Saladax Biomedical, Inc. Signs Agreement with Stockholm`s Karolinska University Hospital

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Tue Jun 30, 2009 10:11am EDT

Arrangement Will Allow European Oncologists and Hospitals Easy Access to New
Tool for 5-FU Dose Management
BETHLEHEM, Pa.--(Business Wire)--
Saladax Biomedical, Inc. (www.saladax.com), developer of the Personalized
Chemotherapy Management (PCM®) line of tests to measure blood levels of cancer
drugs, has signed an agreement with the Karolinska University Hospital, of
Stockholm, Sweden. 

Karolinska will provide clinical laboratory testing for the Saladax
5-Fluorouracil (5-FU) Assay based at their 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. 

About Saladax Biomedical, Inc.
Saladax Biomedical, Inc. is a personalized diagnostics company with its main R&D
and manufacturing facilities based in Bethlehem, PA. Founded in 2004, Saladax is
pioneering the development of an innovative line of proprietary Personalized
Chemotherapy Management (PCM®) assays to test plasma levels of the most commonly
used anti-cancer medicines. In the European Union, Saladax is marketing its 5-FU
PCM Assay directly and has obtained a CE Mark for product distribution. 

For more information about Saladax, visit www.saladax.com or view our video at
http://www.saladax.com/saladaxvideo. 

About Karolinska University Hospital
Karolinska University Hospital, Stockholm, Sweden, is one of the largest
hospitals in Europe and is at the cutting edge of medical research. The hospital
has 1,600 beds and employs 15,000 persons. Approximately 2,100 researchers are
active at the hospital, making the Karolinska University Hospital a force in
establishing Stockholm as a leading region in biomedical research in the world. 



Saladax Biomedical, Inc.
Adrienne Choma
President & COO
201-240-4072
achoma@saladax.com

Copyright Business Wire 2009

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