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

se 3 studies (D9901 and D9902A), Dendreon would expect to achieve the pre-specified criterion for significance and would amend the BLA submission with the FDA based on these interim results.

"The amendment of the SPA allows us to accelerate the expected timing of our final results by a year while maintaining comparable power for the study," said Mitchell H. Gold, president and chief executive officer of Dendreon. "Our commitment to helping patients with prostate cancer is unwavering, and we remain focused on providing the necessary data to the FDA as quickly as possible to enable us to bring PROVENGE to the men in need of a new treatment option."

Conference Call Information

Dendreon will host a conference call tomorrow at 8:00 a.m. PT, 11:00 a.m. ET. To access the live call, dial 1-877-548-7901 (domestic) or +1-719-325-4844 (international). The call will also be audio webcast and will be available from the Company's website at http://www.dendreon.com under the "Investor/Webcasts and Presentations" section. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-888-203-1112 or +1-719-457-0820 for international callers; the conference ID number is 5074038. The replay will be available from 7:30 pm ET on Thursday, March 13 until 11:59 pm ET on Saturday, March 15. In addition the webcast will be archived for on-demand listening for 30 days at http://www.dendreon.com.

About IMPACT Study Design

The IMPACT trial is a randomized, double blind, placebo controlled Phase 3 study, which enrolled just over 500 men with metastatic, androgen independent prostate cancer with a primary endpoint of overall survival.

About Prostate Cancer

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than o
'/>"/>

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:7/29/2015)... , July 29, 2015 /PRNewswire/ - Aeterna Zentaris Inc. ... it has selected an optimized Erk inhibitor molecule ... the development of a new class of potential ... represents a prime target for therapeutic intervention in ... and survival benefits for B-Raf and Mek inhibitors. ...
(Date:7/29/2015)... ... July 29, 2015 , ... Costello served as Lead Levee Design Engineering ... the Orange County, Texas area from future storm surge flooding, such as occurred in ... potential levee alignment alternatives for providing protection, Costello also balanced socio-economic and environmental ...
(Date:7/28/2015)... July 29, 2015 A ... acquiring, rapidly developing and commercialising innovative medicines to ... Highly experienced management team; blue chip ...   Mereo BioPharma Group Ltd ("Mereo"), a recently-formed ... ( c. £76.5m), gross, from blue chip institutional investors ...
(Date:7/28/2015)... 2015 People with a common form of ... and sometimes profound improvements in their hearing and understanding ... a new multicenter study led by specialists at NYU ... online ahead of print in the journal The Laryngoscope July ... in the United States implanted ...
Breaking Biology Technology:Aeterna Zentaris Announces Optimized Erk Inhibitor Compounds For Further Development 2Aeterna Zentaris Announces Optimized Erk Inhibitor Compounds For Further Development 3Preventing Storm Surge Flooding in Houston 2Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 2Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 3Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 4Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 5Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 6Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 7Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 8Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 9Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 10Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company 11Hybrid Cochlear Implants For Common Form Of Hearing Loss May Benefit Millions 2Hybrid Cochlear Implants For Common Form Of Hearing Loss May Benefit Millions 3
... Inc. (OTCBB: GOVX), a biotechnology company that creates, ... its 2010 Annual Report and President,s Letter to ... information on the state of the Company,s finances ... GeoVax,s President Robert T. McNally, Ph.D., provides a ...
... Calif., May 4, 2011 Pharmacyclics, Inc. (Nasdaq: ... results for its fiscal third quarter that ended March ... Broad Clinical Development Progress for Btk Inhibitor PCI-32765 in ... I study, Pharmacyclics has initiated a broad Phase II ...
... 2011 This is a letter from Nicusa Capital urging BioClinica ... 2 and WITHHOLD votes from incumbent Directors Berg, Olukotun, Parker and ... Dr. David E. Nowicki Chairman of the Board BioClinica, Inc. 826 ... the Board of Directors of BioClinica: As of May ...
Cached Biology Technology:GeoVax Labs Announces Availability of 2010 Annual Report and President's Letter to Stockholders 2Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 2Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 3Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 4Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 5Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 6Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 7Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 8Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 9Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 10Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011 11This is a Letter From Nicusa Capital Urging BioClinica Shareholders to Vote AGAINST Proxy Proposal 2 and WITHHOLD Votes From Incumbent Directors Berg, Olukotun, Parker and Weinstein on 2011 Proxy 2This is a Letter From Nicusa Capital Urging BioClinica Shareholders to Vote AGAINST Proxy Proposal 2 and WITHHOLD Votes From Incumbent Directors Berg, Olukotun, Parker and Weinstein on 2011 Proxy 3This is a Letter From Nicusa Capital Urging BioClinica Shareholders to Vote AGAINST Proxy Proposal 2 and WITHHOLD Votes From Incumbent Directors Berg, Olukotun, Parker and Weinstein on 2011 Proxy 4This is a Letter From Nicusa Capital Urging BioClinica Shareholders to Vote AGAINST Proxy Proposal 2 and WITHHOLD Votes From Incumbent Directors Berg, Olukotun, Parker and Weinstein on 2011 Proxy 5
(Date:7/9/2015)... SAN JOSE, Calif. , July 9, 2015 /PRNewswire/ ... human interface solutions, announced today that it will report ... 2015 on Thursday, July 30, 2015 after the close ... call for analysts and investors at 2:00 p.m. PT ... information.    To participate on the live ...
(Date:7/8/2015)... , N.J. and NEW YORK , ... and Guidepoint today announced BD & ... healthcare companies with free access to Guidepoint,s expert network ... start-ups that are developing cutting-edge technologies to improve healthcare ... dedicated Guidepoint research manager, each start-up entrepreneur will be ...
(Date:7/7/2015)... , July 7, 2015 NXT-ID, Inc. (NASDAQ: NXTD ... the growing mobile commerce market announces a revised version of one ... The commercial will air on CNBC in New York ... and San Francisco metro areas. ... focuses on Wocket,s ability to replace all the cards in your ...
Breaking Biology News(10 mins):Synaptics to Report Fourth Quarter, Fiscal Year 2015 Results on July 30 2BD and Guidepoint Team to Connect Healthcare Start-up Companies With Business and Scientific Experts 2BD and Guidepoint Team to Connect Healthcare Start-up Companies With Business and Scientific Experts 3Wocket Smart Wallet Commercials Airing on CNBC to Showcase This Summer's Must- Have Tech Product 2Wocket Smart Wallet Commercials Airing on CNBC to Showcase This Summer's Must- Have Tech Product 3
... Stanford, CA A startling discovery by scientists at ... arguably the most important biological process on Earth. Photosynthesis ... living things by producing food from sunlight, and in ... dioxide. But two studies by Arthur Grossman and colleagues*+ ...
... that leverages A-list female beauty to conserve the earths ... at upscale cosmetics counters around the world. The ... pleased to announce that Chantecaille, a luxury cosmetics company, ... gorgeous new Protected Paradise Face and Eyes compacts to ...
... BIO-key International,Inc. (OTC Bulletin Board: BKYI) today announced plans to ... March 17, 2008,after the market close. In conjunction with the ... live over the Internet,on Tuesday, March 18, 2008 at 9:00 ... Inc. Fourth Quarter and Full Year 2007 ...
Cached Biology News:New twist on life's power source 2New twist on life's power source 3Pew Institute teams with Chantecaille Cosmetics to protect global marine life 2BIO-key(R) Announces Fourth Quarter and Full Year 2007 Earnings Release and Conference Call Schedule 2
... Opticon real-time PCR detection system uses a ... (450-495 nm) and a photomultiplier tube for ... is built on an DNA Engine thermal ... feature. This item includes the thermal cycler, ...
... Precision-designed for Optimal Microdissection , CapSure ... the precise and rapid extraction of populations ... cytology samples with Laser Capture Microdissection., ... Downstream Molecular Analysis , All CapSure LCM ...
... are highly sensitive laser confocal systems designed ... advanced scanners that meet your expectations, differentiating ... and optimizing the signal on the bottom ... the range for increased sensitivity. Results with ...
... four slides. The new ArraySlide 24-4 chamber ... x 7mm) individual printing surfaces for multiple ... studies. Unlike other systems, this device utilizes ... of contaminating adhesives. The chamber itself is ...
Biology Products: