Processa (NASDAQ: PCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced positive efficacy results from the preliminary evaluation of its recently completed Phase 1b clinical trial. The trial defined the maximum tolerated dose (“MTD”) and recommended Phase 2 dose range (“RP2DR”) for Next Generation Capecitabine (“NGC-Cap”) administered to patients with stage III or IV gastrointestinal tract (“GI”) cancer. “We are encouraged by the preliminary efficacy analysis from our NGC-Cap Phase 1b dose-escalating safety/tolerability trial demonstrating some anti-tumor activity in patients with advanced GI cancer who have progressive cancer after relapsing or not responding to prior therapy. The favorable response is likely due to NGC-Cap’s ability to distribute more 5-FU to cancer cells than monotherapy capecitabine. The promising Phase 1b safety and tolerability profile plus these early efficacy signals provide validation for further development of NGC-Cap,” said David Young, PharmD, Ph.D., president of research and development at Processa. “From this Phase 1b trial, we have been able to define the MTD and the RP2DR to use in our Phase 2 Optimal Dosage Regimen trial in breast cancer in the third quarter of 2024.”
To view the full press release, visit https://ibn.fm/yp48Q
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 its novel oncology pipeline with proven cancer-killing active molecules and the Processa Regulatory Science Approach, as well as experience in defining Optimal Dosage Regimens for FDA approvals, Processa not only will provide better therapy options to cancer patients but will also increase the probability of FDA approval for its NGC drugs following an efficient path to approval. Processa’s NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. The company’s approach to drug development is based on more than 30 years of expertise to efficiently design and conduct clinical trials that demonstrate a positive benefit/risk relationship. The Processa team has a track record of obtaining over 30 indication approvals across almost every division of the FDA. Using its proven Regulatory Science Approach, the Processa Team has experience defining the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. 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 – in excess of 200,000 for each NGC drug – who will benefit from each NGC drug. Processa is currently 1) starting to initiate sites for the Phase 2 study that will identify the optimal dosage regimen for Next Generation Capecitabine (“PCS6422” and capecitabine to treat breast, metastatic colorectal, gastrointestinal, pancreatic and other cancers), 2) defining the design of the Next Generation Gemcitabine (“PCS3117” to treat pancreatic, biliary, lung, ovarian, breast and other cancers) Phase 2 optimal dosage regimen study to discuss with FDA, and 3) defining the formulation and toxicology program for 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
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