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Surrogate in Biological Technology

Amicus Therapeutics Presents Positive Results From Phase 2 Extension Study of Amigal(TM) for Fabry Disease at ACMG 2009 Annual Meeting

... supports a Phase 3 clinical trial comparing Amigal to placebo based on a surrogate primary endpoint of the change in the amount of kidney GL-3, the substrate ... to reach final agreement with regulatory agencies on the use of a surrogate endpoint and phase 3 trial design for Amigal, the potential that the ...

Tolerx Expands Phase 3 'DEFEND' Trial of Otelixizumab in Europe

... evaluated. This outcome will be assessed by measuring C-peptide levels (a surrogate of endogenous insulin secretion) and by measuring reductions in the amount ... of beta cells. The primary endpoint will be a measurement of C-peptide, a surrogate measure of beta cell function. For additional information about DEFEND, ...

Amicus Therapeutics Announces Fourth Quarter and Full Year 2008 Financial Results

... supports a Phase 3 clinical trial comparing Amigal to placebo based on a surrogate primary endpoint of the change in the amount of kidney GL-3, the substrate ... 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 ...

Fertility Agency Sweetens Incentives to Gestational Surrogates; Finds Interest Up

... more inquiries during times of economic distress. "Being a gestational surrogate requires a very special type of person," said Robin von Halle, president ... obstetrical history. "Typically, agencies like ours require the surrogate to have health insurance to cover related costs," said von Halle. "In the ...

High-Dose Zevalin(R) With Tandem Stem Cell Infusion Produces 87 Percent Overall Survival in Relapsed/Refractory or High Risk 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 ...

Cell Therapeutics Submits Supplemental Biologics License Application for Zevalin Use in First-Line Consolidation Therapy

... based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival. About First-Line Consolidation Therapy ... 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 ...

FDA Meeting Provides Green Light for Cell Therapeutics Submission of Supplemental Filing for Zevalin(R) Label Expansion

... based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival. "Radioimmunotherapies are currently ... 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 ...

Tests show LLNL detection instrument can monitor the air for all major terrorist threat substances

... of each other without reconfiguring the SPAMS instrument." (In some cases, surrogate materials were used.) Last spring, the researchers announced that their ... diethyl phthalate (a nerve agent surrogate), natural cobalt powder (a surrogate for Cobalt 60 and other radioactive metals) and trinitro-1,3,5-triazinane ...

CTI Enters Into Agreement With Bayer Schering Pharma for Access to Phase III Zevalin(R) FIT Trial Data for Potential U.S. Supplemental Marketing Application

... based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival. Studies to determine whether the Zevalin ... rituximab-naive, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate nonhematologic toxicities were 23.5% ...

New Data Published in Circulation Showed an Increase in HDL Cholesterol Levels with ACTOS(R) (pioglitazone HCl)

... burden, a condition which leads to reduced or blocked blood flow and is a surrogate marker for the risk of heart attack and stroke. CHICAGO examined the ... While not definitive, data from CHICAGO and PERISCOPE, looking at two surrogate markers, have shown a consistent trend toward a reduction of ...

Amicus Therapeutics Announces Second Quarter 2009 Financial Results

... reached agreement with the U.S. Food and Drug Administration (FDA) on the key protocol design elements of its 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. ...

VIA Pharmaceuticals Receives Anticipated Notice From NASDAQ

... expected timetables and the outcomes of such clinical trials; complexities in designing and implementing cardiometabolic clinical trials using surrogate endpoints in Phase 1 and Phase 2 clinical trials which may differ from the ultimate endpoints required for registration of a candidate drug; ...

Rules-Based Medicine, Inc. Launches DiscoveryMAP(TM) Service for Drug and Diagnostic Development

... require sensitive and quantitative data to pinpoint the biomarker patterns that are either directly involved in the disease process or are useful surrogate markers. When those patterns can be reliably measured, the efficiency of drug development is accelerated while achieving greater efficacy and ....

Celsense, Inc Receives NIH Grant to Translate Cell Imaging Technology for Clinical Use

... the number of labeled cells in a user-specified region of interest. It is expected that in vivo cellular imaging will routinely be used to provide a surrogate biomarker for certain cellular therapeutic and drug trials. About Celsense, Inc. Celsense, Inc. is a biotechnology company offering novel ...

OncoGenex Pharmaceuticals Announces OGX-427 Treatment Demonstrates Safety, Evidence of Declines in Circulating Tumor Cells and Reductions in Tumor Markers in a Phase 1 Cancer Trial

... with prostate cancer and a reduction in CA-125 levels was observed in 3 of 5 patients (60%) with ovarian cancer. "CTCs are emerging as an exciting surrogate of anti-cancer activity. The frequent decreases in total and Hsp-27 positive CTC counts, coupled with decreases in serum PSA and CA-125 levels in ...

Cepheid Announces Symposium Speakers and Program Highlights for 19th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

... to rifampicin, a commonly used first-line drug for treatment of the disease. Many studies have shown that rifampicin resistance is a reliable surrogate marker of strains that are multidrug-resistant TB (MDR-TB), and the frequency of MDR-TB is increasing in the EU. The test is expected to enable ...

Transgenomic Completes Licensing Option With Dana-Farber Cancer Institute on Cold-PCR for Enrichment of DNA Mutations

... ratio detection in a routine, cost-effective and high throughput protocol. This level of detection will allow straightforward tumor analysis via surrogate tissues such as blood and urine. About Transgenomic Transgenomic is a global biotechnology company that provides unique products and ...

Cepheid Announces New Diagnostic Technology to Aid World Efforts in Halting the Spread of Mycobacterium Tuberculosis (TB)

... the presence of TB, but also identifies whether it is resistant to Rifampicin, a common first-line drug for treatment of the disease and a reliable surrogate marker of strains that are multidrug-resistant (MDR-TB). The test is expected to enable physicians to dramatically improve patient outcomes -- ...

Opportunities and challenges in uncertainty quantification for complex interacting systems

... In spite of continued growth in computational resources the idea of a computational laboratory serving as surrogate to physical reality still faces conceptual and technical challenges. Chief among these is the characterization of physical reality itself, under ...

Cell Therapeutics Exercises Its Option to Sell Interest in Zevalin Joint Venture to Spectrum Pharmaceuticals for $18 Million

... 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. ...

Nile Therapeutics Announces Positive Results from Phase 1b Safety and Pharmacodynamics Study of CD-NP in Patients with Heart Failure

... Renal function from evaluable patients was assessed via biomarkers including serum creatinine and creatinine clearance, the most frequently used surrogate measure of glomerular filtration rate (GFR) and renal function. CD-NP treatment resulted in a statistically significant reduction of serum ....

Decision Biomarkers Inc Announces Formation of Scientific Advisory Board

... in the Department of Laboratory Medicine and Pathology at Mayo Clinic, Rochester, MN. Dr. Oliver's research includes performance definitions of surrogate biomarkers of efficacy, antibody-antigen binding characterization, and clinical and analytical validation of biomarkers of safety. "We are ...

FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review

... under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, 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. ...

Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug

... 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. ...

OncoGenex Reports Third Quarter Financial Results

... a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints. - On October 7, 2008 OncoGenex and the FDA concluded a meeting whereby the FDA agreed that "durable pain palliation is an ...

eRT Completes Milestone 100th Thorough QT Study

... of its 100th Thorough QT Study. QT has been identified as a crucial cardiac safety marker; specifically, the prolongation of QTc is a known surrogate for assessing the cardiac safety risk of a new drug. eRT conducts Thorough QT Studies as one of the centralized ECG services provided within its ...

FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals' Lead Product Candidate OGX-011

... of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints. "Obtaining Fast Track designation for custirsen sodium while developing our Phase 3 program for hormone-refractory prostate cancer ...

PAREXEL Enhances Early Phase Clinical Development Offering for Central Nervous System Studies

... phase clinical development by adding pain modeling capabilities and combining traditional pharmacodynamic methods with relevant biomarkers, which are surrogate endpoints used to determine safety and efficacy signals. "CNS diseases, which are reported to account for one third of the world's disease burden, ...

ARR Offers Parents 'Extended Choice' in Egg Donor Selections

... June 2 /PRNewswire/ -- Alternative Reproductive Resources (ARR), a leading Chicago-based agency that brings together intended parents, egg donors and surrogate mothers, has announced a program designed to remove some of the pressure from the egg donor selection process. Called Extended Choice, the program ...

Perceptive Informatics Enhances Medical Imaging Capabilities for Assessment of Cardiac Function

... guidelines. The Perceptive Informatics Medical Imaging division leverages advanced technology to help ensure the effective use of imaging surrogate endpoint data as well as secure data access and back-up. The Perceptive Informatics medical imaging team operates globally and services a wide range ...

Dendreon Reports Fourth Quarter and 2007 Year End Financial Results

... Frohlich to senior vice president of clinical affairs and chief medical officer -- Cancer Immunology, Immunotherapy publication on CD54 as surrogate marker of antigen presenting cell activation -- Data correlating the cumulative potency of PROVENGE to overall survival presented at ...

Circassia Initiates Phase II Clinical Study With Novel Anti-Allergy Technology

... which provided proof-of-concept for the ToleroMune technology. The current double-blind, placebo-controlled phase II trial will study both safety and surrogate efficacy outcomes, following escalating doses administered via two different routes (intradermal and subcutaneous). The study is taking place in ...

UW-Madison scientists guide human skin cells to embryonic state

... oocyte, an unfertilized egg. An unknown combination of factors in the egg caused the adult cell nucleus to be reprogrammed and, when implanted in a surrogate mother, develop into a fully formed animal. The new study by Yu and Thomson reveal some of those genetic factors. The ability to reprogram human ...

PTC Therapeutics Announces Encouraging Additional Phase 2 Results of PTC124 in Cystic Fibrosis

... PTC124 can induce production of active CFTR protein. Studies in the U.S. and Israel evaluated nasal transepithelial potential difference (TEPD) as a surrogate for CFTR protein production in adult CF patients. Across the two studies, at both PTC124 dose levels tested, TEPD assessments showed ...

Learning how far your message reaches by Googling yourself

... spending it on better software, another color printer or some other form of business operations improvement (or wed be in Europe). You can create a surrogate of sorts by periodically Googling yourself or specifically, your spokespersons name, your product name and your business name. Particularly if ...

Machine like me

... about our careers, about having a real impact in our jobs we have to consider what that difference is. Part of the technologist role is to play surrogate machine, to encounter the messy, analog real world, understand it at least a little bit, and then place that understanding in progressively more ...

FDA programs encourage and expedite drug development and approval

... patients unresponsive to existing treatments. Under this program, the FDA can approve a product based on substantial evidence of an effect on a surrogate endpoint reasonably likely to predict clinical benefit, such as evidence of how patients feel, function, or appear during well-controlled clinical ...

Principles and applications of electrical cell fusion

... cell fusion because it is the only method efficient enough to produce the desired result. The fusion product is implanted into a surrogate mother and is then carried through the full gestation period. Cloning mammals from embryonic cells was carried out as long ago ...

Principles and applications of electrical cell fusion

... cell fusion because it is the only method efficient enough to produce the desired result. The fusion product is implanted into a surrogate mother and is then carried through the full gestation period. Cloning mammals from embryonic cells was carried out as long ago ...
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