Saladax Biomedical's 5-FU Personalized Chemotherapy Management (PCM(R)) Assay CE Marked for Distribution... ( BETHLEHEM Pa. June 17 /- Saladax ...)

Saladax Biomedical's 5-FU Personalized Chemotherapy Management (PCM(R)) Assay CE Marked for Distribution in the EU

Date:6/17/2008

BETHLEHEM, Pa., June 17 /PRNewswire/ -- Saladax Biomedical, a company specializing in chemotherapy therapeutic drug monitoring, today announced CE mark registration in the European Union (EU) for its 5-FU Personalized Chemotherapy Management (PCM(R)) assay on the Olympus AU400 Clinical Chemistry Analyzer. For European oncologists who prescribe 5-fluorouracil (5-FU) continuous infusion regimens alone or in combination (e.g., FOLFOX and FOLFIRI) for colorectal, stomach, breast, and pancreatic cancers, this simple, evidence-based blood test will show patients' actual plasma 5-FU levels for individualized dosing.

"Until now, a simple, rapid, and cost-effective 5-FU measurement tool that can be easily integrated into day-to-day practice has not been readily available. As a result, colorectal cancer patients receive chemotherapy based on their height and weight, with no monitoring system in place to allow oncologists to correlate dose with clinical patient response on an ongoing basis," said Salvatore Salamone, Ph.D., CEO of Saladax Biomedical. "Access to this simple blood test will arm oncologists with the ability to individualize 5-FU dosing to ensure patients receive the optimal benefit from their treatment."

Recently, results from a Phase III randomized study compared colorectal cancer patients who were dosed with 5-FU based on the current standard dosing method (body surface area or BSA) with patients whose dose was adjusted based on the actual concentration of 5-FU in the patients' blood plasma. The study, which was published in the May issue of the Journal of Clinical Oncology (JCO) concluded:

-- Response rates among monitored patients doubled(i)

-- Two-year overall survival improved by 48 percent(i)

-- Toxic side effects were significantly lower(i)

-- Only 25 percent of BSA dosed patients were in the target range to

receive the optimal therapeutic benefit(i)

- 58 percent of patients were found
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