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ARRAYit Technology Used By Researchers at NIH For Important Discovery

ARRAYit Corporation (OTCQB: ARYC) reports today that researchers at the National Institutes of Health (NIH), National Cancer Institute (NCI) and Northeastern University have used the ARRAYit Microarray Platform to discover biomarkers important in the treatment of prostate cancer.

Promising Screening Tool for Early Detection of Ovarian Cancer

Evaluating its change over time, CA-125, the protein long-recognized for predicting ovarian cancer recurrence, now shows promise as a screening tool for early-stage disease, according to researchers at The University of Texas MD Anderson Cancer Center.

The updated findings are published in Cancer; preliminary data were first presented at the 2010 American Society of Clinical Oncology (ASCO) annual meeting. If a larger study shows survival benefit, the simple blood test could offer a much-needed screening tool to detect ovarian cancer in its early stages – even in the most aggressive forms – in post-menopausal women at average risk for the disease.

MD Anderson has a long history in the research of the important biomarker. In the 1980s, Robert Bast, M.D., vice president for translational research at MD Anderson and co-investigator on the ASCO study, discovered CA-125 and its predictive value of ovarian cancer recurrence. Since then, researchers at MD Anderson and beyond have been trying to determine its role in early disease detection. The marker, however, can become elevated for reasons other than ovarian cancer, leading to false positives in early screening.

“Over the last ten years, there’s been a lot of excitement over new markers and technologies in ovarian cancer,” said Karen Lu, M.D., professor and chair, Department of Gynecologic Oncology and the study’s corresponding author. “I and other scientists in the gynecologic oncology community thought we would ultimately find a better marker than CA-125 for the early detection of the disease. After looking at new markers and testing them head-to-head in strong, scientific studies, we found no marker better than CA-125.”

According to the American Cancer Society, 22,240 women will be diagnosed with ovarian cancer in 2013 and another 14,030 are expected to die from the disease. The challenge, explained Lu, is that more than 70 percent of women with ovarian cancer are diagnosed with advanced disease.

“Finding a screening mechanism would be the Holy Grail in the fight against ovarian cancer, because when caught early it is not just treatable, but curable,” said Lu, also the trial’s principal investigator.

For the prospective, single-arm, 11-year study, 4,051 women were enrolled from seven sites across the country, with MD Anderson serving as the lead site. All were healthy, post-menopausal women, ages 50-74, with no strong family history of breast or ovarian cancer. The study’s primary endpoint was specificity, or few false positives. In addition, the study looked at the positive predictive value, or the number of operations required to detect a case of ovarian cancer.

Each woman received a baseline CA-125 blood-test. Using the Risk of Ovarian Cancer Algorithm (ROCA), a mathematical model based on the patient’s age and CA-125 score, women were stratified to one of three risks groups, with the respective follow-up: “low,” came back in a year for a follow-up blood test; “intermediate,” further monitoring with repeat CA-125 blood test in three months; and “high,” referred to receive transvaginal sonography (TVS) and to see a gynecologic oncologist.

Based on the women’s CA-125 change over time, the average annual rate of referral to the intermediate and high groups were 5.8 percent and .9 percent, respectively. Cumulatively, 117 women (2.9 percent) were determined to be high risk, and thereby received the TVS and were referred to a gynecologic oncologist. Of those women, 10 underwent surgery: four had invasive ovarian cancer; two had borderline disease; one had endometrial cancer and three had benign ovarian tumors – a positive predictive value of 40 percent, which greatly surpasses the clinical benchmark of 10 percent, say the researchers. The specificity of the test was 99.9 percent, explained Lu. The screening failed to detect two borderline ovarian cancers.

Of great importance, said Lu, is that the four invasive ovarian cancers detected were high-grade epithelial tumors, the most aggressive form of the disease, and were caught early (stage IC or IIB), when the disease is not only treatable, but most often curable. Lu also noted that all four women found to have invasive disease were monitored at low risk for three years or more prior to a rising CA-125.

“CA-125 is shed by only 80 percent of ovarian cancers,” explained Bast, the study’s senior author. “At present, we are planning a second trial that will evaluate a panel with four blood tests including CA-125 to detect the cancers we may otherwise miss with CA-125 alone. The current strategy is not perfect, but it appears to be a promising first step.”

While encouraging, the findings are neither definitive, nor immediately practice-changing, stressed Lu; who also said a large, randomized prospective screening trial still needs to be conducted. Such research is ongoing in the United Kingdom; results from more than 200,000 women should be known by 2015.

“As a clinician treating women with this disease for more than ten years, I’ve become an admitted skeptic of ovarian cancer screening. Now, with these findings, I’m cautiously optimistic that in the not too distant future, we may be able to offer a screening method that can detect the disease in its earliest, curable stages and make a difference in the lives of women with this now-devastating disease.”

The study is continuing; and, as follow-up, Lu and her team plan to look at combining other markers with CA-125 to determine the screening impact of their combined change over time.

The study was supported by the National Cancer Institute, and was a research project of MD Anderson’s ovarian cancer Specialized Program of Research Excellence (SPORE), NCI P50 CA83639, the Bioinformatics Shared Resources of MD Anderson CCSG NCI P30 CA16672, the National Foundation for Cancer Research. It has also received philanthropic funds from Golfers Against Cancer, the Tracy Jo Wilson Ovarian Cancer Foundation, the Mossy Foundation, the Norton family and Stuart and Gaye Lynn Zarrow.

In addition to Lu, and Bast, other authors on the study include: Therese Bevers, M.D. Department of Clinical Cancer Prevention, Herbert Fritsche, Ph.D., Department of Laboratory Medicine, Deepak Bedi, M.D., Department of Diagnostic Radiology, Michael T. Deavers, M.D., Department of Pathology and Clinical Pathology; Charlotte Sun, Dr.PH, Department of Gynecologic Oncology, Mary A. Hernandez, Office of Translational Research, all with MD Anderson; Steven Skates, Ph.D., Massachusetts General Hospital and Harvard Medical School; Olasunkanmi Adeyinka, M.D., UT Physicians Family Physicians; William Newland, M.D., The Iowa Clinic; Richard Moore, M.D. and Cornelius Granai, M.D., both with Women & Infants Hospital, Brown University; Leroy Leeds, M.D., OGA Medical Center; Steven Harris, M.D., OB/GYN Associates of Dallas; Jeremy Geffen, M.D., Geffen Cancer Research Institute; and Nora Horick, Harvard Medical School and Massachusetts General Hospital.

As a co-inventor of the CA-125, Bast receives royalties from, and has served as an advisor to, Fujirebio Diagnostics, Inc.

Study: A 2-stage ovarian cancer screening strategy using the Risk of Ovarian Cancer Algorithm (ROCA) identifies early-stage incident cancers and demonstrates high positive predictive value [Cancer]

Source: MD Anderson Cancer Center

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

EMD Serono Establishes Immuno-Oncology Research and Early Development Platform to Advance Innovation in Cancer Therapies

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, recently announced its commitment to the field of cancer immunotherapy by creating a fully dedicated immuno-oncology innovation platform integrating research, early development and biomarker strategies. In addition to the company’s existing oncology platform, this new immuno-oncology platform will focus on developing therapies that leverage the immune system’s natural ability to fight tumors, and work in combination with existing and future therapies.

“We are pleased to announce our commitment to immuno-oncology, recognizing that the complexity of cancer requires diverse approaches that will enable alternative therapeutic interventions,” said Bernhard Kirschbaum, Head of Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “In order to spur research and early development in this specialized area, we have created an innovative environment where researchers and clinicians work side-by-side to advance potential new cancer immunotherapies.”

The new immuno-oncology platform includes three innovation clusters, each of which is focused on discovery research and the advancement of molecules into the clinic through proof of confidence:

  • Therapeutic cancer vaccines: targeting tumor antigens to elicit a tumor-specific immune response
  • Cancer stem cells: targeting cancer stem cells to prevent or reduce tumor formation and inhibit metastases
  • Immunotolerance: eliminating or circumventing inhibitory mechanisms in the immune system that prevent cancer cells from being recognized and attacked by the body

To ensure a broad immuno-oncology research and early development platform, EMD Serono has assembled an in-house team of preeminent researchers and clinicians who will focus resources and technologies to build a portfolio of investigational immunotherapies, while collaborating with premier academia, research and industry organizations to complement internal capabilities.

The current immuno-oncology portfolio comprises therapeutic candidates in early clinical development and a robust pipeline of pre-clinical molecules. Leading therapeutic concepts in the clinic are:

  • A monoclonal antibody targeting PD-L1 (programmed cell death ligand) expressed by various tumors, currently in Phase I in solid tumors
  • NHS-IL12, a cancer immunotherapy targeting IL-12 to the necrotic regions of tumors, sponsored by the United States National Cancer Institute (NCI), currently in Phase I in solid tumors
  • NHS-IL2, targeting IL-2 to the necrotic regions of tumors, completed Phase I and currently preparing for Phase II in solid tumors

“Our goal is to develop leading immunotherapies that work in combination with other therapeutic modalities, understanding that attacking multiple cancer targets simultaneously increases the possibility of therapeutic success,” said Helen Sabzevari, Head of Immuno-Oncology, Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “We are committed to delivering on the promise of immuno-oncology by combining creative thinking with strong research and clinical excellence, and, more importantly, by keeping patient needs at the heart of our efforts.”

Source: EMD Serono

NIH Scientists Find Promising Biomarker for Predicting HPV-related Oropharynx Cancer

Researchers have found that antibodies against the human papillomavirus (HPV) may help identify individuals who are at greatly increased risk of HPV-related cancer of the oropharynx, which is a portion of the throat that contains the tonsils.

In their study, at least 1 in 3 individuals with oropharyngeal cancer had antibodies to HPV, compared to fewer than 1 in 100 individuals without cancer. When present, these antibodies were detectable many years before the onset of disease. These findings raise the possibility that a blood test might one day be used to identify patients with this type of cancer.

The results of this study, carried out by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health, in collaboration with the International Agency for Research on Cancer (IARC), were published online June 17, 2013, in the Journal of Clinical Oncology.

Historically, the majority of oropharyngeal cancers could be explained by tobacco use and alcohol consumption rather than HPV infection. However, incidence of this malignancy is increasing in many parts of the world, especially in the United States and Europe, because of increased infection with HPV type 16 (HPV16). In the United States it is estimated that more than 60 percent of current cases of oropharyngeal cancer are due to HPV16. Persistent infection with HPV16 induces cellular changes that lead to cancer.

HPV E6 is one of the viral genes that contribute to tumor formation. Previous studies of patients with HPV-related oropharynx cancer found antibodies to E6 in their blood.

“Our study shows not only that the E6 antibodies are present prior to diagnosis—but that in many cases, the antibodies are there more than a decade before the cancer was clinically detectable, an important feature of a successful screening biomarker,” said Aimee R. Kreimer, Ph.D., the lead Investigator from the Division of Cancer Epidemiology and Genetics, NCI.

Kreimer and her colleagues tested samples from participants in the European Prospective Investigation into Cancer and Nutrition Study, a long-term study of more than 500,000 healthy adults in 10 European countries. Participants gave a blood sample at the start of the study and have been followed since their initial contribution.

The researchers analyzed blood from 135 individuals who developed oropharyngeal cancer between one and 13 years later, and nearly 1,600 control individuals who did not develop cancer. The study found antibodies against the HPV16 E6 protein in 35 percent of the individuals with cancer, compared to less than 1 percent of the samples from the cancer-free individuals. The blood samples had been collected on average, six years before diagnosis, but the relationship was independent of the time between blood collection and diagnosis. Antibodies to HPV16 E6 protein were even found in blood samples collected more than 10 years before diagnosis.

The scientists also report that HPV16 E6 antibodies may be a biomarker for improved survival, consistent with previous reports. Patients in the study with oropharyngeal cancer who tested positive for HPV16 E6 antibodies prior to diagnosis were 70 percent more likely to be alive at the end of follow-up, compared to patients who tested negative.

“Although promising, these findings should be considered preliminary,” said Paul Brennan, Ph.D., the lead investigator from IARC. “If the predictive capability of the HPV16 E6 antibody holds up in other studies, we may want to consider developing a screening tool based on this result.

Source: Evaluation of Human Papillomavirus Antibodies and Risk of Subsequent Head and Neck Cancer

Source: National Cancer Institute