動中斷以及financings,供應鏈和銷售渠道中斷,總體經濟狀況惡化,包括possible 全國或全球衰退或蕭條;COVID-19 疫情可能對Hemostemix產生的潛在影響,其中可能包括對Hemostemix提供的服務的需求減少;以及金融市場的惡化可能限制Hemostemix獲得外部融資的能力。有關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Hemostemix的披露文件中找到,網址爲。儘管Hemostemix試圖確定可能導致實際結果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結果與預期、估計或預期的結果不符。請讀者注意,上述因素清單並不詳盡。還提醒讀者不要過分依賴前瞻性信息,因爲無法保證他們所依據的計劃、意圖或期望會實現。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Hemostemix截至本新聞發佈之日的預期,因此,在此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Hemostemix明確表示不打算或承擔任何更新或修改任何前瞻性信息的意圖或義務,無論這些信息是由於新信息、未來事件還是其他原因造成的。
譯文內容由第三人軟體翻譯。