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 dosed the first patient in its PCS6422 study. The study is a phase 1b dose-escalation evaluation of the safety and pharmacokinetics of fixed-dose PCS6422 with escalating doses of capecitabine administered orally to patients diagnosed with advanced, refractory gastrointestinal tract tumors. The open-label, multicenter trial is still enrolling patients. The company, whose strategyis to design and develop a pipeline of drugs to improve a patient’s benefit-risk profile compared to existing therapy, noted that PCS6422 is a prime example of the drugs in its pipeline. “We believe that the irreversible inhibitor effects of PCS6422 on the dihydropyrimidine dehydrogenase enzyme may significantly improve exposure to the cancer killing 5-FU metabolites while reducing the 5-FU metabolites, like α-fluoro-β-alanine, related to dose limiting side effects such as hand foot syndrome,” said Processa chief development officer Dr. Sian Bigora in the press release. “The dosing of the first patient in our Phase 1b trial represents an important step to explore PCS6422’s potential as a disease modifying therapy for capecitabine. By the end of 2021, we expect to have interim results evaluating the positive effect that PCS6422 has on capecitabine, while in 2022 we anticipate being able to define a new maximum tolerated dose and potential biomarkers for the PCS6422-capecitabine combination, which will help us to define the pivotal phase 3 study design needed for FDA approval.”
To view the full press release, visit https://ibn.fm/SrMj4
About Processa Pharmaceuticals Inc.
The mission of Processa is to develop drug products that improve the survival and/or quality of life for patients with high unmet medical need conditions. Processa is a development company, not a discovery company, that seeks to identify and develop drugs for patients who need better treatment options than presently exist for their medical condition. To increase the probability of development success, the company’s pipeline only includes drugs that have previously demonstrated some efficacy in the targeted population or a drug with similar pharmacological properties that has been shown to be effective in the population. Processa currently has three drugs in various stages of clinical development: PCS499 for ulcerative necrobiosis in phase 2B, PCS3117 for metastatic pancreatic cancer and non-small cell lung cancer in phase 2B, and PCS6422 for metastatic colorectal cancer and breast cancer in phase 1B. The PCS12852 IND for the treatment of gastroparesis will be submitted in 3Q2021. Members of the Processa development team throughout their careers have been involved with more than 30 FDA drug approvals (including drug products targeted to orphan disease conditions), more than 100 FDA meetings and two FDA regulatory science contracts. 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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