InvestorWire NewsRoom

InvestorNewsBreak

InvestorNewsBreaks – Processa Pharmaceuticals Inc. (NASDAQ: PCSA) Announces Plans to Expand NGC-Cap Program into Advanced or Metastatic Breast Cancer
January 19, 2024

InvestorNewsBreaks – Processa Pharmaceuticals Inc. (NASDAQ: PCSA) Announces Plans to Expand NGC-Cap Program into Advanced or Metastatic Breast Cancer

Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage pharmaceutical company developing the next generation of chemotherapeutic drugs, today announced plans to expand the development of Next Generation Capecitabine (“NGC-Cap”) into the treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial. NGC-Cap combines the administration of PCS6422, the company’s irreversible dihydropyrimidine dehydrogenase (“DPD”) enzyme inhibitor, with the administration of low doses of the commonly used chemotherapy capecitabine, which is already approved as both monotherapy and combination therapy in breast cancer. The decision to begin with a Phase 2 trial in breast cancer followed Processa’s meeting with the FDA, where it was agreed that pursuing breast cancer would lead to a more efficient development program while providing a greater likelihood of FDA approval. “We believe the pursuit of an advanced or metastatic breast cancer indication for NGC-Cap is a logical progression for Processa as it represents a larger market than colorectal cancer with the potential to differentiate NGC-Cap from the presently approved capecitabine as well as other treatments for breast cancer. The FDA and Processa discussed the advantages and disadvantages of developing NGC-Cap in breast cancer and concluded that the development would be a more efficient and straightforward path to approval with an easier enrollment process for the Phase 2 and 3 trials,” said David Young, PharmD, Ph.D., president of research and development at Processa.

To view the full press release, visit https://ibn.fm/SbJCR

About Processa Pharmaceuticals Inc.

Processa is a clinical stage pharmaceutical company focused on developing the Next Generation Chemotherapy (“NGC”) drugs to improve the safety and efficacy of cancer treatment. By combining Processa’s novel oncology pipeline with proven cancer-killing active molecules and Processa’s Regulatory Science Approach as well as experience in defining Optimal Dosage Regimens for FDA approvals, Processa not only will be providing better therapy options to cancer patients but also increase the probability of FDA approval for its Next Generation Chemotherapy (“NGC”) drugs following an efficient path to approval. The company’s approach to drug development, based on more than 30 years of experience, uses its proven Regulatory Science Approach, including the determination of the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. Processa’s NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these FDA-approved drugs while maintaining the existing mechanisms of killing the cancer cells. The advantages of Processa’s NGCs are expected to include fewer patients experiencing side effects that lead to dose discontinuation, more significant cancer response, and a greater number of patients —- over 250,000 patients treated each year for each drug —– who will benefit from each NGC drug. Currently under development are three next generation chemotherapy oncology treatments: Next Generation Capecitabine (“PCS6422” and capecitabine to treat breast, metastatic colorectal, gastrointestinal, pancreatic, and other cancers), Next Generation Gemcitabine (“PCS3117” to treat pancreatic, lung, ovarian, breast, and other cancers), and Next Generation Irinotecan (“PCS11T” to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers). For more information, visit the company’s website at www.ProcessaPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA

About InvestorWire

InvestorWire (“IW”) is a specialized communications platform with a focus on advanced wire-grade press release syndication for private and public companies and the investment community. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, IW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, IW brings its clients unparalleled recognition and brand awareness. IW is where breaking news, insightful content and actionable information converge.

For more information, please visit https://www.InvestorWire.com

Please see full terms of use and disclaimers on the InvestorWire website applicable to all content provided by IW, wherever published or re-published: https://www.InvestorWire.com/Disclaimer

InvestorWire
Los Angeles, CA
www.InvestorWire.com
310.299.1717 Office
[email protected]

InvestorWire is powered by IBN

Recent NewsBreaks

NewsBreaks Categories

Get Started with InvestorWire

To distribute a release in the next 24 hours. Contact our client services team.

(310) 299-1717

Distribute a press release. Submit your release to get started.

Submit Press Release

Set up a Live demonstration. Schedule a date and time that works for you.

Schedule a LIVE Demo

Press Distribution

Explore Press Distribution Solutions

All releases include an unlimited word count* with full wire-grade syndication, our press release enhancement service, and a follow-up InvestorNewsBreak article distributed to thousands of editorial syndication partners.

Discover Add-on Solutions

Increase the impact of your achievements by adding these exclusive solutions from InvestorWire, delivered in conjunction with the InvestorBrandNetwork (IBN).