LOS ALTOS, Calif. - RenovoRx, Inc. (NASDAQ: RNXT), a clinical-stage biopharmaceutical company, has reported positive early-stage clinical data for its Trans-Arterial Micro-Perfusion (TAMP) therapy platform in treating Locally Advanced Pancreatic Cancer (LAPC).
The data, published in The Oncologist, indicates that TAMP, when used with prior chemoradiation, may extend overall survival (OS) in LAPC patients.
The studies, which involved the intra-arterial administration of the chemotherapy drug gemcitabine using RenovoRx's FDA-cleared RenovoCath device, showed a median OS of 12.6 months for 35 evaluable patients.
Notably, patients who received TAMP-delivered chemotherapy following radiation therapy experienced a significantly longer OS of 27.1 months, compared to those who had prior systemic chemotherapy (14.6 months) or no prior treatment (7.0 months).
These results suggest that TAMP could offer a safer and more effective alternative to the current standard of care, potentially improving survival rates and reducing side effects. The most common side effects reported were gastrointestinal-related, with sepsis being the most common Grade 3 toxicity.
The Phase III TIGeR-PaC clinical trial is currently underway to further evaluate TAMP's efficacy in a larger patient population. This trial compares TAMP treatment to conventional systemic intravenous chemotherapy, with the primary endpoint being a 6-month OS benefit.
RenovoRx's approach aims to deliver chemotherapy directly to the tumor site, potentially minimizing systemic toxicities. This method stands in contrast to the three FDA-approved treatments for pancreatic cancer, which have shown less than a two-month median survival benefit over the past decade, often accompanied by increased toxicity rates.
The American Cancer Society's Cancer Facts & Figures 2024 report predicts pancreatic cancer to become the second leading cause of cancer-related deaths by 2030. RenovoRx's ongoing research could represent a significant advancement in the treatment of LAPC, a disease with a historically low 5-year relative survival rate.
The company is also exploring the use of TAMP in treating other types of cancer beyond LAPC. However, it's important to note that RenovoGem, the investigational drug used in conjunction with the RenovoCath for TAMP therapy, has not yet been approved for commercial sale.
InvestingPro Insights
Amid the promising clinical data for RenovoRx's Trans-Arterial Micro-Perfusion (TAMP) therapy, a glance at the company's financial health and market performance provides additional context for investors. RenovoRx (NASDAQ: RNXT) has been navigating the biopharmaceutical landscape with a strategic financial stance, holding more cash than debt on its balance sheet, which is an encouraging sign for stakeholders considering the company's long-term investment potential.
InvestingPro data shows a market capitalization of $30.9 million USD, reflecting the company's current valuation in the market. Despite the challenges in profitability, with the company not being profitable over the last twelve months and analysts not expecting profitability this year, RenovoRx has demonstrated strong returns over the last month, with a 14.16% increase in its price total return. This could be indicative of investor optimism following the recent clinical developments.
InvestingPro Tips reveal that while RenovoRx suffers from weak gross profit margins and trades at a high Price / Book multiple of 17.49, the company's liquid assets exceed its short-term obligations. This liquidity could provide the company with the flexibility to continue funding its clinical trials and research activities. Additionally, RenovoRx does not pay a dividend to shareholders, which is not uncommon for clinical-stage biopharmaceutical companies that often reinvest earnings back into research and development.
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