Processa Expands NGC-Cap for Advanced Breast Cancer Development

Processa Pharmaceuticals, a company dedicated to the advancement of chemotherapeutic drugs, has announced a strategic shift in its development focus. The company is expanding its Next Generation Capecitabine (NGC-Cap) program to include advanced or metastatic breast cancer treatment. This decision follows a productive meeting with the FDA, where it was agreed that the existing data can be utilized to support the Phase 2 trial design for breast cancer.

The FDA has recognized that the pursuit of breast cancer as an indication for NGC-Cap is a logical step, given the larger market potential compared to colorectal cancer. It also presents an opportunity to differentiate NGC-Cap from existing treatments. David Young, President of Research and Development at Processa, highlighted the benefits of this approach, stating that the FDA's endorsement of the current data to support the Phase 2 trial makes the expansion into breast cancer treatment seamless.

Capecitabine, the oral form of 5-FU, is a widely used chemotherapy drug for solid tumors. It is metabolized in the body to produce 5-FU, which is then further metabolized into anabolites that target and kill cancer cells, and catabolites that cause side effects. The DPD enzyme plays a key role in the conversion of 5-FU to catabolites. NGC-Cap combines Capecitabine with PCS6422, an irreversible DPD enzyme inhibitor, to reduce the formation of catabolites and enhance the drug's efficacy.

Processa's NGC drugs are designed to improve upon existing FDA-approved oncology drugs by altering their metabolism and distribution, thereby reducing side effects and increasing the cancer response rate. The company's regulatory science approach and experience in defining optimal dosage regimens aim to increase the likelihood of FDA approval for its NGC drugs.

Breast cancer is the most commonly diagnosed cancer, with over 3.8 million patients and nearly 300,000 new diagnoses in the previous year. The potential market for NGC-Cap in breast cancer, along with colorectal and other cancers, is significant, exceeding 250,000 patients annually.

Processa is in the clinical stage of development for its NGC drugs, which include Next Generation Capecitabine, Next Generation Gemcitabine, and Next Generation Irinotecan. These treatments are designed to provide better therapy options for cancer patients and increase the probability of FDA approval through an efficient development path.

The company's approach is grounded in over 30 years of drug development experience, focusing on modifications of existing FDA-approved drugs to enhance their safety and efficacy. Processa's NGC drugs are expected to benefit a large number of patients, with the potential to treat over 250,000 patients each year for each drug.