Processa Pharmaceuticals (NASDAQ: PCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer. The company today provided an interim analysis from its ongoing phase 1B trial of Next Generation Capecitabine (“NGC-Cap”) in patients with gastrointestinal cancer, which identifies a personalized treatment approach that may yield improved safety and treatment efficacy. “The presence of DPD as expressed by the plasma concentration of FBAL provides us important information that may confirm our hypothesis that we can optimize our dosing of NGC-Cap to maintain efficacy and minimize side effects by carefully tracking each individual patient following an initial dosing of our novel chemotherapy,” said Sian Bigora, Pharm.D., Processa’s chief development and regulatory officer. “By following the chemical concentration in the plasma in each patient, we may be able to actually optimize therapy through individualization of each patient’s dosing regimen. We find these results, albeit early results, to be very encouraging.”
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About Processa Pharmaceuticals Inc.
Processa is a clinical stage pharmaceutical company focused on developing the Next Generation Chemotherapy 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 Next Generation Chemotherapy drugs. Processa’s NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of drugs while maintaining the existing mechanisms of killing the cancer cells. Its 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. Using its proven Regulatory Science Approach, Processa has experience defining the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. The advantages of Processa’s Next Generation Chemotherapy drugs are expected to include fewer patients experiencing side effects that lead to dose discontinuation; more significant cancer response; and a greater number of patients who will benefit from each Next Generation Chemotherapy drug. Currently in its pipeline are three Next Generation Chemotherapy drugs: 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.
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