Breaking News
March 22, 2018 - ENDO: Big Breakfast May Help in Diabetics
March 22, 2018 - I’m not overweight, so why do I need to eat healthy foods?
March 22, 2018 - UCLA-led study suggests unexpected reason for reduction in cardiovascular health disparities
March 22, 2018 - Study suggests detailed neuropsychological assessment for brief cardiac arrest survivors
March 22, 2018 - Anticoagulant drugs found safe to use in patients undergoing surgery for irregular heartbeat
March 22, 2018 - SP Industries appoints Brian Larkin as new President and CEO
March 22, 2018 - GTx Announced New Data Demonstrating Enobosarm’s Potential to Treat Stress Urinary Incontinence
March 22, 2018 - Higher Risk of Brain Deficits in Older Alcoholics
March 22, 2018 - Top US health official resigns in conflict of interest
March 22, 2018 - Study shows benefits of hair loss drug in improving cognitive function and vascular health
March 22, 2018 - Researchers explain link between 2 key Alzheimer’s proteins
March 22, 2018 - Patients on replacement therapy with thyroid hormone may have more comorbidities
March 22, 2018 - Higher online patient ratings linked to urologists who saw fewer Medicare patients
March 22, 2018 - FDA Approves Ilumya (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis
March 22, 2018 - Beer Raises Heart Rate; KardiaBand Hyperkalemia Test; CHD Clinics
March 22, 2018 - A retinal implant that is more effective against blindness
March 22, 2018 - New system based on artificial intelligence provides reliable detection of breast cancer
March 22, 2018 - Research offers new understanding about cause of Parkinson’s disease
March 22, 2018 - HORIBA’s Microsemi CRP analyzer improves quality of care in emergency pediatric units, study shows
March 22, 2018 - Neuroscientists move closer to developing tools for deciphering brain function
March 22, 2018 - New test methods with less fear
March 22, 2018 - Range of Vaginal Dryness Products Can Help Postmenopausal Women: Study
March 22, 2018 - Higher Dose Tx Deemed Safe in Pulmonary TB
March 22, 2018 - Discovery of new ALS gene points to cytoskeleton as potential target for drug development
March 22, 2018 - Diet soda associated with higher odds of diabetic retinopathy
March 22, 2018 - LSD reduces ‘sense of self’
March 22, 2018 - Vitamin D deficiency linked to metabolic syndrome in postmenopausal women
March 22, 2018 - Changes in the intestines may be responsible for reversal of diabetes after bariatric surgery
March 22, 2018 - iPads and Cancer; Clot Retrieval and Stroke: It’s PodMed Double T!
March 22, 2018 - Premature births linked to changes in mother’s bacteria
March 22, 2018 - Brain SPECT scans predict treatment outcomes in patients with depression
March 21, 2018 - Researchers succeed in integrating artificial organelles into cells of living organism
March 21, 2018 - Researchers discover ‘missing mutation’ in severe infant epilepsy
March 21, 2018 - Researchers develop statistics-based computational scheme to zoom in on brain function
March 21, 2018 - Verge joins Genomics England’s Discovery Forum industry partnership
March 21, 2018 - Trovagene Announces First Patient Successfully Completes Cycle 1 of Treatment with PCM-075 in Combination with Low Dose Cytarabine (LDAC) in AML Trial
March 21, 2018 - Congenital Cardiac Cath Tx Often Strays from Guidelines
March 21, 2018 - Marked increase in cardiovascular risk factors in women after preeclampsia
March 21, 2018 - New app may help predict, track manic and depressive episodes in bipolar patients
March 21, 2018 - Discovery of genes could lead to development of novel therapies for EBV-related cancers
March 21, 2018 - High-fat, high-cholesterol diet depletes ranks of artery-protecting immune cells
March 21, 2018 - Research misconduct allegations shadow likely CDC appointee
March 21, 2018 - Most Breast Ca Patients Fail to Get Genetic Counseling
March 21, 2018 - Lopsided ear function can lead to lopsided brain development
March 21, 2018 - Acupuncture helps manage menopausal symptoms, review finds
March 21, 2018 - Motor skill training may contribute to reading skills in obese children
March 21, 2018 - Poor dental health may be related to increased diabetes risk
March 21, 2018 - Chronic opioid users at increased risk of complications after spinal fusion surgery
March 21, 2018 - Study uncovers potential therapeutic target against large family of parasites
March 21, 2018 - NSAID use linked to increased risk of atrial fibrillation
March 21, 2018 - Scientists develop brain “stethoscope” that can detect silent seizures
March 21, 2018 - New method predicts effects of global warming on disease
March 21, 2018 - Insurance Company Hurdles Burden Doctors, May Harm Patients
March 21, 2018 - Renal Transplant from HCV-Positive Donors Feasible
March 21, 2018 - Myelodysplastic syndrome: MedlinePlus Medical Encyclopedia
March 21, 2018 - Research reveals brain mechanism involved in language learning
March 21, 2018 - Many parents still hesitate to try early peanut introduction, survey finds
March 21, 2018 - Audiologist urges tinnitus sufferers facing ‘revolving door healthcare’ to seek support
March 21, 2018 - Study reveals impact of prostate cancer on wives and partners of sufferers
March 21, 2018 - ‘Almost a Miracle Drug’: What We Heard This Week
March 21, 2018 - Study shows NIH spent >$100 billion on basic science for new medicines
March 21, 2018 - Columbia researchers identify nerve cells that drive fruit fly’s escape behavior
March 21, 2018 - Sartorius Stedim Biotech selected by ABL Europe to supply single-use process technologies
March 21, 2018 - Increase in coffee consumption may help battle against colon cancer
March 21, 2018 - Hydrogel may accelerate healing of diabetic ulcers
March 21, 2018 - Dermira’s Two Phase 3 Trials Evaluating Olumacostat Glasaretil in Patients with Acne Vulgaris Did Not Meet Co-Primary Endpoints
March 21, 2018 - DePuy Synthes introduces ACTIS Total Hip System for improving initial implant stability
March 21, 2018 - ‘Oh, It Was Nothing’
March 21, 2018 - Herbal drug kratom linked to salmonella illnesses, CDC says
March 21, 2018 - New optical point-of-care device could enhance screening for thyroid nodules
March 21, 2018 - FDA Expands Approval of Adcetris (brentuximab vedotin) for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination with Chemotherapy
March 21, 2018 - Eosinophilic Esophagitis: Late Manifestation of Allergic March
March 21, 2018 - Signaling pathway involving the Golgi apparatus identified in cells with Huntington’s disease
March 21, 2018 - Quintupling inhaled steroid doses may not benefit children with asthma
March 21, 2018 - Study shows clear connection between cardiovascular fitness in middle age and dementia risk
March 21, 2018 - Premature babies have higher risks of health complications in Bangladesh
March 21, 2018 - Child’s temperament and parenting influence weight gain in babies
March 21, 2018 - Researchers find the heart to be capable of arrhythmia termination after local gene therapy
March 21, 2018 - Inhealthcare to provide digital infrastructure for NHS to help protect people from falls
March 21, 2018 - Flu Season Finally Slowing Down
C-Path receives support from European Medicines Agency for liver injury biomarker

C-Path receives support from European Medicines Agency for liver injury biomarker

image_pdfDownload PDFimage_print

Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) has issued a Letter of Support for measurement of glutamate dehydrogenase (GLDH) as a biomarker of hepatocellular liver injury. The letter was awarded to C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC) to encourage the further study of serum GLDH for monitoring hepatocellular liver injury.

The letter–in response to data submitted by the PSTC Hepatotoxicity Working Group (HWG) and D-RSC–describes EMA’s thoughts on the value of GLDH and supports further evaluation. In it, EMA encourages PSTC and D-RSC to investigate “the voluntary and complementary use of serum GLDH, in conjunction with currently used biomarkers of liver injury, as a clinical biomarker of liver injury.” EMA also supports PSTC’s generation of additional clinical safety data, and plans for further clinical studies to potentially enable formal qualification of GLDH in the future.

“Many of the proteins currently monitored to evaluate liver safety are also found in muscle tissue,” says Jane Larkindale, D.Phil., Executive Director of D-RSC. “In situations where a patient has underlying muscle injury, such as muscular dystrophies, levels of these enzymes may be high in the absence of liver injury. Monitoring of GLDH levels may allow liver injury caused by novel drugs to be detected in this population of patients.”

D-RSC is dedicated to developing tools to accelerate development of safe drugs for Duchenne, and monitoring safety of such drugs is important. PSTC is dedicated to the development of safety biomarkers, so collaboration between the two C-Path consortia accelerated development of this biomarker.

“At C-Path, we are constantly looking to work in partnership across our many consortia, and the GLDH biomarker qualification presented the perfect opportunity for such a collaboration between PSTC and D-RSC,” says John-Michael Sauer, PhD, Biomarker Program Officer and Executive Director of PSTC.

EMA support encourages the biomarker’s use in both nonclinical and exploratory clinical studies as a marker of hepatocellular liver injury, and indicates that this biomarker has strong potential for use in humans and warrants additional exploration and gathering of data.

Says C-Path President and CEO Martha A. Brumfield, PhD, “The data package submitted to EMA supporting use of this liver-injury biomarker, developed by PSTC and D-RSC in partnership, exemplifies successful cross-consortium collaboration at C-Path, and EMA’s support of this biomarker is a harbinger of future success for both consortia. Developing reliable biomarkers remains one of the most productive methods of aligning and streamlining research and regulatory processes.”

The Letter of Support for this biomarker is posted on the EMA website, and can also be accessed via the C-Path PSTC website.​


Critical Path Institute Receives Regulatory Support for Liver Injury Biomarker

Tagged with:

About author

Related Articles