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Surrogate in Medical Technology

Tolerx Presents Data at 69th Scientific Sessions of the American Diabetes Association

... Dose Optimization of Pre-Clinical Otelixizumab surrogate NEW ORLEANS, June 8 /PRNewswire/ -- Tolerx, ... dose-optimization study conducted with a surrogate of its Phase 3 anti-CD3 monoclonal antibody, ... beta cell function as measured by c-peptide, a surrogate measure of beta cell function. The primary ...

Amicus Therapeutics Announces Positive Progress of Three Lead Clinical Programs and General Outlook for 2009

... that time that it was not opposed to the use of a surrogate primary endpoint, pending further discussions ... trial comparing Amigal to placebo based on a surrogate primary endpoint of the change in the amount of ... with regulatory agencies on the use of a surrogate endpoint and phase 3 trial design for Amigal; the ...

Perceptive Informatics Introduces Medical Imaging Methodology to Accelerate Development Decisions About Alzheimer's Treatments

... for new compounds. Medical imaging is increasingly being used as a surrogate endpoint or biomarker of drug efficacy in all phases of CNS trials. With ... Informatics Medical Imaging Group has helped to develop and validate novel surrogate endpoints for a variety of CNS disorders. Perceptive offers a range of ...

Zevalin(R) Following Short-Course Chemotherapy with CHOP + Rituximab (CHOP-R) Doubles Complete Remission Rate in First-Line Treatment of Follicular Non- Hodgkin's Lymphoma

... based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival. About Zevalin(R) Zevalin(R) ... rituximab-nave, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February ...

Landmark Study Demonstrates Potential of Radioimmunotherapy for Treatment of Indolent B-Cell Non-Hodgkin's Lymphoma

... based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival. About Zevalin(R) Zevalin(R) ... rituximab-naive, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February ...

Amicus Therapeutics Announces Successful Completion of End of Phase 2 Meeting With FDA for Amigal in Fabry Disease

... The Agency further indicated that it is not opposed to the use of a surrogate primary endpoint, pending further discussion and final agreement on the ... to reach final agreement with regulatory agencies on the use of a surrogate endpoint and phase 3 trial design for Amigal, the potential that results ...

Clinical Proof of Concept for TGF-beta 2-Inhibitor AP 12009 in Phase Iib EMEA provides Guidance on Phase III Design and Approval Requirements

... conduct an interim analysis using the progression rate at 14 months as the surrogate endpoint. Positive results will allow submission for conditional approval ... The SAWP at the EMEA indicated that, due to the rarity of the disease, the surrogate endpoint would be accepted, provided that the response data are supported ...

Newly Approved HIV Drug Shows Great Promise

... of drugs used to treat serious or life-threatening conditions, based on surrogate endpoints that demonstrate meaningful therapeutic advantage over existing ... Accelerated approval is based on evidence of a drug's effect on a surrogate endpoint that reasonably suggests clinical benefit. Accelerated approval ...

Studies Suggest Key Correlation Between Lung Cancer Subtype and Treatment Outcomes

... The effectiveness of ALIMTA in second-line NSCLC was based on the surrogate endpoint, response rate. There are no controlled trials demonstrating a ... The effectiveness of ALIMTA in second-line NSCLC was based on the surrogate endpoint, response rate. There are no controlled trials demonstrating a ...

Landmark Study for GSK's Cervical Cancer Vaccine Published in The Lancet

... probability the abnormal cells will become cancer cells. CIN 1, 2 and 3 refers to mild, moderate or severe cell changes respectively. CIN 2+ is the surrogate marker for cervical cancer. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and 280,000 women will die from it each ...

ALP Life Sciences, LLC Announces Nanoveson(TM) Patent Filing and Whitepaper Availability on Proposed Therapy for Non-Alcoholic Fatty Liver Disease (NAFLD) and Comorbid Diseases

... metabolism. Orphan disease indication targets for inflammatory diseases may be pursed through clinical trials focused on arachidonic acid specific surrogate end points. David K. Barker, Founder and CEO of ALP Life Sciences, LLC stated, "The preliminary evidence for the Nanoveson(TM) hypotheses is ...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

... reached agreement with the U.S. Food and Drug Administration (FDA) on the key protocol design elements of the pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. ...

Perceptive Informatics Enhances Investigator Application of New RECIST Version in Imaging-Based Oncology Trials

... of the new RECIST 1.1 criteria. These experts will address medical, scientific, and regulatory solutions to improve the use of medical imaging as a surrogate endpoint in oncology trials. "Independent review using RECIST is an essential part of pivotal oncology trials," said Kenneth G. Faulkner, ...

TargeGen Announces Successful Completion of Patient Enrollment in Clinical Trial of JAK2 Inhibitor TG101348 in Myelofibrosis Patients and Scheduled Presentation of Preliminary Trial Data at EHA Conference in Berlin

... included identification of a maximum tolerated dose (MTD) in the dose-escalation phase and accumulation of safety data, assessments of drug effect on surrogate markers, biomarkers, and presumptive clinical endpoints in both phases of the study. Preliminary trial data presented at the 2008 ASH conference ...

Cepheid Announces European Release of First On-Demand Molecular Test for Simultaneous Detection of Mycobacterium tuberculosis (TB) and Resistance to Rifampicin

... identify Mycobacterium tuberculosis (MTB) and resistance to rifampicin (RIF), a common first-line drug for treatment of the disease and a reliable surrogate marker of strains that are multidrug-resistant (MDR-TB). Xpert MTB/RIF is expected to enable clinicians to dramatically improve patient ...

CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency

... Approval was based on a pivotal phase II prospective, open-label pharmacokinetic (PK) and safety study using maximum clot firmness as a surrogate endpoint for hemostatic efficacy. "As a leader in developing safe, effective and high-quality biologic therapies, CSL Behring is committed to ...

FDA Submission of B-R-A-H-M-S MR-proANP Kryptor

... fragment: the Mid-Regional pro-Atrial Natriuretic Peptide (MR-proANP). In contrast to the mature peptide, MR-proANP is a stable and reliable surrogate measurement of atrial natriuretic peptide levels. The clinical benefits of MR-proANP were analyzed within an international, multi-center, ...

Cloned Human Embryos Successfully Reprogrammed Using Human - But Not Animal - Eggs

... fear of tissue rejection. Due to the serious shortage of human donor eggs, cows, rabbits, and other animals have long been considered an attractive surrogate source of eggs. Although previous reports have documented the formation of cloned embryos using both human and animal eggs, to-date, there has been ...

Zevalin Consolidation in Patients With Complete Remission After Induction Therapy Results in Durable Remission of More Than 67 Months

... under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL. ...

PTC Announces Data Showing That PTC124 Causes Statistically Significant Improvements in Chloride Channel Function in Cystic Fibrosis Patients

... genetic defects responsible for CF. Earlier studies of PTC124 in adults with CF evaluated nasal transepithelial potential difference (TEPD) as a surrogate for the presence and activity of the CFTR protein. Across a variety of studies, TEPD assessments showed statistically significant improvements of ...

Quigley Anti-Viral Compound QR448(a) Successfully Prevents Transmission of Infectious Bronchitis in Chickens

... safety, exposure and handling concerns of IBV in a large scale experiment, Arkansas type vaccine virus was recognized as a comparable surrogate for this investigation. The infected birds were reintroduced to their colony after which time one colony of birds were spray treated with ...

Data Confirm Synvista Therapeutics Haptoglobin Diagnostic Test Kit Success in Rapidly Determining Cardiovascular Risk in Patients with Diabetes

... aid physicians in predicting cardiovascular risk in patients with diabetes. The study was presented today at the 2008 Cardiovascular Biomarkers and surrogate Endpoints Symposium in Bethesda, Maryland. "This study shows the utility of our proprietary technology to diagnose Hp2-2 Diabetes, a disease ...

Amicus Therapeutics Announces Second Quarter 2008 Financial Results

... agreed that Amigal meets the criteria to be considered for accelerated approval. The Agency further indicated that it is not opposed to the use of a surrogate primary endpoint, pending further discussion and final agreement on the Phase 3 trial design. Amicus, along with its partner Shire Human Genetic ...

Tolerx Initiates Dosing of Otelixizumab, a Novel Type 1 Diabetes Agent, in DEFEND, a Phase 3 Clinical Trial

... required to control blood glucose levels by inhibiting the destruction of beta cells. The primary endpoint will be a measurement of C-peptide, a surrogate measure of beta cell function. Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), fewer ...

CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

... under accelerated approval for the treatment of relapsed or refractory, rituximab-nave, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of ...

'Hibernation-On-Demand' Drug Hydrogen Sulfide Significantly Improves Survival After Extreme Blood Loss

... blood removal while seven served as controls. In both test groups, the rats maintained a reduced yet stable level of carbon-dioxide production, a surrogate measure of metabolism. Once H2S was removed, metabolic rates returned to normal. In contrast, the untreated animals steadily grew metabolically ...

FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)

... to other organs in a small number of patients. Subpart E is an FDA regulation that allows the accelerated approval of a biologic agent based on a surrogate endpoint or an effect on a clinical endpoint other than survival and is most common in serious diseases or for medications that fill an unmet medical ...

Kendle Experts to Present at the Drug Information Association 44th Annual Meeting

... 23 EDC: Faster Horse or Model T? Sylva Collins, PhD, Vice President, Global Biometrics 10:30 a.m. - 12 p.m. June 24 Biomarkers and surrogate Endpoints: Definitions, Background, and Validation Lisa Jenkins, PhD, Regulatory Group Leader 8 - 9:30 a.m. General Process and Best ...

PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity

... no CFTR protein is produced. Previous studies of PTC124 adult patients with CF evaluated nasal transepithelial potential difference (TEPD) as a surrogate for the presence and activity of the CFTR protein. Across the short- and long-term clinical trials at high and low doses of PTC124, TEPD assessments ...

Synvista Therapeutics Reports Results of Three Phase 2 Clinical Trials of SYI-2074 in Diabetic Patients with Cardiovascular Disease

... "We are choosing not to advance the SYI-2074 program in the very competitive area of acute coronary syndrome at this time, in the absence of stronger surrogate markers of efficacy," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics. "We are pleased to have ...

Regado Biosciences Announces Publication in Circulation of Clinical Trial Results of REG1 Anticoagulation System

... injection of RB006 achieved a prompt, consistent, and dose-dependent prolongation of activated partial thromboplastin time (aPTT), a well-accepted surrogate marker of the blood's ability to clot. In addition, a 1 mg/kg dose of RB006 resulted in essentially complete Factor IXa inhibition. The study also ...

Exelixis Reports Positive Clinical Pharmacodynamics Data for PI3K/mTOR Inhibitor XL765 at ASCO

... Robust Pathway Inhibition in Tumor and surrogate Tissues at Well-Tolerated Doses CHICAGO, May 31 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL ) reported ...

Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results

... self-reporting a feeling of complete evacuation. Bristol Stool Form Scale (BSFS): A seven-point scale measuring stool consistency. BSFS is a surrogate marker of gastrointestinal transit time. About Linaclotide Linaclotide is a first-in-class compound currently being evaluated for the treatment ...

New Data Showed ACTOS(R) (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients With Type 2 Diabetes

... on carotid intima-media thickness (CIMT), defined as the thickness of the inner lining of a patient's neck arteries. CIMT is an established surrogate marker of atherosclerosis. The CHICAGO analysis demonstrated a similar result on the progression of atherosclerosis as was observed in PERISCOPE. ...

Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies

... the patient self-reporting a feeling of complete evacuation. Bristol Stool Form Scale (BSFS): A seven-point scale measuring stool consistency and a surrogate marker of gastrointestinal transit time. About Chronic Constipation (CC) As many as 26 million Americans suffer from CC. Patients with CC ...

Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial

... approval), as agreed upon with the FDA under an SPA, consists of: (i) a single Phase 3 trial in subjects with microalbuminuria based on the surrogate marker of regression of microalbuminuria as the primary endpoint; (ii) supportive data from previously conducted clinical studies; and (iii) ...

TargeGen Announces Initiation of Clinical Trial of JAK2 Inhibitor TG101348 in Myeloproliferative Disease Patients

... label dose escalating protocol include identification of a maximum tolerated dose (MTD), accumulation of safety data, measurement of drug effect on surrogate markers, biomarkers, and presumptive clinical endpoints. About TargeGen, Inc. TargeGen, Inc. is a privately held vascular ...

Innovative Brain Scanning for Alzheimer's Screening Unveiled

... to be the first approved Alzheimer's disease screening test which directly evaluates a patient's cognitive performance. "We are not looking at a surrogate biomarker which may or may not correlate with Alzheimer's. Instead, we are directly measuring the cognitive deficits caused by the disease," says ....

Exelixis Initiates Phase 1/2 Trial of XL184 in Patients With Non-Small Cell Lung Cancer

... correlative studies will evaluate MET amplification and EGFR mutational status. MET and EGFR signaling activity will be assessed in tumor and surrogate tissue. Data from an ongoing phase 1 trial of XL184 in patients with advanced malignancies were presented in October 2007 at the 2007 ...

Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data

... approval), as agreed upon with the FDA under an SPA, consists of: (i) a single Phase 3 trial in patients with microalbuminuria based on the surrogate marker of regression of microalbuminuria as the primary endpoint; (ii) supportive data from previously conducted clinical studies; and (iii) ...
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Breaking Biology News(10 mins):Potential therapy for incurable Charcot-Marie-Tooth disease 2New study throws into question long-held belief about depression 2
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Breaking Medicine News(10 mins):Health News:veEDIS Clinical Systems “Delivers,” as the 2014 Edition CEHRT Emergency Department EHR System is Implemented at Lawrence Medical Center 2Health News:veEDIS Clinical Systems “Delivers,” as the 2014 Edition CEHRT Emergency Department EHR System is Implemented at Lawrence Medical Center 3Health News:Dr. Sabrina Fabi of Cosmetic Laser Dermatology Recognized as Vitals Top 10 Doctor 2Health News:Women for Water Partnership and Sharon Kleyne Call for Greater Women’s Role in Global Water Issues 2Health News:Women for Water Partnership and Sharon Kleyne Call for Greater Women’s Role in Global Water Issues 3Health News:Diet Doc’s Medical Weight Loss Programs Announce New Help for Patients Who Want to Overcome Depression Caused by Excess Weight 2Health News:Diet Doc’s Medical Weight Loss Programs Announce New Help for Patients Who Want to Overcome Depression Caused by Excess Weight 3Health News:The Canton Group is Recognized by the Baltimore Business Journal as the Largest Web Design Firm in Baltimore 2
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