Innovative NGC-Cap Clinical Trial for Breast Cancer Begins

Processa Pharmaceuticals Begins Exciting Phase 2 Trial

Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) is thrilled to announce a pivotal moment in cancer treatment as they have officially dosed the first patient in their Phase 2 clinical trial utilizing NGC-Cap against metastatic breast cancer. This milestone marks a significant step in the journey towards enhancing the efficacy and safety of breast cancer treatments.

Adaptive Design of the Phase 2 Trial

This innovative Phase 2 trial is designed as a randomized study that compares the new therapy NGC-Cap with the widely used monotherapy capecitabine. The main goal is to thoroughly evaluate NGC-Cap's safety and efficacy profile while identifying the optimal dosage regimen that best serves patients battling advanced breast cancer.

Insights from Leadership

David Young, PharmD, Ph.D., who serves as the President of Research and Development at Processa, remarked on the importance of this milestone. He expressed optimism that the Phase 2 trial will build upon the encouraging results from prior Phase 1b studies. The interim analysis results of this ongoing trial are anticipated to shed light on its potential effectiveness and are expected to be shared with stakeholders by mid-2025.

Global Scope and Patient Inclusion

This trial, designated NCT06568692, is not just a local endeavor. It represents a global effort, as it unfolds across multiple centers. The structure allows for the participation of 60 to 90 patients, enhancing the diversity of data collected on this treatment's effectiveness and safety. So far, three clinical trial sites, some hosting multiple locations, have secured the necessary institutional review board approvals and are actively recruiting patients, with plans to extend this reach to around 30 sites internationally.

The Problem of Metastatic Breast Cancer

Breast cancer remains a critical health concern globally, being the second most frequently identified cancer. The numbers are staggering: over 2 million new cases were registered recently, leading to approximately 665,000 deaths worldwide. Sadly, the survival rate for those diagnosed with metastatic breast cancer is only about 30% over five years, which emphasizes the urgent need for improved treatment alternatives.

How NGC-Cap Works

At the core of NGC-Cap is its innovative combination which integrates PCS6422, a unique irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of capecitabine. It's fascinating how capecitabine, an oral prodrug, converts in the body to 5-fluorouracil (5-FU) and subsequently metamorphoses into biologically active compounds that target cancer cells. However, ineffective conversion often results in debilitating side effects, reducing treatment efficacy. The inclusion of DPD inhibition is crucial as it mitigates the undesirable transformation of 5-FU, enhancing patient tolerance and therapeutic outcomes.

Processa's Commitment to Innovation

Processa Pharmaceuticals is driven by a mission to redefine cancer treatment through its Next Generation Chemotherapy (NGC) approach. They are focused on modifying existing FDA-approved therapies, optimizing them to change how these drugs are metabolized. With their strong regulatory science foundation, they aim to develop therapies that are not only more effective but also kinder to patients facing the difficulties of cancer treatments.

Looking Towards the Future

The launch of this Phase 2 trial illustrates Processa's unwavering commitment to advancing cancer treatment methodology. The insights gathered from this study have the potential to significantly alter the therapeutic landscape for patients suffering from metastatic breast cancer, inspired by the hope that lies within innovative treatments.

Frequently Asked Questions

What is NGC-Cap?

NGC-Cap is a novel treatment being investigated for metastatic breast cancer, combining the DPD inhibitor PCS6422 with low doses of capecitabine.

Why is the Phase 2 trial important?

The Phase 2 trial seeks to establish the safety and efficacy of NGC-Cap compared to standard treatments, which could lead to better patient outcomes.

How many patients will be involved in the trial?

Approximately 60 to 90 patients with advanced breast cancer are expected to participate in this global study.

When can results be expected?

The interim results from the trial are anticipated to be available around mid-2025, providing updates on NGC-Cap's effectiveness.

How does Processa Pharmaceuticals contribute to cancer care?

Processa Pharmaceuticals is dedicated to developing next-generation chemotherapy drugs, aiming to enhance the safety and effectiveness of current cancer treatments.

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