Medicus Pharma Ltd Receives Study May Proceed Approval from United Arab Emirates (UAE) Department of Health (DOH) to Commence Phase 2 Clinical Study (SKNJCT-004) to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)
Medicus Pharma Ltd (NASDAQ: MDCX) has received approval from the UAE Department of Health to begin a Phase 2 clinical study (SKNJCT-004) for treating Basal Cell Carcinoma (BCC) of the skin. The study will involve 36 patients across four UAE medical centers, including Cleveland Clinic Abu Dhabi.
The randomized, double-blind trial will evaluate two dose levels of D-MNA (100μg and 200μg) against a placebo. This follows successful Phase 1 results from March 2021, where the treatment showed safety and tolerability with 6 participants achieving complete responses. The company is also conducting a Phase 2 study (SKNJCT-003) in the US, which showed positive interim results with over 60% clinical clearance.
Additionally, Medicus recently announced plans to acquire Antev Ltd., a UK biotech company developing Teverelix for prostate cancer and urinary retention treatment.
Medicus Pharma Ltd (NASDAQ: MDCX) ha ottenuto l'approvazione dal Dipartimento della Salute degli Emirati Arabi Uniti per avviare uno studio clinico di Fase 2 (SKNJCT-004) per il trattamento del Carcinoma a cellule basali (BCC) della pelle. Lo studio coinvolgerà 36 pazienti in quattro centri medici degli Emirati, incluso il Cleveland Clinic Abu Dhabi.
Lo studio randomizzato e in doppio cieco valuterà due dosaggi di D-MNA (100μg e 200μg) rispetto a un placebo. Questo segue i risultati positivi della Fase 1 di marzo 2021, in cui il trattamento ha dimostrato sicurezza e tollerabilità con 6 partecipanti che hanno ottenuto risposte complete. L'azienda sta inoltre conducendo uno studio di Fase 2 (SKNJCT-003) negli Stati Uniti, che ha mostrato risultati intermedi positivi con oltre il 60% di clearance clinica.
Inoltre, Medicus ha recentemente annunciato l'intenzione di acquisire Antev Ltd., una società biotech britannica che sviluppa Teverelix per il trattamento del cancro alla prostata e della ritenzione urinaria.
Medicus Pharma Ltd (NASDAQ: MDCX) ha recibido la aprobación del Departamento de Salud de los Emiratos Árabes Unidos para iniciar un estudio clínico de Fase 2 (SKNJCT-004) para tratar el Carcinoma Basocelular (BCC) de la piel. El estudio involucrará a 36 pacientes en cuatro centros médicos de los EAU, incluyendo Cleveland Clinic Abu Dhabi.
El ensayo aleatorizado y doble ciego evaluará dos dosis de D-MNA (100μg y 200μg) frente a un placebo. Esto sigue a los exitosos resultados de la Fase 1 de marzo de 2021, donde el tratamiento demostró seguridad y tolerabilidad con 6 participantes que lograron respuestas completas. La compañía también está realizando un estudio de Fase 2 (SKNJCT-003) en EE. UU., que mostró resultados intermedios positivos con más del 60% de aclaramiento clínico.
Además, Medicus anunció recientemente planes para adquirir Antev Ltd., una empresa biotecnológica del Reino Unido que desarrolla Teverelix para el tratamiento del cáncer de próstata y la retención urinaria.
Medicus Pharma Ltd (NASDAQ: MDCX)가 UAE 보건부로부터 피부 기저세포암(BCC) 치료를 위한 2상 임상시험(SKNJCT-004) 시작 승인을 받았습니다. 이 연구는 클리블랜드 클리닉 아부다비를 포함한 UAE 내 4개 의료기관에서 36명의 환자를 대상으로 진행됩니다.
무작위 배정, 이중 맹검 방식의 이번 시험은 D-MNA의 두 용량(100μg 및 200μg)을 위약과 비교 평가합니다. 이는 2021년 3월 성공적인 1상 결과에 이은 것으로, 당시 치료는 안전성과 내약성을 입증했으며 6명의 참가자가 완전 반응을 보였습니다. 회사는 미국에서도 2상 연구(SKNJCT-003)를 진행 중이며, 60% 이상의 임상적 제거율이라는 긍정적인 중간 결과를 발표했습니다.
또한 Medicus는 최근 전립선암 및 요정체 치료제인 테베렐릭스를 개발하는 영국 바이오텍 기업 Antev Ltd. 인수 계획을 발표했습니다.
Medicus Pharma Ltd (NASDAQ : MDCX) a obtenu l'approbation du Département de la Santé des Émirats arabes unis pour lancer une étude clinique de Phase 2 (SKNJCT-004) visant à traiter le carcinome basocellulaire (BCC) de la peau. L'étude impliquera 36 patients dans quatre centres médicaux des Émirats, dont la Cleveland Clinic Abu Dhabi.
L'essai randomisé en double aveugle évaluera deux doses de D-MNA (100μg et 200μg) par rapport à un placebo. Cela fait suite aux résultats positifs de la Phase 1 en mars 2021, où le traitement a démontré sa sécurité et sa tolérance avec 6 participants ayant obtenu des réponses complètes. La société mène également une étude de Phase 2 (SKNJCT-003) aux États-Unis, qui a montré des résultats intermédiaires positifs avec plus de 60 % de clairance clinique.
De plus, Medicus a récemment annoncé son intention d'acquérir Antev Ltd., une société biotechnologique britannique développant Teverelix pour le traitement du cancer de la prostate et de la rétention urinaire.
Medicus Pharma Ltd (NASDAQ: MDCX) hat von der Gesundheitsbehörde der VAE die Zulassung erhalten, eine Phase-2-Studie (SKNJCT-004) zur Behandlung des Basalzellkarzinoms (BCC) der Haut durchzuführen. Die Studie wird 36 Patienten an vier medizinischen Zentren in den VAE umfassen, darunter die Cleveland Clinic Abu Dhabi.
Die randomisierte, doppelblinde Studie wird zwei Dosierungsstufen von D-MNA (100μg und 200μg) gegen ein Placebo vergleichen. Dies folgt auf erfolgreiche Phase-1-Ergebnisse vom März 2021, bei denen die Behandlung Sicherheit und Verträglichkeit zeigte und 6 Teilnehmer vollständige Remissionen erreichten. Das Unternehmen führt zudem eine Phase-2-Studie (SKNJCT-003) in den USA durch, die positive Zwischenergebnisse mit über 60 % klinischer Clearance zeigte.
Außerdem hat Medicus kürzlich Pläne bekannt gegeben, Antev Ltd., ein britisches Biotechnologieunternehmen, das Teverelix für die Behandlung von Prostatakrebs und Harnverhaltung entwickelt, zu übernehmen.
- Phase 1 study demonstrated safety with no dose-limiting toxicities or serious adverse events
- Previous study showed complete response in 6 participants with nodular BCC
- Positive interim analysis of US Phase 2 trial showing over 60% clinical clearance
- Expansion of clinical trial sites to Europe and UAE indicates strong growth trajectory
- Strategic acquisition of Antev Ltd. will expand product pipeline
- Small sample size of 36 participants in the UAE Phase 2 trial
- Interim results are preliminary and may not correlate with final study findings
Insights
Medicus's non-invasive BCC treatment advances with UAE Phase 2 approval, showing promising early efficacy signals from previous studies.
This regulatory milestone for Medicus Pharma represents a strategic geographic expansion of their clinical program for D-MNA, their non-invasive treatment for basal cell carcinoma (BCC). The newly approved UAE Phase 2 study (SKNJCT-004) will evaluate two dose levels (100μg and 200μg) against placebo, randomizing 36 patients across four prestigious medical centers in the UAE.
The maximum dose proposed (200μg) has already demonstrated a favorable safety profile in their completed Phase 1 study, with no dose-limiting toxicities or serious adverse events reported among the 13 participants. More impressively, 6 participants in that study achieved complete responses, defined as the histological disappearance of BCC at the final examination.
This UAE study complements their ongoing US-based Phase 2 trial (SKNJCT-003), which recently showed promising interim results with >60% clinical clearance after evaluating over 30 patients. This positive signal prompted expansion of that study from 60 to 90 subjects, indicating confidence in the treatment's potential.
The company's relationship with IROS, a UAE-based CRO under the M42 portfolio, provides valuable local expertise for navigating regional regulatory requirements. Conducting parallel studies across different geographies (US, UAE, and planned European expansion) demonstrates an aggressive development strategy that could accelerate the overall clinical timeline and broaden potential market access.
For investors, this multi-regional approach may indicate management's confidence in their candidate while potentially reducing regulatory risk through data from diverse patient populations. The non-invasive nature of D-MNA for treating a common skin cancer represents a potentially differentiated approach in a field where surgical excision remains the standard of care.
The Clinical Study Is Expected to Randomize 36 Participants in Cleveland Clinic Abu Dhabi (CCAD) and Three Other Clinical Sites in UAE
Philadelphia, Pennsylvania--(Newsfile Corp. - May 22, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce that it has received study may proceed approval from the UAE DOH to commence Phase 2 clinical study (SKNJCT-004) to non-invasively treat BCC of the skin.
The study is expected to randomize thirty-six (36) patients in four sites in UAE, which are Cleveland Clinic Abu Dhabi (CCAD), Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), and American Hospital of Dubai (AHD).
Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company.
Clinical Trial Design (SKNJCT-004)
The clinical study, SKNJCT-004, is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 36 subjects presenting with BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA.
The high-dose, 200μg D-MNA, proposed in the study is the maximum dose that was used in the Company's Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021.
SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA, was well tolerated across all dose levels in all 13 participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAEs). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with 6 participants 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.
The Company also has SKNJCT-003 Phase 2 clinical study currently underway in nine (9) clinical sites across United States which commenced randomizing patients in August 2024. In March 2025 the Company also announced a positively trending interim analysis for SKNJCT-003 demonstrating more the
In April 2025, the company also announced entering into a binding letter of intent to acquire Antev Ltd. ("Antev"), a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention (AURr) episodes due to enlarged prostate.
For further information contact:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com
About Medicus Pharma Ltd:
Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets.
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 is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in UAE.
In April 2025, the company also announced entering into a binding letter of intent to acquire Antev Ltd. ("Antev"), a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention (AURr) episodes due to enlarged prostate. The transaction with Antev is subject to the completion of satisfactory due diligence by Medicus, negotiation of definitive agreements, obtaining applicable corporate, regulatory and other third-party approvals and the fulfillment of customary closing conditions. No assurances can be made that the parties will successfully negotiate and enter into a definitive agreement, or that the proposed transactions will be consummated on the terms or timeframe currently contemplated, or at all.
Cautionary Notice on Forward-Looking Statements
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 commencement of the SKNJCT-004 study and the potential results of and benefits of such study, the potential Antev transaction, including the entry into a definitive agreement in respect of the Antev transaction, the closing of the transaction or the timing thereof, the potential benefits of the Antev transaction, if consummated, including plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix, and the potential market opportunities related thereto, the results of the interim analysis, which may or may not correlate with the findings of the clinical study report that will be compiled following completion of the phase 2 study, the Company's plans and expectations concerning, and future outcomes relating to, the submission and advancement of the phase 2 clinical protocol, the randomization of patients and size of the study, the Company's intention to complete and submit an interim data analysis to the FDA and to request a Type C meeting and the timing thereof, the Company's aim to fast fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, 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", "on track", "aim", "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. 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.
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 www.sedarplus.ca 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.
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FAQ
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