Processa Pharmaceuticals Announces First Patient Dosed in Phase 2 Clinical Trial of NGC-Cap in Metastatic Breast Cancer
Processa Pharmaceuticals (Nasdaq: PCSA) has announced the dosing of the first patient in a Phase 2 clinical trial for NGC-Cap, targeting advanced or metastatic breast cancer. The trial (NCT06568692) is a global, multicenter, open-label study comparing two doses of NGC-Cap to FDA-approved monotherapy capecitabine in 60-90 patients.
Key points:
- The trial aims to evaluate NGC-Cap's safety-efficacy profile and determine optimal dosage regimens.
- Interim analysis results are expected in mid-2025.
- Three clinical trial sites have received approval, with plans to activate approximately 30 sites worldwide.
- Breast cancer is the second most common cancer globally, with over 2 million cases diagnosed in 2022.
- The five-year survival rate for metastatic breast cancer is approximately 30%.
Processa Pharmaceuticals (Nasdaq: PCSA) ha annunciato la somministrazione del primo paziente in un trial clinico di Fase 2 per NGC-Cap, mirato al carcinoma mammario avanzato o metastatico. Lo studio (NCT06568692) è uno studio globale, multicentrico e in aperto che confronta due dosi di NGC-Cap con la capecitabina, terapia monofarmaco approvata dalla FDA, su 60-90 pazienti.
Punti chiave:
- Lo studio mira a valutare il profilo di sicurezza-efficacia di NGC-Cap e a determinare i regimi posologici ottimali.
- I risultati dell'analisi intermedia sono attesi per la metà del 2025.
- Tre siti di studio clinico hanno ricevuto approvazione, con piani per attivare circa 30 siti in tutto il mondo.
- Il carcinoma mammario è il secondo tipo di cancro più comune a livello globale, con oltre 2 milioni di casi diagnosticati nel 2022.
- Il tasso di sopravvivenza a cinque anni per il carcinoma mammario metastatico è di circa il 30%.
Processa Pharmaceuticals (Nasdaq: PCSA) ha anunciado la dosis del primer paciente en un ensayo clínico de Fase 2 para NGC-Cap, dirigido al cáncer de mama avanzado o metastásico. El ensayo (NCT06568692) es un estudio global, multicéntrico y abierto que compara dos dosis de NGC-Cap con la capecitabina, terapia monofármaco aprobada por la FDA, en 60-90 pacientes.
Puntos clave:
- El ensayo tiene como objetivo evaluar el perfil de seguridad-eficacia de NGC-Cap y determinar los regímenes de dosificación óptimos.
- Se esperan resultados del análisis intermedio para mediados de 2025.
- Tres sitios de ensayos clínicos han recibido aprobación, con planes de activar aproximadamente 30 sitios en todo el mundo.
- El cáncer de mama es el segundo tipo de cáncer más común a nivel mundial, con más de 2 millones de casos diagnosticados en 2022.
- La tasa de supervivencia a cinco años para el cáncer de mama metastásico es de aproximadamente el 30%.
프로세사 제약(나스닥: PCSA)은 NGC-Cap에 대한 2상 임상시험의 첫 번째 환자 투여를 발표했습니다. 이 시험은 진행성 또는 전이성 유방암을 타겟으로 하고 있습니다. 연구(NCT06568692)는 NGC-Cap의 두 가지 용량을 FDA 승인 단일 요법인 카페시타빈과 비교하는 글로벌 다기관 개방형 연구로, 60~90명의 환자를 대상으로 하고 있습니다.
주요 사항:
- 이 시험은 NGC-Cap의 안전성-유효성 프로필을 평가하고 최적 복용량 요법을 결정하는 것을 목표로 합니다.
- 중간 분석 결과는 2025년 중반에 예상됩니다.
- 세 개의 임상 시험 사이트가 승인을 받았으며, 전 세계적으로 약 30개의 사이트를 활성화할 계획입니다.
- 유방암은 전 세계에서 두 번째로 흔한 암으로, 2022년에 200만 건 이상의 진단 사례가 있었습니다.
- 전이성 유방암의 5년 생존율은 약 30%입니다.
Processa Pharmaceuticals (Nasdaq: PCSA) a annoncé la dosage du premier patient dans un essai clinique de Phase 2 pour NGC-Cap, ciblant le cancer du sein avancé ou métastatique. L'essai (NCT06568692) est une étude mondiale, multicentrique et en ouvert comparant deux doses de NGC-Cap à la monothérapie de capécitabine approuvée par la FDA chez 60-90 patients.
Points clés :
- L'essai vise à évaluer le profil de sécurité-efficacité de NGC-Cap et à déterminer les schémas posologiques optimaux.
- Les résultats de l'analyse intermédiaire sont attendus pour mi-2025.
- Trois sites d'essai clinique ont reçu une approbation, avec des plans pour activer environ 30 sites dans le monde.
- Le cancer du sein est le deuxième cancer le plus courant au niveau mondial, avec plus de 2 millions de cas diagnostiqués en 2022.
- Le taux de survie à cinq ans pour le cancer du sein métastatique est d'environ 30 %.
Processa Pharmaceuticals (Nasdaq: PCSA) hat die Dosierung des ersten Patienten in einer Phase-2-Studie für NGC-Cap bekannt gegeben, die auf fortgeschrittenen oder metastasierten Brustkrebs abzielt. Die Studie (NCT06568692) ist eine globale, multizentrische, offene Studie, die zwei Dosen von NGC-Cap mit der von der FDA zugelassenen Monotherapie Capecitabine bei 60-90 Patienten vergleicht.
Wichtige Punkte:
- Die Studie zielt darauf ab, das Sicherheits- und Wirksamkeitsprofil von NGC-Cap zu bewerten und optimale Dosierungsschemata zu bestimmen.
- Die Ergebnisse der Zwischenanalyse werden für Mitte 2025 erwartet.
- Drei klinische Studienstandorte haben die Genehmigung erhalten, mit Plänen zur Aktivierung von etwa 30 Standorten weltweit.
- Brustkrebs ist die zweithäufigste Krebsart weltweit, mit über 2 Millionen diagnostizierten Fällen im Jahr 2022.
- Die fünfjährige Überlebensrate bei metastasiertem Brustkrebs liegt bei etwa 30%.
- First patient dosed in Phase 2 trial for NGC-Cap in metastatic breast cancer
- Trial designed to compare NGC-Cap to FDA-approved capecitabine
- Potential for NGC-Cap to be more effective and better tolerated than capecitabine and 5-FU
- Three clinical trial sites approved, with plans to expand to 30 sites worldwide
- Interim analysis results expected in mid-2025
- None.
Insights
The initiation of Processa Pharmaceuticals' Phase 2 trial for NGC-Cap in metastatic breast cancer is a significant development. This study aims to compare NGC-Cap with the standard-of-care capecitabine, potentially offering a more effective and tolerable treatment option. Key points to consider:
- The adaptive design allows for flexibility in determining optimal dosage, aligning with FDA's Project Optimus Initiative.
- The interim analysis expected in mid-2025 will be a critical milestone for assessing NGC-Cap's potential.
- With
30% 5-year survival rates for metastatic breast cancer, there's a clear unmet need for improved therapies. - The global scope of the trial, with plans for approximately 30 sites worldwide, suggests a robust study design.
While promising, investors should note that Phase 2 results are still preliminary. The true value proposition will depend on NGC-Cap demonstrating superior efficacy or safety compared to capecitabine, which could significantly impact Processa's market position in oncology.
The commencement of this Phase 2 trial for NGC-Cap is noteworthy in the breast cancer treatment landscape. Several aspects stand out:
- NGC-Cap's potential to improve upon capecitabine and 5-FU, which are cornerstone therapies in breast cancer treatment, could be game-changing if successful.
- The trial's design, comparing two NGC-Cap doses to standard capecitabine, is strategically sound for demonstrating potential superiority.
- The inclusion of personalized therapy evaluation is forward-thinking and aligns with the trend towards precision oncology.
However, it's important to temper expectations. Many promising cancer therapies fail in later-stage trials. The real test will be NGC-Cap's ability to meaningfully improve outcomes in a field where incremental gains are often the norm. The interim analysis in 2025 will provide critical insights, but full results will be necessary to assess NGC-Cap's true clinical impact and commercial potential.
- Phase 2 trial is an adaptive designed randomized study comparing NGC-Cap to monotherapy capecitabine
- Results from this Phase 2 trial will evaluate NGC-Cap’s safety-efficacy profile and help to define the optimal dosage regimen in patients with metastatic breast cancer
HANOVER, Md., Oct. 02, 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 first patient has been dosed in a Phase 2 clinical trial evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer.
“Dosing the first patient in this Phase 2 trial is a significant step in the development of NGC-Cap as a more effective and better tolerated treatment than widely used capecitabine and 5-FU,” stated David Young, PharmD, Ph.D., President of Research and Development at Processa. “We expect this Phase 2 trial to build upon NGC-Cap’s positive Phase 1b findings and we look forward to announcing the results from our interim analysis of this Phase 2 trial in mid-2025.”
The Phase 2 trial (NCT06568692) is a global multicenter, open-label, adaptive designed safety-efficacy 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.
To date, three clinical trial sites, including some with multiple clinical locations, have received institutional review board approval to participate in this study and are recruiting patients. Processa plans to activate approximately 30 sites worldwide.
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 breast cancer is approximately
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-fluorouracil (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 causing side effects while simultaneously decreasing tumor exposure to 5-FU and its cancer-killing anabolites.
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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