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New Data Demonstrates 5-FU Personalized Chemotherapy Management (PCM(R)) Assay Provides Similar Performance to More Complicated Liquid Chromatography-Mass Spectrometry (LC-MS/MS)
Date:6/23/2008

BETHLEHEM, Pa., June 23 /PRNewswire/ -- A new blood test may make it easier for oncologists to accurately measure and personalize 5-fluorouracil (5-FU) dosing for patients undergoing continuous infusion chemotherapy regimens. Data from a multicenter trial showed that a nanoparticle-based immunoassay from Saladax Biomedical, called 5-FU Personalized Chemotherapy Management (PCM(R)), performed as well as high performance liquid chromatography (HPLC) or LC-MS/MS, but was easier to use, more rapid and more amenable to widespread clinical use. The data was presented at the 2008 Hematology/Oncology Pharmacy Association and the International Society of Oncology Pharmacy Practitioners' (HOPA/ISOPP) annual meeting in Anaheim, Calif.

5-FU is a cornerstone treatment regimen for colorectal cancer; the third leading cause of cancer deaths in the United States.(i)

"This evidence-based tool for monitoring the actual drug concentrations of 5-FU in the blood will enable simplified, personalized dose management with the goal of minimizing toxicity and maximizing the therapeutic benefit of 5-FU treatment," said Salvatore Salamone, Ph.D., CEO of Saladax Biomedical. "This is important because a significant amount of scientific evidence over the last decade demonstrates that the effectiveness of the 5-FU regimen is burdened by potentially severe and life-threatening side effects."

To date, analysis of 5-FU blood plasma levels could only be performed by complex, labor-intensive, expensive, and physical analytical methods such as HPLC that have insufficient capacity to be used in high volume clinical settings. The 5-FU PCM assay could provide the same HPLC or LC-MS/MS-like performance, while offering advantages of automation, small sample size, and improved turn-around time for oncologists.

The multicenter study evaluated 5-FU blood plasma levels at three sites, according to the Clinical and Laboratory Standards Institute (CLSI) protocol. 5-FU blood plasma levels were evaluated using the 5-FU PCM assay and cross- analyzed using LC-MS/MS cross-reactivity, precision, and stability to ensure accuracy. Researchers found that the PCM assay was precise and analytical results correlated well with those obtained from the validated HPLC method.

A recent study demonstrated that monitoring patients' 5-FU blood plasma levels and adjusting chemotherapy doses to achieve optimal levels of 5-FU can improve response rates and minimize toxicity when compared to standard-of-care dosing based on height and weight (known as body surface area or BSA). The May issue of the Journal of Clinical Oncology (JCO) featured results of a Phase III randomized study of colorectal cancer patients who were dosed with 5-FU based on the current standard, BSA compared with patients who had doses personalized according to 5-FU blood plasma levels. The study concluded that only 25 percent of patients were in target range, while 17 percent were found to be over-dosed and 58 percent of patients were found to be under-dosed. Additionally, this study demonstrated that after 5-FU doses was adjusted to achieve appropriate plasma levels, patients experienced improved response rates and nearly doubled overall survival, in addition to significantly lower toxicity.(ii)

About Personalized Medicine

Personalized medicine denotes treatments tailored individually for patients. Recognizing that patients respond differently to treatments, it is only recently that scientific tools have become available to enable identification of individual patient or disease differences at the molecular or genetic level. These tools enable physicians to formulate individualized treatment plans more effectively. For example, knowledge of genetic variations can now help physicians optimize breast cancer therapy or better manage dosing of blood thinning drugs.

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.(iii) 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.(i) 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.(ii)

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.

References

(i) American Cancer Society, "What are the Key Statistics for Colorectal Cancer?," March 5, 2008, http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_are_the_key_stati sti cs_for_colon_and_rectum_cancer.asp (April 22, 2008).

(ii) 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.

(iii) World Health Organization, "World Cancer Report." April 3, 2003, http://www.who.int/mediacentre/news/releases/2003/pr27/en/ (April 22, 2008).


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