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 ineffective.

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 therapeutic range.

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 study).

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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