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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

Life Technologies and RainTree Oncology Services Announce Collaboration to Bring Molecular Tumor Testing to Community Oncologists

Life Technologies Corporation (NASDAQ: LIFE) and RainTree Oncology Services recently announced they have entered into a collaboration agreement designed to further the advancement of personalized care for cancer patients.

Through the collaboration, RainTree and Life Technologies will seek to make the latest advances in molecular testing available to the broader patient market and will work to develop a streamlined protocol for entering patients into clinical trials for new targeted therapies.

Key elements of the collaboration are:

  • Collaborate on matching oncology patients to clinical trials using a Next Generation Sequencing Oncology screening panel;
  • Develop a clinical trials recruitment database which incorporates RainTree’s broad patient data set, enhanced by other data sources, including Life’s Compendia analytics engine;
  • Educate private payors and health plans about the benefits of Next Generation Sequencing; and
  • Build and market comprehensive product, test and data offerings for clinical research organizations.

“Today’s announcement emphasizes RainTree Oncology Services’ commitment to providing access to cutting edge capabilities to the over 600 community oncologists and approximately 40 practices that we serve,” said Mike Martin, chief executive officer of RainTree. “The world of personalized medicine is moving very fast, and the collaboration with Life Technologies ensures we stay active in the development of advanced molecular diagnostic capabilities to connect our physicians and patients with the latest in therapeutic discovery.”

“Our goal is to ensure that patients in the community setting have the same access to advanced technologies, such as genetic sequencing, as patients in the top academic centers,” said Ronnie Andrews, president of genetic and medical sciences at Life Technologies. “This collaboration also establishes a mechanism for pharmaceutical companies to identify the patients they need for clinical trials to bring new, targeted therapies to market.”

“Life Technologies and RainTree Oncology share a mutual commitment to improving cancer care in the community setting, where the majority of patients are diagnosed and treated,” said Andrews.

Through the collaboration, Life Technologies intends to participate in development of next generation sequencing panels that will allow for deep interrogation of tumors. Additional assays may also be developed under the collaboration. Patient data will be housed in a de-identified format in a proprietary database, which will be made available to pharmaceutical companies to recruit Phase 1 patients, as well as to participating clinical research organizations to support recruitment for later phase trials.

The agreement provides for RainTree and Life Technologies to leverage RainTree’s data sets, and utilize the information to enrich patient populations for early phase clinical trials and apply advanced bioinformatics techniques via Life Technologies’ proprietary Compendia Oncomine® solution to help identify targeted therapeutics for trials on certain tumor genotypes.

More than one half of cancer patients are seen in community oncology practices, according to Inside Oncology, Academic Cancer Centers (NCCC). The more than 500 new targeted compounds currently in development are leading to a large unmet need for recruitment of patients based on specific molecular profiles.

“Efficiently identifying clinical trial candidates for new targeted therapies has presented an obstacle in bringing new drugs to market,” said Dr. Jeff Patton, chief medical officer of RainTree and chief executive officer of Tennessee Oncology. “Through our collaboration with Life Technologies, we will be able to tap into new genetic information that, along with our existing data sets, will help guide patients to enroll in clinical trials based on the genetic signatures of their tumors.”

Source: Life Technologies

University of Maryland, Baltimore’s Licensing Deals Fuel Local Life Sciences Community

University of Maryland (UM) Ventures recently announced agreements between University of Maryland, Baltimore (UMB) and five different life sciences companies across the Baltimore/Washington metropolitan region. The companies include Montgomery County-based Rexahn Pharmaceuticals, Baltimore County-based Plasmonix, Prince Georges County-based IGI Technologies, Howard County-based A&G Pharmaceuticals, and Frederick County-based BioAssay Works. These deals are part of UM Ventures’ continual efforts to accelerate technology commercialization, advance industry collaboration, and support projects with commercial value at both the Baltimore and College Park campuses of the university.

“UMB is very excited to collaborate with these companies, each an innovator in its own right,” said Phil Robilotto, Assistant Vice President, Office of Technology Transfer, UMB. “These types of collaborations are at the core of our mission to channel the expertise of our industry partners and highlight our efforts to support the Maryland biotechnology community.”

UMB/Rexahn Exclusive License Agreement: In June 2013, UMB and Rexahn Pharmaceuticals, a clinical-stage biopharmaceutical company developing the next generation of cancer drugs, executed an exclusive license agreement for a novel drug delivery platform, Nano-Polymer-Drug Conjugate Systems (NPDCS), which was co-developed by researchers with the University of Maryland (UM) School of Pharmacy in the Department of Pharmaceutical Sciences, including Assistant Professor Anjan Nan, Ph.D. Rexahn’s platform uses existing chemotherapeutic agents, delivering them directly into cancer tumors. The UMB/Rexahn collaboration began after the company and a team of UMB researchers received a Maryland
Industrial Partnership (MIPS) award. The MIPS program is aimed at technology acceleration, providing funds that are matched by Maryland companies to support university-based research.

UMB/Plasmonix License Agreement: Also in June 2013, UMB entered into a license agreement with Plasmonix for a pathogen detection technology. Plasmonix focuses on the enhancement of luminescent signals through advanced use of metal nanoparticles, applying its technology in life science and diagnostic assays. Joseph Lakowicz, Ph.D., Professor of Biochemistry & Molecular Biology within the UM School of Medicine, invented the licensed UMB technology. His laboratory focuses on advancement of fluorescence compositions and methods for use in both research and commercial applications.

UMB Option Agreements with IGI Technologies/A&G Pharmaceuticals: UMB also executed option agreements (giving each company the exclusive right to evaluate a university technology for a short period of time prior to executing a full license agreement) during June 2013 with IGI Technologies and A&G Pharmaceuticals, both university start-ups, although at different stages of company development. Founded by Raj Shekhar, Ph.D., and William Plishker, Ph.D., former UM School of Medicine researchers from the Department of Diagnostic Radiology, IGI Technologies is an emerging start-up developing high-speed medical image registration technology through a Phase II Small Business Technology Transfer (STTR) award from the National Institutes of Health (NIH). A&G Pharmaceuticals, which was founded as a UMB startup in 2007, is discovering and developing theranostics (drug/test combinations) that improve screening, detection, and treatment of cancer. The company also offers custom antibody development through its service division – Precision AntibodyTM. UMB’s option agreement with A&G Pharmaceuticals is to explore the potential for the company’s development of a new cancer diagnostic test based on the tissue biomarker research of lead inventor Yun Qiu, Ph.D., Professor of Pharmacology, UM School of Medicine.

UMB/BioAssay Works Commercial Evaluation and Option Agreement: In September 2012, UMB entered into a commercial evaluation and option agreement with BioAssay Works to evaluate a Staph aureus diagnostic technology based on the work of lead inventor, Mark E. Shirtliff, Associate Professor, Department of Microbial Pathogenesis, with a dual appointment in UM Schools of Dentistry and Medicine. Dr. Shirtliff studies bacterial biofilms, a mode of growth where pathogens such as Staph aureus become resistant to conventional therapy. He was
awarded the 2013 BioMaryland LIFE Prize for his promising Staph vaccine work. BioAssay Works focuses on antibody-based and antigen-based detection technologies, and on their application in lateral-flow immunoassay. The partnership between BioAssay Works and UMB may lead to the development of a rapid and sensitive test for Staph, in particular the treatment-resistant type (“MRSA”).

Since UM Ventures launched in 2012, the University has helped faculty entrepreneurs manage and commercialize their discoveries, and has helped student entrepreneurs participate in and lead real-world early-stage business ventures. UMB and UMCP startups include a wide range of success stories. UM Ventures provides resources, funding, and expertise to help startups bring innovative technologies to the market.

Source: University of Maryland

Study Reveals Much-needed Strategy to Protect Against Deadly Liver Fibrosis

Chronic liver disease is a leading cause of death in the United States, in part because it often causes the formation of harmful scar tissue—a process known as fibrosis. A study published by Cell Press August 15 in the journal Immunity reveals the central role the immune molecule interleukin 33 (IL-33) plays in the formation of liver fibrosis. The findings suggest that drugs targeting this molecule could serve as a new treatment strategy to protect against liver fibrosis.

“Currently, the therapeutic options for liver fibrosis are limited and not curative,” says senior study author Stefan Wirtz of Friedrich-Alexander University Erlangen-Nuremberg. “We identified novel immunological factors that contribute to the development of liver fibrosis, opening up new avenues for the treatment of this serious condition.”

Liver fibrosis refers to the accumulation of harmful deposits of extracellular matrix (ECM) proteins, and it can eventually lead to organ failure. Past studies have suggested that this kind of damage is associated with abnormal immune responses in the liver, but very little was known about the molecules and cells that contribute to fibrosis.

In the new study, Wirtz and his team found that the amount of IL-33 in the blood was higher than normal in patients with liver disease. Following up on this observation, they discovered that injection of IL-33 into mice caused ECM proteins to build up in the liver, whereas mice that were genetically modified to lack IL-33 were largely protected from fibrosis. The researchers went on to identify the immune networks underlying IL-33’s harmful effects and discovered that this molecule activates immune cells called type 2 innate lymphoid cells (ILC2), which had never before been linked to liver disease.

“Our findings reveal IL-33 as a novel biomarker that could potentially lead to early detection of fibrosis in patients, which may be extremely valuable for preventing further damage to the liver,” Wirtz says. “Moreover, the study shows that drugs targeting IL-33 or ILC2 responses could be a promising strategy to protect against fibrosis and chronic liver disease.”

Study: Interleukin-33-Dependent Innate Lymphoid Cells Mediate Hepatic Fibrosis [Immunity]

Source: EurekAlert!

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