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Home > Press > New Data Demonstrates 5-FU Personalized Chemotherapy Management (PCM(R)) Assay Provides Similar Performance to More Complicated Liquid Chromatography-

Abstract:
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.

New Data Demonstrates 5-FU Personalized Chemotherapy Management (PCM(R)) Assay Provides Similar Performance to More Complicated Liquid Chromatography-

BETHLEHEM, PA | Posted on June 23rd, 2008

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 Biomedical
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.

For more information, please click here

Contacts:
Saladax Biomedical, Inc.
116 Research Drive, Bethlehem, PA 18015
Click here for directions to facility

PHONE (610) 419-6731
FAX (610) 849-5001

Copyright © PR Newswire Association LLC.

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