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

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 to be under-dosed and had doses

adjusted upward(i)

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

side effects(i)

"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, M.D., Ph.D. 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."

About Colorectal Cancer

Colorectal cancer is a worldwide public health problem, with more than 940,000 new cases diagnosed each year, resulting in approximately 500,000 deaths annually.(ii) In the U.S., it is the third leading cause of cancer mortality, and in 2008, nearly 50,000 deaths will be attributed to this disease.(iii) Its incidence rate is strongly correlated with age. Data from industrialized countries demonstrate that the incidence of colorectal cancer rises three-fold between the ages of 60 and 80 years.(i)

About Saladax

Saladax Biomedical is pioneering the development of novel, rapid, and cost-effective immunoassays that will enable routine blood-level monitoring of anti-cancer drugs to become the standard of care in treating cancer patients. With Personalized Chemotherapy Management (PCM), oncologists will be able to adjust the administered dose based on each patient's individual drug level, leading to reduced toxicity, improved outcome and lower cancer care costs. Saladax is headquartered at the business incubator of the Ben Franklin Technology Partners (BFTP) of Northeastern Pennsylvania on the campus of Lehigh University in Bethlehem. The 5-FU PCM test will be available to U.S. clinicians later this year through a major reference laboratory.


(i) Gamelin, E, Delva, R, Jacob, J, et al: "Individual fluorouracil dose

adjustment based on pharmacokinetic follow-up compared with

conventional dosage: Results of a multicenter randomized trial of

patients with metastatic colorectal cancer." J. Clin Oncol 13:2099-

2105, 2008.

(ii) World Health Organization, "World Cancer Report." April 3, 2003, (April

22, 2008).

(iii) American Cancer Society, "What are the Key Statistics for Colorectal Cancer?", March 5, 2008, sti cs_for_colon_and_rectum_cancer.asp (April 22, 2008).

SOURCE Saladax Biomedical
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