Processa Pharmaceuticals Shares Updates on Product Pipeline and Financial Performance
The Phase 2 trial for NGC-Cap in breast cancer is currently in progress.
Results from the NGC-Cap Phase 1b trial showed a favorable safety profile along with early signs of anti-tumor activity.
Preclinical studies have indicated that NGC-Iri delivers a higher concentration of cancer-fighting SN-38 molecules to tumors compared to both irinotecan and Onivyde.
HANOVER, Md. — Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), a clinical-stage pharmaceutical company dedicated to developing the next generation of chemotherapeutic drugs with enhanced efficacy and safety, has provided updates regarding its product pipeline, upcoming milestones, business activities, and financial results for recent months.
“We have made substantial progress in advancing our three development programs this year, particularly with our lead candidate NGC-Cap,” stated George Ng, Chief Executive Officer of Processa Pharmaceuticals. “After receiving FDA clearance for our NGC-Cap IND application, we launched a Phase 2 clinical trial focused on metastatic breast cancer. We are eager to begin enrolling patients in this multicenter, open-label study and anticipate an initial data readout soon.”
Key Program Developments
Processa is committed to creating next-generation chemotherapies (NGC) that aim to enhance FDA-approved oncology drugs, ultimately extending patient survival and improving quality of life. This is achieved by modifying the metabolism and distribution of these drugs within the body, specifically targeting cancer cells. The company employs a Regulatory Science Approach that incorporates principles from the FDA’s Project Optimus Oncology initiative, ensuring a more favorable benefit-risk profile for its drugs.
PCS6422: Next-Generation Capecitabine (NGC-Cap)
NGC-Cap is a novel combination of PCS6422 and capecitabine, which serves as the oral prodrug of 5-fluorouracil (5-FU). PCS6422 enhances the metabolism of 5-FU, allowing for better distribution to target cancer cells. With FDA approval for a Phase 2 trial in metastatic breast cancer, Processa has initiated a globally cooperative, open-label study that compares NGC-Cap with monotherapy capecitabine. This approach is expected to lead to improved patient outcomes through an efficient development program as outlined with the FDA.
Research Findings
The Phase 1b study of NGC-Cap revealed greater exposure of 5-FU in patients with advanced gastrointestinal cancers who had previously failed treatments. Approximately 66.7% of evaluable patients showed partial responses or stable disease, resulting in a progression-free survival range of 5 to 11 months. This encouraging data supports the potential of NGC-Cap to surpass existing therapies, justifying further evaluations and studies.
Current Trials and Future Plans
Processa is also in the process of developing PCS3117, a next-generation gemcitabine that may offer alternatives for patients who are resistant to standard gemcitabine treatments. The company plans to engage in discussions with the FDA to explore potential trial designs, reinforcing its commitment to refining patient selection strategies.
Additionally, PCS11T, an analog of SN-38, is under investigation with the goal of enhancing efficacy and safety across various cancer types currently treated with irinotecan. Preclinical studies have already shown favorable distribution characteristics in tumors compared to other formulations.
Second Quarter Financial Overview
In the second quarter of this year, Processa reported research and development expenses totaling $1.7 million, alongside a rise in general administrative expenses to $1.4 million due to increased professional fees. The net loss for this quarter was $3.0 million, reflecting the ongoing exploration and development of innovative therapies and technologies.
About Processa Pharmaceuticals, Inc.
Processa is dedicated to developing next-generation chemotherapy drugs aimed at enhancing current oncology treatments. Their ongoing efforts leverage a sophisticated combination of proven drug mechanisms, regulatory science approaches, and a robust pipeline of oncology products to provide more effective and safer therapeutic options for cancer patients.
For more information, please contact:
Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
Frequently Asked Questions
What is the focus of Processa Pharmaceuticals?
Processa Pharmaceuticals is focused on developing next-generation cancer therapies that aim to improve safety and efficacy compared to existing treatments.
What recent trial has Processa initiated?
Processa has launched a Phase 2 clinical trial for NGC-Cap, which targets patients with metastatic breast cancer, following FDA approval.
How does NGC-Cap work?
NGC-Cap is designed to modify the metabolism of 5-FU to enhance its delivery to cancer cells, potentially improving treatment outcomes.
What were the financial results for the second quarter?
For the second quarter, Processa reported a net loss of $3.0 million, with research and development expenses remaining consistent with the previous year.
Who can I contact for investor relations regarding Processa Pharmaceuticals?
You can contact Yvonne Briggs at LHA Investor Relations by calling (310) 691-7100 or via email at ybriggs@lhai.com.
