Processa Pharmaceuticals (NASDAQ: PCSA), a developer of next-generation chemotherapies (“NGCs”), has dosed the first patient in its NGC-Capecitabine (combination of PCS6422 and capecitabine) 300 mg dose group. This group is designed to obtain critical information on the drug exposure vs. adverse event relationship. The company noted that patients treated with next-generation chemotherapy-capecitabine have not had hand-foot syndrome or cardiotoxicity adverse events. “We are pleased to have now dosed the first patient in our 300 mg dose group,” said Processa Pharmaceuticals president and CEO Dr. David Young in the press release. “This dose group will provide more information on the drug exposure vs. adverse event relationship, which is critical to FDA approval given FDA’s Project Optimus Oncology initiative. In addition, the data obtained from this dose group will help us to better understand how PCS6422 alters capecitabine metabolism to form more cancer-killing metabolites and fewer metabolites that only cause dose-limiting side effects. We anticipate completion of enrollment in the phase 1B trial in mid-2023 and are excited to have high exposure of the cancer-killing metabolites without the hand-foot syndrome or cardiotoxicity side effects that typically occur in 50–70% of the patients presently treated with FDA-approved capecitabine. Further, we expect our discussions on our phase 2B trial with FDA in mid-April to enhance our collaboration with the FDA on their Project Optimus Oncology initiative for all our NGCs while clearing the way to both finalize our phase 2B protocol and to initiate the trial in the second half of this year.”
To view the full press release, visit https://ibn.fm/cXKug
About Processa Pharmaceuticals Inc.
Processa Pharmaceuticals has a mission to develop the next-generation chemotherapies (with existing clinical evidence of safety and efficacy) for cancer patients who need better cancer drugs to extend survival and/or improve their quality of lives. The company uses its Regulatory Science Approach and the principles of the FDA’s Project Optimus Oncology initiative to provide an efficient development program, increase the probability of approval, and provide a safer and better cancer treatment that can be easily differentiated from what is presently on the market and in development. Processa is developing three next-generation chemotherapy oncology treatments: Next-Generation Capecitabine (PCS6422 and Capecitabine to treat metastatic colorectal, gastrointestinal, breast, 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
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