Precision Therapeutics Presents Clinical Data Showing the ChemoFx® Drug Response Test Has Predictive Value in Recurrent Epithelial Ovarian Cancer

ECC 2013

PITTSBURGH--()--Precision Therapeutics announced today that a recent clinical study supporting the predictive value of the ChemoFx® chemoresponse assay in recurrent ovarian cancer was presented at the 2013 European Cancer Congress (ECCO-ESMO-ESTRO), held September 27 – October 1, 2013 in Amsterdam, Netherlands. The study, titled, Evaluation of a Chemoresponse Assay as Both a Prognostic and Predictive Marker in the Treatment of Persistent or Recurrent Ovarian Cancer, was presented as part of the “Diagnostics/Biomarkers” session of the biennial conference.

The ability of ChemoFx® to function as a predictive marker of patient outcome in persistent and recurrent ovarian cancer was evaluated in cooperation with MD Anderson Cancer Center, Mayo Clinic and UPMC Magee Women’s Hospital of Pittsburgh. Several approaches were used for estimating the assay’s predictive value in 262 patients with recurrent epithelial ovarian cancer who were treated with one of 15 therapies. The assay’s relative ability to predict progression-free survival for patients treated with a therapy for which they were considered to be sensitive (‘match’) was compared to the average prognostic value of sensitivity to a randomly selected treatment (‘mismatch’). Patients were classified based on assay results and clinical treatment, and the percentage of sensitive therapies was included in multivariate analysis.

The assay result for ‘match’ was significantly associated with progression-free interval (hazard ratio (HR) =0.67, 95% CI=0.50-0.91, p=0.009). Based on repeated (3000) simulations, the mean hazard ratio for ‘mismatch’ was 0.81 (95% range=0.66-0.98), suggesting that ‘match’ results were predictive of response to a specific treatment. Furthermore, while 47% of tumors were non-sensitive to all assayed therapies and 9% were sensitive to all, 44% displayed heterogeneity in assay results. Improved outcome was associated with administration of a sensitive therapy, regardless of homogeneous or heterogeneous assay responses across all of the assayed therapies, indicating that the value of ChemoFx for predicting outcome was not due to tumor biology alone. The association between assay result for administered therapy and progression-free survival remained statistically significant in multivariate analysis (HR=0.60, 95% CI=0.36-1.02, p=0.057), independent of the percentage of S therapies.

The lead author of the study is Robert L. Coleman, M.D., FACOG, FACS. Dr. Coleman serves as Professor in the Department of Gynecologic Oncology and Reproductive Medicine and Vice Chair of Clinical Research at the University of Texas MD Anderson Cancer Center in Houston, Texas.

“Development of clinically relevant predictive biomarkers guiding therapeutic decisions is one of the most relevant and important endpoints to realize the promise of individualized medicine,” said Dr. Coleman. “We are hopeful interrogation of cancer biology as it relates to specific therapeutics will help close the gap between blinded and directed therapy to maximize outcomes.”

“Precision is committed to developing products that aim to improve patient outcomes through every stage of cancer treatment,” said Sean McDonald, President and CEO of Precision. “We continue to study the use of ChemoFx® as both a prognostic and predictive marker in personalizing and refining cancer treatments for patients with advanced stage and recurrent ovarian cancer.”

About Ovarian Cancer Recurrence and Treatment
More than 22,000 women in the United States are diagnosed with ovarian cancer each year.1 Seventy to 90% of all women with ovarian cancer have their disease recur, and 25% of recurrences occur less than 6 months from the end of the first-line therapy.2 The majority of patients with ovarian cancer (more than 70%), present with advanced disease at initial diagnosis,3 and women with advanced ovarian cancer tend to have multiple relapses and undergo several rounds of chemotherapy.4 There have been modest gains in ovarian cancer statistics in two decades, with only a small percentage of improvement in overall survival rates for recurrent ovarian cancer.

About Precision Therapeutics
Precision Therapeutics, a leading life-science company based in Pittsburgh, Pennsylvania, is dedicated to utilizing precision medicine for personalized cancer care. Precision offers a portfolio of products developed to help guide physicians and patients with difficult clinical decisions throughout the cancer care continuum. The company’s leading products for personalized cancer care include:

  • ChemoFx® Drug Response Assay, which can identify platinum-resistant/refractory primary ovarian patients, helping physicians in the selection of effective treatment upfront for patients newly diagnosed. Studies have also shown a 14 month (65%) improvement in overall survival (OS) and 50% improvement in progression free survival (PFS) when recurrent ovarian cancer patients are treated with responsive therapies as indicated by ChemoFx®. Precision Therapeutics currently receives ChemoFx® specimens from over 270 top medical institutions including 20 of the 21 National Comprehensive Cancer Network (NCCN) Member Institutions, and 8 of the US News and World Report Top 10 Hospitals for Cancer Care.
  • BioSpeciFx®, a select portfolio of clinically relevant molecular tests that provide information about drug response and patient prognosis.
  • Precision also offers the microRNA-based Rosetta miRview® mets2 Tumor of Origin test, which Identifies 42 tumor origins with overall specificity up to 99% and overall sensitivity up to 85%.
  • Additionally, in 2013 Precision plans to release two new genomic products under the GeneFx® brand that examine a patient’s tumor at the molecular level in order to garner information about a patient’s individual disease and potentially inform effective treatment options.

For more information, visit: www.precisiontherapeutics.com or www.chemofx.com.

1 Siegel R, et al. CA Cancer J Clin 2012;62:10-29.
2 Ushijima K. “Treatment for Recurrent Ovarian Cancer—At First Relapse.” J Oncol. 2010;2010:497429.
3 NCCN Guidelines for Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer, v1.2013. www.nccn.org.
4 Ovarian Cancer National Alliance (www.ovariancancer.org) and SEER Cancer Statistics Review, 1975–2005, National Cancer Institute. Bethesda, Md., http://seer.cancer.gov/csr/1975_2005/.

Contacts

Precision Therapeutics Inc.
Pam Ranallo, 412-432-1500 ext. 1502
pranallo@ptilabs.com

Contacts

Precision Therapeutics Inc.
Pam Ranallo, 412-432-1500 ext. 1502
pranallo@ptilabs.com