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:4/17/2015)... 17, 2015 CIO Review ( http://www.cioreview.com ... 20 Most Promising Pharma and Life Science Technology Solution ... global compliance software platform for life sciences companies. ... a panel of experts and members of CIO Review’s ... MediSpend Platform has been on our radar for some ...
(Date:4/17/2015)... 17, 2015  Guggenheim Securities, the investment banking and ... hiring of William Tanner as a Managing ... Tanner will start work at Guggenheim in May 2015 ... office. "Bill brings a wealth of biotech ... experienced and highly acclaimed healthcare team," said Matthew ...
(Date:4/17/2015)... 17, 2015 Global Stem Cells ... Stem Cell Summit 2015 April 27 - 29, 2015 ... developments in all areas of stem cell research including ... cells and regenerative medicine. , The conference will ... well as translational research in stem cell therapies, regenerative ...
(Date:4/17/2015)... BellBrook Labs announced today that they ... powerful Orthogonal Pooled Screening (OPS) Platform developed and ... Lankenau Institute for Medical Research (LCGC) in Wynnewood, ... successful drug discovery outcomes using far more efficient ... available nowhere else, coupled to a state-of-the-art compound ...
Breaking Biology Technology:MMIS Chosen by CIO Review as Top 20 Most Promising Pharma and Life Science Technology Solution Providers 2015 2Guggenheim Securities Hires Biotech Analyst William Tanner in Expansion of Healthcare Coverage 2Global Stem Cells Group To Join GTCbio Stem Cell and Regenerative Medicine Summit in Boston, April 27-29, 2015 2Global Stem Cells Group To Join GTCbio Stem Cell and Regenerative Medicine Summit in Boston, April 27-29, 2015 3BellBrook Labs and Lankenau Institute Partner to Accelerate Drug Discovery using Orthogonal Pooled Screening 2
... Pa., Oct. 2 /PRNewswire/ - Respironics, Inc. (Nasdaq:,RESP) ... the outstanding shares,of Apollo Light Systems, Inc., a ... light therapy systems for melatonin suppression and,circadian rhythm ... company is located in American Fork, Utah and ...
... Oct. 2 Monitorforhire.com, the,fastest source for ... even faster. The company has added a ... respond immediately to work requests via,PDA or ... Scott Freedman, president of monitorforhire.com says that ...
... Oct. 2 454 Life Sciences, a Roche,company, ... to,conduct large scale genetic re-sequencing in hundreds of ... responses to a widely,prescribed class of drug. The ... sufficient genetic variation can be identified and,validated to ...
Cached Biology Technology:Respironics Acquires Apollo Light Systems, Inc., Expands into Circadian Rhythm Device-Based Therapy Market 2Respironics Acquires Apollo Light Systems, Inc., Expands into Circadian Rhythm Device-Based Therapy Market 3New Pharmacogenomic Approach: 454 Life Sciences and Perlegen to Collaborate in Drug Response Sequencing Study 2New Pharmacogenomic Approach: 454 Life Sciences and Perlegen to Collaborate in Drug Response Sequencing Study 3
(Date:3/20/2015)... 20, 2015 Research and Markets ... the "India Sensors Market Forecast and Opportunities ... The sensor market is projected to grow at ... Consumer electronics, automotive, industrial and healthcare sectors are ... country. In addition, adoption of MEMS technology in ...
(Date:3/20/2015)... --Research and Markets ( http://www.researchandmarkets.com/research/vkzvcs/iris_biometrics ) has announced ... Business Report" report to their offering. This ... Thousands. The report provides separate comprehensive analytics for the US, ... Europe , Asia-Pacific , ... America . Annual estimates and forecasts are ...
(Date:3/17/2015)... March 17, 2015 MedNet Solutions ... in clinical study management systems, is pleased to ... at ARENA,s Outsourcing in Clinical Trials Southeast conference ... provides an excellent forum for MedNet to showcase ... affordable software-as-a-service (SaaS) eClinical technology platform. ...
Breaking Biology News(10 mins):India Sensors Market Forecast and Opportunities 2020 - STMicroelectronics held the largest share in 2014 2India Sensors Market Forecast and Opportunities 2020 - STMicroelectronics held the largest share in 2014 3Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 2Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 3Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 4Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 5Connect With MedNet Solutions At Outsourcing In Clinical Trials Southeast 2
... Spanish . Innovative, kid-friendly strategies ... skillsare emerging from scientific studies funded by the Agricultural ... Johnston, John P. Foreyt and Chermaine Tyler and their ... in which many of their Texas middle-school participants achieved ...
... in the 1990s the hole in Earth,s protective ... acid rain worse, scientists are reporting. Their study ... once used in aerosol spray cans, air conditioners, refrigerators, ... Physical Chemistry A , a weekly publication. Jeffrey ...
... Scientists at L,Oral, in hot pursuit of the hidden elements of ... "beauty is only skin deep." In fact, their work indicates that ... is much deeper. It actually is linked to molecules within the ... (C&EN), ACS, weekly newsmagazine. C&EN Senior Editor Lisa M. ...
Cached Biology News:Kids lose pounds, gain fitness in Houston study 2
Porcine parvovirus and mycoplasma tested. Contains 0.5 g/L of trypsin (1:250) and 0.2 g/L of EDTA4Na in Hanks' Balanced Salt Solution without CaCl2 MgCl2 6H2O and MgSO4 7H2O. Contains phenol red....
...
...
... P Set from different Cynomolgus monkey ... organs maybe available upon request. ... from the whole set, and pay ... All Dr. P Set products ...
Biology Products: