Processa Pharmaceuticals Announces FDA Clearance of IND Application for a Phase 2 Clinical Trial of NGC-Cap in Breast Cancer
Processa Pharmaceuticals (Nasdaq: PCSA) has received FDA clearance for its Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), paving the way for a Phase 2 clinical trial in advanced or metastatic breast cancer. The open-label study, set to begin enrollment in Q3 2024, will compare two doses of NGC-Cap to FDA-approved monotherapy capecitabine in 60-90 patients. Initial data is expected mid-2025.
NGC-Cap demonstrated 5-10 times more 5-fluorouracil exposure to cancer cells in a Phase 1b study, potentially offering greater efficacy with a similar or better safety profile than existing capecitabine treatments. The trial aims to evaluate NGC-Cap's safety-efficacy profile, determine optimal dosage regimens, and explore personalized therapy options for breast cancer patients.
Processa Pharmaceuticals (Nasdaq: PCSA) ha ricevuto l'approvazione della FDA per la sua domanda di Nuovo Farmaco Investigativo (IND) per il Capecitabina di Nuova Generazione (NGC-Cap), aprendo la strada a un trial clinico di Fase 2 per il cancro al seno avanzato o metastatico. Lo studio, che inizierà l'arruolamento nel terzo trimestre del 2024, confronterà due dosaggi di NGC-Cap con la capecitabina approvata dalla FDA in monoterapia su 60-90 pazienti. I dati iniziali sono attesi per metà del 2025.
NGC-Cap ha dimostrato di fornire 5-10 volte più esposizione al 5-fluorouracile per le cellule cancerose in uno studio di Fase 1b, offrendo potenzialmente una maggiore efficacia con un profilo di sicurezza simile o migliore rispetto ai trattamenti di capecitabina esistenti. Il trial ha l'obiettivo di valutare il profilo di sicurezza-efficacia di NGC-Cap, determinare i regimi di dosaggio ottimali e esplorare opzioni terapeutiche personalizzate per i pazienti affetti da cancro al seno.
Processa Pharmaceuticals (Nasdaq: PCSA) ha recibido la autorización de la FDA para su solicitud de Nuevo Medicamento de Investigación (IND) para Capecitabina de Nueva Generación (NGC-Cap), allanando el camino para un ensayo clínico de Fase 2 en cáncer de mama avanzado o metastásico. El estudio, que comenzará su reclutamiento en el tercer trimestre de 2024, comparará dos dosis de NGC-Cap con la capecitabina aprobada por la FDA en monoterapia en 60-90 pacientes. Se esperan datos iniciales para mediados de 2025.
NGC-Cap demostró 5-10 veces más exposición a 5-fluorouracilo en células cancerosas en un estudio de Fase 1b, potencialmente ofreciendo una mayor eficacia con un perfil de seguridad similar o mejor que los tratamientos de capecitabina existentes. El ensayo tiene como objetivo evaluar el perfil de seguridad y eficacia de NGC-Cap, determinar los regímenes de dosificación óptimos y explorar opciones de terapia personalizada para pacientes con cáncer de mama.
프로세사 제약(나스닥: PCSA)은 FDA로부터 차세대 카페시타빈(NGC-Cap)에 대한 새로운 약물 임상시험(IND) 신청 승인을 받았으며, 이를 통해 진행성 또는 전이성 유방암 대상의 2상 임상 시험이 가능해졌습니다. 오픈 라벨 연구는 2024년 3분기에 모집을 시작할 예정이며, 60-90명의 환자를 대상으로 NGC-Cap의 두 가지 용량을 FDA 승인 단일 요법 카페시타빈과 비교합니다. 초기 데이터는 2025년 중반에 제공될 예정입니다.
NGC-Cap은 1b상 연구에서 암 세포에 대해 5-10배 더 높은 5-플루오로우라실 노출을 나타내어 기존 카페시타빈 치료보다 유사하거나 더 나은 안전성 프로필로 더 높은 효능을 제공할 잠재력을 가지고 있습니다. 이 시험의 목표는 NGC-Cap의 안전성-효능 프로필을 평가하고, 최적의 용량 요법을 결정하며, 유방암 환자에게 맞춤형 치료 옵션을 탐색하는 것입니다.
Processa Pharmaceuticals (Nasdaq: PCSA) a reçu l'approbation de la FDA pour sa demande de médicament expérimental (IND) portant sur la Capécitabine de Nouvelle Génération (NGC-Cap), ouvrant la voie à un essai clinique de Phase 2 pour le cancer du sein avancé ou métastatique. L'étude, qui doit commencer son recrutement au troisième trimestre 2024, comparera deux doses de NGC-Cap à la capécitabine approuvée par la FDA en monothérapie sur 60-90 patients. Les premières données sont attendues pour la mi-2025.
NGC-Cap a démontré une exposition 5 à 10 fois supérieure au 5-fluorouracile dans les cellules cancéreuses lors d'une étude de Phase 1b, offrant potentiellement une plus grande efficacité avec un profil de sécurité similaire ou meilleur que les traitements à base de capécitabine existants. L'essai vise à évaluer le profil de sécurité-efficacité de NGC-Cap, à déterminer les schémas de dosage optimaux et à explorer les options de thérapie personnalisée pour les patients atteints de cancer du sein.
Processa Pharmaceuticals (Nasdaq: PCSA) hat die Genehmigung der FDA für ihren Antrag auf ein Investigational New Drug (IND) für Capecitabine der nächsten Generation (NGC-Cap) erhalten, was den Weg für eine Phase 2 klinische Studie bei fortgeschrittenem oder metastasiertem Brustkrebs ebnet. Die offene Studie, die im dritten Quartal 2024 mit der Rekrutierung beginnen soll, vergleicht zwei Dosen von NGC-Cap mit der von der FDA zugelassenen Monotherapie Capecitabine an 60-90 Patienten. Erste Daten werden Mitte 2025 erwartet.
NGC-Cap zeigte in einer Phase 1b Studie 5-10 mal höheres 5-Fluorouracil-Exposure für Krebszellen und könnte möglicherweise eine größere Wirksamkeit bei einem ähnlichen oder besseren Sicherheitsprofil im Vergleich zu bestehenden Capecitabine-Behandlungen bieten. Die Studie zielt darauf ab, das Sicherheits- und Wirksamkeitsprofil von NGC-Cap zu bewerten, optimale Dosierungsregime zu bestimmen und personalisierte Therapieoptionen für Brustkrebspatienten zu erkunden.
- FDA clearance of IND application for NGC-Cap, allowing Phase 2 trial initiation
- NGC-Cap showed 5-10 times more 5-fluorouracil exposure to cancer cells in Phase 1b study
- Potential for greater efficacy with similar or better safety profile compared to existing capecitabine treatments
- Phase 2 trial enrollment to begin in Q3 2024 with initial data expected mid-2025
- None.
Insights
The FDA clearance of Processa Pharmaceuticals' IND application for NGC-Cap marks a significant milestone in breast cancer treatment development. As an oncology researcher, I find several aspects of this news particularly intriguing:
- NGC-Cap's potential to deliver 5-10 times more 5-fluorouracil to cancer cells compared to standard capecitabine is remarkable. This increased potency could translate to improved efficacy in treating advanced or metastatic breast cancer.
- The safety profile, reported as better or similar to existing capecitabine monotherapy, is encouraging. If maintained in larger trials, this could offer patients a more tolerable treatment option.
- The adaptive design of the upcoming Phase 2 trial, comparing two NGC-Cap doses to standard capecitabine, aligns well with the FDA's Project Optimus Initiative. This approach should help optimize dosing strategies, potentially leading to more personalized treatment regimens.
However, it's important to note that while the Phase 1b results are promising, the true test will come in this larger Phase 2 study. The expected mid-2025 data readout will be pivotal in determining NGC-Cap's potential to address the unmet need for more effective, less toxic chemotherapy options in breast cancer treatment.
From a financial perspective, this FDA clearance for Processa Pharmaceuticals' NGC-Cap IND is a positive development, but investors should temper their expectations:
- The breast cancer market is substantial, with over 2 million cases diagnosed globally in 2022. A more effective capecitabine alternative could capture a significant market share.
- However, the timeline for potential commercialization is long. With initial Phase 2 data expected mid-2025, a product launch is likely several years away, assuming all trials are successful.
- Processa's financial position will be important to monitor. Clinical trials are expensive and the company may need additional funding to complete the development process.
- The adaptive trial design is financially prudent, potentially allowing for more efficient use of resources and faster decision-making based on interim results.
While this news is encouraging, it's important to note that many oncology drugs fail in later-stage trials. Investors should view this as a positive step but maintain a balanced perspective on the long road ahead for NGC-Cap's development and potential market entry.
The development of NGC-Cap raises several important ethical considerations:
- The potential for increased efficacy with a similar or better safety profile aligns well with the ethical principle of beneficence - maximizing benefits while minimizing harm to patients.
- The adaptive trial design, which allows for dose optimization and personalized therapy evaluation, reflects a commitment to patient-centered research. This approach could lead to more tailored treatments, potentially improving outcomes and quality of life for breast cancer patients.
- However, it's important to ensure that patient selection for the trial is equitable and representative of the diverse population affected by breast cancer. Ethical recruitment practices and clear informed consent processes will be essential.
- As the trial progresses, researchers must remain vigilant in monitoring for any unexpected side effects, particularly given the increased potency of NGC-Cap. The ethical obligation to protect trial participants must remain paramount.
Overall, the development of NGC-Cap appears to be proceeding with due consideration for ethical principles in clinical research. The potential to improve upon a widely used chemotherapy agent could significantly benefit patients, provided that rigorous ethical standards are maintained throughout the development process.
Open-label Phase 2 trial in breast cancer to begin this quarter
Initial data expected mid-2025
HANOVER, Md., July 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), its lead product candidate. The IND supports the initiation of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer, which is expected to begin enrollment this quarter.
“We are proud to achieve this significant milestone for NGC-Cap and look forward to entering the clinic for the treatment of advanced or metastatic breast cancer, where capecitabine is a standard of care. We previously demonstrated in our Phase 1b study that NGC-Cap is more potent than monotherapy capecitabine, providing up to 5-10 times more 5-fluorouracil exposure to cancer cells. This greater exposure resulted in a greater efficacy, with a safety profile better or similar to existing monotherapy with capecitabine,” stated David Young, PharmD, Ph.D., President of Research and Development. “Initial data from the Phase 2 trial are expected mid-2025.”
“Although capecitabine is among the most widely used chemotherapy drugs, particularly for the treatment of solid tumors, there remains the need for a more effective chemotherapy treatment with fewer or less-severe side effects,” he added. “We believe that NGC-Cap can fulfill this need.”
Breast cancer is the second most common cancer and a leading cause of cancer-related death. More than 2 million cases of breast cancer were diagnosed in 2022 with more than 665,000 deaths globally. The five-year survival rate for those diagnosed with metastatic disease is approximately
The Phase 2 study will be a global multicenter, open-label, adaptive design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients with advanced or metastatic breast cancer. The trial is designed to evaluate the safety-efficacy profile of NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens of NGC-Cap as required by the FDA Project Optimus Initiative and to evaluate the possibility of personalizing NGC-Cap therapy. Processa expects to enroll the first patient into this trial in the third quarter of 2024.
About Capecitabine Administered with PCS6422 (NGC-Cap)
NGC-Cap combines the administration of PCS6422, the Company’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of capecitabine. Capecitabine is the oral prodrug of 5-FU, and along with 5-FU is among the most widely used chemotherapy drugs, particularly for the treatment of solid tumors. When metabolized (after oral ingestion) it becomes 5-FU in the body, which, in turn, metabolizes to molecules called anabolites that actively kill duplicating cells, such as cancer cells, and to molecules called catabolites that only cause side effects. The presence of the DPD enzyme plays an integral role in the undesirable conversion of 5-FU to catabolites while simultaneously decreasing tumor exposure to 5-FU and it’s anabolites.
The NGC-Cap Phase 1b study evaluated ascending doses of capecitabine when combined with a fixed dose of PCS6422 in patients with advanced, relapsed or refractory progressive gastrointestinal tract cancer. These patients had to relapse from or fail all other treatments. NGC-Cap demonstrated greater 5-fluorouracil (5-FU) exposure and lower fluoro-beta-alanine (FBAL) exposure with a better or similar side effect profile compared with monotherapy capecitabine, as well as preliminary anti-tumor activity. In all evaluable patients who received one dose of PCS6422 and seven days of capecitabine, partial responses or stable disease was observed in
About Processa Pharmaceuticals, Inc.
Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path.
For more information, visit our website at www.processapharma.com.
Forward-Looking Statements
This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.
Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
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