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:4/23/2015)... Calif. , April 23, 2015  Veracyte, Inc. (NASDAQ: ... into a definitive agreement to sell approximately $40 million ... the agreement, the investors will purchase an aggregate of ... of $8.15 per share, the closing stock price on ... new and existing investors, including Broadfin Capital, Camber Capital, ...
(Date:4/23/2015)... , April 23, 2015  Metanome, Inc., an ... the company has changed its name to Diversigen, ... positioning as the single commercial source for the ... capitalize on the diverse opportunities of the microbiome. ... Diversigen accepts – including those that are difficult ...
(Date:4/23/2015)... SAN FRANCISCO, CA (PRWEB) April 23, 2015 ... drug delivery, today announced that the United States Patent ... on the Company’s NANOPOR™ technology. US ... and covers Delpor’s microfabricated drug delivery device ... uses Delpor’s proprietary NANOPOR™ technology for the sustained (zero-order) ...
(Date:4/22/2015)... 22, 2015   MPIRICA Health Inc. , ... in Series A financing from the McQuinn Trust, ... accelerate consumer and employer awareness of MPIRICA.com, delivering ... over 4,800 U.S. hospitals. "As a ... very concerned about choosing the hospital and surgeon ...
Breaking Biology Technology:Veracyte, Inc. Announces $40 Million Private Placement 2Veracyte, Inc. Announces $40 Million Private Placement 3Veracyte, Inc. Announces $40 Million Private Placement 4Metanome Announces Corporate Name Change to Diversigen 2Delpor, Inc. Announces the Issuance of 2 New US Patents Based on its Nanopore Technology which Enables the Sustained Release of Drugs from a Small Implant Device 2Delpor, Inc. Announces the Issuance of 2 New US Patents Based on its Nanopore Technology which Enables the Sustained Release of Drugs from a Small Implant Device 3MPIRICA Health Inc. Secures $1.6M to Promote FICO-Like Quality Scores for Surgeries 2
... 28 Boston,Scientific Corporation (NYSE: BSX ) ... that Boston Scientific has completed its acquisition of ... April 16.,Under the terms of the transaction, all ... per share in cash, for a total of,approximately ...
... N.J., May 28 National Stem Cell,Holding, Inc. (OTC: ... steps to,change its name to Proteonomix, Inc. The change ... Michael Cohen, President/CEO, stated: "Our new name reflects the ... development stage and,commencing the commercialization of our technologies. These ...
... Provides Additional Global Corporate Finance, Management and ... Manufacturing ... (TSX: NVN) announced today the appointment of Gordon H.,Busenbark to ... chief financial officer of Xytis Pharmaceuticals, a privately,held development-stage specialty ...
Cached Biology Technology:Boston Scientific Completes Acquisition of CryoCor 2Boston Scientific Completes Acquisition of CryoCor 3National Stem Cell Holding, Inc. Announces the Change of Its Name to Proteonomix, Inc. 2National Stem Cell Holding, Inc. Announces the Change of Its Name to Proteonomix, Inc. 3Nventa Appoints Gordon H. Busenbark to Board of Directors 2
(Date:3/20/2015)... --Research and Markets ( http://www.researchandmarkets.com/research/rswjb4/hand_geometry ) has announced ... Business Report" report to their offering. This ... Thousands. The report provides separate comprehensive analytics for the US, ... Europe , Asia-Pacific , ... Annual estimates and forecasts are provided for the ...
(Date:3/19/2015)... March 19, 2015  NXT-ID, Inc. (NASDAQ: NXTD ... on the growing mobile commerce market, announces its biometric payment ... clip that aired this week on Washington DC,s ... In a segment "The Next Great Thing", host ... way to pay, and ,a really big breakthrough in mobile ...
(Date:3/17/2015)... March 17, 2015 Emotient, the leader ... today announced general availability of Emotient Analytics ... the analysis of facial expressions. The system analyzes ... content, products and services. It delivers audience response ... sentiment - as derived from facial evidence of ...
Breaking Biology News(10 mins):Hand Geometry - Global Strategic Business Report 2015: An Essential Security Component for both Government & Enterprise Sector 2Hand Geometry - Global Strategic Business Report 2015: An Essential Security Component for both Government & Enterprise Sector 3Hand Geometry - Global Strategic Business Report 2015: An Essential Security Component for both Government & Enterprise Sector 4NXT-ID's Wocket Smart Wallet Featured on Fox News Segment, "The Next Great Thing" 2NXT-ID's Wocket Smart Wallet Featured on Fox News Segment, "The Next Great Thing" 3New Emotient Web Service Measures Audience Response Using On-Demand Facial Expression Analysis 2New Emotient Web Service Measures Audience Response Using On-Demand Facial Expression Analysis 3New Emotient Web Service Measures Audience Response Using On-Demand Facial Expression Analysis 4
... Fluctuations in penguin populations in the Antarctic are linked more ... to changes in their habitats, according to a new study ... Academy of Sciences . Funded in part by the Lenfest ... "winners" of changing conditions, such as large-scale ice melting, may ...
... NEW YORK (April 11, 2011) -- Weill Cornell Medical ... Surgeons have announced that The Mortimer D. Sackler, M.D. ... awarded to The Rockefeller University,s Dr. Fernando Nottebohm for ... the discovery of neuronal replacement. Dr. Nottebohm is ...
... FINDINGS: Certain differentiated cells in breast tissue can spontaneously ... researchers. Until now, scientific dogma has stated that differentiation ... return to the flexible stem-cell state on their own. ... well as for breast cancer cells. RELEVANCE: ...
Cached Biology News:Penguins that shun ice still lose big from a warming climate 2Sackler Prize awarded to pioneering neuroscientist 2Sackler Prize awarded to pioneering neuroscientist 3Scientists identify a surprising new source of cancer stem cells 2Scientists identify a surprising new source of cancer stem cells 3
Melanoma Antigen, Family C, 1 (MAGEC1) Rabbit anti-Human Polyclonal Antibody Immunogen: Synthetic peptide - KLH conjugated Family: New Recommended Storage: Long term: -20C; Short term: +4...
...
ECE-1 (H-60)...
Mouse monoclonal [AE3] to Cytokeratin 1 - 8, prediluted ( Abpromise for all tested applications). Antigen: Tissue / cell preparation - Human epidermal cells. Entrez GeneID: 140807 Swiss P...
Biology Products: