Navigation Links
FDA Agrees to Amend Dendreon's Special Protocol Assessment for Phase 3 IMPACT Study of PROVENGE
Date:3/12/2008

-Amended Agreement Accelerates Expected Timing of Final Analysis by One Year While Maintaining Comparable Powering of Interim and Final Results- -Dendreon to Hold Conference Call on Thursday, March 13, 2008 at 11:00 AM

ET-

SEATTLE, March 12 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) has agreed to an amended Special Protocol Assessment (SPA) for the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE(R) (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the IMPACT trial to amend the Biologics License Application (BLA) for licensure of PROVENGE.

The amended SPA accelerates the expected timing of the final IMPACT results by approximately one year while maintaining comparable powering of the study's interim and final results. By increasing the number of events and decreasing the alpha (false positive error) spending function for the interim analysis, the Company is able to reduce the number of events for the final analysis (from 360 to 304) and still maintain a comparable statistical power for both the interim and final analyses. Interim results are still expected in the second half of 2008; however, final results are now expected in the second half of 2009 rather than 2010.

Based on the statistical plan in the amended SPA, if the treatment effect at the interim analysis for the IMPACT trial is consistent with the integrated results of the previous two completed pha
'/>"/>

SOURCE Dendreon Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. FDA Agrees to Review Cimzia(R) File for the Treatment of Rheumatoid Arthritis
2. Inverness Medical Innovations Agrees to Acquire ParadigmHealth
3. Inverness Medical Innovations Agrees to Acquire Panbio Ltd.
4. Forest Laboratories, Inc. Announces Amendment to Bystolic(TM) (nebivolol) Agreement
5. Mylan Announces Amendment to Bystolic(TM) (Nebivolol) Agreement
6. Neurobiological Technologies Announces Amendment of License and Cooperation Agreement with Merz Pharmaceuticals and Childrens Hospital
7. Barr Confirms Patent Challenge of Namenda(R) Tablets, 5mg & 10mg
8. ExonHit and bioMerieux Amend Their Strategic Partnership
9. Halozyme Therapeutics Amends Stockholder Rights Plan
10. Beanstalk Capital Ltd. and iCo Therapeutics Inc. amend arrangement agreement
11. Genmab Amends HuMax-CD4 Pivotal Study in CTCL
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2014)... 18, 2014 Leatherwood Plastics has ... material, to stay competitive in the semiconductor, clean ... materials ultimately impact product quality and productivity, according ... , Established in 1980 in Lewisville, TX, ... fabricators have left the business. Much of Leatherwood’s ...
(Date:9/18/2014)... 18, 2014  MEI Pharma, Inc. (Nasdaq: MEIP ... novel therapies for cancer, announced today that Daniel P. ... at BioCentury,s NewsMakers in the Biotech Industry conference ... from the Millennium Broadway Hotel & Conference Center in ... presentation can be accessed at www.meipharma.com . A replay ...
(Date:9/18/2014)... Oncothyreon Inc. (NASDAQ: ONTY ) today announced ... offerings of 10,000,000 shares of its Common Stock at ... for expected gross proceeds of $20 million and 10,000 ... a price to the public of $2,000.00 per share, ... of Series A Convertible Preferred Stock is non-voting and ...
(Date:9/18/2014)... 2014   Sigma-Aldrich Corporation (Nasdaq: ... into a new gene editing partnership with the ... Under the partnership, Sigma-Aldrich will provide the Vector ... and dedicated gene editing bioinformaticians. The ... at the U-M Medical School. One initiative already ...
Breaking Biology Technology:Leatherwood Plastics Selects Vycom’s Flametec PVC-C Material to Stay Competitive in Semiconductor and Lab Equipment Industries 2MEI Pharma To Present At BioCentury's NewsMakers Conference 2MEI Pharma To Present At BioCentury's NewsMakers Conference 3Oncothyreon Prices $40 Million Concurrent Public Offerings of Common Stock and Preferred Stock 2Oncothyreon Prices $40 Million Concurrent Public Offerings of Common Stock and Preferred Stock 3Sigma-Aldrich, University of Michigan Medical School Establish CRISPR Core Lab Partnership 2Sigma-Aldrich, University of Michigan Medical School Establish CRISPR Core Lab Partnership 3Sigma-Aldrich, University of Michigan Medical School Establish CRISPR Core Lab Partnership 4
... Tips for Better Blood ... Sugar Management, BRIDGEWATER, N.J., ... with diabetes, Emmy nominated actress and,Broadway star Aida Turturro is teaming up ... diabetes to reach,better levels of blood sugar control. Ms. Turturro,s personal story ...
... security guards, police officers and armed forces into Robocops, repelling ... in carbon nanotechnology however could give those in the line ... of damage. , A research paper published in ... Centre for Advanced Materials Technology at the University of Sydney ...
... Dragon Pharmaceutical Inc.,(TSX: DDD; OTCBB: DRUG; BBSE: ... 7ACA production has been successfully implemented on ... validates the Company,s research,and development efforts to ... immediate benefits to production operations by,increasing production ...
Cached Biology Technology:Actress Aida Turturro Tells Americans to Start Now to Talk With Their Healthcare Provider About Taking Control of Their Diabetes 2Actress Aida Turturro Tells Americans to Start Now to Talk With Their Healthcare Provider About Taking Control of Their Diabetes 3Actress Aida Turturro Tells Americans to Start Now to Talk With Their Healthcare Provider About Taking Control of Their Diabetes 4Using nanotech to make Robocops 2Dragon Announces R&D Achievement in Biotech Manufacturing Process 2Dragon Announces R&D Achievement in Biotech Manufacturing Process 3
(Date:9/18/2014)... cycles of carbon and nitrogen comprise all spheres ... environmental systems have caused imbalances and perturbations that ... (GHGs). Increased GHGs result in climate changes which ... oceans and the atmosphere. Understanding these feedback mechanisms ... of environmental science during the past three decades. ...
(Date:9/18/2014)... up to 400 kilometres in search of a home, which ... Clownfish spend their entire adult lives under the protection of ... open ocean, says study co-author, Dr Hugo Harrison from the ... at James Cook University. , "In the past we haven,t ... rare glimpse into how far they can swim, crossing large ...
(Date:9/17/2014)... engineering professor and his doctoral student have designed a ... water collected from fog and dew., The device could ... deserts around the globe., Cheng Luo, professor in the ... candidate in the same College of Engineering department, published ... of ACS, (American Chemical Society) Applied Materials ...
Breaking Biology News(10 mins):Greenhouse gas research enters a new era 2Nemo's epic journey to find a new home 2Shorebird's beak inspires UT Arlington research on water collection 2
... The majority of rare diseases are hereditary. But despite ... exact cause remains unclear. The discovery of the underlying ... diagnosis and the development of innovative approaches to their ... Genetics and the Institute of Medical Genetics at the ...
... The incidence of psychotic disorders varies greatly ... course, and treatment response across individuals. High rates ... cannabis users, and traumatised individuals reflect the causal ... progress in the area of molecular genetics, has ...
... the environment specifically to creatures that live in water ... Carolina State University toxicologists. In a study published in ... NC State researchers show that water fleas take up nitrates ... fertilizers and convert those chemicals into nitric oxide. Nitric ...
Cached Biology News:All genes in 1 go 2Developmental gene-environment interactions: A model for psychosis 2Developmental gene-environment interactions: A model for psychosis 3Developmental gene-environment interactions: A model for psychosis 4Developmental gene-environment interactions: A model for psychosis 5Developmental gene-environment interactions: A model for psychosis 6Fertilizer chemicals linked to animal developmental woes 2
Collected from sexually mature, mixed sex, mixed breed dogs. Serum from specific breeds available by request....
... EPS 301 Power Supply, 1. ... maximum.Constant voltage or constant current modes.Single-unit ... precision and reproducibility.Suitable for submarine, mini ... as well as semidry and mini ...
Mouse Serpin F1/PEDF MAb (Clone 199315)...
Mouse MMP-24 (MT5-MMP) MAb (Clone 143908)...
Biology Products: