Data Published in Anticancer Research Show ChemoFx(R) Assay Results Correlate With Outcomes in Breast Cancer

Wednesday, July 2, 2008 General News
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PITTSBURGH, July 1 Precision Therapeutics Inc. announcedtoday that results from the ChemoFx(R) Assay, a cell-based test that examinesthe response of a specific patient's tumor to various chemotherapies,correlate with pathologic complete response in breast cancer patients treatedwith neoadjuvant (pre-operative) chemotherapy. Data published in AnticancerResearch show that the assay accurately predicted response to therapy 75% ofthe time. This study, done in conjunction with US Oncology, a leading cancerresearch and treatment network, represents the company's first publication inthe breast cancer setting.

"Achieving pathologic complete response is an important goal for patientsin the neoadjuvant breast cancer setting. Precision Therapeutics' datademonstrate that ChemoFx has the potential to predict which chemotherapyregimens will be most effective, thus potentially sparing patients fromunnecessary toxicity associated with ineffective treatment," said JoyceO'Shaughnessy, MD, of Baylor-Sammons Cancer Center in Dallas and associatestudy investigator. Ongoing definitive trials are evaluating whether thepromising results from our study with ChemoFx will help us design morepersonalized pre-operative treatment strategies."

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

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

About the study

Tissue specimens were obtained from a subset of patients (N=34) enrolledin the US Oncology 02-103 trial between April 2005 and April 2006. The studywas a Phase II trial of patients with locally advanced stage II and III breastcancer treated with four cycles of preoperative therapy consisting of5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by four cycles ofdocetaxel 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'stumor response to various types, combinations and doses of chemotherapyselected by the patient's physician. The laboratory test examines how manycancer cells are killed after exposure to treatment, using a patient's livingcancer cells that have been removed during a biopsy, aspiration or surgicalprocedure. ChemoFx can be tested in all solid tumor types and may be used inprimary, recurrent, and metastatic tumors.

About Precision Therapeutics

Precision Therapeutics is an oncology services company dedicated to theindividualization of cancer therapy. Precision Therapeutics is a leader in thedevelopment and delivery of personalized treatment support tools that assistphysicians and benefit cancer patients. For more information, call 800-547-6165 or email Heather Theoret Rockwell Precision Therapeutics Inc. 412-432-1500 ext. 1589

SOURCE Precision Therapeutics Inc.

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