CESAR and Saladax Biomedical Collaborate on a Study of Optimized 5-FU Dosing in Colorectal Cancer Patients

A single arm study in metastatic colorectal cancer patients treated with pharmacokinetic (PK) guided 5-fluorouracil regimens

Feb 13, 2012, 10:17 ET from Saladax Biomedical, Inc.

VIENNA and BETHLEHEM, Pa., Feb. 13, 2012 /PRNewswire/ -- Saladax Biomedical, Inc. and the Central European Society for Anticancer Drug Research (CESAR) announced today they will be collaborating in a single arm study of metastatic colorectal cancer patients treated with the chemotherapy drug 5-fluorouracil (5-FU) and whose dose will be optimized based upon actual 5-FU blood levels.  5-FU levels will be measured using Saladax's assay technology.

CESAR is the sponsor of this Saladax-supported study designed to determine whether target blood levels of 5-FU can be maintained throughout the course of treatment by optimizing the dose administered to individual patients at each infusion.  The goals of the study are to achieve a stable target blood level of 5-FU and to determine whether this dose optimization is able to reduce 5-FU-related toxicities.  The Saladax-developed My5-FU automated immunoassay will be used to provide rapid, simple and cost-effective measurement of 5-FU levels to allow timely personalized dose adjustment.

The four-center study is planned to enroll 80 metastatic colorectal cancer patients and is expected to be completed within one year.  Individual patients will remain on study until a total of six doses of 5-FU treatment have been administered and the end-of-treatment visit has been performed. 

Dr. Martin Wilhelm of CESAR, chair of the study, explained: "We expect that the 5-FU clinical trial we are undertaking will add to the growing body of evidence that pharmacokinetic optimization of 5-FU dosing has the potential to markedly improve patient quality of life through a reduction of grade 3/4 mucositis and diarrhea, which can result in hospitalization and premature treatment termination."

About colorectal cancer
According to GLOBOCAN 2008, colorectal cancer is the fourth leading cause of cancer-related deaths in the world.  With approximately 1.23 million cases detected annually, it is expected to cause about 610,000 deaths per year.  Depending upon the stage of the disease, colorectal cancer treatment consists of two or more treatment modalities -- surgery, radiation therapy, chemotherapy and/or targeted therapies. 

5-FU is the foundation of chemotherapy treatment in colorectal cancer.  5-FU is typically dosed based upon the patient's body mass or Body Surface Area (BSA), a calculation that does not take into account the various factors that affect how individual patients absorb and clear the drug.  Other studies have demonstrated that a majority of colorectal cancer patients treated with 5-FU dosed by BSA may not be achieving the optimal systemic drug concentration to ensure best treatment efficacy and controlled toxicity.

About pharmacokinetic-guided dosing
There is evidence of the relationship between 5-FU plasma concentrations, drug-associated toxicity (especially mucositis and diarrhoea) and clinical outcome.  These data are derived from various pharmacological studies in patients suffering from colorectal and head and neck cancers.  The aim of dose monitoring and optimization is to decrease toxicity while maintaining or improving treatment efficacy as compared to the standard of care.  Prospective pharmacokinetic studies with dose adjustments are important to evaluate the value of 5-FU dose management.

About the CESAR Central European Society for Anticancer Drug Research-EWIV 
In the context of the pan-European Early Drug Development Network, CESAR represents a Central European platform for new development of novel drugs and therapies in oncology.  The scientific activity in the Working Groups encompasses the development of active substances (AWO), pharmacokinetic studies (APOH) and clinical studies in Phase I, II and III.  CESAR fosters cooperation with academic study groups, individual institutions in oncology and the pharmaceutical industry.  The CESAR Central Office (CCO) in Vienna offers the appropriate infrastructure for all phases of clinical trials, ranging from planning and implementation to project management, clinical documentation and statistical analyses.  CESAR, as a European Economic Interest Grouping (EEIG), is the umbrella organization of the registered societies CESAR Germany and CESAR Austria (with members from Austria and Switzerland).

About Saladax Biomedical, Inc.
Saladax Biomedical develops and commercializes novel diagnostic assays to achieve the promise of personalized medicine through dose management and companion diagnostic products for existing and new therapeutics.  The Company's dose management technology enables physicians to optimize drug dosing to meet individual patient needs, leading to improved response and quality of life.  The Company's 15 MyCare™ dose management assays are comprised of proprietary, automated and cost-effective in vitro diagnostic tests, with a principal focus in oncology.  The first MyCare assay available is for one of the most common anticancer drugs, 5-fluorouracil (5-FU).  This assay is sold by Saladax in Europe as a CE-marked product and will be distributed in Japan by FALCO biosystems.  In the United States and Canada, Myriad Genetic Laboratories, Inc. provides testing for 5-FU dose optimization under the trademark OnDose® through a license to Saladax proprietary technology.  Saladax also works with pharmaceutical companies to develop companion diagnostics to provide important clinical information to assist in developing and administering new and existing compounds.  For more information, visit www.saladax.com.

My5-FU is a registered trademark of Saladax Biomedical, Inc.
OnDose is a trademark of Myriad Genetics, Inc. 

CESAR Central European Society for Anticancer Drug Research - EWIV
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