Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage pharmaceutical company now focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, will be presenting at the annual Digestive Disease Week (“DDW”) conference. The conference will be held on May 6–9, 2023, in Chicago. The company will be reporting on the data gathered during its recent study, titled “PCS12852, A Novel 5-HT 4 Agonist Improves GCSI Symptom Scores and Gastric Emptying in Gastroparesis Patients.” According to the announcement, PCS12852 has been shown to be safe and efficacious in a phase 2 proof-of-concept trial in gastroparesis patients; it also improved both gastroparesis symptom scores and gastric emptying rate. Processa Pharmaceuticals chief development and regulatory officer Sian Bigora will present the results during a research forum session, titled “AGA Gastroparesis and Small Intestinal Dysmotility” and slated for the first day of the conference. “We continue to see encouraging results with our drug-development pipeline, and inclusion in the DDW conference as an oral presentation is important and continued validation for our Regulatory Science approach,” said Processa Pharmaceuticals president and CEO in the press release. “Since the FDA-approved gastroparesis drugs have severe safety limitations, the fact that PCS12852 is ready to move to a phase 2b trial given the positive safety and efficacy results in our proof-of-concept gastroparesis trial is a significant milestone. The company is diligently exploring strategies to advance or monetize the program. We look forward to a robust discussion of the data throughout the DDW conference, and to providing continued updates to our shareholders.”
To view the full press release, visit https://ibn.fm/GOm8U
About Processa Pharmaceuticals Inc.
Processa is a clinical-stage pharmaceutical company focused on developing the next-generation chemotherapy (“NGC”) drugs to improve the safety and efficacy of cancer treatment. By combining Processa’s novel oncology pipeline with proven cancer-killing active molecules and the Processa Regulatory Science Approach as well as experience in defining Optimal Dosage Regimens for FDA approvals, Processa not only will be providing better therapy options to cancer patients but also increase the probability of FDA approval for its NGC drugs following an efficient path to approval. Processa’s NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these FDA-approved drugs while maintaining the existing mechanisms of killing the cancer cells. The company’s approach to drug development is based on more than 30 years of drug-development expertise to efficiently design and conduct clinical trials that demonstrate a positive benefit/risk relationship.
The Processa team has a track record of obtaining more than 30 approvals for indications across almost every division of FDA. Using its proven Regulatory Science Approach, the Processa team has experience defining the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. The advantages of Processa’s NGCs are expected to include fewer patients experiencing side effects that lead to dose discontinuation, more significant cancer response and a greater number of patients — in excess of 200,000 for each NGC drug — who will benefit from each NGC drug. Currently under development are three next generation chemotherapy oncology treatments: Next Generation Capecitabine (PCS6422 and capecitabine to treat metastatic colorectal, gastrointestinal, breast, pancreatic, and other cancers), Next Generation Gemcitabine (PCS3117 to treat pancreatic, lung, ovarian, breast, and other cancers), and Next Generation Irinotecan (PCS11T to treat lung, colorectal, gastrointestinal, pancreatic and other cancers). 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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