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Saladax Biomedical receives CE mark for new PCM assay

Saladax Biomedical : 19 June, 2008  (New Product)
Saladax Biomedical has received CE mark registration in the European Union for the company’s 5-FU Personalized Chemotherapy Management (PCM) assay on the Olympus AU400 Clinical Chemistry Analyser
For European oncologists who prescribe 5-fluorouracil (5-FU) continuous infusion regimens alone or in combination (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, PhD, chief executive officer 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.'

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 were published in the May issue of the Journal of Clinical Oncology (JCO) and concluded:

- Response rates among monitored patients doubled;

- Two-year overall survival improved by 48 percent;

- Toxic side effects were significantly lower;

- Only 25 percent of BSA dosed patients were in the target range to receive the optimal therapeutic benefit;

- 58 percent of patients were found to be under-dosed and had doses adjusted upward;

- 17 percent were found to be over-dosed, increasing the risk of severe side effects.

'The availability of the 5-FU PCM Assay will give oncologists in the EU a powerful, cost-effective tool in the battle against colorectal cancer,' said Erick Gamelin, MD, PhD director of the Paul Papin Cancer Center in Angers, France and primary investigator of the Phase III JCO study. 'Our Phase III study demonstrates that the majority of patients are either over-dosed or in most cases, under-dosed. Personalized 5-FU dosing allows us to substantially reduce severe toxicity while improving patient quality of life and treatment outcomes.'

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