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Precision Therapeutics, Inc. Announces Unparalleled Results That Show Recurrent Ovarian Cancer Patients Live 65% Longer in Breakthrough Prospective Clinical Trial


8/19/2013 9:26:50 AM

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PITTSBURGH--(BUSINESS WIRE)--Precision Therapeutics, Inc., a life science company dedicated to developing personalized medicine products for individualized cancer care, today announced that compelling results have been accepted for publication in Gynecologic Oncology, a leading, peer-reviewed clinical oncology journal. The accepted study is currently located on the Gynecologic Oncology website.

The prospective study, conducted in conjunction with Yale University School of Medicine and over 30 additional cancer centers nationwide, showed that recurrent ovarian cancer patients treated with a chemotherapy identified as sensitive by the ChemoFx® drug response assay lived 14-months longer, a (65%) improvement in overall survival, as compared to patients treated by non-sensitive chemotherapies classified by ChemoFx.

Additionally, ChemoFx was able to identify at least one sensitive chemotherapy agent for more than half of the recurrent ovarian cancer patients studied, approximately doubling current statistics suggesting that only 20 to 30 percent of cancer patients with recurrent ovarian cancer benefit when treated with chemotherapy chosen empirically.1

262 evaluable patients were treated with one of 15 study-designated standard chemotherapy treatments selected by the treating oncologist, who was not informed of the ChemoFx results. When blinded to the results of the assay, physicians treated 25% of patients with a sensitive chemotherapy, while more than half (52%) of the study participants showed at least one assay-sensitive chemotherapy from which they could have benefited had the physician been assay-informed. The data implies that if ChemoFx results were utilized by physicians prior to treatment, the number of patients receiving sensitive treatments, and thereby experiencing improved survival outcomes, could have more than doubled. The study clearly shows that patients treated with sensitive chemotherapies identified by ChemoFx outperformed patients treated with alternate chemotherapies.

Median progression free survival also improved by 50% for patients treated with sensitive chemotherapies as identified by ChemoFx vs. those treated with non-sensitive agents (hazard ratio [HR] = 0.67, p = 0.009). The association with assay response was consistent in both platinum-sensitive and platinum-resistant tumors (HR: 0.71 vs. 0.66) and was independent of other covariates in multivariate analysis (HR = 0.66, p = 0.020). A statistically significant 14-month improvement in median overall survival (37.5 months for patients treated with sensitive agents vs. 23.9 months for who were not, HR = 0.61, p = 0.010) was also reported.

“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 65% 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 study.

ChemoFx results show a dramatic difference when compared to recent recurrent ovarian cancer studies that produced limited improvements in progression free survival (2-3 months), and very few if any improvement in overall survival (2 months)2-14

This breakthrough study shows that through the use of the ChemoFx assay, treating physicians can treat with effective chemotherapy drugs which may help extend the life of patients afflicted with this disease. No recent test, therapy or innovation compares in terms of impact on patient’s lives and it is reason for new hope for the treatment of this disease.

“The clinical significance of this study is that ChemoFx may have predictive abilities, enabling a physician to choose the most effective pharmaceutical treatment from among the available options for ovarian cancer,” said Robert Holloway, MD, Medical Director of Florida Hospital Gynecologic Oncology.

About Ovarian Cancer Recurrence and Treatment

More than 22,000 women in the U.S. are diagnosed with ovarian cancer each year.15 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.16 The majority of patients with ovarian cancer (more than 70%), present with advanced disease at initial diagnosis17, and women with advanced ovarian cancer tend to have multiple relapses and undergo several rounds of chemotherapy.18 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 patients.19,20

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

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

2Pfisterer, JCO 2005 Gemcitabine Plus Carboplatin Compared With Carboplatin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer: An Intergroup Trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG

3Gonzalez-Martín Ann Oncol 2005, Randomized phase II trial of carboplatin versus paclitaxel and carboplatin in platinum-sensitive recurrent advanced ovarian carcinoma: a GEICO (Grupo Espanol de Investigacion en Cancer de Ovario) study. Ann Oncol. 2005 May;16(5):749-55. Epub 2005 Apr 7

4Parmar Lancet 2005 Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR2.2ttrial. Lancet. 2003 Jun 21;361(9375):2099-106.

5Poveda Ann Oncol 2011Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months)subpopulation of OVA-301 phase III randomized trial. Ann Oncol. 2011 Jan;22(1):39-48. doi: 10.1093/annonc/mdq352. Epub 2010 Jul 19.

6Aghajanian JCO 2012 OCEANS:ARandomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, http://jco.ascopubs.org/content/30/17/2039

7Wagner BJC 2012 Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients. Br J Cancer. 2012 Aug 7;107(4):588-91. doi: 10.1038/bjc.2012.307. Epub 2012 Jul 26.

8Bokkel Huinink JCO 1997 Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer http://jco.ascopubs.org/content/15/6/2183

9Piccart JCO 2000 Oxaliplatin or Paclitaxel in Patients With Platinum-Pretreated Advanced Ovarian Cancer: A Randomized PhaseII Study of the European Organization for Research and Treatment of Cancer Gynecology Group, http://jco.ascopubs.org/content/18/6/1193.full.pdf

10O’Byrne Proc Am Soc Clin Oncol 2002 Pegylated liposomal doxorubicin in ovarian cancer Int J Nanomedicine. 2006 September; 1(3): 229–239.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2426807/

11Mutch JCO 2007 Ferrandina JCO 2008 Phase III Trial of Gemcitabine Compared With Pegylated Liposomal Doxorubicin in Progressive or Recurrent Ovarian Cancer, VOLUME 26 NUMBER 6 FEBRUARY 20 2008, http://jco.ascopubs.org/content/26/6/890.full.pdf

12Lortholary Ann Onc 2011 Weekly paclitaxel as a single agent or in combination with carboplatin or weekly topotecan in patients with resistant ovarian cancer: the CARTAXHY randomized phase II trial from Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO). Ann Oncol. 2012 Feb;23(2):346-52. doi: 10.1093/annonc/mdr149. Epub 2011 May 11. http://www.ncbi.nlm.nih.gov/pubmed/2156207213Pujade-Lauraine ASCO 2012 AURELIA: A randomized phase III trial evaluating bevacizumab (BEV) plus chemotherapy (CT) for platinum (PT)-resistant recurrent ovarian cancer (OC). Journal of Clinical Oncology, 2012 ASCO Annual Meeting Proceedings (Post-Meeting Edition).Vol 30, No 18_suppl (June 20 Supplement), 2012: LBA5002© 2012 American Society of Clinical Oncology http://meeting.ascopubs.org/cgi/content/short/30/18_suppl/LBA5002?rss=1

13Ushijima K. “Treatment for Recurrent Ovarian Cancer—At First Relapse.” J Oncol. 2010;2010:497429.

14Kaye JCO 2012Phase II, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly (ADP-ribose) polymerase inhibitor, and pegylated liposomal doxorubicin in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer. J Clin Oncol. 2012 Feb 1;30(4):372-9. doi: 10.1200/JCO.2011.36.9215. Epub 2011 Dec 27. http://www.ncbi.nlm.nih.gov/pubmed/22203755

15Siegel R, et al. CA Cancer J Clin 2012;62:10-29.

16Coleman, R. L. et al. Nat. Rev. Clin. Oncol. advance online publication 5 February 2013; doi:10.1038/nrclinonc.2013.5 Latest research and treatment of advanced-stage epithelial ovarian cancer Nat Rev Clin Oncol, Vol. advance online publication (5 February 2013), doi:10.1038/nrclinonc.2013.5 by Robert L. Coleman, Bradley J. Monk, Anil K. Sood, Thomas J. Herzog

17NCCN Guidelines for Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer, v1.2013. www.nccn.org.

18Ovarian 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/. 6 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.

19JNCI 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

20Chia 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)

Contacts

Precision Therapeutics Inc.

Pam Ranallo, 412-432-1500 ext. 1502

pranallo@ptilabs.com

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