Processa Pharmaceuticals Announces Expansion of NGC-Cap Program into Advanced or Metastatic Breast Cancer
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The expansion of Next Generation Capecitabine (NGC-Cap) into Phase 2 trials for advanced or metastatic breast cancer by Processa Pharmaceuticals signifies a strategic move into a larger patient market. Capecitabine, the precursor molecule, is well-established in the treatment of breast cancer, primarily as a cytotoxic agent that interferes with DNA synthesis. The potential differentiation of NGC-Cap from existing treatments could hinge on improved efficacy or safety profiles, which would be a significant advancement in oncology therapeutics. Furthermore, the FDA's agreement to use existing data expedites the trial process, potentially reducing the time to market for NGC-Cap, pending successful trial outcomes.
From a clinical perspective, the focus on breast cancer, given its high incidence rate, suggests that NGC-Cap could address a substantial unmet need if it demonstrates superior benefits over current therapies. The ease of enrollment mentioned could be due to the high prevalence of the disease, which may facilitate faster patient recruitment and trial completion. The implications for patients could be profound, offering a new line of therapy that may improve survival rates or quality of life.
Processa Pharmaceuticals' decision to target the breast cancer market with NGC-Cap reflects a calculated approach to tap into a significant oncology segment. Breast cancer, being the most diagnosed cancer type, represents a substantial market opportunity. The annual potential market for NGC-Cap, spanning breast, colorectal and other cancers, exceeds 250,000 patients, indicating a robust commercial potential. The strategic alignment with key opinion leaders and the formation of a scientific advisory board specializing in breast cancer could foster credibility and support for NGC-Cap's market entry.
Investors may view the FDA's supportive stance as a positive indicator for Processa's regulatory pathway, potentially impacting the company's stock valuation. The market will closely monitor the Phase 2 trial outcomes for indications of NGC-Cap's competitive advantage over existing treatments. Positive results could lead to significant market share capture and revenue growth for Processa. Conversely, any setbacks could have a detrimental effect on investor confidence and the company's financial prospects.
The financial implications of Processa Pharmaceuticals' strategic pivot towards breast cancer treatment with NGC-Cap are multifaceted. The FDA's endorsement of the existing data to support the Phase 2 trial design could imply cost savings in the drug development process, potentially enhancing Processa's financial efficiency. The company's proactive steps in identifying key opinion leaders and advancing the study design may be viewed positively by the investment community as indicators of management's commitment to executing its strategic vision.
Given the size of the breast cancer market and the prevalence of the disease, successful clinical outcomes for NGC-Cap could lead to a substantial increase in Processa's revenue streams. However, investors should consider the inherent risks associated with clinical trials, including the possibility of negative results or unforeseen safety issues. The long-term financial health of the company will likely be influenced by NGC-Cap's clinical performance and its ability to secure regulatory approval and market acceptance.
FDA and Processa agree to expand NGC-Cap development into breast cancer providing a more efficient path to approval
FDA agrees that existing data and studies can be used to support the Phase 2 breast cancer trial design
HANOVER, MD, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces it plans to expand the development of Next Generation Capecitabine (“NGC-Cap”) into the treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial. Following the Processa meeting with the FDA, Processa has decided the next NGC-Cap trial would be a Phase 2 trial in breast cancer. This decision was supported through discussions with the FDA where Processa agreed with the FDA that pursuing breast cancer will lead to a more efficient development program while providing a greater likelihood of FDA approval. The FDA stated that the previously generated data in past and existing studies could be used to directly support the Phase 2 trial in breast cancer.
“We believe the pursuit of an advanced or metastatic breast cancer indication for NGC-Cap is a logical progression for Processa as it represents a larger market than colorectal cancer with the potential to differentiate NGC-Cap from the presently approved capecitabine as well as other treatments for breast cancer. The FDA and Processa discussed the advantages and disadvantages of developing NGC-Cap in breast cancer and concluded that the development would be a more efficient and straightforward path to approval with an easier enrolment process for the Phase 2 and 3 trials,” said David Young, PharmD, Ph.D., President of Research and Development at Processa. “Capecitabine is already approved as both monotherapy and combination therapy in breast cancer, which contributes to the logic and efficiency of our current direction. In addition, the FDA’s agreement that our present data would support a Phase 2 trial in breast cancer makes the expansion seamless. We believe our Phase 2 trial will provide the safety-efficacy data to preliminarily demonstrate the benefit of NGC-Cap over capecitabine and other treatment options.”
“Based on this expansion to breast cancer we have identified breast cancer key opinion leaders to join our scientific advisory board, have already determined the Phase 2 study design which we expect to share with the FDA soon, and plan to initiate our Phase 2 study in the third quarter of 2024,” concluded Young.
Breast cancer is the most diagnosed cancer, representing approximately
About Capecitabine Administered with PCS6422 (NGC-Cap)
NGC-Cap combines the administration of PCS6422, the Company’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with the administration of low doses of the commonly used chemotherapy Capecitabine.
Capecitabine is the oral form of 5-FU and, along with 5-FU, is among the most widely used chemotherapy drugs available, particularly for solid tumors. When metabolized (after oral ingestion), it becomes 5-FU in the body, which, in turn, metabolizes to molecules called anabolites that actively kill duplicating cells, such as cancer cells, and to molecules called catabolites that only cause side effects. The presence of the DPD enzyme plays an integral role in the undesirable conversion of 5-FU to catabolites.
PCS6422 is an analog of uracil that irreversibly inhibits DPD. PCS6422 is neither toxic nor active as a single agent in animals at comparable dose levels. However, when administered in combination with Capecitabine or 5-FU, PCS6422 decreases the metabolism of 5-FU to the catabolites that only cause side effects, allowing more of the 5-FU to distribute to cancer cells.
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 Processa’s 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 (NGC) drugs following an efficient path to approval. The company’s approach to drug development, based on more than 30 years of drug development experience, uses its proven Regulatory Science Approach, including the determination of the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. 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 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 ---- over 250,000 patients treated each year for each 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 breast, metastatic colorectal, gastrointestinal, 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 our website at www.processapharma.com.
Forward-Looking Statements
This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.
For More Information:
Investors:
Bret Shapiro
CORE IR
ir@processapharma.com
Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com
FAQ
What is Processa Pharmaceuticals, Inc.'s plan for NGC-Cap development?
What did the FDA agree to regarding the use of existing data and studies for the Phase 2 breast cancer trial design?
What is the potential market for NGC-Cap in terms of breast, colorectal, and other cancers?
When does Processa Pharmaceuticals, Inc. plan to initiate the Phase 2 study for breast cancer?
