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Breakthrough Study from UCLA Demonstrate Can-Fite’s Piclidenoson as a Treatment for Vascular Dementia

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Can-Fite BioPharma (NYSE American: CANF) announced breakthrough results from a UCLA study demonstrating the efficacy of Piclidenoson in treating vascular dementia. The study, led by Dr. S. Thomas Carmichael at UCLA's Geffen School of Medicine, showed that Piclidenoson successfully restored tissue integrity and behavioral function in a vascular dementia mouse model.

Vascular dementia, the second most common form of dementia after Alzheimer's, currently has no FDA-approved treatments. The global market for vascular dementia treatments is valued at $6 billion as of 2025, with a projected 5% CAGR through 2035. Piclidenoson, a selective A3 adenosine receptor agonist, has already demonstrated a strong safety profile in hundreds of psoriasis patients through Phase 2 and Phase 3 clinical studies.

Can-Fite BioPharma (NYSE American: CANF) ha annunciato risultati rivoluzionari da uno studio condotto presso UCLA che dimostrano l'efficacia di Piclidenoson nel trattamento della demenza vascolare. Lo studio, guidato dal Dr. S. Thomas Carmichael presso la Geffen School of Medicine di UCLA, ha evidenziato come Piclidenoson sia riuscito a ripristinare l'integrità dei tessuti e la funzione comportamentale in un modello murino di demenza vascolare.

La demenza vascolare, la seconda forma più comune di demenza dopo l'Alzheimer, attualmente non dispone di trattamenti approvati dalla FDA. Il mercato globale per i trattamenti della demenza vascolare è valutato a 6 miliardi di dollari nel 2025, con un tasso di crescita annuo composto previsto del 5% fino al 2035. Piclidenoson, un agonista selettivo del recettore A3 dell'adenosina, ha già dimostrato un solido profilo di sicurezza in centinaia di pazienti con psoriasi durante studi clinici di Fase 2 e Fase 3.

Can-Fite BioPharma (NYSE American: CANF) anunció resultados innovadores de un estudio de UCLA que demuestra la eficacia de Piclidenoson en el tratamiento de la demencia vascular. El estudio, dirigido por el Dr. S. Thomas Carmichael en la Geffen School of Medicine de UCLA, mostró que Piclidenoson restauró con éxito la integridad tisular y la función conductual en un modelo murino de demencia vascular.

La demencia vascular, la segunda forma más común de demencia después del Alzheimer, actualmente no cuenta con tratamientos aprobados por la FDA. El mercado global para tratamientos de demencia vascular se valoró en 6 mil millones de dólares en 2025, con una tasa compuesta anual proyectada del 5% hasta 2035. Piclidenoson, un agonista selectivo del receptor A3 de adenosina, ya ha demostrado un sólido perfil de seguridad en cientos de pacientes con psoriasis durante estudios clínicos de Fase 2 y Fase 3.

Can-Fite BioPharma (NYSE American: CANF)� UCLA 연구에서 Piclidenoson� 혈관� 치매 치료� 효과적임� 입증� 획기적인 결과� 발표했습니다. UCLA� Geffen 의과대� Dr. S. Thomas Carmichael가 주도� � 연구� Piclidenoson� 혈관� 치매 � 모델에서 조직� 완전성과 행동 기능� 성공적으� 회복시켰음을 보여주었습니�.

혈관� 치매� 알츠하이머에 이어 � 번째� 흔한 치매 유형이며, 현재 FDA 승인 치료제가 없습니다. 혈관� 치매 치료제의 � 세계 시장 규모� 2025� 기준 60� 달러이며, 2035년까지 연평� 성장� 5%가 예상됩니�. Piclidenoson은 선택� A3 아데노신 수용� 작용제로�, 이미 수백 명의 건선 환자� 대상으� � 2� � 3� 임상시험에서 안전성이 입증되었습니�.

Can-Fite BioPharma (NYSE American : CANF) a annoncé des résultats révolutionnaires issus d'une étude de l'UCLA démontrant l'efficacité du Piclidenoson dans le traitement de la démence vasculaire. L'étude, dirigée par le Dr S. Thomas Carmichael à la Geffen School of Medicine de l'UCLA, a montré que le Piclidenoson a réussi à restaurer l'intégrité tissulaire et les fonctions comportementales dans un modèle murin de démence vasculaire.

La démence vasculaire, la deuxième forme la plus courante de démence après la maladie d'Alzheimer, ne bénéficie actuellement d'aucun traitement approuvé par la FDA. Le marché mondial des traitements de la démence vasculaire est estimé à 6 milliards de dollars en 2025, avec un taux de croissance annuel composé prévu de 5 % jusqu'en 2035. Le Piclidenoson, un agoniste sélectif du récepteur A3 de l'adénosine, a déjà démontré un bon profil de sécurité chez des centaines de patients atteints de psoriasis lors d'études cliniques de phases 2 et 3.

Can-Fite BioPharma (NYSE American: CANF) gab bahnbrechende Ergebnisse einer UCLA-Studie bekannt, die die Wirksamkeit von Piclidenoson bei der Behandlung von vaskulärer Demenz zeigt. Die Studie unter der Leitung von Dr. S. Thomas Carmichael an der Geffen School of Medicine der UCLA zeigte, dass Piclidenoson die Gewebeintegrität und das Verhalten in einem Mausmodell der vaskulären Demenz erfolgreich wiederherstellte.

Vaskuläre Demenz, die zweithäufigste Form der Demenz nach Alzheimer, hat derzeit keine von der FDA zugelassenen Behandlungen. Der globale Markt für vaskuläre Demenzbehandlungen wird für 2025 auf 6 Milliarden US-Dollar geschätzt, mit einer prognostizierten jährlichen Wachstumsrate (CAGR) von 5 % bis 2035. Piclidenoson, ein selektiver A3-Adenosinrezeptor-Agonist, hat bereits in Phase-2- und Phase-3-Studien an Hunderten von Psoriasis-Patienten ein gutes Sicherheitsprofil gezeigt.

Positive
  • Successful demonstration of Piclidenoson's efficacy in vascular dementia mouse model
  • Large market opportunity with $6 billion global market size and 5% CAGR
  • Established safety profile from previous clinical trials in hundreds of patients
  • Potential first-in-class treatment for currently untreated condition
Negative
  • Still in early experimental stages for vascular dementia indication
  • Will require extensive clinical trials before potential FDA approval
  • Faces competition from existing off-label treatments

Insights

UCLA study shows Can-Fite's Piclidenoson restored function in vascular dementia mice models, targeting a $6B market with no FDA-approved treatments.

This UCLA-led preclinical study represents a potentially significant advancement in vascular dementia treatment. The research demonstrated that Piclidenoson, an A3 adenosine receptor agonist, restored tissue integrity and behavioral function in a mouse model specifically designed to replicate human vascular dementia pathophysiology.

What makes this finding particularly noteworthy is the complete lack of FDA-approved therapies for vascular dementia, the second most common form of dementia after Alzheimer's. Current approaches rely on off-label use of drugs like donepezil or memantine, which only address symptoms rather than modify disease progression.

The mechanism of action—targeting the A3 adenosine receptor—is scientifically sound for this application. A3AR modulation has established anti-inflammatory properties, which is relevant since vascular dementia involves inflammatory processes following cerebrovascular damage. Piclidenoson has already demonstrated a favorable safety profile in hundreds of psoriasis patients through Phase 2 and 3 trials, suggesting potential for faster clinical development.

With a $6 billion global market growing at a projected 5% CAGR through 2035, the commercial opportunity is substantial. The aging global population and increased diagnosis rates further expand this potential market. If Piclidenoson advances successfully through clinical trials for this indication, it could address a significant unmet medical need while capturing meaningful market share as a first-in-class agent for vascular dementia.

Ramat Gan, Israel, July 28, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced that a leading group from University of Los Angeles (UCLA), demonstrate that Piclidenoson showed efficacy in an experimental model of vascular dementia.

The study headed by Dr.  S. Thomas Carmichael, M.D., Ph.D., Professor and Chair Frances Stark Chair, Department of Neurology, Geffen School of Medicine at UCLA, utilized  a vascular dementia mouse model with focal ischemia replicating many elements of the complex pathophysiology of human vascular dementia. Piclidenoson was found to restore tissue integrity and behavioral function in this vascular dementia model.

Vascular dementia is the second most common cause of dementia after Alzheimer's disease, and caused by impaired blood flow to the brain, often due to stroke or chronic small vessel disease. There are no U.S. FDA approved therapies for this condition. Drugs that are used off-label, including donepezil or memantine, are used symptomatically or to address co-morbidities. Additionally, antihypertensives, antiplatelets, and statins are used to prevent further vascular damage, but none of these medications are disease-modifying. Nevertheless, due to an aging population and increasing diagnosis, the global market for Vascular Dementia is estimated at $6 billion as of 2025, with an expected CAGR of 5% through 2035.

“A first-in-class agent such as Piclidenoson that could provide neuroprotection and improve vascular health would fill a significant unmet need and likely capture a large share of the growing Vascular Dementia market.,� stated Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma.

Piclidenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile in hundreds of patients with Psoriasis and demonstrated anti-inflammatory activity in Phase 2 and Phase 3 clinical studies.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: .

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements�. Forward-looking statements can be identified by the use of forward-looking words such as “believe,� “expect,� “intend,� “plan,� “may,� “should� or “anticipate� or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our market and other conditions, history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors� section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on April 14, 2025 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contact

Can-Fite BioPharma

Motti Farbstein

+972-3-9241114


FAQ

What are the results of UCLA's study on Can-Fite's (CANF) Piclidenoson for vascular dementia?

The UCLA study demonstrated that Piclidenoson successfully restored tissue integrity and behavioral function in a vascular dementia mouse model with focal ischemia.

What is the market size for vascular dementia treatments in 2025?

The global market for vascular dementia treatments is estimated at $6 billion in 2025, with an expected growth rate of 5% CAGR through 2035.

Are there any FDA-approved treatments for vascular dementia?

No, there are currently no FDA-approved therapies for vascular dementia. Current treatments are used off-label, including donepezil and memantine.

What is Piclidenoson's current development status for Can-Fite (CANF)?

Piclidenoson is a selective A3 adenosine receptor agonist that has completed Phase 2 and Phase 3 clinical studies for psoriasis, demonstrating safety in hundreds of patients.

How does vascular dementia compare to other types of dementia?

Vascular dementia is the second most common cause of dementia after Alzheimer's disease, caused by impaired blood flow to the brain due to stroke or chronic small vessel disease.
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