FOR IMMEDIATE RELEASE
Saladax Biomedical, Inc. Announces the Presentation of the CESAR Study Results for Pharmacokinetically-Guided Dosing of 5-Fluorouracil in Colorectal Cancer at 2015 ASCO Meeting
Advantages of a Practical Approach to Personalized Dosing of 5-FU Demonstrated
BETHLEHEM, PA, June 9, 2015 – Saladax Biomedical, Inc. recently presented results from the Central European Society for Anticancer Research (CESAR) study at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015 taking place in Chicago, Illinois. The presentation is available on the Saladax website at www.saladax.com.
Using the most common infusional 5-FU regimens to treat colorectal cancer (CRC), the CESAR study (clinical trial identifier: EUDRACT 2011-003553026) was conducted in seven centers in Germany. The study demonstrated that regardless of the regimen, standard dosing 5-FU using body surface area resulted in highly variable and unpredictable exposure, with the majority (65%) of CRC patients being under-dosed. Pharmacokinetically (PK) guided adjustment of 5-FU doses controlled individual patient exposure: after just two cycles the PK-guided dosing resulted in higher doses and significantly more patients achieving the optimal 5-FU exposure range. These results have been reproduced in several other studies done in Europe, the US, and China. When compared to historical data, personalization of dosing led to an overall lower incidence of toxicity, despite the higher doses being administered.
These findings verify the results from multiple studies demonstrating the importance of optimizing 5-FU therapy on a patient-by-patient basis to lower toxicity and improve efficacy. PK-guided dose adjustment makes it possible for more patients to achieve an effective 5-FU dose with less toxicity.
About Saladax Biomedical, Inc.:
Saladax Biomedical is a leader in the development high-value diagnostic services and products. Products that deliver actionable data to help physicians select and optimize the use of current and new pharmaceutical products to improve health and positively impact the economics of care: diagnostics that make a difference
Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. For more information visit: www.saladax.com.
Salvatore Salamone, Ph.D.