Medicus Pharma Ltd. Announces Minor Use (MUMS) Designation From the FDA for Doxorubicin-Containing Microneedle Array (D-MNA) Patch
Medicus Pharma Ltd. Announces Minor Use (MUMS) Designation From the FDA for Doxorubicin-Containing Microneedle Array (D-MNA) Patch
Company to Submit Product Development Plan to Treat External Squamous Cell Carcinoma (SCC) in Horses
公司将提交针对马外部鳞状细胞癌(SCC)的产品开发计划
Toronto, Ontario and Philadelphia, Pennsylvania--(Newsfile Corp. - December 12, 2024) - Medicus Pharma Ltd. (NASDAQ: MDCX) (TSXV: MDCX) ("Medicus" or the "Company") is pleased to announce that its Investigational New Animal Drug (INAD File No.013880) has received Minor Use in Major Species Designation ("MUMS") from the U.S. Food and Drug Administration ("FDA") for its dissolvable Doxorubin-containing microneedle array (D-MNA) to treat external squamous cell carcinoma (SCC) in horses. The company received a notification from the FDA on December 9th 2024.
加拿大安大略省多伦多和美国宾夕法尼亚州费城--(资讯文件CORP - 2024年12月12日)- Medicus Pharma Ltd.(纳斯达克:MDCX)(TSXV:MDCX)("Medicus"或"公司")欣然宣布,其实验性新动物药品(INAD文件编号013880)已获得美国食品药品管理局("FDA")的主要物种小规模使用认证("MUMS"),用于治疗马的外部鳞状细胞癌(SCC)的可溶性多索沙星微针阵列(D-MNA)。公司于2024年12月9日收到FDA的通知。
MUMS is a status similar to Orphan Drug status for human drugs. It entitles the company to an extended 7-year period of exclusive marketing following approval or conditional approval, provided that the company meets all requirements for maintaining the designation.
MUMS是一种类似于人用药品的孤儿药状态的认证,允许公司在获批或条件获批后享有长达7年的独占市场资格,前提是公司满足所有保持该认证的要求。
"In a relatively short period of time, we have made remarkable progress with the FDA in advancing the clinical development program of the veterinary application of our novel D-MNA patch in treating SCC in horses," stated Dr. Raza Bokhari, Executive Chairman & CEO. "Developing a non-invasive treatment for equine SCC represents an untapped market opportunity that we are excited to pursue. The MUMS designation is an important catalyst to provide us a first mover advantage and also position us to possibly have a commercially viable product as early as 2026."
"在相对较短的时间内,我们已在推进针对马SCC的兽用应用的新型D-MNA贴片的临床开发计划与FDA取得了显著进展,"执行董事会主席兼首席执行官Dr. Raza Bokhari表示。"开发一种非侵入性治疗马SCC的方法代表了一个尚未开发的市场机会,我们对此感到兴奋。MUMS认证是为我们提供首发优势的重要催化剂,并使我们有可能在2026年尽早拥有商业化产品。"
Doxorubicin-containing microneedle array (D-MNA) is a patent protected dissovable transdermal patch with cellulose based microneedle arrays that are tip-loaded with doxorubicin. After application, the microneedles function by penetrating the strateum corneum layer of the skin, create a temporary microchannel, penetrate the tumor, dissolve and release doxorubicin into the target tumor, and eradicate the cancer cells.
含多索沙星的微针阵列(D-MNA)是一种受专利保护的可溶性经皮贴片,采用以纤维素为基础的微针阵列,针头装载多索沙星。贴片应用后,微针通过穿透皮肤表皮层,创造一个临时微通道,穿透肿瘤,溶解并释放多索沙星至目标肿瘤,灭活癌细胞。
Squamous Cell Carcinoma (SCC) in Horses
马的鳞状细胞癌(SCC)
SCC is a mucocutaneous skin tumor in horses, primarily affecting adult or aged horses with white or partially white coats. Breeds like Appaloosa, Belgian, American Paint, and Pinto are particularly susceptible. SCC often develops in areas with minimal pigmentation and sparse hair, notably around mucous membranes. More specifically, tumors are mainly seen around the eyes, lips, nose, anus, and external genitalia. The overall incidence of SCC is 2-3% and recent estimates of the US horse population range from 6.6 to 7.25 million horses.
SCC是马的一种粘膜皮肤肿瘤,主要影响成年或老年马,尤其是白色或部分白色毛发的马。像阿帕卢萨、比利时、美国斑马和班图马等品种特别容易受到影响。SCC通常出现在色素极少和毛发稀疏的区域,尤其是在粘膜周围。更具体地说,肿瘤主要出现在眼睛、嘴唇、鼻子、肛门和外生殖器周围。SCC的总体发生率为2-3%,最近的美国马匹数量估计在660,000到725万之间。
Current treatment includes surgery to remove the largest mass, cryotherapy of the smaller mass, and local injection of a chemotherapy drug. In some cases, a topical chemotherapeutic drug will be prescribed in the form of drops (tumors near the eye) or cream (tumors in other parts of body). Additionally, some horses are put on an oral drug called piroxicam that may slow the return of the cancerous cells.
当前治疗包括手术去除最大肿瘤,对小肿瘤进行冷冻疗法,以及局部注射化学治疗药物。在某些情况下,可能会开具局部化学治疗药物,以滴剂(眼睛附近的肿瘤)或乳膏(身体其他部位的肿瘤)形式使用。此外,一些马匹可能会口服一种叫做吡罗昔康的药物,这可能会减缓癌细胞的复发。
For further information contact:
如需更多信息,请联系:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
卡罗琳·博纳,主席
(610) 636-0184
cbonner@medicuspharma.com
Jeremy Feffer
LifeSci Advisors
(212) 915-2568
jfeffer@lifesciadvisors.com
杰雷米·费弗
LifeSci顾问
(212) 915-2568
jfeffer@lifesciadvisors.com
About Medicus Pharma Ltd:
关于Medicus Pharma Ltd:
Medicus Pharma Ltd. (NASDAQ: MDCX) (TSXV: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets.
Medicus Pharma Ltd.(纳斯达克:MDCX)(TSXV:MDCX)是一家生物科技/生命科学公司,致力于加速新型和颠覆性治疗资产的临床开发项目。
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 skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells. The Company has completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company submitted a Phase 2 IND clinical protocol to the FDA in January 2024 for a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) that is expected to randomize up to 60 patients. The study is designed to evaluate the efficacy of two dose of two dose levels (100 and 200 ug) of D-MNA compared to placebo (P-MNA) in subjects with nodular BCC. Patient recruitment is currently underway in nine sites across the United States.
SkinJect Inc.是Medicus Pharma Ltd.的全资子公司,作为一家开发阶段的生命科学公司,专注于商业化新型非侵入性治疗基础细胞皮肤癌,使用专利的可溶性微针贴片将化疗药物递送至肿瘤细胞以消灭肿瘤。该公司于2021年3月完成了一项1期安全性和耐受性研究(SKNJCt-001),达到了安全性和耐受性的主要目标;该研究还描述了调查产品D-MNA的疗效,六(6)名参与者在切除病变的组织学检查中显示完全反应。该公司于2024年1月向FDA提交了一项2期IND临床协议,进行一项随机、对照、双盲、多中心临床研究(SKNJCt-003),预计将随机选择多达60名患者。该研究旨在评估两种剂量水平(100和200微克)D-MNA与安慰剂(P-MNA)在结节性BCC患者中的疗效。患者招募目前正在美国九个地点进行。
Cautionary Notice on Forward-Looking Statements
关于前瞻性声明的警告通知
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, without limitation, statements regarding the Company's plans and expectations concerning, and future outcomes relating to, its product development plans and clinical development programs, including improvements thereto and the timing thereof, and approval from the FDA and the timing thereof. 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.
本新闻稿中的某些信息构成根据适用证券法的“前瞻性信息”。“前瞻性信息”被定义为基于对未来经济条件和行动方向的假设而披露的可能事件、条件或财务表现的信息,包括但不限于,关于公司的计划和预计情况,以及与其产品开发计划和临床开发项目相关的未来结果,包括对此的改进及其时间,及FDA的批准及其时间的声明。前瞻性声明通常但并非总是通过使用“可能”、“也许”、“将”、“可能将导致”、“将会”、“应该”、“估计”、“计划”、“项目”、“预测”、“打算”、“期望”、“预见”、“相信”、“寻求”、“继续”、“目标”或这些术语的否定和/或相反形式或其他类似表达来识别。
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+ and on EDGAR, 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.
这些陈述涉及已知和未知的风险、不确定性及其他因素,这些因素可能导致实际结果、表现或成就与这些陈述所表达或暗示的情况有重大差异,包括在公司在SEDAR+和EDGAR上公开的文件中描述的风险因素,这可能影响公司的普通股的交易价格和流动性。本新闻稿中包含的前瞻性陈述明确受到这一警示性声明的限制,并反映我们截至本日期的期望,因此此后可能会发生变化。公司不承担对任何前瞻性陈述进行更新或修订的意图或义务,无论是因新信息、未来事件或其他原因,除非法律要求。
Readers are cautioned that the foregoing list is not exhaustive and readers are encouraged to review the Company's long form prospectus accessible on the Company's profile on SEDAR+ at and on EDGAR at www.sec.gov. 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.
提醒读者,前述列表并非详尽无遗,并鼓励读者查阅公司在SEDAR+上的长形式招股说明书及在EDGAR上的资料(网址:www.sec.gov)。此外,提醒读者不要对前瞻性陈述过于依赖,因为无法保证所依据的计划、意图或期望会实现。尽管在准备时管理层认为这些信息是合理的,但可能会证明是错误的,实际结果可能与预期有重大差异。
Neither the 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.
TSX Venture Exchange及其监管服务提供者(如该术语在TSX Venture Exchange规定中所定义的)不对本新闻稿的充分性或准确性承担责任。