Precision Therapeutics Announces Topline Prospective Clinical Data Demonstrating Significant Improvement in Overall Survival and Progression Free Survival in Recurrent Ovarian Cancer using Personalized Chemotherapy Diagnostic ChemoFx®

  • First medical innovation in two decades using personalized medicine to show significant clinical results and improved outcomes for patients with ovarian cancer
  • ChemoFx doubled the recurrent ovarian cancer patients with a responsive drug– a dramatic improvement to the one-in-four response rate observed in patients treated empirically
  • Late-breaking data presented at Society of Gynecologic Oncology Annual Meeting

LOS ANGELES--()--Precision Therapeutics, Inc., a life science company that develops and markets personalized medicine products for individualizing cancer care, today announced results from a nine-year, multi-center, blinded prospective clinical study which demonstrated statistically significant improvement in overall survival and progression free survival in 262 patients with recurrent ovarian cancer whose tumors were tested with ChemoFx®, a personalized chemotherapy diagnostic.

Recurrent ovarian cancer patients in the clinical study who were treated with a chemotherapy drug identified to be responsive by the ChemoFx assay experienced a statistically significant improvement of 50% in overall survival, versus those patients treated by drugs classified as resistant by ChemoFx. The study also showed statistically significant improvement in progression free survival. In the clinical study, ChemoFx was able to identify at least one sensitive chemotherapy drug for more than half of the recurrent ovarian cancer patients studied, approximately doubling the statistics that show only 25 to 30 percent of cancer patients with recurrent ovarian cancer benefit from a chemotherapy treatment chosen empirically.1 These topline results were presented at a medical symposium and in a poster session held during the Society of Gynecologic Oncology (SGO) Annual Meeting on March 9-12, 2013 in Los Angeles, California.

“This clinical study is a landmark for the treatment of ovarian cancer because it is the first prospective data that definitively shows that a personalized diagnostic test can make a significant clinical impact by improving overall survival by 50% in women with this devastating cancer,” said Thomas J. Rutherford MD, PhD, Professor of ObGyn and Reproductive Sciences and Section Chief, Gynecologic Oncology at the Yale School of Medicine, and lead investigator in the ChemoFx clinical study.

“We see ChemoFx as an example of the power of personalized cancer diagnostics that put innovative technology in the hands of physicians to help inform treatment decisions, with the ultimate goal of improving patient outcomes,” said Sean McDonald, President and CEO of Precision Therapeutics. “We are excited to bring our late-breaking data to share with the treatment community at the SGO meeting, and look forward bringing ChemoFx to all gynecologic patients through the 1,000 board certified treating gynecologic oncologists in the US. We believe this test will have a profound impact on the treatment of this dreadful disease.”

Patients in the study’s treatment group had their cancer cells tested with ChemoFx to assess tumor response among 12 to 15 clinically equivalent chemotherapy options that National Comprehensive Cancer Network (NCCN) cancer guidelines recommend for persistent or recurrent ovarian cancer. ChemoFx was confirmed as an independent predictive factor for progression free survival and overall survival per multivariate Cox proportional hazards analysis. The company expects to publish comprehensive data from the clinical study in the near future.

“The results of this prospective study suggest that ChemoFx may serve as an important tool in selecting more effective drugs to improve the outcome of recurrent ovarian cancer patients,” said John Chan, MD, Associate Professor, Division of Gynecologic Oncology, University of California at San Francisco, Helen Diller Family Comprehensive Cancer Center. “This late breaking data on the utility of assay-directed treatment with ChemoFx will move us forward toward more personalized treatment for ovarian cancer.”

“With a devastating cancer, like ovarian cancer, which has an extremely high recurrence rate in 70% to 90% of patients, it is a groundbreaking moment when there is new clinical data, like these data with ChemoFx, showing that we have a chance to dramatically improve treatment for many patients,” said Thomas Krivak, MD, Associate Professor, University of Pittsburgh Physicians Magee Gynecologic Cancer Program, and an investigator in the ChemoFx clinical study.

“We have seen modest improvements in long-term survival for women with ovarian cancer in the past two decades, despite the availability of several new drugs and treatment strategies.

The data from this multi-institution, blinded observational clinical trial with ChemoFx is a highly significant advancement in understanding how the biology of each patient’s tumor may hold answers for treatments that could result in improvements in survival beyond what we are seeing currently,” said Robert Holloway, MD, Medical Director of Florida Hospital Gynecologic Oncology. “Furthermore, the significance of this study from a clinical standpoint is that this test may have predictive abilities, enabling a physician to choose the most effective pharmaceutical treatment from among the available options for ovarian cancer.”

About Ovarian Cancer Recurrence and Treatment

More than 22,000 women are diagnosed with ovarian cancer each year [in the U.S.] 2 70% 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.3 The majority of patients with ovarian cancer (more than 70%), present with advanced disease at initial diagnosis4, and women with advanced ovarian cancer tend to have multiple relapses and undergo several rounds of chemotherapy.5 There have been modest gains in ovarian cancer statistics in two decades, with statistics showing only small percentage of improvement in overall survival rates for recurrent ovarian cancer.7

About ChemoFx®

ChemoFx®, is a proprietary, CLIA certified and commercially-available chemoresponse assay which measures an individual’s tumor response to a range of therapeutic alternatives under consideration by the treating physician. By testing multiple chemotherapies on a patient's tumor cells before clinically treating a cancer patient, ChemoFx® helps determine the chemotherapies that are more likely to be effective and, therefore, provides valuable insights that help inform physicians' treatment decisions with a goal of improving patient outcomes.

Precision Therapeutics currently receives ChemoFx® specimens from 271 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. Over 60,000 patient specimens to date have been tested with ChemoFx®.

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®, a chemoresponse assay which measures an individual’s tumor response to a range of therapeutic alternatives and BioSpeciFx®, a select portfolio of clinically relevant molecular tests that provide information about drug response and patient prognosis. Additionally, in 2013 Precision is releasing two new gene signature products, under the GeneFx® brand. GeneFx Colon is a 634-transcript microarray assay that has been independently validated to predict risk of disease recurrence in stage II colon cancer patients. It is currently undergoing an additional independent validation using a large cooperative group cohort. GeneFx Lung is a 15-gene microarray assay that has been independently validated in 5 separate patient groups to predict risk of mortality in early stage non-small cell lung cancer (NSCLC), and may also be able to predict which of those patients will experience benefit from chemotherapy.

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

1 National Cancer Institute, Ovarian Epithelial Cancer Treatment PDQ, http://www.cancer.gov/cancertopics/pdq/treatment/ovarianepithelial/HealthProfessional/Page6#Section_473.

2 Siegel R, et al. CA Cancer J Clin 2012;62:10-29.

3 Ushijima K. “Treatment for Recurrent Ovarian Cancer—At First Relapse.” J Oncol. 2010;2010:497429.

4 NCCN Guidelines for Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer, v1.2013. www.nccn.org.

5 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/.

* JNCI 2006- J Natl Cancer Inst. 2006 Aug 2;98(15):1036-45.

JCO 2006- J Clin Oncol. 2006 Mar 1;24(7):1127-35.

JNCI 2003- J Natl Cancer Inst. 2003 Sep 3;95(17):1320-9.

JCO 2009- J Clin Oncol. 2009 Mar 20;27(9):1419-25. doi: 10.1200/JCO.2008.19.1684. Epub 2009 Feb 17

7 Chia VM, Lowe KA, O’Malley C, et al. An updated assessment of global ovarian cancer trends. International Journal of Gynecologic Cancer. 2012;22(8 suppl 3)

ChemoFx® and BioSpecifFx® are registered trademarks of Precision Therapeutics, Inc.

Contacts

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

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Contacts

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