July 2008

July 2008 Precision's Quarterly Newsletter
By Precision Therapeutics

What we do.
Precision Therapeutics is a diagnostics services company dedicated to providing physicians and patients with actionable clinical information to personalize cancer treatments. Precision’s ChemoFx®, a proprietary live tumor cell-based platform, measures an individual patient’s tumor sensitivity and resistance to a range of therapeutic alternatives under consideration by a physician.

Precision CEO Named Entrepreneur of the Year
Precision President and CEO Sean McDonald was named regional Ernst & Young Entrepreneur of the Year® 2008 in June. This award recognizes outstanding entrepreneurs who are building and leading dynamic growth businesses. “Being named an Ernst & Young Entrepreneur of the Year is a great honor for me and my team as we work towards our goal of improving the lives of people living with cancer,” said McDonald. Sean joined Precision in 2001. Prior to that, Sean founded Automated Healthcare in 1992, developing the first roboticsbased solution to hospital pharmacy management. Automated Healthcare was acquired by McKesson Corporation in 1996.

Breast Cancer Studies Program
In our last issue, we profiled our gynecologic cancer studies program. This month, Precision’s growing breast cancer program is in the spotlight. In addition to a recent publication demonstrating correlation between ChemoFx results and clinical outcomes (see details at right) and two pilot studies demonstrating the ability to test breast cancer tissue from core needle and MAMMOTOME® biopsies, the following studies are ongoing:

• NSABP B-40: Precision is currently involved in this prospective trial of 1200 primary breast cancer patients receiving one of three neoadjuvant chemotherapy regimens +/- bevacizumab. ChemoFx is performed on biopsies from each patient and correlated with pathologic response. For more information about NSABP B-40, visit www.nsabp.pitt.edu/B40_Protocol_Brochure.pdf.
  
  
• DOD Study: This prospective 280-person study aims to develop a biomarker to predict pathologic complete response in women treated with a neoadjuvant chemotherapy regimen of the physician’s choice. In addition to ChemoFx testing, genotypic characteristics of the tumor and patient will be determined by genomic profiling via gene expression analysis of tumor RNA.
  

1st Results in Breast Cancer Show ChemoFx Correlates with Outcomes

• Data published in Anticancer Research show that ChemoFx accurately predicted pathologic complete response 75% of the time in a prospective neoadjuvant breast cancer study done in conjunction with US Oncology, a leading cancer network
  
  
• According to study investigator Joyce O'Shaughnessy MD of Baylor Cancer Center in Dallas "Achieving pathologic complete response is an important goal for patients in the neoadjuvant breast cancer setting. Precision Therapeutics' data demonstrate that ChemoFx has the potential to predict which chemotherapy regimens will be most effective, thus potentially sparing patients from unnecessary toxicity associated with ineffective treatment…"
  
  
• The study also demonstrated that ChemoFx can be successfully performed on biopsies; 84% of tissue samples as small as 35 mg (two 14 gauge core biopsies) were grown and tested successfully
  
  
• The test’s reproducibility was also confirmed in this study, showing that chemoresponse profiles had a coefficient of variation <3%

ASCO Data: ChemoFx Correlates with Survival in Ovarian Cancer

• In a study of 206 primary ovarian cancer patients, data show that patients treated with a ChemoFxresponsive drug had an overall survival 1.4 times longer than those treated with a ChemoFx-nonresponsive drug
  
  
• Nearly two-thirds of patients’ tumors were more responsive to a treatment identified by ChemoFx than to the treatment they actually received
  
  
• Contrary to the notion that patients are either sensitive to all drugs or resistant to all drugs, this study demonstrated that 88% of patients had varying degrees of response to the panel of drugs tested
  
  
• Analysis indicated that patient survival could be improved by 26 to 39 months using assay results to help select therapy

Multiple Choice:
The following types of specimens can be tested with ChemoFx:
A) Surgical specimens
B) Core needle biopsies
C) Ascites
D) Pleural fluid
E) All of the above

Answer: E) All of the above! Precision can test almost any type of malignant specimen.

Observational Study Update
Precision’s observational study is currently accruing gynecologic cancer patientswho have had ChemoFxperformed. To date, 325 patients from 27 sites have been enrolled. For more information, contact us at 877-628-8472.

Did You Know?
Since introduction, over 5,000 ChemoFx tests have been performed in over 30 different types of cancers.

April 20-26 is National Medical Laboratory Professionals Week!
Precision would like to thank the many lab professionals in-house and around the country with whom we work. Please take a moment to recognize the important work that your local lab does every day!

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 treatment support tools that assist physicians and benefit cancer patients. For more information visit www.precisiontherapeutics.com, call 800-547-6165 or email info@ptilabs.com