Business
Processa Pharmaceuticals Provides Corporate Update and Announces Year End 2022 Financial Results
Company focused on the development of Next Generation Chemotherapy drugs in 2023 and out-licensing/business development efforts for non-oncology assets.Dose
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"Company focused on the development of Next Generation Chemotherapy drugs in 2023 and out-licensing/business development efforts for non-oncology assets.Dose escalations continue for Next Generation Capecitabine with no observed adverse events associated with the catabolites of capecitabine.FDA discussions mid-April on Next Generation Capecitabine Phase 2B trial and overall development following Project Optimus initiative. HANOVER, MD., March 30, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (\"Processa\" or the \"Company\"), a developer of Next Generation Chemotherapy drugs that provide a better safety-efficacy profile than their widely used FDA-approved counterparts, today provided an update on their clinical programs and announced financial results for the year ended December 31, 2022. Dr. David Young, President and CEO of Processa, commented, “We completed a successful Phase 2A trial of PCS12852 in patients with gastroparesis, positioning the asset well for potential out-licensing or business development opportunities. Today, we are focusing our energy and efforts on the Next Generation Chemotherapies (NGCs) that can reshape the landscape of chemotherapy. Our first NGC to move into Phase 2B will be Next Generation Capecitabine (NGC-Cap). Since 50-70% of the patients on capecitabine typically have dose-limiting side effects, one major benefit of NGC-Cap is to significantly decrease or potentially eliminate these side effects, so patients do not need to reduce their dose or discontinue treatment entirely. As a safer and potentially more efficacious version of the presently used capecitabine, the target population for NGC-Cap includes patients with such cancers as colorectal, breast, pancreatic, and many other solid tumor cancers. These cancers have more than 200,000 newly diagnosed cases per year in the U.S. We look forward to meeting with the FDA in mid-April to discuss our NGC-Cap Phase 2B trial and hope to initiate the Phase 2B trial in colorectal cancer in the second half of 2023. Given we are working with an approved established cancer-killing molecule, and we will be following the principles of Project Optimus, we anticipate efficiencies in the development of NGC-Cap that we believe will confer better odds of success, while providing better and safer drugs to hundreds of thousands of patients in n...