Processa Pharmaceuticals (NASDAQ: PCSA), a diversified clinical-stage company developing products to improve survival and/or the quality of life for patients who have an unmet medical need conditions, is reporting positive results from its ongoing Next-Generation Capecitabine (“NGC”) phase 1B trial. According to the company, the trial indicates that NGC dosage regimens may have potential better safety and efficacy profiles than current chemotherapy options. The company is reporting that the NGC dosage regimens are significantly more potent than existing FDA-approved capecitabine therapy; they also form less of the metabolites that cause dose-limiting side effects with no tumor-killing properties. According to the announcement, the company anticipates meeting with the U.S. Food and Drug Administration (“FDA”) next year to confirm that its phase 2B trial design conforms with the agency’s Project Optimus Oncology initiative; that initiative is focused on identifying optimal dosing regimens while moving away from maximum tolerated dosing approach. The company also announced that it expects to enroll patients into its phase 2B trial beginning next year. “We have identified NGC regimens that have potency significantly greater than existing therapy and no dose-limiting side effects, unlike existing capecitabine therapy where approximately 25–60% of the patients require dose modifications or discontinuation,” said Processa Pharmaceuticals president and CEO Dr. David Young in the press release. “In addition, we understand the effect of different NGC regimens on the timeline of DPD irreversible inhibition and a patient’s production of new DPD, allowing us to better define the relationship between various NGC dosage regimens, 5-FU exposure and the safety of NGC.”
To view the full press release, visit https://ibn.fm/2vDUG
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 its Regulatory Science Approach criteria when selecting drugs for development 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”), a gastroparesis, functional constipation program. Members of the Processa development team have been involved with more than 30 drug approvals for indications in almost every division of 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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