Correlation Between ChemoFx Assay and Improved Survival in Patients with Ovarian Cancer

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Precision Therapeutics Inc. announced today that the ChemoFx Assay, a cell-based test that examines the response of a specific patient’s tumor to various chemotherapies, correlates with significantly longer overall survival (OS) in patients with primary ovarian cancer. Patients who received a treatment determined by ChemoFx to lead to the best tumor response had an overall survival 1.4 times longer than those receiving a treatment shown by ChemoFx to be non-responsive.

Despite the fact that all patients had the same type of tumor, 88 percent of patients exhibited varying degrees of response to different agents when evaluated by the cell-based test. The analysis also found that nearly two-thirds of patients’ tumors were more responsive to a treatment identified by ChemoFx, than to the treatment they actually received. Based on these results, a mathematical model was created to estimate survival had patients been treated with a drug that ChemoFx identified as more likely to result in a greater tumor response. The analysis found that median OS could be extended as much as 23 to 38 months.

“These overall survival data demonstrate that the responsiveness to treatment established by this sensitivity assay in the laboratory setting, may in fact translate into meaningful clinical outcomes for patients,” said Thomas J. Herzog, MD, director of gynecologic oncology at the Columbia University Medical Center and lead investigator of the study. “If these results are confirmed in current ongoing trials, this will be a significant step towards establishing individualized treatment strategies for patients who will require chemotherapy.”

About the Study
Patients analyzed in the study had stage II-IV primary epithelial ovarian cancer that was tested by ChemoFx between 1997 and 2003, and received at least one course of chemotherapy. The study evaluated differences in OS between patients who received treatment that was deemed responsive, intermediate-responsive or non-responsive based on ChemoFx test results.

Of the 206 patients analyzed:
• Median OS of Assay non-responsive patients was 39.2 months
• Median OS of Assay intermediate-responsive patients was 62.5 months
• Median OS of Assay responsive patients was 80.4 months

When accounting for cancer stage and debulking – the reduction of tumor size due to surgery or radiation treatment – overall survival was significantly associated with the ChemoFx Assay and the cancer stage. In the model simulating improved survival if patients were treated with a therapy that caused a greater tumor response, median OS of patients treated with an Assay non-responsive drug could be improved from 39.2 to 62.5 months and median OS of patients treated with an Assay intermediate-responsive drug could be improved from 62.5 to 101.3 months.

“People with cancer often require additional treatment after receiving the standard of care chemotherapy. ChemoFx Assay can provide valuable information that could spare the patient from unnecessary toxicity associated with a potentially ineffective treatment,” said Sean McDonald, CEO Precision Therapeutics. “The goal of ChemoFx is to empower patients and physicians with additional diagnostic information to help determine the most appropriate course of therapy for each individual patient.”

This retrospective, multi-center analysis is a published abstract at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and is available at http://www.asco.org.

About ChemoFx®
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 used in primary, recurrent, and metastatic tumors.

ChemoFx can be tested in all solid tumor types, with ovarian and breast tumors being primarily tested. Other solid tumors most commonly tested include endometrial, colorectal, genitourinary, head and neck, lung, brain, pancreas, hepato-biliary.

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.

Source: Precision Therapeutics Inc.

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