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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

BioTime’s Subsidiary OncoCyte Corporation Publishes Data on the Gene FSIP1 as a Breast Cancer-Specific Marker

BioTime, Inc. (NYSE MKT: BTX) and BioTime’s subsidiary OncoCyte Corporation recently announced the publication of a scientific report on the gene FSIP1 and its potential as a marker for breast cancer. The paper, published in the peer-reviewed journal Biomarkers in Medicine and available online today, describes the microarray-based approach used to identify FSIP1 as a breast cancer biomarker with significantly elevated expression in breast tumors expressing the estrogen receptor, which represents 70-80% of all breast cancers. In addition to elevated gene expression, FSIP1 protein was also expressed within tumors at significant levels whereas little to no expression was found in most normal tissues, including healthy breast tissue. Combined, these findings lay the foundation for novel diagnostic and therapeutic strategies, including the measurement of FSIP1 in the blood as a screen for the presence of cancer, as well as targeting of FSIP1 as an antigen in cancer immunotherapy approaches.

Based on large unmet need, market size, and data generated thus far from patient sample screening, OncoCyte is initially focusing its efforts on identifying biomarkers that may be used to detect and monitor breast and bladder cancers. OncoCyte has been developing, characterizing, and manufacturing monoclonal antibodies for use in detecting breast cancer, in preparation for the initiation of the first clinical study of PanC-DxTM and is currently working with a select group of cancer researchers to finalize a study protocol for submission to the institutional review boards of the study sites. If clinical trials are successful, OncoCyte intends to launch PanC-DxTM as an in vitro diagnostic (IVD) in Europe before seeking FDA approval required to market PanC-DxTM in the United States.

University Of California, San Diego School Of Medicine To Investigate Risk Factors For Parkinson’s Disease Via Parkinson’s Progression Markers Initiative (PPMI)

University of California, San Diego School of Medicine will be one of 23 official clinical sites of the Parkinson’s Progression Markers Initiative’s (PPMI) new arm to study at-risk populations for Parkinson’s disease (PD). The $55 million landmark observational clinical study launched in 2010 to define one or more biomarkers of PD and now seeks to better understand potential risk factors of the disease. The University of California, San Diego School of Medicine has been a part of PPMI for three years and is currently enrolling for the new, pre-motor arm of the study.

The pre-motor arm of PPMI will enroll participants who do not have Parkinson’s disease and are living with one of three potential risk factors for PD: a reduced sense of smell (hyposmia); rapid eye movement sleep behavior disorder (RBD); or a mutation in the LRRK2 gene (the single greatest genetic contributor to PD known to date). Validating these risk factors could not only enable earlier detection of the disease, but open new avenues in the quest for therapies that could slow or stop disease progression.

“Understanding risk factors for Parkinson’s disease could help to identify therapies that may prevent the onset of motor symptoms in future generations of PD patients,” said Douglas Galasko, MD, the principal investigator for the study at the University of California, San Diego School of Medicine.

Local residents can easily get involved in this research by being one of 10,000 individuals needed to complete a brief online survey (www.michaeljfox.org/takethesmellsurvey) about their sense of smell. People over the age of 60 who do not have Parkinson’s disease are needed to take the survey. Most respondents will be sent a scratch-and-sniff smell test and brief questionnaire in the mail to be completed at home. Some individuals may also be asked to undergo more extensive testing.

“In the third year of PPMI, it is evident that a large-scale biomarker study is not only possible in Parkinson’s disease, but is already yielding scientific insights that could help transform the field of Parkinson’s research,” said Todd Sherer, PhD, CEO of The Michael J. Fox Foundation for Parkinson’s Research. “None of this progress would be possible without the willing volunteers who donate their time and energy to the pursuit of a cure.”

Source: PR Newswire

Assurex Health Releases Major Update to GeneSight Psychotropic Test Panel

Assurex Health recently announced the release of GeneSight® Psychotropic 2.0, its lead psychiatric pharmacogenomic test panel. This latest GeneSight Psychotropic version has been updated to include four additional medications that now cover a total of 36 of the most commonly prescribed psychotropic medications in the US. The added antidepressant and antipsychotic medications include Viibryd® (vilazodone), Latuda® (lurasidone), Saphris® (asenapine), and Invega® (paliperidone). Additionally, the GeneSight Psychotropic 2.0 report includes information for 17 psychotropic medications that have pharmacogenomic information in their FDA approved labels.

“Assurex Health is committed to bringing the latest clinical and scientific findings to support clinicians and their patients in selecting medications to treat neuropsychiatric disorders,” according to Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health. “GeneSight Psychotropic 2.0 now includes recently approved FDA medications, a new gene polymorphism, and easy-to-understand information to help categorize individual psychotropic medications.”

GeneSight is a unique pharmacogenomic treatment decision support product that tests for clinically important genetic variants affecting a patient’s response to psychiatric medications. GeneSight provides information that helps clinicians make informed, evidence-based decisions about proper drug selection, delivered in a simple and easily understood report. Prescribing a medication regimen that is more likely to succeed because it is tailored to an individual patient’s genetic profile can help the clinician better manage the patient’s disease and improve patient outcomes.

A Mayo Clinic prospective clinical study published recently in Translational Psychiatry (Oct. 2012) compared GeneSight-guided prescribing versus treatment-as-usual prescribing in adult patients with a primary diagnosis of a major depressive disorder over an 8 week period. The study found up to a 4-fold increase in symptom improvement for GeneSight-guided patients. An Assurex Health sponsored one-year blinded retrospective study of adult patients with a diagnosis of depressive or anxiety disorder, also published recently in Translational Psychiatry (Mar. 2013), demonstrated that patients taking genetically inappropriate or “red bin” medications based on the GeneSight report had substantially higher rates of medical utilization, 3-fold greater medical absence days, and 4-fold greater medical disability claims than study patients on non-red bin medications.

Source: Assurex Health

Studies Show bioTheranostics’ Breast Cancer Index Identifies Breast Cancer Patients at Risk for Early and Late Recurrence, and Predicts Benefit from Extended Endocrine Therapy

bioTheranostics, developer of innovative molecular diagnostics, reported results from two new studies evaluating the performance of its Breast Cancer Index (BCI) biomarker assay in estrogen-receptor positive (ER+), early stage breast cancer. Study results showed that BCI predicts which women with early stage ER+ breast cancer are at risk for early and late distant recurrence, and which are most likely to benefit from continuing treatment with endocrine therapy after completing five years of tamoxifen.

BCI is a combinatorial biomarker with a novel mechanism of action composed of Molecular Grade Index (MGI) and the two-gene expression ratio HOXB13/IL17BR (H/I).

In a study published online in the Journal of the National Cancer Institute, tumor samples from 83 patients with breast cancer recurrence were matched to 166 patients without disease recurrence from the MA.17 trial, a landmark randomized clinical study that demonstrated improved disease-free survival with extended letrozole therapy in postmenopausal patients with ER+ breast cancer who were recurrence-free following an initial five years of tamoxifen therapy. In patients receiving extended endocrine therapy, a high H/I gene expression ratio, as measured by the BCI assay, remained significantly associated with benefit from extended endocrine therapy (p=0.0061), representing a 16.5 percent reduction in the risk of recurrence with extended letrozole treatment compared with placebo. Patients with low H/I did not benefit from extended letrozole treatment. The study authors concluded that the BCI assay identifies a subgroup of breast cancer patients disease-free after five years of tamoxifen therapy who are at risk for late recurrence, and that high H/I predicts benefit from extended endocrine therapy. The study was conducted by researchers from leading institutions, including Massachusetts General Hospital.

A second study, published online in the journal Clinical Cancer Research, examined the ability of the BCI test to predict early (0-5 years) and late (>5 years) distant recurrence in ER+, lymph node-negative breast cancer patients. The study was a retrospective analysis of tumor samples from tamoxifen-treated patients from the randomized, prospective Stockholm trial (n=317) and a multi-institutional cohort from two academic medical centers (n=358). Within the Stockholm trial cohort, BCI stratified the majority (~65 percent) of patients as low risk, with <3 percent distant recurrence rate for 0-5 years and 5-10 years. In the multi-institutional cohort, which had larger tumors, 55 percent of patients were classified by BCI as low risk, with a <5 percent distant recurrence rate for 0-5 and 5-10 years. For both groups, the BCI assay was the most significant prognostic factor beyond standard clinicopathological factors for 0-5 and >5 years. The authors concluded that the ability of the BCI test to assess risk of both early and late distant recurrence has clinical utility for decisions of chemotherapy at diagnosis and for decisions about extended endocrine therapy beyond five years.

Richard Ding, president and CEO of bioTheranostics, said there is a growing need for novel biomarkers in ER+ early stage breast cancer that guide disease management beyond the initial 5-year window. “Breast Cancer Index is the only biomarker test that has been shown in prospective trials to predict the benefit of extended endocrine therapy,” Ding said. “The results of these key studies illustrate the importance of the BCI test in identifying which patients are at risk for early and late breast cancer recurrence, and who among them will benefit from extended endocrine therapy, which is of significant clinical value. This critical information should allow many women to avoid unnecessary treatment and for the clinical focus to be on those in most need of therapy.”

Study: Prediction of Late Disease Recurrence and Extended Adjuvant Letrozole Benefit by the HOXB13/IL17BR Biomarker

Study: Breast Cancer Index Identifies Early-Stage Estrogen Receptor–Positive Breast Cancer Patients at Risk for Early- and Late-Distant Recurrence

Source: Business Wire