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Laboratory Test May Predict Effectiveness of ERBITUX(R) for Individual Colorectal Cancer Patients
Date:6/1/2009

Data Presented Today at American Society of Clinical Oncology

ORLANDO, Fla., June 1 /PRNewswire/ -- Precision Therapeutics, Inc. today presented data demonstrating the use of ChemoFX(R), a chemosensitivity assay, to predict the effectiveness of cetuximab (ERBITUX(R)) on the colorectal cancer cells of individual patients. Results from the study show that of the 54 primary colorectal cultures tested, eight percent were responsive to cetuximab, a result that is consistent with the reported clinical response rate for cetuximab in colorectal carcinoma patients (11 percent). A predictive assay such as this could give physicians the edge they need to determine if cetuximab is appropriate for a patient before administering the biologic. Colorectal cancer is the second leading cause of cancer-related deaths among men and women in the United States.

"We are very pleased with the results of this study and the potential ChemoFX has to help physicians find the right treatment, the first time, for their patients," said Sean McDonald, President and CEO, Precision Therapeutics, "Colorectal cancer can be devastating and we hope to give patients and physicians the edge they need to effectively treat this disease."

Cetuximab is FDA-approved to treat head and neck cancer and colorectal carcinomas. Due to the low population response rate to cetuximab, a biomarker that can identify patients with an increased likelihood for response would be of great clinical utility. ChemoFx(R) is a test that measures an individual cancer patient's probable tumor response to various chemotherapeutic and biologic agents -- providing both sensitivity and resistance information. As such, ChemoFx(R) provides valuable insights that can help guide physicians' treatment decisions and give both physicians and patients an edge against cancer.

"One in twenty people in the United States will be diagnosed with colorectal cancer in their lifetime," said Dr. Holly Gallion, Vice President Clinical Affairs, Precision Therapeutics, "Studies such as this move us a step closer to increasing the accuracy of the chemotherapy and biologic decision-making process for oncologists and their patients."

About the Study

The chemoresponse assay (ChemoFx(R)) was developed using four different immortalized carcinoma cell lines (designated; NCI-H292, NCI-H522, NCI-H1666, Calu3). The chemoresponse assay was also performed on 54 cultures of primary human colorectal cancer. Cell lines and specimens were treated with a serial dose of 10 concentration of cetuximab for 72 hours, stained with a nuclear dye, and remaining post-treatment live cells were counted. Two of the examined cell lines showed response to cetuximab treatment; EC50 values for NCI-H292 and NCI-H1666 were 825nM and 13nM, respectively. NCI-H522 and Calu3 were deemed non-responsive to cetuximab. Dose-response curves of the 54 primary colorectal cultures revealed that eight (8) percent of the cultures tested were responsive to cetuximab, 22 percent had an intermediate response, and 70 percent were deemed non-responsive. These results are consistent with a reported clinical response for cetuximab in colorectal carcinoma patients.

About Precision Therapeutics

Precision Therapeutics is a diagnostics services company dedicated to providing physicians and patients with actionable clinical information to personalize cancer treatments. Precision Therapeutics is a leader in the development and delivery of treatment support tools that assist physicians and benefit cancer patients. For more information visit www.precisiontherapeutics.com, call 800-547-6165 or email info@precisiontherapeutics.com.


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SOURCE Precision Therapeutics, Inc.
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