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Northwestern Medicine Enrolls First Participant in Midwest for Research Study of Personalized Vaccine for Aggressive Brain Tumors

Northwestern Medicine® recently joined a landmark clinical trial to investigate if a vaccine made from a patient’s own brain tumor is effective in slowing tumor progression and extending survival. The randomized phase II trial will study how well giving the study vaccine with or without Avastin (bevacizumab) works in treating patients with recurrent glioblastoma multiforme (GBM). The study is the largest randomized brain tumor vaccine trial ever funded by the National Cancer Institute (NCI) and is chaired by Andrew T. Parsa, MD, PhD, who joined Northwestern Memorial Hospital in July as the new chair of neurological surgery. The first participant in the Midwest, and only third in the country, was enrolled in the trial last week at Northwestern Memorial.

The trial will enroll more than 200 participants with recurrent glioblastoma that can be surgically removed. Following the participant’s surgery, the tumor is sent to an industry collaborator Agenus Inc., where the participant’s specific personalized vaccine, designated as HSPPC-96, is created. The vaccine is unique to the individual participant and is engineered to trigger an immune system response to kill tumor cells that may remain following surgery.

“This is truly personalized medicine where the patient’s own tumor is being used to help fight their cancer,” said Parsa, who is also the Michael J. Marchese Professor and chair of the department of neurological surgery at Northwestern University Feinberg School of Medicine and a member of the of Robert H. Lurie Comprehensive Cancer Center of Northwestern University and part of the Northwestern Brain Tumor Institute. “The vaccine provokes a tumor-specific immune response that is specific to that patient. The T cells, which are the part of the immune system that fights disease, tracks down the cancer cells and kills them.”

Parsa launched this area of research in 2006 at the University of California, San Francisco (UCSF). Previous phases of this research have returned promising results finding that the vaccine extended survival for participants with glioblastoma when compared to standard therapies. In this next phase, researchers are seeking to understand if the vaccine is safe and more effective when given with Avastin, a drug that is known to shrink brain tumors and is a standard therapy for recurrent glioblastoma. Trial participants will be randomized to either receive the vaccine alone, concurrently with Avastin or Avastin only. Jeffrey Raizer, MD, co-director of the Northwestern Brain Tumor Institute (NBTI), is the principal investigator for the trial at Northwestern.

“This vaccine therapy has the potential to extend the lives of patients who often have limited options when their tumor returns,” said Raizer, medical director of neuro-oncology at Northwestern Memorial, associate professor of neurology at the Feinberg School and a member of the Lurie Cancer Center. “Previous results indicate that we may be able to extend survival longer by combining the therapy with other drugs, such as Avastin, that may boost the immune response of the vaccine.”

Each year, 17,000 Americans are diagnosed with glioblastoma, a particularly aggressive form of brain cancer. This type of tumor is often resistant to standard therapies and median survival is approximately 15 months from the point of first diagnosis.

“This research does not present a cure for brain tumors, but instead a potential way to convert the cancer into a chronic disease – something comparable to diabetes that you may be able to live with and control with medication,” said Parsa.

A successful trial could lead to the vaccine potentially being approved to treat recurrent brain tumors, making it one of only a few approved therapeutic cancer vaccines.

“Vaccine therapy is rapidly emerging as a potential treatment for many types of cancers and we’re proud that Northwestern is part of this exciting research,” said Steven T. Rosen, MD, director of the Lurie Cancer Center, director of cancer programs at Northwestern Memorial, and Genevieve E. Teuton Professor of Medicine at the Feinberg School. “This field of research has the potential to offer safer and less toxic cancer therapies that can be personalized to each individual patient.”

The study is sponsored by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the NCI, and the vaccine is being developed by Agenus Inc. Parsa has not received any financial support or travel expense from the company.

To learn more about the clinical trial, call 312-695-2047 or email kskirnyk@nmff.org. Enrollment criteria can be viewed on the Lurie Cancer Center website.

Northwestern’s neurology and neurological surgery program is ranked as 7th in the country on the U.S. News & World Report 2013-14 Best Hospitals specialty rankings and 1st in Chicago. This is the seventh consecutive year that Northwestern is the highest ranked neurological program in Illinois and Chicago. The departments of neurology and neurological surgery provide treatment for a full range of neurological disorders and offer patients the latest and most sophisticated treatment and surgical options. Our neurologists and neurosurgeons are actively engaged in clinical research to advance new therapies and uncover the causes and cures of neurological diseases.

Source: PR Newswire

Response Genetics, Inc. Announces Contract With Blue Cross and Blue Shield of Illinois

Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests that help determine a patient’s response to cancer therapy, recently announced that it has recently executed a provider contract with Blue Cross and Blue Shield of Illinois. Blue Cross and Blue Shield of Illinois has 7.4 million members, most of whom are located in the State of Illinois.

With the execution of this agreement, oncologists and pathologists affiliated with this health plan now have the ability to more easily offer Response Genetics’ suite of molecular predictive testing for their patients battling lung, colon, gastric, and melanoma cancers. Response Genetics’ tests provide treating physicians with actionable information that help enable the best therapy to be employed for each individual patient. The personalized medicine inherent in Response Genetics’ testing services brings with it a value proposition that is expected to improve patient outcomes and as a result enhance efficiencies in health care delivery.

The contract with this Blue Cross Blue Shield Association affiliate complements Response Genetics’ existing managed care network and gives the CLIA-licensed lab access to millions of additional Blue Cross Blue Shield-insured members located primarily in Illinois and the Midwestern United States. Blue Cross and Blue Shield of Illinois is the oldest and largest health plan based in Illinois.

Source: Response Genetics

Team Finds Markers Related to Ovarian Cancer Survival and Recurrence

Researchers at the University of Illinois have identified biomarkers that can be used to determine ovarian cancer survival and recurrence, and have shown how these biomarkers interact with each other to affect these outcomes. Their findings appear in the journal PLOS ONE.

Researchers try to find molecules called biomarkers that help determine a person’s likelihood of getting a disease or, if they have already been diagnosed, how far the disease has advanced. Genes, transcription factors and microRNAs are often used as biomarkers because these molecules can be heralds of disease or portents of susceptibility.

Genes are segments of DNA that code for proteins or other molecules that perform the functions of the cell. Transcription factors regulate these genes by binding to specific DNA sequences, preventing or inducing the genes to be “expressed” at higher or lower levels. MicroRNAs, as their name suggests, are small RNA molecules that regulate an intermediate stage of gene expression. Transcription factors and microRNAs also can regulate each other.

The relationships among transcription factors, microRNAs and target genes can be visualized as interconnected networks. These intricate webs are often used to determine how diseases such as cancer proceed. Analyzing how these networks function in cancer can offer insight into how tumor cells proliferate and differentiate, undergo (or resist) programmed cell death, and how likely they are to become invasive.

According to the American Cancer Society, an estimated 22,240 women will be diagnosed with ovarian cancer in 2013, and 14,230 will die of the disease; this makes ovarian cancer the fifth most common cause of cancer death in women.

The high prevalence of ovarian cancer and ovarian cancer deaths in the U.S. prompted U. of I. animal sciences professor Sandra Rodriguez-Zas and doctoral researcher Kristin Delfino to search for biomarkers associated with ovarian cancer survival and recurrence.

“We knew that there are specific biomarkers that have been associated with ovarian cancer, but we were looking at whether we could more accurately predict survival or age at cancer recurrence considering hundreds of interacting biomarkers simultaneously,” Rodriguez-Zas said.

The team used data from the Cancer Genome Atlas, which contains information about ovarian cancer patients’ age, survival, cancer recurrence, treatment, tumor stage, tumor grade and genomic expression. The researchers then performed statistical tests to tie these factors to patients’ survival time, measured in months from diagnosis to death, and their recurrence time, measured in months from diagnosis to recurrence.

“The networks change for people who have different rates of survival, so we looked at what’s being expressed in high-survival patients compared to what’s being expressed in low-survival patients,” Delfino said.

The team was able to confirm the association of 21 microRNAs with ovarian cancer. They also found 838 target genes and 12 transcription factors associated with ovarian cancer survival and 734 target genes and eight transcription factors associated with ovarian cancer recurrence.

“We were able to find many biomarkers that held the same relationship with survival no matter the cancer treatment, as well as some that were unique in their relationship with survival depending on the treatment the patient had received,” Rodriguez-Zas said.

Delfino said that a network-based approach is more predictive of ovarian cancer survival and recurrence than a single-molecule-based perspective.

“We took a step back and looked at everything from a network point of view instead of just individually to see how the components interacted with each other and how the biomarkers were associated with ovarian cancer survival and recurrence,” Delfino said.

“This demonstrated that the consideration of networks of microRNAs, transcription factors, and target genes allows us to identify reliable indicators of cancer survival and recurrence and serves as the basis for effective prognostic tools,” Rodriguez-Zas said.

Delfino believes this study opens the door to the creation of less invasive diagnostic tests and more specialized treatment options for women with ovarian cancer.

“In the future we’d like to be able to just take a little sample of your DNA and be able to tell you what’s going to happen, what we can do to prevent it, and how to cut cancer off before it ever reaches that point,” Delfino said. “Everyone is different, and hopefully, we will be able to specify the treatment that will best treat the individual patient.”

Study: Transcription Factor-MicroRNA-Target Gene Networks Associated with Ovarian Cancer Survival and Recurrence

Source: University of Illinois at Urbana-Champaign

First Test to Objectively Diagnose Fibromyalgia Now Available

A recent peer-reviewed study, published in BMC Clinical Pathology,[1] reveals a medical breakthrough discovering multiple biomarkers based upon highly sensitive and reproducible medical investigations. Conducted by the University of Illinois College of Medicine at Chicago (UIC) and EpicGenetics, a privately-held biomedical company, the research has led to the development of The FM/a® Test (www.thefmtest.com), the first test to objectively diagnose fibromyalgia.

Researchers at the UIC Department of Pathology conducted a statistically significant study involving more than 200 patients, comparing those clinically diagnosed with fibromyalgia to healthy patients. The study revealed that patients with fibromyalgia have a dysregulation disorder affecting protein molecules called chemokines and cytokines, produced by white blood cells. While fibromyalgia patients have been classified to be hyperactive (or overactive) responders, the study showed that people with fibromyalgia have immune production patterns which may make them more vulnerable to stress, thereby leading to chronic pain, severe fatigue, diffuse muscle tenderness, insomnia, and other unbearable symptoms long associated with fibromyalgia. Evaluation of The FM Test patient results will provide a continuing database that could lead to further insight into what may cause and exacerbate fibromyalgia and permit the development of standards to determine effective treatments.

EpicGenetics worked with fibromyalgia support groups to recruit participants in the clinical research study and is collaborating with groups such as the National Fibromyalgia & Chronic Pain Association to educate the fibromyalgia community and others about the availability of The FM Test.

“The results of our research have allowed us to ‘pull back the curtain’ and identify specific diagnostic biomarkers in fibromyalgia,” said Bruce S. Gillis, MD, MPH, member of the clinical faculty at the UIC College of Medicine and founder of EpicGenetics. “For decades, the medical community has viewed fibromyalgia with much skepticism. Patients have been stigmatized, and many are spending thousands of dollars and years of frustration in search of a diagnosis. Our breakthrough provides patients with hope and validation that their symptoms are real, and we hope physicians who commonly see patients with fibromyalgia will embrace and value this test for its role in the advancement of medical care.”

According to the American College of Rheumatology, fibromyalgia affects more than 12.3 million people in the United States, comparable to the number of people affected by cancer. Patients who experience symptoms, such as chronic pain and fatigue, depression and insomnia, spend an average of three to five painful years seeking a diagnosis and $4,800-$9,300 annually on associated medical costs. Until now, there has been no conclusive test to confirm the diagnosis of fibromyalgia.

The FM Test, a simple blood test with more than 93 percent sensitivity, now makes it possible for anyone to find out if they have fibromyalgia. The FM Test costs $744 with conclusive results available to most patients usually in a week or less – a fraction of the time and money the average patient currently spends seeking a diagnosis.

By completing a simple symptoms questionnaire at www.thefmtest.com, patients and their doctors can find out if they qualify for the test. If a patient meets the requirements, they can arrange for the test at their doctor’s office or at an independent blood draw facility.

“The elegantly designed study by Dr. Gillis and his co-investigators represents a milestone on the path our group charted 25 years ago when we first hypothesized that cytokines play a role in fibromyalgia2. It is hoped that this and future work sponsored by EpicGenetics will lead to a greater understanding of how the immune system, fatigue, sleep disorders, chronic stress and pain interact in patients with fibromyalgia and related disorders,” said Daniel J. Wallace MD, FACP, FACR, a clinical professor of medicine at the David Geffen School of Medicine at UCLA based at Cedars-Sinai Medical Center, and a member of the Scientific Advisory Board of EpicGenetics.

Source: Business Wire

Cancer Biomarker Study Data Presented at the 2012 AACR Meeting

A roundup of five research studies on cancer biomarkers that were presented early last week at the American Association for Cancer Research (AACR) 103nd Annual Meeting in Chicago, Illinois.