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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

Breakthrough Case Study Highlights New Biomarker for Cancer and Inflammation

A groundbreaking peer reviewed case report by Dr. Isaac Eliaz, M.D. of Amitabha Medical Clinic, demonstrates for the first time the clinical use of novel biomarker galectin-3 to assess cancer progression and inflammation. The case study titled, “The Role of Galectin-3 as a Marker of Cancer and Inflammation in a Stage IV Ovarian Cancer Patient with Underlying Pro-Inflammatory Comorbidities,” was published in the July 2013 issue of Case Reports in Oncology. This report is the first of its kind to expand the diagnostic and prognostic applications of the galectin-3 blood serum test, introducing an important clinical tool to assess risk and progression of metastatic cancer and inflammatory diseases.

In 2011, the galectin-3 blood test was approved by the U.S. Food and Drug Administration for the screening and prognosis of congestive heart failure and cardiovascular disease. Approval was granted after an extensive body of published data, including long-term population studies, demonstrated the active role of elevated galectin-3 in cardiovascular conditions, fibrosis and early mortality. However, a rapidly expanding field of published galectin-3 research also highlights the significance of this rogue molecule as a novel biomarker that is both an active culprit as well as a byproduct of numerous inflammatory and malignant cellular processes beyond cardiovascular disease.

An expert on galectin-3, Dr. Eliaz applies the data obtained in this case study to shed further light on excess galectin-3’s mechanisms of action, specifically inflammatory response to injury and cancer progression. In this report, Dr. Eliaz presents the first published case documenting the clinical use of galectin-3 to monitor cancer progression and treatment response, as well as inflammatory conditions. These findings point to an expanded clinical model using galectin-3 testing in the diagnostic and prognostic assessment of numerous chronic, inflammatory diseases.

Unlike biomarkers such as C-reactive protein (CRP), which only indicate the presence of inflammation, galactin-3 is shown to play a direct role in initiating disease progression. It is a protein normally present in the body at low concentrations, where it is involved in numerous functions including cell growth and communication. At elevated levels, however, galectin-3 fuels numerous pathologic processes including chronic inflammation and the progression of inflammation to fibrosis; cancer cell adhesion, migration, angiogenesis, and metastasis. Elevated galectin-3 also allows cancer cells to evade immune response. Research demonstrates elevated galectin-3 levels in patients with melanoma, lung, breast, prostate, colorectal, ovarian, and head and neck cancers as well as non-Hodgkin’s lymphoma and others. Galectin-3 levels are also found to be higher in patients with metastatic disease than in patients with localized tumors.

Dr. Eliaz states, “This new case report and significant clinical observation supports the need for further research on the role of galectin-3. The galectin-3 test could well become one of our most important clinical tools in assessing and monitoring a wide range of conditions beyond cardiovascular disease, including metastatic cancer and inflammatory conditions.”

Study: The Role of Galectin-3 as a Marker of Cancer and Inflammation in a Stage IV Ovarian Cancer Patient with Underlying Pro-Inflammatory Comorbidities [Case Reports in Oncology]

Source: PR Newswire

MicroRNAs have Diagnostic and Prognostic Potential in Urinary Bladder Cancer

German researchers have identified four biomarkers that correctly determine malignancy of urinary bladder cancers and contribute to the accurate prediction of patient outcomes. Their results are published in the September issue of The Journal of Molecular Diagnostics.

Current prognosticators of bladder cancer, such as tumor grade, stage, size, and number of foci, have limited usefulness for clinicians since they do not accurately reflect clinical outcomes. Therefore, investigators have been searching for new biomarkers with better diagnostic and prognostic capabilities. Focusing on the role of microRNAs (miRNAs), small non-coding RNAs, researchers have identified four miRNAs that together perfectly discriminated between nonmalignant and malignant tissue, including one alone that classified 81% of the samples correctly. Levels of two miRNAs correlated with overall survival time.

Urinary bladder cancer is the fourth most common cancer in the West. According to the National Cancer Institute, it is estimated that in the United States 72,570 individuals will be diagnosed with and 15,210 will die of cancer of the urinary bladder in 2013. At presentation, in 75% of patients the cancers are confined to the mucosa or submucosa (known as non-muscle invasive bladder cancer, NMIBC), whereas in 25% of cases the cancers have already invaded nearby muscle (muscle-invasive bladder cancer, MIBC).

In a series of experiments, investigators analyzed bladder tissue from patients with NMIBC, MIBC, and nonmalignant bladders. After screening 723 miRNAs by microarray, they selected a subset of 15 distinctively deregulated miRNAs for further validation by real-time quantitative PCR. Seven miRNAs were found to be up-regulated, and eight were down-regulated in malignant bladder tissue samples compared to healthy tissue. Four miRNAs were expressed differently in bladder cancers that invaded muscle compared to those that did not. With one exception, no correlation was found between tumor stage and miRNA levels.

When all 15 of the selected miRNAs were considered together, they correctly classified 100% of tissues as either normal or malignant. Further analysis identified four miRNAs that led to 100% correct classification, and one miRNA (miR-130b) that by itself had an 81% accuracy rate. “These results underline the great potential of miRNAs to serve as diagnostic markers, as previously noted for other urological tumors,” says lead investigator Klaus Jung, MD, the Department of Urology at the University Hospital Charité, Berlin and the Berlin Institute for Urologic Research.

The investigators found that tumor grading could not be correlated with overall survival. Yet, they were able to find two miRNAs that significantly correlated with survival: miR-141 and miR-205. miR-141 showed a trend (P=0.08) of being able to stratify patients with muscle-invasive tumors into two groups with different overall survival times. “This finding could be of clinical importance, but these results must be interpreted cautiously,” says Dr. Jung. “However, previously published studies underline the possible prognostic potential of miRNAs to predict progression and disease-specific or overall survival in bladder cancer patients.”

miRNAs are small non-coding RNAs that contain between 19 and 24 nucleotides. miRNAs regulate gene expression by degrading messenger RNAs or impairing their translation. In recent years there has been a growing interest in miRNAs as potential diagnostic and/or prognostic biomarkers in cancers and other diseases.

Study: miRNA Profiling Identifies Candidate miRNAs for Bladder Cancer Diagnosis and Clinical Outcome [Journal of Molecular Diagnostics]

Source: Elsevier

PerkinElmer Expands Prenatal Screening Test Offerings, Introducing First Early Onset Preeclampsia Screening Test in the U.S.

PerkinElmer, a global leader in human and environmental health and an innovator in the field of prenatal screening for more than thirty years, announced today the first available early onset preeclampsia screening test in the United States. The PreeclampsiaScreen™ | T1 serum screening test enables physicians to more precisely detect asymptomatic patients in the first trimester of pregnancy who are at high risk for developing the dangerous condition, allowing for earlier identification, management and intervention. Early onset preeclampsia is a potentially serious condition that affects 0.5% of all pregnancies, often contributing more to the pregnant mother’s and baby’s risks of morbidity and mortality than does the late form of the disorder.

“This first of its kind screen is our latest commitment to providing clinicians with new, innovative ways to address some of today’s most challenging prenatal clinical scenarios,” said Jim Corbett, Senior Vice President and President, Diagnostics and Life Sciences & Technology for PerkinElmer. “Together with our recent advances, including offering a non-invasive prenatal test based on cell-free fetal DNA, plus a wide range of prenatal testing from biochemical screening to SNP microarray testing to detect birth defects and chromosome abnormalities, we’re giving physicians effective new tools for patient management.”

According to Dr. Jiri Sonek, MD RDMS, President, Fetal Medicine Foundation USA, and Adjunct Professor, Department of Obstetrics and Gynecology from Wright State University, “Preeclampsia is one of the remaining great challenges in obstetrics. It is a major cause of maternal, fetal, and neonatal morbidity and mortality. Fortunately, some physicians may recommend a simple and inexpensive intervention to reduce the risk of preeclampsia which is available in the form of low-dose aspirin. However, this treatment is effective only if begun early in pregnancy. That is why first trimester screening is such a critical component of preeclampsia prevention.”

Early onset preeclampsia is defined as preeclampsia, a sudden increase in blood pressure and protein in the urine, which leads to delivery of the fetus prior to 34 weeks’ gestation. If found early, options such as increased monitoring, modified activity, bed rest and medication can help reduce or avoid complications related to early onset preeclampsia.

PreeclampsiaScreen™ | T1 is administered during the first trimester of pregnancy through a simple blood test to detect three biochemical markers in the mother’s blood: PAPP-A (pregnancy-associated plasma protein-A); PlGF (placental growth factor) and AFP (alpha fetoprotein) that, when evaluated collectively with personal demographic data, provide an individual risk of developing early onset preeclampsia. Physicians have the option to provide two additional biophysical measurements for their patients — mean arterial pressure (MAP) and uterine artery Doppler pulsatility index (UtAD-PI) – each increasing the sensitivity of the screen when included in the testing protocol.

Source: PerkinElmer