A Dose Of Reality About Chemotherapy Dosing - Saladax Has The Antidote - My5-FU™

Bethlehem, PA /PRNewswire/ - Saladax Biomedical, Inc. announced today that Saladax Biomedical Laboratories is offering a simple blood test for the personalization and optimization of 5-fluorouracil (5-FU) dosing to help oncologists improve treatment outcomes and minimize the drug's toxic side effects. The test is called My5-FU™. 5-FU is a chemotherapy drug commonly used in the treatment of many different cancer types, including colorectal, head & neck and breast cancers.

Presently, chemotherapy dosing is based on the body surface area (BSA) formula, which was developed in 1916 and is used to calculate the surface area of a human body based on an individual's height and weight. The use of BSA for chemotherapy dosing is and has been the standard practice since the introduction of the first chemotherapy drugs in the 1950's, but only due to the lack of a better means for determining the appropriate dose in an individual 1. Since the BSA formula was developed in 1916, we have learned that not all human bodies metabolize medications the same way, in the same time frame, or with the same outcome. No two individuals of the same height and weight will absorb and clear drugs at exactly the same rate. There are many factors besides just height and weight that impact drug absorption and clearance, including age, gender, metabolism, disease state, organ function, drug-drug interactions, and genotype. BSA provided a historical safety net for universal dosing practices, but better precision is what is really needed to obtain optimal outcomes for patients undergoing chemotherapy. Which side of the dosing equation would you want to be on during chemo treatment?

Recent clinical studies have highlighted the serious flaws of the BSA dosing method 2-6. Over 80% of colorectal cancer patients were found to have received therapeutically suboptimal dosing of 5-FU; 68% of these patients were under-dosed, jeopardizing their treatment outcomes, and 13% were overdosed, putting them at high risk of serious toxic side effects from their treatment. To learn more about BSA dosing, and the issues around it, please read visit www.bettercancercare.com.

My5-FU is about to change those statistics.

My5-FU is one of a line of MyCare™ blood tests offered by Saladax Biomedical Laboratories. The test requires a simple venous blood draw to be performed a minimum of two hours prior to the end of a 5-FU infusion cycle. The My5-FU test results provide the oncologist information about the concentration of the drug in the patient's blood as well as their overall systemic exposure to the drug. Based on the exposure levels, the doctor can adjust the next dose to achieve the optimal exposure level for best treatment results with minimized toxicities. This method of personalized dosing is referred to as pharmacokinetic (PK) guided dosing.

It is time for a change to the way your chemotherapy drugs are dosed. The MyCare line of blood tests is now available to truly personalize and calibrate your chemotherapy dosing.

About Saladax Biomedical, Inc.:
Saladax Biomedical is a leader in the development and deployment of high quality diagnostic services and products, delivering actionable data to help physicians to select and optimize the use of current and new pharmaceutical products, with the goals of improving health and positively impacting the economics of care. Saladax also serves as a valuable collaborator for pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. Since 1988, laboratories must be inspected and pass stringent requirements to be certified and registered as a Clinical Laboratory Improvement Act (CLIA) laboratory. Saladax Biomedical Laboratories is certified and registered under the CLIA regulations by the Office of Clinical Standards and Quality (OCSQ), a division of The Centers for Medicare & Medicaid Services (CMS) that regulates laboratory testing performed on humans.

Additional information.is available at www.Saladax.com and www.MyCareTests.com.

References:

1. Felici A, Verweij J, Sparreboom A. Dosing strategies for anticancer drugs: the good, the bad and body-surface area. Eur J Cancer. 2002;38:1677–1684.
2. Adapted from Saam J, Critchfield GC, Hamilton SA, et al. Body surface area–based dosing of 5-fluorouracil results in extensive interindividual variability in 5-fluorouracil exposure in colorectal cancer patients on FOLFOX regimens. Clin Colorectal Cancer.2011;10(3):203-206.
3. Gamelin EC, 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. 2008;26(13):2099-2105.
4. Saif MW, et.al. Pharmacokinetically (PK) guided dose adjustment of 5-fluorouracil (5-FU): a rational approach to improving therapeutic outcomes. J Nat'l Cancer Inst. 2009;101(22):1543-1552.
5. Capitain O, et al. Individual Fluorouracil (5-FU) Dose Adjustment in FOLFOX Based on Pharmacokinetic (PK) Follow-Up Compared With Conventional Body-Area-Surface Dosing: A Phase II, Proof-of-Concept Study. Clin Colorectal Cancer. 2012;11(4): 263-267.
6. Kline CLB, et.al. Personalized dosing via pharmacokinetic (PK) monitoring of 5-Fluorouracil (5-FU) might reduce toxicity in early or late stage colorectal cancer patients treated with infusional 5-fluorouacil-based chemotherapy regimens. Clin Colorectal Cancer. In Press, 2014.