Navigation Links
NW Bio Takes Next Steps In Moving Forward With Its Phase III Brain Cancer Trial In Europe
Date:2/15/2013

p>This engagement to manage NW Bio's Phase III brain cancer trial in Europe builds upon the foundations of the Company's European programs which have been in development since 2010.  In the U.K., preparations completed by the Company for the Phase III trial include regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA – equivalent to the FDA), nationwide Ethics Committee approval (equivalent to Institutional Review Board approvals in the U.S.), selection and qualification of the first four trial sites (major opinion leader centers), institutional reviews and approvals at the lead site, Kings College Hospital, and manufacturing technology transfer and validation in the U.K.

In Germany, preparations for the Phase III trial completed by the Company include the establishment of a wholly owned subsidiary (NW Bio GmbH) with a highly experienced CEO formerly in the senior management of Schering A.G. for many years, as well as selection of 24 candidate trial sites (including all major opinion leader centers in brain cancer), half a year of manufacturing technology transfer followed by a 2-year regulatory process for manufacturing certification by both the national and local regulators in Germany, further followed by development of a validated data package sufficient to support Phase III trial designation, then preparation and submission of the Phase III clinical trial application package to the national regulator (the PEI), and initial preparations for Ethics Committee approvals (equivalent to IRB approvals in the U.S.) at trial sites.

"Putting in place a CRO of PAREXEL's caliber is one of the final building blocks for our Phase III trial in Europe.  After 3 years of extensive preparatory work, this is an important milestone and a reflection of the exciting potential of this trial" commented Linda F. Powers
'/>"/>

SOURCE Northwest Biotherapeutics
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. In basic science, sometimes it takes individual benefactors like Roys Poyiadjis to fuel innovation
2. HealthClubExperts.com Takes Aim at Youth Obesity, Set to Launch Youth Fitness Equipment
3. Rivalz Sports Group, Inc Sportstalk Station WRSO 810 AM Orlando Officially Takes Over And Goes Live With Sports Programming
4. Inovio Pharmaceuticals Takes Major Stride Toward Universal Influenza Vaccine
5. The Growing Cost of Aging: Express Scripts Study Shows Medication Use for Normal Aging Conditions Overtakes Costs of Treating Most Chronic Diseases
6. seca Takes the Right Measures to Combat Childhood Obesity
7. Are there HCG diet dangers? US HCG Injections Takes a Look.
8. Comprehensive Care Corporation Implements Steps to Increase Margins and Sustain Profitability
9. MetroStar Home Health Medical Equipment Steps Up Its Recovery Efforts to Aid Victims of Hurricane Sandy
10. Lilly Provides Update on Next Steps for Solanezumab
11. Lung Cancer Alliance Congratulates 75 Medical Centers For Moving Swiftly And Responsibly On Lung Cancer Screening
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2014)... NEW YORK , Aug. 27, 2014 /PRNewswire/ ... report is available in its catalogue: ... http://www.reportlinker.com/p02316641/Global-Animal-Health-Market-2014-2018.html About Animal Health ... prevent animal diseases or treat animals to enhance ... increase the yield of animal food. The Global ...
(Date:8/27/2014)... Aug. 27, 2014 North American lighting leader ... 100 Award for the new OSRAM ITOS ® PHASER ... light module for microscopy, endoscopy and surgical head lamps that ... higher efficacy and lamp life. "We,re honored to ... the most innovative new technologies of the past year," said ...
(Date:8/27/2014)... 27, 2014  CVS Caremark (NYSE: CVS ... clinical affiliation with MedStar Health, a leading health care ... and the Washington, DC , ... care services for patients. Through this clinical affiliation, MedStar ... support, medication counseling, chronic disease monitoring and wellness programs ...
Breaking Medicine Technology:Global Animal Health Market 2014-2018 2Global Animal Health Market 2014-2018 3Global Animal Health Market 2014-2018 4Global Animal Health Market 2014-2018 5Global Animal Health Market 2014-2018 6Global Animal Health Market 2014-2018 7OSRAM ITOS PHASER 3000 Laser and LED Light Module Recognized With Prestigious R&D 100 Award 2OSRAM ITOS PHASER 3000 Laser and LED Light Module Recognized With Prestigious R&D 100 Award 3CVS Caremark Announces New Clinical Affiliation with MedStar Health 2CVS Caremark Announces New Clinical Affiliation with MedStar Health 3
... , MONTREAL and DUSSELDORF, Germany, Dec. ... solutions, is pleased to announce that FUJIFILM Europe GmbH is now ... several of their PACS and Mammography solutions using Fujifilm ... computer based radiography, offering the world,s first internet-based PACS (SYNAPSE) and ...
... , REDONDO BEACH, Calif., Dec. 1 Reproductive Partners ... (eSET) Encouragement Program to provide a financial incentive for ... for success to consider reducing the chance of twins ... in advanced reproductive technology today is reducing the number ...
Cached Medicine Technology:FUJIFILM Europe Teams Synapse with Matrox Xenia 2FUJIFILM Europe Teams Synapse with Matrox Xenia 3Reproductive Partners Announces Elective Single Embryo Transfer (eSET) Encouragement Program 2
(Date:8/27/2014)... Lauderdale, FL (PRWEB) August 27, 2014 ... cost-effective money-saving dental plans, has launched in the ... consumers access to quality, affordable dental care services ... leading destination for Tennessee consumers looking to save ... reduced-fee dental rates as a member of discount ...
(Date:8/27/2014)... For those who want to build ... products are very practical. Top10BestSEOHosting.com today announces that ... the best ASP.NET hosting suppliers of this year. ... top web hosting provider for a long time, ... today. Recently proclaimed one of the fastest growing ...
(Date:8/27/2014)... Philadelphia, PA. Inc. magazine ranked Holganix ... list, an exclusive ranking of the nation’s fastest-growing privately ... at the most important segment of the economy - ... exposure as members of the Inc. 500 list include ... “Some of world’s greatest companies have had their start ...
(Date:8/27/2014)... Altena, AR (PRWEB) August 27, 2014 ... in August 2014, is about Seed Digging, which a ... mental health therapy models, yet works to bring permanent ... people with addictions and mental health disorders cured on ... clutter from their own minds and find incredible inner ...
(Date:8/27/2014)... August 28, 2014 Recently, iFitDress.com, a ... announced its new designs of romantic bridal gowns ... enjoy a promotional price (up to 66 percent off) ... the company’s product line has been updated with these ... and patient. iFitDress.com hopes that all clients can gain ...
Breaking Medicine News(10 mins):Health News:DentistSave.com Launches Discount Dental Plans in Tennessee for Consumers, Businesses, and Groups 2Health News:DentistSave.com Launches Discount Dental Plans in Tennessee for Consumers, Businesses, and Groups 3Health News:Top10BestSEOHosting.com Releases the Best ASP.NET Hosting Suppliers of This Year: Hostgator, Arvixe and FatCow 2Health News:Inc Magazine Unveils 33rd Annual List of America's Fastest-Growing Private Companies - the Inc. 500 2Health News:Shawna Burns, Counselor, Releases Debut Book, "Seed Digging," to Improve Lives of Children and Adults with Addictions and Mental Health Disorders 2Health News:Promotion For Romantic Bridal Gowns Launched By Professional Company iFitDress.com 2
... debilitating headaches, researchers say, , , MONDAY, March 9 (HealthDay News) ... migraines, it might not be all in your head. , ... are more likely to visit emergency rooms with migraines if ... effect, too, although it is not as significant. , The ...
... SplashPLEASANT GROVE, Utah, March 9 What,s in a ... www.myomed.com ), names like Tom Brady, LaDainian Tomlinson, Willie ... helping people. Endorsements by professional athletes of this caliber ... actually used the product for a couple of years ...
... Western Reserve University School of Medicine Department of Ophthalmology ... along with three individual awards that could total up ... (RPB) Foundation. These are the most grants awarded in ... sciences program since 1997. In that time, the program ...
... Time to World,s Largest Breast Cancer Organization Founded in Her ... the global breast cancer movement 29 years ago by promising ... of the disease, that she would do everything in her ... tenure as U.S. Chief of Protocol has ended, Ambassador Brinker ...
... Borrowing from the iconic I Love NY logo, Ogilvy ... in a new campaign logo for the American Red Cross ... designed to recruit New Yorkers to become Red Cross Reserve ... of Governor David Paterson -- is part of a multi-channel ...
... Martin,s Ashley Treatment Center in MarylandHAVRE DE GRACE, Md., ... noted authority and lecturer on alcoholism who co-founded Father ... Grace, MD, died today at his home in Havre ... lectures on alcoholism as a disease, delivered to alcoholics ...
Cached Medicine News:Health News:Warmer-Than-Average Temperatures Raise Migraine Risk 2Health News:Warmer-Than-Average Temperatures Raise Migraine Risk 3Health News:Tom Brady Endorsed Pain Cream Returns to Natural Products Expo 2Health News:Case Western Reserve awarded nearly $1 million from Research to Prevent Blindness Foundation 2Health News:Susan G. Komen for the Cure(R)'s Founder, Nancy G. Brinker, Reengages With Organization Following Tenure as U.S. Chief of Protocol 2Health News:American Red Cross of Greater New York Launches New Effort to Recruit 10,000 Disaster Volunteers 2Health News:American Red Cross of Greater New York Launches New Effort to Recruit 10,000 Disaster Volunteers 3Health News:The Rev. Joseph C. Martin, Leading Authority on Alcoholism and Addiction Treatment, Dies at 84 2Health News:The Rev. Joseph C. Martin, Leading Authority on Alcoholism and Addiction Treatment, Dies at 84 3Health News:The Rev. Joseph C. Martin, Leading Authority on Alcoholism and Addiction Treatment, Dies at 84 4
... graphic display and IOL power calculation software. ... include firmware module with SRKII, SRKT, Holladay ... tones increase in frequency the closer you ... alignment is achieved with corneal indentation. Triple ...
The CryoSurgery console is the control center for CryoCath's surgical probe. It is a modular system made up of a console control unit and a tank dolly system. The system can be used as a unit or in s...
... a malleable, single-use cryosurgical probe developed to ... probe will ablate cardiac tissue while a ... procedure, such as coronary artery bypass grafting ... repair and as part of the Maze ...
The Medtronic CardioRhythm Marinr Catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing a...
Medicine Products: