Saladax Biomedical, Inc. (SBI) has announced a major step toward the practice of personalized medicine among cancer patients with the development of the first monoclonal antibodies able to measure 5-Fluorouracil (5-FU) in plasma.
The data were presented during the annual meeting of the American Society of Clinical Oncology.
Development of the 5-FU monoclonal antibodies is the cornerstone to the first tests to measure plasma levels of this toxic drug, and is just one of several assays for chemotherapy agents being developed by SBI.
The company's unique line of immunoassays will enable oncologists to measure chemotherapy blood levels and then adjust the dose being administered to each individual patient based on the results.
According to SBI Chairman and Chief Executive Officer Dr. Salvatore J. Salamone, the 5-FU assay, and the others the company is developing, will also help minimize adverse side effects.
"In the case of 5-FU," said Salamone, "2 to 3% of the population are predisposed to severe toxic side effects due to a genetic polymorphism and other factors."
"The PCM test for 5-FU will alert oncologists to high risk patients and in some cases save lives."
Studies have shown high pharmacokinetic variability of 5-FU and a relationship between systemic levels of the drug and clinical outcome.
"This variability is the result of multiple factors that influence individual patient metabolic rates, including age, disease state, organ function, drug-drug interactions, and others, as well as genetic predisposition," explained Salamone.
Managing 5-FU dosing is already routine in some cancer centers, particularly in France, relying upon physical analysis by liquid chromatography/mass spectroscopy.
However, the cost and amount of time required for such analysis limits its utility in the clinical setting.
The Saladax PCM assays, by comparison, will be performed on clinical analyzers routinely found in U.S. laboratories and will generate between 300 and 1000 test results per hour.
Saladax Biomedical, Inc. is a research-based, healthcare diagnostics company with its main R&D and manufacturing facilities based in Bethlehem, PA.
Founded in 2004, SBI is focused on the development of Personalized Chemotherapy Management (PCM) assays to test plasma levels of the most commonly used anti-cancer medicines.
Final assay development is underway for the highest volume use drugs, with anticipated FDA filings by year-end 2006.