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Cancer Research UK and CRT Collaborate with Abcodia to Discover and Develop Tests for Early Diagnosis of Cancer

Cancer Research UK and its commercial arm, Cancer Research Technology (CRT), have joined forces with Abcodia, the biomarker validation company with a focus on cancer screening, to develop new blood tests to detect a range of cancers when they are still at a very early stage.

The strategic alliance will focus on biomarkers to detect cancers before patients develop symptoms, concentrating on cancers which currently have limited screening tests available, such as non-small cell lung cancer.

Detecting cancer earlier will give doctors the best chance to treat cancer effectively, before the disease develops and spreads when it becomes more difficult to treat. Identifying patients at an early stage will also provide the scientific and pharmaceutical communities with the ability to select patients for the development of a new generation of anti-cancer medicines.

The partnership combines Cancer Research UK’s extensive clinical oncology and scientific network with Abcodia’s expertise in the longitudinal profiling of biomarkers, as well as its exclusive access to one of the world’s largest prospective collections of serum samples available for biomarker research. This collection is derived from the UK Collaborative trial for Ovarian Cancer Screening* (UKCTOCS) run at University College London (UCL) and contains more than five million serum samples. The trial is part funded by Cancer Research UK.

The samples in the collection have been taken from healthy people annually and in many cases, up to 10 years prior to a cancer diagnosis. The collaboration will use these samples to select biomarkers which provide a clear indication of change in the early pre-diagnosis stages of disease.

Cancer Research UK, CRT and Abcodia will seek partnerships in the UK and internationally, with academic and commercial organisations which have leading-edge biomarker technology, to discover, validate and further develop the markers.

Dr Julie Barnes, Abcodia’s CEO, said: “We are delighted to be able to work with Cancer Research UK and CRT in this new global venture. The early diagnosis of cancer has never been more important and with the collective expertise that this alliance can bring, we hope to make a real difference in the field of early cancer detection and screening.”

The alliance is particularly interested in seeking markers that may be expressed in serum; for example, proteins, microRNAs – regulators of gene expression, exosomes ¬– cell-derived vesicles, autoantibodies – antibodies targeting an individual’s own proteins, and DNA methylation – a molecular switch to turn DNA on and off. Both genetic and acquired risk factors will also be investigated.

Abcodia and CRT will jointly commercialise any biomarkers discovered during the collaboration and share revenues resulting from potential licensing deals with additional third parties.

Dr Harpal Kumar, Cancer Research UK’s chief executive, said: “Earlier detection of cancer remains a huge challenge but also a tremendous opportunity. We know that for most types of cancer, the earlier we detect them, the greater the chance of being able to treat them effectively and successfully. Furthermore, treating earlier stage disease is usually associated with fewer side effects from treatment for our patients. The scope and scale of this alliance, aimed at developing new tests for a range of cancers at their earliest stage, before symptoms develop, is very exciting. The combination of expertise formed by this partnership provides a great opportunity to accelerate this vital biomarker research, which we hope will help save thousands of lives from cancer.”

Professor Ian Jacobs, Vice President at the University of Manchester, Principle Investigator of UKCTOCS and an Abcodia founder, said: “I’m delighted that the biobank developed through UKCTOCS will be used for such an important collaborative venture which has potential to yield important discoveries and to benefit patients through early detection across a range of cancers.”

Dr Keith Blundy, Cancer Research Technology’s chief executive, said: “This important alliance combines Cancer Research UK’s clinical expertise, with the commercialisation expertise of both Abcodia and CRT. Together with additional technology partners, we hope to be able to identify early detection biomarkers that will enable patients to be treated as soon as possible, ultimately saving lives.”

Source: Abcodia

Biomarker Identification May Lead to New Noninvasive Test for Colorectal Cancer Detection

The average 5-year survival for colorectal cancer (CRC) is less than 10% if metastasis occurs, but can reach 90% if detected early. A new non-invasive test has been developed that measures methylation of the SDC2 gene in tissues and blood sera. This test detected 87% of all stages of colorectal cancer cases (sensitivity) without significant difference between early and advanced stages, while correctly identifying 95% of disease-free patients (specificity). The results are published in the July issue of The Journal of Molecular Diagnostics.

According to the US Centers for Disease Control and Prevention, CRC is the second leading cancer killer in the US affecting both men and women. In 2009, close to 137,000 people in the US were diagnosed with CRC, with close to a 40% mortality rate.

There are other screening choices for CRC, including fecal occult blood testing (FOBT), fecal immunochemical testing, and colonoscopy. Colonoscopy is the gold standard of CRC screening, but patient resistance – mostly due to the unpleasant preparation – has curbed widespread adoption. FOBT is non-invasive but has limited sensitivity, particularly for early disease. A sensitive and specific non-invasive test using blood or stool could to be a more preferable option with the potential of saving many lives.

In their search for a biomarker that could be used for the early detection of CRC, investigators from Genomictree, Inc. and Yonsei University College of Medicine in Seoul, South Korea, performed DNA microarray analysis coupled with enriched methylated DNA using tissues from primary tumors and non-tumor tissues from 12 CRC patients. After step-wise filtering, they found a set of genes that were highly methylated across all of the CRC tumors. Ultimately they identified one gene, SDC2, which encodes the membrane syndecan-2 protein, a protein that is known to participate in cell proliferation, cell migration, and is expressed in colon mesenchymal cells. The methylation level of target region of SDC2 assessed in tumor tissue was found to be significantly higher than that from paired adjacent non-tumor tissue.

The next step was to clinically validate the biomarker by analyzing SDC2 methylation levels in primary tumors and paired-adjacent non-tumor tissue samples from 133 CRC patients. Investigators found that in the transcriptional regulatory region of the SDC2 gene, tumor samples showed significantly higher levels of methylation than the control samples. SDC2 methylation positivity ranged from 92.9% to 100% when samples were stratified according to stages of cancer.

Further, investigators found that the SDC2 biomarker could be measured in serum samples from CRC patients and healthy individuals. “The SDC2 methylation test was able to detect 92% for detection of stage I cancer patients indicating that SDC2 is suitable for early detection of CRC where therapeutic interventions have the greatest likelihood of curing the patient from the disease,” says first author TaeJeong Oh, PhD.

The authors suggest that the SDC2 methylation test they describe could possibly be used as an alternative to or in conjunction with colonoscopy. It could also be used to monitor cancer progression and treatment. Dr. Sungwhan An, corresponding author and CEO of Genomictree, Inc., commented: “We are very excited with this result using a small amount of serum DNA from less than 1ml of blood. I believe a greater volume of blood will further improve the clinical performance of this test. We are currently preparing another set of clinical validation studies evaluating SDC2 methylation in serum DNA from patients with early adenoma.” In future research the authors will explore whether this biomarker is specific to CRC or universal among other cancers.

Source: Gnome-Wide Identification and Validation of a Novel Methylation Biomarker, SDC2, for Blood-Based Detection of Colorectal Cancer

Source: EurekAlert!

AAPA Poster Presentation Explores Connection between Biomarkers and Science-Based Personalized Nutrition Therapy in the Management of Major Depressive Disorder

An examination of the latest genetic and physiologic biomarker research and its application in viable therapeutic options for patients with Major Depressive Disorder (MDD) was the focus of a breakthrough poster presentation which debuted at the American Academy of Physician Assistants (AAPA) annual conference, IMPACT 2013. The poster and complete study findings were presented by Ian V. Mackey, M.S., P.A.-C, Physician Assistant, Rush University Medical Center.

Building on data that shows obesity and inflammation predict poorer response to antidepressant therapy, the poster shed light on the link between biomarkers associated with conditions of inflammation, oxidative stress, and obesity and a patient’s potential response to treatment with adjunctive L-methylfolate. The presentation was aimed at helping inform and educate physician assistants (PA), who are often the first line of defense for patients presenting with MDD and critical to the proper treatment of the condition. The poster findings also come on the heels of a study published in the American Journal of Psychiatry which demonstrated twice as many patients responded when given adjunctive L-methylfolate 15mg compared to adjunctive placebo (continuation of SSRI monotherapy). In terms of tolerability, discontinuations due to adverse events were no different than placebo when adding L-methylfolate to SSRI treatment in patients with MDD.

“It’s vital that we make it a practice to assess the patient as a whole as opposed to assessing just their symptoms of MDD,” said Ian Mackey, M.S., P.A.-C. “As these findings indicate, other medical problems, concomitant medications and inflammation are becoming increasingly important in choosing the correct interventions for patients with MDD.”

Taking into account MDD can include metabolic components associated with poor Selective Serotonin Reuptake Inhibitors (SSRI) response, the poster presentation, Effect of L-methylfolate on Inflammatory Markers a Randomized Clinical Trial of Patients with Major Depression, analyzed 75 outpatients inadequately responding to an SSRI who were enrolled in a 60-day study, divided into two, 30-day evaluation periods according to Sequential Parallel Comparison Design (SPCD). Patients were randomized to receive L-methylfolate 15mg + SSRI for 60 days; placebo + SSRI for 30 days followed by L-methylfolate 15mg + SSRI for 30 days; or placebo + SSRI for 60 days. The SSRI doses remained constant during the study. Pooled 30-day results demonstrated significantly greater benefits in all-comers with adjunctive L-methylfolate 15mg + SSRI compared to placebo + SSRI (continued SSRI monotherapy). The magnitude of difference between response to adjunctive L-methylfolate and adjunctive placebo was 17.7% (p=0.04). Pooled differences in mean change on HDRS-17 and HDRS-28 were significantly greater (p=0.05 and p=0.02 respectively) with L-methylfolate superior to placebo.

Results also show that patients with SSRI-resistant MDD stratified by biomarkers of inflammation (hsCRP), oxidative stress (4-HNE) and methylation (SAM/SAH ratio) responded better to adjunctive L-methylfolate 15mg compared to adjunctive placebo. In an analysis of a priori endpoints, patients with baseline levels of hsCRP at or above the median (p=0.05) and 4-HNE (p=0.003) at or above the median and SAM/SAH ratio below the median (p=0.005) experienced a significantly greater treatment effect in favor of adjunctive L-methylfolate. In an exploratory analysis, patients with obesity defined as BMI ≥30 kg/m2 demonstrated a significantly greater treatment effect with adjunctive L-methylfolate versus adjunctive placebo (p=0.001).

The AAPA’s annual conference is focused on identifying and discussing innovative solutions that empower PAs at all stages of their careers to improve patient health. IMPACT 2013 remains the largest PA-focused Continuing Medical Education (CME) event in the world, with approximately 6,000 PAs and students in attendance. IMPACT 2013 took place May 25-29 at the Walter E. Washington Convention Center in Washington, D.C.

Source: Business Wire

Ignyta Announces Acquisition of Actagene Oncology and Entry into Oncology Personalized Medicine

Ignyta, Inc. recently announced that it has acquired Actagene Oncology, Inc., effective May 20, 2013. Actagene was a San Diego based privately held biotechnology company founded in February 2013 that was developing personalized medicines for high unmet need cancer indications, based on cancer genome mining and sequencing.

Caris Life Sciences ASCO Presentation Highlights the Utility of Molecular Profiling for the Management of Rare and Aggressive Cancers

Caris Life Sciences™, a leading biosciences company focused on fulfilling the promise of personalized medicine, presented findings yesterday at the 2013 ASCO annual meeting from the analysis of its Caris Molecular Intelligence™ database. This database examined the results of molecular profiling of both common and rare cancer types for the identification of potentially clinically actionable targets.

For the purposes of this study, 42,000 patient tumors were analyzed in total, covering 150 histological subtypes received from more than 6,400 physicians worldwide. Furthermore, 14,700 of these cases, or 35 percent of the tumors profiled, are typically categorized as “rare” tumors, a patient segment that is typically underserved by current guidelines and where molecular profiling has the potential to significantly impact patient care.

Breaking the data down by tumor type, these findings included profiling the following tumor types:

  • 6,000-plus Ovarian cancers
  • 5,000-plus Breast cancers
  • 6,000-plus Non-small-cell lung cancers
  • 5,000-plus Colorectal cancers
  • 2,000-plus Pancreatic cancers
  • 14,000-plus Rare cancers

Caris has remained technology-agnostic in its approach to tumor profiling, employing a wide range of profiling technologies to uncover a broad array of key biomarkers, based upon review of the latest clinical literature showing correlations to known therapies. Technologies utilized for this comprehensive database included mutational analysis by Sanger Sequencing, Next-Generation Sequencing, Polymerase Chain Reaction (PCR), Gene Copy Number alterations and translocations by Fluorescent In Situ Hybridization/Chromogenic In Situ Hybridization (FISH/CISH), Methylation analysis, and protein expression by immunohistochemistry (IHC).

“To date, Caris has profiled nearly 50,000 patients, which is the largest and most comprehensive collection of biomarker profiles in the industry today,” said Zoran Gatalica , M.D., DSc, Executive Medical Director at Caris Life Sciences, and a lead researcher in this study. “This study provided critical insights into the distribution of common and rare genetic and protein alterations, with direct and potential treatment implications. Our multi-technology approach to tumor profiling has been critical to building this extensive database, as it provides the most meaningful biomarker analysis and thorough interrogation of the cancer pathways.”

Daniel Von Hoff , M.D., FACP, of the Translational Genomics Research Institute (TGen) in Phoenix, Ariz., presented results from its study, Integrating Molecular Profiling Into Cancer Treatment Decision Making: Experience With Over 35,000 Cases, at this year’s ASCO annual meeting.

“Because of the size and depth of this database, these data points hold significant potential to detect rare molecular aberrations and biomarker targets in patients with common or rare cancers,” said Dr. Von Hoff , Physician in Chief and Director of Translational Research at TGen; Professor of Medicine at both Mayo Clinic, Scottsdale and the University of Arizona College of Medicine; and Chief Scientific Officer at Scottsdale Healthcare and US Oncology. “The developmental and potential clinical applicability and relevance of tumor profiling is particularly compelling in cases of rare or resistant tumors, where treatment guidelines are more limited and current clinical trial data is often insufficient.” Dr. Von Hoff’s presentation was held Sunday, June 2, 2013, at 8:15 a.m. at E-354 B.

Source: PR Newswire