Aditxt Subsidiary Pearsanta Submits a Grant Application Seeking to Advance Clinical Trials for Mitomic® Prostate Test, Targeting Early Detection in High-Risk Patients
Aditxt (NASDAQ: ADTX) subsidiary Pearsanta has submitted a $2 million grant application to the DoD's Prostate Cancer Research Program. The funding aims to advance clinical trials for the Mitomic® Prostate Test (MPT™), a blood test for early detection of clinically significant prostate cancer. The proposed study involves validating MPT™ and conducting a randomized clinical trial with up to 1,000 men to evaluate its effectiveness in reducing unnecessary biopsies.
The prostate cancer diagnostic market is expected to grow from $6.2 billion in 2023 to $11.5 billion by 2032. Prostate cancer affects 1 in 8 men, with an estimated 299,010 new cases and 35,250 deaths expected in the US this year. Pearsanta's Mitomic Technology Platform uses mitochondrial DNA mutations for early disease detection, focusing on various cancers and conditions like endometriosis.
Pearsanta, una sussidiaria di Aditxt (NASDAQ: ADTX), ha presentato una richiesta di finanziamento di 2 milioni di dollari al Programma di Ricerca sul Cancro Prostatico del DoD. Il finanziamento è volto a potenziare gli studi clinici per il Test Prostatico Mitomic® (MPT™), un esame del sangue per la rilevazione precoce del cancro prostatico clinicamente significativo. Lo studio proposto prevede di convalidare l'MPT™ e di condurre uno studio clinico randomizzato su un massimo di 1.000 uomini per valutarne l'efficacia nella riduzione delle biopsie non necessarie.
Il mercato della diagnostica per il cancro prostatico è previsto crescere da 6,2 miliardi di dollari nel 2023 a 11,5 miliardi di dollari entro il 2032. Il cancro alla prostata colpisce 1 uomo su 8, con un stimato 299.010 nuovi casi e 35.250 decessi previsti negli Stati Uniti quest'anno. La Piattaforma Tecnologica Mitomic di Pearsanta utilizza le mutazioni del DNA mitocondriale per la rilevazione precoce delle malattie, concentrandosi su vari tipi di cancro e condizioni come l'endometriosi.
Pearsanta, una subsidiaria de Aditxt (NASDAQ: ADTX), ha presentado una solicitud de subvención de 2 millones de dólares al Programa de Investigación del Cáncer de Próstata del DoD. El financiamiento tiene como objetivo avanzar en los ensayos clínicos para el Test Prostatico Mitomic® (MPT™), un análisis de sangre para la detección temprana de cáncer de próstata clínicamente significativo. El estudio propuesto implica validar el MPT™ y realizar un ensayo clínico aleatorizado con hasta 1,000 hombres para evaluar su efectividad en la reducción de biopsias innecesarias.
Se espera que el mercado de diagnóstico del cáncer de próstata crezca de 6.2 mil millones de dólares en 2023 a 11.5 mil millones de dólares para 2032. El cáncer de próstata afecta a 1 de cada 8 hombres, con un estimado de 299,010 nuevos casos y 35,250 muertes previstas en EE. UU. este año. La Plataforma Tecnológica Mitomic de Pearsanta utiliza mutaciones del ADN mitocondrial para la detección temprana de enfermedades, enfocándose en varios tipos de cáncer y condiciones como la endometriosis.
Aditxt (NASDAQ: ADTX)의 자회사 Pearsanta가 DoD의 전립선암 연구 프로그램에 200만 달러 규모의 보조금 신청서를 제출했습니다. 이 자금은 Mitomic® 전립선 검사(MPT™)의 임상 시험을 진행하기 위한 것입니다. MPT™는 임상적으로 중요한 전립선암을 조기에 발견하는 혈액 검사입니다. 제안된 연구는 MPT™를 검증하고 1,000명까지의 남성을 대상으로 무작위 임상 시험을 실시하여 불필요한 생검을 줄이는 효율성을 평가하는 것입니다.
전립선암 진단 시장은 2023년 62억 달러에서 2032년 115억 달러로 성장할 것으로 예상됩니다. 전립선암은 8명 중 1명에게 발생하며, 올해 미국에서 299,010개의 신규 사례와 35,250명의 사망자가 예상됩니다. Pearsanta의 Mitomic 기술 플랫폼은 조기 질병 발견을 위해 미토콘드리아 DNA 변이를 사용하며, 다양한 암과 자궁내막증과 같은 질환에 집중하고 있습니다.
Pearsanta, une filiale d'Aditxt (NASDAQ: ADTX), a soumis une demande de subvention de 2 millions de dollars au Programme de Recherche sur le Cancer de la Prostate du DoD. Le financement vise à faire avancer les essais cliniques pour le Test Prostatique Mitomic® (MPT™), un test sanguin pour la détection précoce du cancer de la prostate cliniquement significatif. L'étude proposée vise à valider le MPT™ et à réaliser un essai clinique randomisé avec jusqu'à 1 000 hommes pour évaluer son efficacité à réduire les biopsies inutiles.
Le marché du diagnostic du cancer de la prostate devrait passer de 6,2 milliards de dollars en 2023 à 11,5 milliards de dollars d'ici 2032. Le cancer de la prostate touche 1 homme sur 8, avec environ 299 010 nouveaux cas et 35 250 décès prévus aux États-Unis cette année. La plateforme technologique Mitomic de Pearsanta utilise des mutations de l'ADN mitochondrial pour la détection précoce des maladies, en se concentrant sur divers cancers et conditions telles que l'endométriose.
Pearsanta, eine Tochtergesellschaft von Aditxt (NASDAQ: ADTX), hat einen 2-Millionen-Dollar-Zuschussantrag beim Prostatakrebsforschungsprogramm des DoD eingereicht. Die Finanzierung zielt darauf ab, klinische Studien für den Mitomic® Prostatatest (MPT™), einen Bluttest zur frühen Erkennung von klinisch signifikantem Prostatakrebs, voranzutreiben. Die vorgeschlagene Studie umfasst die Validierung des MPT™ und die Durchführung einer randomisierten klinischen Studie mit bis zu 1.000 Männern, um die Wirksamkeit zur Reduzierung unnötiger Biopsien zu bewerten.
Der Markt für Diagnostik von Prostatakrebs wird voraussichtlich von 6,2 Milliarden Dollar im Jahr 2023 auf 11,5 Milliarden Dollar bis 2032 wachsen. Prostatakrebs betrifft 1 von 8 Männern, und in den USA werden in diesem Jahr schätzungsweise 299.010 neue Fälle und 35.250 Todesfälle erwartet. Die Mitomic-Technologie-Plattform von Pearsanta nutzt Mutationen der mitochondrialen DNA zur frühen Krankheitsdiagnose und konzentriert sich auf verschiedene Krebserkrankungen und Zustände wie Endometriose.
- Potential $2 million non-dilutive funding for clinical trials
- MPT™ blood test shows robust diagnostic performance for clinically significant prostate cancer
- Prostate cancer diagnostic market expected to grow from $6.2 billion to $11.5 billion by 2032
- Mitomic Technology Platform has potential for early detection of various cancers and conditions
- Grant application outcome uncertain
- Clinical trial results and effectiveness of MPT™ not yet proven
- Closing of transactions with Appili and Evofem subject to various conditions and approvals
Insights
The submission of a grant application by Pearsanta for the Mitomic® Prostate Test (MPT™) is a potentially significant step in prostate cancer diagnostics. The $2 million funding sought could accelerate the validation and clinical trial process for this blood-based test, which detects a specific mitochondrial DNA deletion associated with clinically significant prostate cancer.
If successful, the MPT™ could address a critical need in prostate cancer screening. The test aims to better identify men with PSA levels in the 2-10 ng/mL range who have clinically significant prostate cancer, potentially reducing unnecessary biopsies. This is particularly important given the high prevalence of prostate cancer and the limitations of current screening methods.
However, it's important to note that this is still in the early stages. The grant application doesn't guarantee funding and even if funded, the clinical trial results will be critical in determining the test's actual effectiveness and potential market impact.
The prostate cancer diagnostic market presents a significant opportunity, with projected growth from
Pearsanta's MPT™, if successful, could capture a portion of this growing market. The test's potential to reduce unnecessary biopsies aligns with the trend towards non-invasive, cost-effective diagnostic solutions. However, market penetration will depend on:
- Clinical trial results demonstrating clear advantages over existing methods
- Regulatory approvals
- Adoption by healthcare providers and inclusion in screening guidelines
While promising, investors should be cautious. The path from grant application to market success is long and uncertain, especially in the competitive and highly regulated healthcare sector.
Prostate Cancer Diagnostic Market: Expected Growth from
The MPT™, a blood test detecting a specific 3.4 kb mitochondrial DNA deletion, has shown robust diagnostic performance for clinically significant prostate cancer. The proposed study aims to first validate the MPT™ in its CLIA/CAP facility in
Prostate cancer is a significant health concern worldwide, according to the World Health Organization (WHO), with an estimated 1.5 million new cases diagnosed globally in 2024, making it the second most common cancer among men and the fourth most common cancer overall. In
Pearsanta’s Mitomic Technology Platform seeks to harness the unique properties of mitochondrial DNA (mtDNA) to detect disease through non-invasive, blood-based liquid biopsies. This platform is designed to identify specific mutations in mtDNA indicative of various diseases. Due to its high mutation rate and cell persistence, mtDNA has the potential to be an excellent biomarker for early disease detection. Currently, the program focuses on developing tests for early cancer detection, ovarian, prostate, and lung cancers, and addressing non-cancerous conditions like endometriosis.
“Submitting this grant application to the Prostate Cancer Research Program is a significant step in our ongoing mission to revolutionize early disease detection,” said Christopher Mitton, President of Pearsanta. “Prostate cancer remains one of the most challenging cancers for men worldwide, highlighting the urgent need for more accurate and non-invasive diagnostic tools. We believe that securing this non-dilutive funding would allow us to accelerate our efforts to demonstrate the test's clinical utility and contribution to prostate cancer diagnostics. The MPT™ has the potential to significantly improve clinical outcomes by reducing unnecessary biopsies and enabling the early detection of prostate cancers. As we advance the validation of the MPT™ for clinical use and position it as a laboratory-developed test, we are confident that this innovation, if successful, will transform prostate cancer diagnostics and improve patient outcomes globally."
The DoD’s PCRP Implementation Science Award is a highly competitive funding opportunity to accelerate the adoption of evidence-based practices in prostate cancer care. Pearsanta's application underscores its commitment to advancing healthcare through innovative diagnostic solutions and reflects its ongoing efforts to address some of the most pressing challenges in healthcare.
Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, commented, “Through the Aditxt platform, we are seeking to accelerate Pearsanta’s path to commercialization, positioning it for long-term success as it advances innovations in precision health. This aligns with our broader strategy to accelerate each subsidiary to achieve growth and make a significant impact. By advancing these efforts, we aim to bring promising innovations to market that address critical healthcare needs and improve patient outcomes globally.”
Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women’s health. For the latter two programs, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. (“Evofem”) (OTCQB: EVFM), which focuses on women’s health. Each program will be designed to function autonomously while collectively advancing Aditxt’s mission of discovering, developing, and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close.
About Aditxt, Inc.
Aditxt, Inc.® is an innovation platform dedicated to discovering, developing, and deploying promising innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued and empowers collective progress.
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About Pearsanta, Inc.
Pearsanta is a commercial-stage company dedicated to revolutionizing precision diagnostics through advanced technologies. Leveraging its proprietary Mitomic® Technology Platform, Pearsanta focuses on early disease detection, significantly improving patient outcomes. The company’s diagnostic portfolio includes ovarian and prostate cancers and endometriosis tests. By identifying specific mitochondrial DNA (mtDNA) mutations, Pearsanta’s non-invasive, blood-based liquid biopsies provide rapid and accurate disease detection. Committed to enhancing lifelong well-being, Pearsanta addresses critical healthcare needs with innovative solutions that empower individuals to achieve optimal health.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s ability to finance and execute its strategic M&A initiatives; the Company’s ability to obtain the necessary funding and partner to commence clinical trials; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth, and strategies; the Company’s ability to raise additional capital; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled “Risk Factors” in Aditxt’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Mary O’ Brien
mobrien@aditxt.com
(516) 753-9933
Source: Aditxt, Inc.
FAQ
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