Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical need conditions, has started its amended maximum-tolerated dose (“MTD”) phase 1B trial for Next Generation Capecitabine, or the combination of PCS6422 and capecitabine. The company announced that the first patient, who has been diagnosed with advanced, refractory gastrointestinal cancer, has been dosed. Previously, Processa reported that a single dose of its proprietary PSC6422 successfully inhibited dihydropyrimidine dehydrogenase (“DPD”), which resulted in capecitabine that was an estimated 50 times more potent than FDA-approved capecitabine; however, the improved potency did not last throughout the seven days of capecitabine dosing. According to the announcement, the amended protocol provides a more precise timeline of DPD inhibition and de novo formation while at the same time providing critical essential data about the effectiveness of a personalized medicine approach for Next Generation Capecitabine. “Our goal with Next Generation Capecitabine is to provide a more effective and/or safer therapy for patients with gastrointestinal cancer and other types of cancer,” said Processa chair and CEO Dr. David Young in the press release. “The revisions to the original protocol will now provide the data, which will not only allow us to significantly increase the potency of Next Generation Capecitabine throughout capecitabine dosing but could also lead to more optimal dosing for each patient through an individualized-personalized medicine approach. We expect to have preliminary data on a better Next Generation Capecitabine regimen by mid-2022 and anticipate that the MTD for Next Generation Capecitabine will be determined by the end of 2022. We then plan to move to either a phase 2B or phase 3 trial in 2023 based on our discussions with FDA.”
To view the full press release, visit https://ibn.fm/WHqpE
About Processa Pharmaceuticals Inc.
The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The company uses these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include PCS6422 (“PCS6422”), a metastatic colorectal cancer and breast cancer program; PCS499 (“PCS499”), an ulcerative necrobiosis lipoidica program; and PCS12852 (“PCS12852”), GI motility/gastroparesis program. The members of the Processa development team have been involved with more than 30 drug approvals by the FDA, including drug products targeted to orphan disease conditions, and more than 100 FDA meetings throughout their careers. 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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