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

Precision Therapeutics, Inc., a life science company dedicated to developing personalized medicine products for individualized cancer care, recently 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.

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.

Study: A prospective study evaluating the clinical relevance of a chemoresponse assay for treatment of patients with persistent or recurrent ovarian cancer [Gynecologic Oncology]

Source: Business Wire

ITN Type 1 Diabetes Study Identifies Subset of Patients with Strong Response to Therapy

Primary results from a new clinical trial show that patients with type 1 diabetes treated with the monoclonal antibody teplizumab (MacroGenics, Inc.) exhibit greater preservation of C-peptide, a biomarker of islet cell function, compared to controls. Further analyses identified a discrete subset of the treatment group that demonstrated especially robust responses (“responders”), suggesting that these patients could be identified prior to treatment. The trial, entitled “Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes” (AbATE), was conducted by the Immune Tolerance Network (ITN). The results are available online and will be published in the November issue of the journal Diabetes.

The AbATE study, led by Kevan Herold, MD (Yale University), tested teplizumab, which targets the CD3 receptor found on T cells, in patients with new-onset type 1 diabetes. CD3 is required for T-cell activation, which can lead to the destruction of insulin-producing beta cells. A previous ITN study with teplizumab showed that a single course of the drug slowed C-peptide decline in new-onset patients for a year, after which the effects waned. The aim of the AbATE study was to test whether C-peptide preservation could be prolonged by administering two courses of teplizumab, one year apart.

In this open-label, Phase II study, 77 new-onset patients (ages 8 to 30 years old) were randomized to receive either teplizumab or a control. Those in the treatment arm received the scheduled treatment consisting of two 14-day courses of teplizumab, one year apart. Both arms received intensive diabetes care from certified diabetes educators and were followed for two years. The primary endpoint compared C-peptide preservation between the two groups.

After two years, the teplizumab-treated group showed significantly greater preservation of C-peptide (75-percent higher responses compared to the control group).

Further analysis revealed that within the treatment arm two groups of patients could be distinguished based on their C-peptide levels: one group, considered “responders” (22/49), showed very little C-peptide decline over the course of the study (only a 6 percent reduction from baseline), while the “non-responders” (27/49) exhibited a similar rate of C-peptide decline as the control group (less than 40-percent reduction from baseline).

Investigators measured various biomarkers and cell types that might distinguish between these two groups. They found that, at trial entry, “responders” had lower hemoglobin A1c levels (a marker of glucose concentration in the blood) and used less insulin at baseline, compared to “non-responders”. Differences in specific T-cell subsets also distinguished between the two groups at baseline, suggesting that immune status might contribute to drug responsiveness. However, further studies will be required to confirm these results.

“This overall approach to identifying characteristics of individuals most likely to respond to therapies shows great promise because the responders in this study experienced a robust and prolonged drug effect,” said Dr. Herold. “This type of response has not been seen in other studies of immune therapies.”

Type 1 diabetes is a disease marked by immune destruction of insulin-producing beta cells in the pancreas. New-onset patients usually have 20 to 40 percent of their normal beta cell mass remaining, which is still capable of producing insulin. Preserving this remaining mass, even temporarily, could improve long-term clinical outcomes.

Immune modulators, like teplizumab, represent a promising means of inducing tolerance; however, no drug has been shown to prevent or reverse disease, and only a few have temporarily delayed disease progression. The ability to identify a subgroup of patients who may be more responsive to therapy could greatly enhance the clinical use of immune modulators and improve outcomes for those patients. Further analyses with specimens collected from the AbATE study are ongoing to understand the mechanism of response.

Source: EurekAlert!

CardioDx Announces Medicare Coverage for Corus CAD Gene Expression Test for the Diagnosis of Obstructive Coronary Artery Disease

CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, recently announced data demonstrating that Corus® CAD, the only clinically validated gene expression test for the assessment of obstructive coronary artery disease (CAD), has higher diagnostic accuracy than commonly used risk assessment modalities including symptom evaluation and myocardial perfusion imaging (MPI) in women. The sex-specific analysis of the PREDICT (Personalized Risk Evaluation and Diagnosis in the Coronary Tree) Trial was presented during a poster session at the Women’s Health 2013: 21st Annual Congress, which took place in Washington D.C. from March 22 nd – 24th.

There is a growing body of clinical evidence confirming that standard diagnostic approaches used to evaluate patients for obstructive CAD lead to many unnecessary noninvasive and invasive procedures such as MPI, stress echocardiogram, computed tomography angiography and coronary angiography, especially in women[1]. According to the results of the PREDICT Trial, MPI was not a significant predictor of obstructive CAD in women. This may be due to the presence of breast and fatty tissue in women, which leads to a higher rate of false-positive diagnoses[2] and, consequently, a higher rate of unnecessary referrals for additional invasive testing. The study also found that chest pain and other clinical factors are not reliable predictors of obstructive CAD in women. The traditional chest pain symptom classification as defined by Diamond and Forrester is helpful in diagnosing men, but does not correspond to presence of obstructive CAD in women. Furthermore, women with obstructive CAD tend to present with atypical, nonspecific symptoms such as shortness of breath, fatigue, and abdominal pain. Only the Corus CAD score and dyslipidemia were associated with the findings of obstructive CAD in women.

“Since the symptoms of coronary disease in women are not as well defined as in men, clinicians cannot use the same assessment criteria in women as they do in men,” said Alexandra Lansky, MD, Associate Professor of Medicine and Director of the Cardiovascular Research Center, Yale University School of Medicine, the senior author of the study and one of the PREDICT co-investigators. “Women have more angina and less obstructive coronary artery disease compared to age-matched men and are significantly over-referred to invasive coronary angiography, as current noninvasive diagnostic approaches have limitations in women. Women need tests that are both specific to their biology and can reliably assess the origin of their symptoms. Corus CAD is the only sex-specific test for evaluating obstructive CAD and represents a paradigm shift in how clinicians may diagnose heart disease in women, who account for half of the U.S. population.”

The PREDICT cohorts analyzed included 1,160 stable non-diabetic men and women referred for cardiac catheterization with typical and atypical symptoms suggestive of obstructive CAD or who were asymptomatic with a high risk of CAD: a substudy of 492 women was included in this sex-specific analysis. Of the women referred to invasive coronary angiography with abnormal MPI results (N=295), only 22 percent had obstructive CAD upon invasive coronary angiography. The study showed that Corus CAD results were more accurate than MPI and were significantly associated with the extent and severity of obstructive CAD. Corus CAD was a significant classifier of obstructive CAD in the overall population (p<0.001) and in the male (p=0.001) and female (p<0.001) subgroups separately, whereas MPI was not found to be an independent indicator of obstructive CAD. Each 10-point increase in the Corus CAD score was associated with a twofold increase in the likelihood of obstructive CAD in men, and a 3.4-fold increase in the likelihood of obstructive CAD in women. The results demonstrate the improved ability of Corus CAD to safely exclude obstructive CAD as a diagnosis, particularly in women.

Separately, a poster confirming the clinical utility of Corus CAD in the primary care setting to accurately exclude the diagnosis of obstructive CAD in stable, symptomatic female patients was also presented at the Women’s Health Congress. The poster titled, “The Use of a Personalized Gene Expression Test to Improve Decision Making in the Evaluation of Women with Symptoms of Suspected Obstructive Coronary Artery Disease” represents a substudy that included 141 women of a 317 total patient population in this sex-specific analysis led by Michael Conlin, MD, Johns Creek Primary Care. Results showed that Corus CAD scores could reliably separate female patients into elevated risk (score ≥15) and low risk (score ≤15) groups, allowing primary care physicians to more accurately triage patients. Use of Corus CAD led to a reduction in referrals to cardiologists of 77 percent in the low-scoring female patient group (p<0.001).

“With test overutilization contributing to the approximately $5 billion in annual cardiac-related diagnostic costs in this population, primary care providers are concerned with accountable care now more than ever,” said Dr. Conlin. “As the symptoms in women are harder to diagnose, they are often referred to additional and more invasive testing that ultimately produces low yields of obstructive CAD. Therefore, we welcome sex-specific tools like Corus CAD to help us more effectively identify the right patients who need further noninvasive and invasive cardiac workup.”

Among the 141 women studied, 73 percent had low Corus CAD scores. PCPs referred 12 percent of patients with low scores and 48 percent with non-low scores to cardiology. Of the patients with low scores who underwent additional testing, none were found to have clinically significant obstructive CAD. The average follow-up duration was 163 days, and no patients experienced a major adverse event during this time. 

Source: CardioDx

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®

Precision Therapeutics, Inc., a life science company that develops and markets personalized medicine products for individualizing cancer care, recently 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.”

Source: Business Wire

Horizon Discovery Establishes Three New Centers of Excellence in Asia

Horizon Discovery (Horizon), a leading provider of research tools to support the development of personalized medicines, recently announced it has established three new Centers of Excellence (CoE’s) for gene editing in Asia. The new Centers are at Aichi Cancer Center, Japan, Seoul National University, South Korea, and the National Cancer Centre (NCC), Singapore. Horizon will support the three research centers in their application of its proprietary gene engineering technology, GENESIS™, to generate human isogenic cell lines harboring specific genes/mutations relating to cancer.

“We are delighted these three new institutes have joined our Centers of Excellence program,” said Dr Rob Howes, Principal Scientist, Horizon. “We are excited to continue expanding our rAAV genome editing network into Asia, and hope to add to this further through 2013.”

The Aichi Cancer Center is Horizon’s second CoE in Japan, and will focus on elucidation of the molecular mechanisms of viral proliferation and oncogenesis of Epstein Barr Virus, as part of the world-wide effort to combat virally-initiated cancers. The principal investigator for this program will be Dr. Takayuki Murata.

Seoul National University, Institute of Molecular Biology and Genetics, will work with Horizon to create isogenic cell lines to study the regulatory mechanisms of BubR1 spindle assembly checkpoint, in order to increase understanding of the basis of genetic instability of cancer. Associate Professor Hyunsook Lee will be leading the program for Seoul National University.

Dr Daniel SW Tan, PI at the NCC Singapore, Department of Medical Oncology, will use Horizon’s technology to study the effects on cell lines of cancer-causing EGFR mutations, which are implicated in a wide range of cancer types.

These centers become part of the larger Horizon Centers of Excellence network, which includes high profile Institutions such as Cambridge University, UCL, Yale University, Washington University in St Louis, the NCI in Bethesda, and the National Cancer Centre, Japan.

Source: Business Wire