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Medicus Pharma Ltd. Publishes Phase 1 Clinical Study Report Demonstrating Safety & Tolerability in All Participants With Basal Cell Carcinoma

Medicus Pharma Ltd. Publishes Phase 1 Clinical Study Report Demonstrating Safety & Tolerability in All Participants With Basal Cell Carcinoma

Medicus Pharma Ltd. 發佈第一期臨床研究報告,證明所有基底細胞癌參與者的安全性和耐受性
newsfile ·  02/15 20:30

The Clinical Study Report Also Describes Efficacy in 6 Participants

臨床研究報告還描述了6名參與者的療效

Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Medicus Pharma Ltd. (TSXV: MDCX) (FSE: N46) ("Medicus" or the "Company") is pleased to announce that it has published the abbreviated clinical study report (CSR) from the SKNJCT-001 Phase 1 safety and tolerability study.

安大略省多倫多--(Newsfile Corp.,2024年2月15日)——Medicus Pharma Ltd.(TSXV:MDCX)(FSE:N46)(“Medicus” 或 “公司”)欣然宣佈,它已經發布了 SKNJCT-001 1期安全性和耐受性研究的縮寫臨床研究報告(CSR)。

SKNJCT-001 is an open-label, dose-escalation, placebo-controlled trial to evaluate dose limiting toxicity (DLT), maximum tolerated dose (MTD), safety and tolerability of dissolvable microneedle arrays loaded with the chemotherapeutic agent doxorubicin (D-MNA) in participants with basal cell carcinoma (BCC). The study enrolled 13 subjects across five dose levels (25 ug, 50 ug, 100 ug, 200 ug, and placebo).

SKNJCT-001 是一項開放標籤、劑量遞增、安慰劑對照試驗,旨在評估基底細胞癌 (BCC) 參與者中載有化療藥物多柔比星 (D-MNA) 的可溶性微針陣列的劑量限制毒性 (DLT)、最大耐受劑量 (MTD)、安全性和耐受性。該研究招收了五種劑量水平(25微克、50微克、100微克、200微克和安慰劑)的13名受試者。

The study report is available at . The associated NCT number for the SKNJCT-001 trial is NCT03646188.

該研究報告可在以下網址獲得。SKNJCT-001 試驗的相關的 NCT 編號爲 NCT03646188。

Phase 1 study, SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA was found to be safe and well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), serious adverse events (SAE), or study discontinuations. Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The maximum tolerated dose was established at 200 ug.

1 期研究,SKNJCT-001 實現了其安全性和耐受性的主要目標。研究產品D-MNA被發現在所有參與研究的十三(13)名參與者中,在所有劑量水平下均安全且耐受性良好,沒有劑量限制毒性(DLT)、嚴重不良事件(SAE)或研究中止。此外,實驗室參數、生命體徵、心電圖和體格檢查中沒有全身影響或臨床上顯著的異常發現。最大耐受劑量確定爲200 ug。

The CSR also describes the efficacy of the investigational product, D-MNA, with 6 subjects experiencing complete responses. The Complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit. The participants profile, demonstrating complete responses, was diverse and all participants (6/6) had nodular subtype of BCC.

企業社會責任還描述了研究產品D-MNA的功效,6名受試者的反應完全正確。完全反應的定義是,在研究訪問結束後的最後一次切除中,BCC 在組織學上消失。參與者的概況顯示了完整的回應,並且所有參與者(6/6)的結節亞型均爲BCC。

The Company, earlier this year, has submitted to the United States Food and Drug Administration (FDA) a Phase 2 Investigational New Drug (IND) clinical protocol (SKINJCT-003) to non-invasively treat BCC using micro-array needles containing doxorubicin (D-MNA). The Company is seeking comments from the FDA to revise and amend the IND and finalize the protocol.

今年早些時候,該公司已向美國食品藥品監督管理局(FDA)提交了二期研究性新藥(IND)臨床方案(SKINJCT-003),使用含有多柔比星(D-MNA)的微陣列針頭對BCC進行非侵入性治療。該公司正在徵求美國食品和藥物管理局的意見,以修改和修改IND並最終確定協議。

The Company also announced that it has engaged the services of Independent Trading Group ("ITG") and Integral Wealth Securities Limited ("Integral") to provide market-making services with the objective of maintaining a reasonable market and improving the liquidity of the Company's common shares.

該公司還宣佈,已聘請獨立交易集團(“ITG”)和Integral Wealth Securities Limited(“Integral”)提供做市服務,目的是維持合理的市場並改善公司普通股的流動性。

Under the ITG agreement, ITG will receive compensation of $6500 per month, payable monthly in advance. The agreement is for an initial term of three months and will renew for additional one-month terms unless terminated. The agreement may be terminated by either party with 30 days' notice. There are no performance factors contained in the agreement and ITG will not receive shares or options as compensation. ITG and the Company are unrelated and unaffiliated entities and at the time of the agreement, neither ITG nor its principals have an interest, directly or indirectly, in the securities of the Company.

根據ITG協議,ITG將獲得每月6500美元的薪酬,按月提前支付。該協議的初始期限爲三個月,除非終止,否則將延長一個月的期限。任何一方均可提前 30 天通知終止該協議。協議中不包含任何績效因素,ITG不會獲得股票或期權作爲薪酬。ITG和公司是無關的獨立實體,在協議簽訂時,ITG及其委託人均未直接或間接地在公司的證券中擁有權益

Under the Integral agreement, Integral will receive compensation of $6000 per month, payable monthly in advance. The agreement is for an initial term of three month. There are no performance factors contained in the agreement and Integral will not receive shares or options as compensation. Integral and the Company are unrelated and unaffiliated entities and at the time of the agreement, neither Integral nor its principals have an interest, directly or indirectly, in the securities of the Company.

根據積分協議,Integral每月將獲得6000美元的補償,按月提前支付。該協議的初始期限爲三個月。協議中不包含任何績效因素,Integral不會獲得股票或期權作爲補償。Integral和公司是無關的獨立實體,在協議簽訂時,Integral及其委託人均未直接或間接地在公司的證券中擁有權益。

For further information contact:

欲了解更多信息,請聯繫:

Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com

卡羅琳·邦納,總統
(610) 636-0184
cbonner@medicuspharma.com

LHA Investor Relations
Tirth T. Patel
212-201-6614
tpatel@lhai.com

LHA 投資者關係
Tirth T. Patel
212-201-6614
tpatel@lhai.com

About Medicus Pharma Ltd:

關於 Medicus Pharma Ltd:

Medicus Pharma Ltd. (TSXV: MDCX) is a clinical stage, multi-strategy holding company focused on investing in and accelerating novel life sciences and bio-technology companies through FDA approved clinical trials.

Medicus Pharma Ltd.(多倫多證券交易所股票代碼:MDCX)是一家臨床階段、多策略的控股公司,專注於通過美國食品藥品管理局批准的臨床試驗,投資和加速新型生命科學和生物技術公司的發展。

Through our diverse experience and extensive industry network, we are building Medicus into a leading pharmaceutical holding company, committed to delivering better treatment outcomes and alleviate pain and suffering. Utilizing a thesis driven collaborative process, we identify, acquire and advance relatively de-risked clinical stage assets through clinical development and commercialization.

通過我們豐富的經驗和廣泛的行業網絡,我們正在將Medicus打造成一家領先的製藥控股公司,致力於提供更好的治療效果並減輕疼痛和痛苦。我們利用以論文爲導向的協作流程,通過臨床開發和商業化,識別、收購和推進風險相對較小的臨床階段資產。

SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell and squamous cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells.

SkInject Inc.是Medicus Pharma Ltd的全資子公司,處於發展階段,專注於將基底細胞和鱗狀細胞皮膚癌的新型非侵入性療法商業化,使用獲得專利的可溶性微針貼劑來提供用於根除腫瘤細胞的化療藥物。

Cautionary Notice on Forward-Looking Statements

關於前瞻性陳述的警示性通知

Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes future- oriented financial information with respect to prospective financial performance, financial position or cash flows that is presented as a forecast or a projection. Forward-looking statements are often but not always, identified by the use of such terms as "may", "might", "will", "will likely result", "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" or the negative and/or inverse of such terms or other similar expressions.

根據適用的證券法,本新聞稿中的某些信息構成 “前瞻性信息”。“前瞻性信息” 定義爲基於對未來經濟狀況和行動方針的假設的有關可能事件、狀況或財務業績的披露,包括以預測或預測形式列報的有關預期財務業績、財務狀況或現金流的面向未來的財務信息。前瞻性陳述通常但並非總是通過使用 “可能”、“可能”、“將”、“可能的結果”、“將”、“應該”、“估計”、“計劃”、“項目”、“預測”、“打算”、“期望”、“預期”、“相信”、“尋求”、“繼續”、“目標” 或此類術語的否定和/或反面來確定,其他類似的表達方式。

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's public filings on SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof, and thus are subject to change thereafter. The Company 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.

這些聲明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業績、業績或成就與此類聲明所表達或暗示的結果存在重大差異,包括公司在SEDAR+的公開文件中描述的風險因素,這些風險因素可能會影響公司普通股的交易價格和流動性等。本新聞稿中包含的前瞻性陳述受本警示聲明的明確限制,反映了我們截至本新聞稿發佈之日的預期,因此此後可能會發生變化。除非法律要求,否則公司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。

Readers are cautioned that the foregoing list is not exhaustive and readers are encouraged to review the Prospectus accessible on the Company's profile on SEDAR+ at . Readers are further cautioned not to place undue reliance on forward-looking statements 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.

請讀者注意,上述清單並不詳盡,鼓勵讀者在SEDAR+的公司簡介上查看招股說明書,網址爲。還提醒讀者不要過分依賴前瞻性陳述,因爲無法保證這些陳述所依據的計劃、意圖或預期會實現。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的結果存在重大差異。

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in 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投資交易所及其監管服務提供商(該術語在多倫多證券交易所風險投資交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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