Citius Oncology Deploys AI Platform to Amplify the Performance of its Commercial Team Ahead of LYMPHIR Launch
Citius Oncology (NASDAQ:CTOR) has announced the deployment of a proprietary AI platform to enhance its commercial team's performance ahead of the anticipated LYMPHIR™ launch for cutaneous T-cell lymphoma (CTCL) treatment. The platform leverages advanced data analytics and machine learning to identify potential LYMPHIR candidates and optimize healthcare provider engagement.
The AI system analyzes treatment patterns and diagnosis data to support targeted prescriber outreach. It features a continuous learning model that integrates real-world U.S. claims data and marketing performance analytics to deliver predictive insights and enable personalized customer engagement across digital and in-person channels.
Citius Oncology (NASDAQ:CTOR) ha annunciato l'implementazione di una piattaforma proprietaria di AI per potenziare le performance del team commerciale in vista del previsto lancio di LYMPHIR™ per il trattamento del linfoma cutaneo a cellule T (CTCL). La piattaforma sfrutta analisi avanzate dei dati e machine learning per individuare potenziali candidati a LYMPHIR e migliorare il coinvolgimento dei professionisti sanitari.
Il sistema di AI esamina i pattern terapeutici e i dati diagnostici per supportare attività di contatto mirato con i prescrittori. Include un modello di apprendimento continuo che integra i dati real-world delle richieste di rimborso negli Stati Uniti e le analisi delle performance di marketing, offrendo insight predittivi e permettendo un engagement personalizzato con i clienti su canali digitali e in presenza.
Citius Oncology (NASDAQ:CTOR) ha anunciado el despliegue de una plataforma propietaria de IA para mejorar el desempeño de su equipo comercial antes del esperado lanzamiento de LYMPHIR™ para el tratamiento del linfoma cutáneo de células T (CTCL). La plataforma utiliza análisis de datos avanzados y aprendizaje automático para identificar posibles candidatos a LYMPHIR y optimizar el compromiso con los proveedores de atención médica.
El sistema de IA analiza patrones de tratamiento y datos de diagnóstico para apoyar un alcance dirigido a los prescriptores. Cuenta con un modelo de aprendizaje continuo que integra los datos del mundo real de reclamaciones en EE. UU. y analíticas de rendimiento de marketing para ofrecer perspectivas predictivas y permitir un compromiso personalizado con los clientes tanto en canales digitales como presenciales.
Citius Oncology (NASDAQ:CTOR)는 피부 T세포 림프종(CTCL) 치료제 LYMPHIR™의 출시를 앞두고 상업팀의 성과를 향상시키기 위해 자체 AI 플랫폼을 도입했다고 발표했습니다. 해당 플랫폼은 고급 데이터 분석과 머신러닝을 활용해 LYMPHIR 후보군을 식별하고 의료진과의 접촉을 최적화합니다.
이 AI 시스템은 치료 패턴과 진단 데이터를 분석해 표적화된 처방자 소통을 지원합니다. 연속 학습 모델을 포함하고 있어 미국 실제 청구 데이터와 마케팅 성과 분석을 통합하여 예측 인사이트를 제공하고 디지털 및 대면 채널 전반에 걸쳐 맞춤형 고객 참여를 가능하게 합니다.
Citius Oncology (NASDAQ:CTOR) a annoncé le déploiement d'une plateforme propriétaire d'IA afin d'améliorer les performances de son équipe commerciale avant le lancement attendu de LYMPHIR™ pour le traitement du lymphome cutané à cellules T (CTCL). La plateforme exploite des analyses de données avancées et le machine learning pour repérer les candidats potentiels à LYMPHIR et optimiser l'engagement des professionnels de santé.
Le système d'IA analyse les schémas de traitement et les données de diagnostic pour appuyer des actions ciblées auprès des prescripteurs. Il comprend un modèle d'apprentissage continu qui intègre les données de remboursements réelles aux États-Unis et des analyses de performance marketing pour fournir des insights prédictifs et permettre un engagement client personnalisé via des canaux numériques et en personne.
Citius Oncology (NASDAQ:CTOR) hat die Einführung einer proprietären KI-Plattform angekündigt, um die Leistung seines Vertriebsteams vor dem erwarteten Start von LYMPHIR™ zur Behandlung des kutanen T-Zell-Lymphoms (CTCL) zu verbessern. Die Plattform nutzt fortgeschrittene Datenanalytik und Machine Learning, um potenzielle LYMPHIR-Kandidaten zu identifizieren und die Interaktion mit Gesundheitsdienstleistern zu optimieren.
Das KI-System wertet Behandlungsverläufe und Diagnosedaten aus, um gezielte Prescriber-Ansprache zu unterstützen. Es verfügt über ein kontinuierlich lernendes Modell, das Real-World-Claims-Daten aus den USA und Marketing-Performance-Analysen integriert, prädiktive Erkenntnisse liefert und personalisierte Kundenansprache über digitale und persönliche Kanäle ermöglicht.
- Implementation of AI platform to enhance commercial team efficiency and targeting
- Continuous learning model integrating real-world claims data for improved decision-making
- Platform designed to optimize lean commercial infrastructure and accelerate healthcare provider education
- LYMPHIR product not yet launched - pending market introduction
- Effectiveness of the AI platform remains unproven in real-world application
Insights
Citius Oncology's AI platform deployment should enhance LYMPHIR's commercial launch by optimizing targeting and engagement with healthcare providers.
Citius Oncology's deployment of a proprietary AI platform represents a strategic move to maximize the efficiency of its commercial launch for LYMPHIR, its novel therapy for cutaneous T-cell lymphoma (CTCL). The platform appears designed to address one of the most significant challenges in specialty pharmaceutical launches: precisely identifying the right prescribers whose patients could benefit from the therapy.
The system leverages machine learning algorithms to analyze treatment patterns and diagnosis data, creating a feedback loop that continuously refines targeting precision. This approach is particularly valuable in rare disease categories like CTCL, where identifying appropriate patients is challenging due to the small, dispersed patient population.
The platform's integration of U.S. claims data and marketing performance analytics creates a dynamic system that should allow Citius to optimize its commercial strategy in real-time as market conditions evolve. By enabling more precise targeting and personalized engagement strategies, the company can potentially accelerate physician education and adoption while operating with a leaner commercial infrastructure than traditionally required for specialty product launches.
This technology investment indicates Citius is taking a data-driven approach to commercialization, which could translate to more efficient use of marketing resources and potentially faster market penetration for LYMPHIR upon approval. For a smaller biopharmaceutical company, this capability may help level the playing field against larger competitors with more extensive commercial resources.
Proprietary model informs targeted sales and marketing strategies with feedback loop that
augments precision and impact of targeting and engagement
The proprietary system uses company-defined criteria to identify patterns in treatment and diagnosis, enabling our commercial team to immediately target prescribers whose patients may benefit from LYMPHIR. The platform uses machine learning to continuously refine its ability to identify potential LYMPHIR candidates and allow the commercial team to support more informed patient care.
"We look forward to having this innovative AI platform amplify the precision and impact of our experienced commercial and marketing teams. This proprietary platform is designed to augment the clinical expertise and experience of our salesforce. It is a tool that enhances how we connect science, clinical need and patient access in a more intelligent and scalable way," stated Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma.
Designed as a continuous learning model, the AI platform adapts over time through ongoing integration of real-world
By leveraging robust data analysis, experienced sales and marketing professionals, and machine learning, Citius Oncology is uniquely positioned to optimize its lean commercial infrastructure, accelerate healthcare provider education, and most importantly, enhance clinical decision-making and access to care for patients living with CTCL.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface of tumor cells and immunosuppressive regulatory T-cells (T-regs) and is internalized. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. This action leads to direct tumoricidal effects as well as a transient depletion of T-regs to enhance overall antitumor activity.
In 2021, denileukin diftitox received regulatory approval in
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.
INDICATION
LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CAPILLARY LEAK SYNDROME
Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS
Capillary Leak Syndrome
LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome.
As defined, CLS occurred in
Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated.
Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL.
Visual Impairment
LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in
Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation.
Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity.
Infusion-Related Reactions
LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in
Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion [see Dosage and Administration (2.3)]. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.
Interrupt or discontinue LYMPHIR based on severity [see Dosage and Administration (2.4)]. Institute appropriate medical management.
Hepatotoxicity
LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in
Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.
Embryo-Fetal Toxicity
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR.
ADVERSE REACTIONS
The most common adverse reactions (≥
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.
Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.
In the
Lactation
Risk Summary
No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.
Females and Males of Reproductive Potential
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman.
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR.
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose.
Infertility
Males
Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown.
Pediatric Use
Safety and effectiveness of LYMPHIR in pediatric patients have not been established.
Geriatric Use
Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Citius Pharmaceuticals at 1-844-459-6744.
Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR.
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius is actively engaged with the FDA to outline next steps for both programs. Citius Pharmaceuticals owns
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma or Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; our ability to use the latest technology to support our commercialization efforts; our need for substantial additional funds; our ability to maintain Nasdaq's continued listing standards; our ability to successfully implement and maintain distribution agreements with current or other future distribution partners; potential disruptions or performance issues involving third-party logistics providers; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's and Citius Pharma's Annual Reports on Forms 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Oncology, Inc.
FAQ
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