Processa Pharmaceuticals: Advancements in Chemotherapy Pipeline
![Processa Pharmaceuticals: Advancements in Chemotherapy Pipeline](https://investorshangout.com/images/blog/ihnews-Processa%20Pharmaceuticals%3A%20Advancements%20in%20Chemotherapy%20Pipeline.jpg)
Processa Pharmaceuticals Provides Product Pipeline and Financial Update
Phase 2 trial with NGC-Cap in breast cancer underway
NGC-Cap Phase 1b trial demonstrated a favorable safety profile with preliminary anti-tumor activity
Preclinical studies demonstrated NGC-Iri delivers more cancer-killing SN-38 molecules to tumor than either irinotecan or Onivyde
HANOVER, Md. — Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, provides updates on its product pipeline, upcoming milestones and business activities, and reports financial results for the recent months.
“We made significant progress in advancing our three development programs year-to-date, with a particular focus on our lead candidate NGC-Cap,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “Upon receiving FDA clearance of our NGC-Cap IND application, we initiated a Phase 2 clinical trial in metastatic breast cancer. We look forward to enrolling patients in this multicenter, open-label study and expect to have an initial data readout in the near future.”
Key Program Updates
Processa is dedicated to developing next-generation chemotherapies (NGC) aimed at improving FDA-approved oncology drugs, to extend patient survival and enhance quality of life. This is done by modifying how the drugs are metabolized and distributed 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 to ensure a more favorable benefit-risk profile for its drugs.
PCS6422: Next-Generation Capecitabine (NGC-Cap)
NGC-Cap is an innovative combination of PCS6422 and capecitabine, which is the oral prodrug of 5-fluorouracil (5-FU). PCS6422 modifies the metabolism of 5-FU, achieving better distribution to target cancer cells. With FDA approval for a Phase 2 trial in metastatic breast cancer, Processa has begun a globally cooperative, open-label study, comparing NGC-Cap to monotherapy capecitabine. This is expected to improve patient outcomes through an efficient development program as outlined with the FDA.
Research Outcomes
The Phase 1b study of NGC-Cap indicated greater exposure of 5-FU in patients with advanced gastrointestinal cancers who had failed previous treatments. Results showed that approximately 66.7% of evaluable patients experienced partial responses or stable disease, demonstrating a progression-free survival of 5 to 11 months. This promising data supports NGC-Cap's potential to outperform existing therapies, warranting further evaluations and studies.
Current Trials and Future Initiatives
Processa is also developing PCS3117, a next-generation gemcitabine that may provide alternatives for patients resistant to typical gemcitabine treatment. The company is scheduled to engage FDA discussions to explore potential trial designs, emphasizing its mission to refine patient selection strategies.
Additionally, PCS11T, an analog of SN-38, is under investigation, aiming to improve efficacy and safety in various cancer types currently treated with irinotecan. Preclinical studies already indicated favorable distribution characteristics in tumors compared to alternative formulations.
Second Quarter Financial Results
For the second quarter of the current year, Processa reported research and development expenses of $1.7 million and general administrative expenses that rose to $1.4 million due to an increase in professional fees. The net loss for this quarter stood at $3.0 million, reflecting the exploration and development of innovative therapies and technologies.
About Processa Pharmaceuticals, Inc.
Processa is committed to creating next-generation chemotherapy drugs designed to enhance current oncology treatments. The ongoing efforts utilize an advanced combination of proven drug mechanisms, regulatory science approaches, and a strong pipeline of oncology products to deliver more effective and safer therapy options for cancer patients.
For more information, 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 concentrates on developing next-generation cancer therapies, focusing on enhancing safety and efficacy compared to existing treatments.
What recent trial has Processa initiated?
Processa has started a Phase 2 clinical trial for NGC-Cap, targeting metastatic breast cancer patients, following FDA approval.
How does NGC-Cap work?
NGC-Cap is designed to alter the metabolism of 5-FU to improve delivery to cancer cells, potentially enhancing therapeutic outcomes.
What were the financial results for the second quarter?
Processa reported a net loss of $3.0 million, with research and development expenses unchanged from the prior year.
Who can I contact for investor relations regarding Processa Pharmaceuticals?
You can reach Yvonne Briggs at LHA Investor Relations via (310) 691-7100 or ybriggs@lhai.com.
About Investors Hangout
Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/
Related Articles
- ARHT Media Reports Strong Q2 2024 Financial Results
- Par Pacific Holdings to Attend Key Investor Conferences
- Tarsus Pharmaceuticals Participates in Healthcare Conference
- TC Energy Completes $7.9 Billion Notes Offering Success
- ARHT Media Initiates Strategic Review of Operations
- Silvano Fashion Group Reports Q2 and 6M 2024 Financial Performance
- Nvidia Earnings Exceed Expectations Amid Market Challenges
- Market Updates: Technology Stocks Struggle Amid Earnings Reports
- HP Inc. Focuses on Cost Cuts and AI PCs for Growth
- Nvidia's Revenue Forecast: Key Insights and Market Reaction