HANOVER, Md. - Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application. The clearance paves the way for a Phase 2 clinical trial of Next Generation Capecitabine (NGC-Cap), the company's lead product candidate, in patients with advanced or metastatic breast cancer. The trial is set to begin enrollment this quarter, with initial data expected by mid-2025.
The upcoming global multicenter trial will compare two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in about 60 to 90 patients. It aims to determine the optimal dosage regimens as part of the FDA Project Optimus Initiative and explore personalized therapy possibilities with NGC-Cap.
NGC-Cap combines PCS6422, Processa’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with lower doses of capecitabine, a widely used chemotherapy drug for solid tumors. The Phase 1b study of NGC-Cap showed it to be more potent than capecitabine alone, offering greater exposure to the active cancer-killing agent 5-fluorouracil (5-FU) while demonstrating a safety profile that was better or similar to monotherapy with capecitabine.
David Young, PharmD, Ph.D., President of Research and Development at Processa, stated, "We are proud to achieve this significant milestone for NGC-Cap and look forward to entering the clinic for the treatment of advanced or metastatic breast cancer."
Breast cancer remains the second most common cancer globally, with more than 2 million cases diagnosed in 2022 and over 665,000 deaths. The five-year survival rate for metastatic disease is approximately 30%.
Processa Pharmaceuticals has announced the outcomes of its 2024 Annual Meeting of Shareholders and shared promising preliminary results from a Phase 1b clinical trial of its Next Generation Capecitabine (NGC-Cap) for patients with advanced gastrointestinal tract cancer.
The Phase 1b clinical trial aimed to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for NGC-Cap. The study found that NGC-Cap may deliver more 5-Fluorouracil (5-FU) to cancer cells compared to capecitabine monotherapy, potentially improving efficacy and tolerability for various cancers treated with capecitabine and 5-FU.
The company plans to continue its investigation into these two dosage regimens in a Phase 2 trial with breast cancer patients, aiming to determine the optimal dosage for future pivotal trials.
InvestingPro Insights
As Processa Pharmaceuticals (NASDAQ:PCSA) moves forward with its Phase 2 clinical trial for NGC-Cap, investors are closely monitoring the company's financial health and market performance. According to InvestingPro, there are a few key points to consider:
Firstly, despite the company's promising scientific progress, Processa's financials reflect some challenges. The company has been quickly burning through cash, which is a concern for long-term sustainability. This is corroborated by their operating income, which shows a significant loss of $10.16 million over the last twelve months as of Q1 2024. Additionally, Processa's stock has experienced a substantial decline over the past month, with a 24.11% drop in price total return. This could indicate investor skepticism about the company's future profitability, especially considering that analysts do not anticipate Processa will be profitable this year.
On the brighter side, Processa holds more cash than debt on its balance sheet, which is a positive sign for the company's liquidity. Moreover, their liquid assets exceed short-term obligations, suggesting that the company is in a decent position to meet its immediate financial commitments.
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With a market capitalization of $4.86 million and a price/book ratio of 0.55 as of Q1 2024, Processa's valuation reflects the market's tempered expectations. The company's share price, at a previous close of $1.7, is just 9.44% of its 52-week high, underscoring the significant downturn it has faced over the last year.
As Processa Pharmaceuticals embarks on this crucial phase of clinical trials, investors will be watching both the scientific and financial outcomes to gauge the company's potential for success in the competitive oncology market.
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