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Data Published in Anticancer Research Show ChemoFx(R) Assay Results Correlate With Outcomes in Breast Cancer
Date:7/1/2008

Ability to Perform Testing on Biopsy-sized Specimens Allows for Greater

Clinical Utility in all Breast Cancer Settings

PITTSBURGH, July 1 /PRNewswire/ -- Precision Therapeutics Inc. announced today that results from the ChemoFx(R) Assay, a cell-based test that examines the response of a specific patient's tumor to various chemotherapies, correlate with pathologic complete response in breast cancer patients treated with neoadjuvant (pre-operative) chemotherapy. Data published in Anticancer Research show that the assay accurately predicted response to therapy 75% of the time. This study, done in conjunction with US Oncology, a leading cancer research and treatment network, represents the company's first publication in the breast cancer setting.

"Achieving pathologic complete response is an important goal for patients in the neoadjuvant breast cancer setting. Precision Therapeutics' data demonstrate that ChemoFx has the potential to predict which chemotherapy regimens will be most effective, thus potentially sparing patients from unnecessary toxicity associated with ineffective treatment," said Joyce O'Shaughnessy, MD, of Baylor-Sammons Cancer Center in Dallas and associate study investigator. Ongoing definitive trials are evaluating whether the promising results from our study with ChemoFx will help us design more personalized pre-operative treatment strategies."

Other major findings of the study addressed technical aspects of the assay, including the feasibility of performing the test on small amounts of tissue and the reproducibility of test results. The study demonstrated that the test could be successfully performed 84% of the time on tissue samples as small as 35 mg (2 14 gauge core needle biopsies). This finding is significant because historically chemoresponse assays have been limited by the need for a large amount of tissue (1-5 grams). The small tissue requirement demonstrated in this study is crucial in the breast cancer setting, as the diagnosis is often made by biopsy. The reproducibility of the test was also confirmed in this study, showing that chemoresponse profiles had a coefficient of variation <3%.

"We are excited to publish our first results in breast cancer that are tied to patient outcomes. These findings further validate the use of the ChemoFx assay to assist in selection of therapy for cancer patients," said Precision Therapeutics CEO Sean McDonald.

About the study

Tissue specimens were obtained from a subset of patients (N=34) enrolled in the US Oncology 02-103 trial between April 2005 and April 2006. The study was a Phase II trial of patients with locally advanced stage II and III breast cancer treated with four cycles of preoperative therapy consisting of 5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by four cycles of docetaxel with capecitabine. HER-2 positive patients also received Herceptin. The final manuscript for 02-103 is pending.

About ChemoFx(R)

ChemoFx is a decision support tool that measures a specific patient's tumor response to various types, combinations and doses of chemotherapy selected by the patient's physician. The laboratory test examines how many cancer cells are killed after exposure to treatment, using a patient's living cancer cells that have been removed during a biopsy, aspiration or surgical procedure. ChemoFx can be tested in all solid tumor types and may be used in primary, recurrent, and metastatic tumors.

About Precision Therapeutics

Precision Therapeutics is an oncology services company dedicated to the individualization of cancer therapy. Precision Therapeutics is a leader in the development and delivery of personalized treatment support tools that assist physicians and benefit cancer patients. For more information visit http://www.precisiontherapeutics.com, call 800-547-6165 or email info@ptilabs.com.

Contact:

Heather Theoret Rockwell

Precision Therapeutics Inc.

412-432-1500 ext. 1589

hrockwell@ptilabs.com


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SOURCE Precision Therapeutics Inc.
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