Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage biopharmaceutical company developing products to improve the survival and quality of life for patients who have unmet medical needs, has released information regarding its next-generation capecitabine study. According to the company, the next-generation capecitabine dosage regimen, which is a combination of PCS6422 administered with capecitabine, successfully inhibited dihydropyrimidine dehydrogenase (“DPD”), resulting in altering the metabolism of 5-fluoruracil (“5-FU”) during the first 24 to 48 hours after PCS6422 administration but not throughout the entire seven days of capecitabine dosing. PCSA plans to continue to evaluate the timeline of DPD inhibition and de novo formation in order to identify PCS6422 regimens that may inhibit DPD throughout capecitabine dosing. “Given the interim findings on the DPD activity, the company plans to modify the Phase 1b trial to not only determine the MTD of capecitabine but also to further evaluate the timeline of DPD inhibition and de novo formation in an effort to define 6422 regimens which will maintain DPD inhibition throughout capecitabine dosing,” said Processa Pharmaceuticals CEO and chair Dr. David Young in the press release. “Although in the first two cohorts, dose limiting toxicities (“DLTs”) did not occur and drug-related adverse events were only grade 1 with no hand-foot syndrome noted, we will postpone enrolling cohort 3 in order to modify our phase 1b protocol and interact with the FDA regarding the modification of our trial. The aims of our proposed modifications are to develop a more precise timeline of DPD inhibition, DPD de novo formation, as well as interpatient variability. Processa will begin to collect the data to individualize the treatment of next-generation capecitabine for cancer patients, leading to a more personalized or precision-based medicine approach.”
To view the full press release, visit https://ibn.fm/wQRY0
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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