Karolinska University Hospital to offer Saladax 5-fluorouracil assay
to European oncologists
2 July 2009
Saladax Biomedical, Inc. has signed an agreement with the Karolinska
University Hospital, of Stockholm, Sweden to provide clinical laboratory
testing for the Saladax 5-fluorouracil (5-FU) assay based at the
University's specialty clinical laboratory facility.
In collaboration with Karolinska, Saladax can now offer 5-FU testing
and 5-FU dose management to hospitals and oncologists throughout Europe
that want to offer their patients the benefits of 5-FU dose management
without setting up their own laboratory testing.
5-FU, used in combination with other drugs, is the mainstay of
treatment for colorectal cancer and is also used in combating head &
neck and breast cancer. Current dosing of 5-FU based on Body Surface
Area (BSA) results in up to a 30-fold variability in patient blood
levels. If the drug blood level is too high, it can cause significant
side-effects. Conversely, at too low a level it is clinically
Results of a recent clinical study published in the May 2008 issue of
the Journal of Clinical Oncology confirm that carefully monitoring the
level of drug in individual colorectal cancer patients can result in
dramatically increased efficacy of treatment, prolonged symptom-free
survival and a reduction in serious side-effects.
The principal author of the study, Dr. Erick Gamelin at the Paul
Papin Cancer Center in Angers, France, reported dosing based on BSA
resulted in 68% of patients having sub-therapeutic plasma levels; 17% of
patients were over-dosed and only 15% were actually in the optimal
Patients whose 5-FU dose was adjusted during the course of treatment
to achieve optimal blood concentrations, experienced a statistically
significant (P=0.004) doubling of objective response rate, from 17% to
34%, and a trend towards improvement in median overall survival from 16
months to 22 months (overall survival was not an endpoint in this
The most serious side effects were significantly reduced despite
increase in 5-FU dosing for the 68% of patients that were found to be
under dosed with BSA-based dosing.
“Easy access to the 5-FU PCM Assay will provide oncologists with a
proven tool to improve treatment outcomes and a better quality of life
for their cancer patients. Optimal 5-FU plasma levels are
well-established and guidance for dose adjustment to achieve optimal
blood levels will be provided by Karolinska,” stated Professor Olof
Beck, who heads the Karolinska clinical laboratory.
“We are very gratified to have a highly respected institution like
Karolinska provide 5-FU PCM testing services to our European clients.
PCM offers the oncology community a concrete step forward in offering
personalized medicine to their cancer patients,” said Dr. Salvatore J.
Salamone, CEO of Saladax.
Physicians interested in utilizing the 5-FU PCM Assay should contact
Saladax Biomedical for further information.
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