HANOVER, MD - Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a clinical-stage pharmaceutical company, has announced favorable preliminary results from a Phase 1b clinical trial of its Next Generation Capecitabine (NGC-Cap) for patients with advanced gastrointestinal tract cancer. The trial aimed to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR).
The study evaluated NGC-Cap in Stage III or IV patients who had relapsed or were refractory to prior treatments, including capecitabine or 5-Fluorouracil (5-FU). Early findings indicate that NGC-Cap, which combines PCS6422 with low doses of capecitabine, may distribute more 5-FU to cancer cells compared to capecitabine monotherapy.
In the highest dose group, all three patients showed progression-free survival (PFS) for approximately 5 to 7 months, with two partial responses and one stable disease. Overall, 66.7% of patients in the trial exhibited PFS ranging from 5 to 11 months. The results suggest that NGC-Cap could offer a more effective and tolerable chemotherapy option for various cancers treated with capecitabine and 5-FU.
Processa plans to further investigate these two dosage regimens in a Phase 2 trial with breast cancer patients to determine the optimal dosage for future pivotal trials. The company's approach to drug development leverages its team's extensive experience in achieving FDA approvals and aims to provide better therapeutic options for cancer patients.
The information in this article is based on a press release statement from Processa Pharmaceuticals.
InvestingPro Insights
As Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) advances in clinical trials with promising results for its Next Generation Capecitabine (NGC-Cap), investors and stakeholders are keeping a close eye on the company's financial health and market performance. Here are some key insights from InvestingPro that may provide a broader context for evaluating the company's prospects:
Despite the clinical progress, Processa's financial metrics raise some concerns. The company's market capitalization stands at a modest $4.52 million, reflecting the market's current valuation of the firm. Additionally, the company is facing significant challenges, as indicated by a negative P/E ratio of -0.26 and an adjusted P/E ratio for the last twelve months as of Q1 2024 of -0.46. This suggests that investors are wary of the company's earnings potential in the near term.
Furthermore, Processa's stock performance has been underwhelming, with a staggering 6-month price total return of -90.54% as of the latest data point in 2024. This is compounded by a 1-year price total return of -88.83%, signaling a significant decline in investor confidence over the past year.
On a more positive note, an InvestingPro Tip highlights that Processa holds more cash than debt on its balance sheet, which could provide some financial flexibility as the company continues to fund its clinical trials. However, another InvestingPro Tip cautions investors that the company is quickly burning through cash, which is a critical factor to consider given the high costs associated with drug development and the path to potential commercialization.
For those interested in a deeper dive into Processa Pharmaceuticals' financials and future outlook, InvestingPro offers additional tips that could help in making a more informed investment decision. In total, there are 13 InvestingPro Tips available for PCSA, which you can access by visiting https://www.investing.com/pro/PCSA. Don't forget to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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