Navigation Links
Arena Pharmaceuticals Initiates Second and Third Pivotal Trials Evaluating Lorcaserin for the Treatment of Obesity
Date:12/13/2007

Patients with FDA-defined Valvulopathy Permitted to Enroll in 2nd and 3rd

Pivotal Trials - Echocardiogram Screening Requirement Eliminated

SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced the initiation of patient screening in the second and third Phase 3 pivotal trials evaluating the efficacy and safety of its lead drug candidate, lorcaserin hydrochloride, for weight management in overweight and obese patients. Known as BLOSSOM (Behavioral modification and Lorcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), these one-year, double-blind, randomized and placebo-controlled trials are expected to collectively enroll approximately 3,750 overweight and obese patients. Consistent with Arena's proposal, the Food and Drug Administration, or FDA, is allowing patients with FDA-defined valvulopathy to enroll in both BLOSSOM and BLOOM-DM. This is different from the design of the initial lorcaserin pivotal study known as BLOOM, in which echocardiography was used to screen for patients with FDA-defined valvulopathy and exclude those patients from enrolling in the trial. Instead, in BLOSSOM and BLOOM-DM, there are no such echocardiographically defined exclusion criteria, although serial echocardiograms will be obtained to extend the lorcaserin safety database. BLOOM, BLOSSOM and BLOOM-DM comprise the entire planned pivotal trial program for lorcaserin.

"Eliminating the requirement of screening echoes, and receiving permission from the FDA to expand the patient population of the lorcaserin pivotal trial program to include patients with FDA-defined valvulopathy, is a signifi
'/>"/>

SOURCE Arena Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6

Related biology technology :

1. Arena Pharmaceuticals to Present at the Bear Stearns 20th Annual Healthcare Conference
2. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiogaphic Data Safety Monitoring Board Review
3. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiographic Data Safety Monitoring Board Review
4. Arena Pharmaceuticals Selected to Join New NASDAQ NeuroInsights Neurotech Index
5. Arena Pharmaceuticals to Present at Two Upcoming Investor Conferences
6. Arena Pharmaceuticals to Report Third Quarter 2007 Financial Results and to Host Conference Call and Webcast on Wednesday, October 17, 2007
7. Arena Pharmaceuticals Announces Third Quarter 2007 Financial Results
8. Arena Pharmaceuticals to Present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
9. Arena Pharmaceuticals Appoints Phillip M. Schneider and Randall E. Woods to Board of Directors
10. Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
11. China Biopharmaceuticals Holdings Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2013)... Calif. , June 19, 2013  Continuing its ... myocardial infarction (MI), Beckman Coulter , Inc. announces ... of its new Access AccuTnI+3 troponin I assay for ... "Clinicians have depended on Beckman Coulter,s ... new AccuTnI+3 assay has the proven performance to continue ...
(Date:6/19/2013)... (PRWEB) June 19, 2013 Today DuPont ... young people to become leaders in the greatest challenge ... billion people in 2050. Borel spoke at the ... Conference in Atlanta, about urgent need for students to ... are local, science-based, sustainable and reached in collaboration with ...
(Date:6/19/2013)... 2013 BioConvergence team members Curtis ... at 2013’s BioLogistics Summit in San Francisco earlier ... Cold Chain IQ and IQPC, addressed the increasingly ... in part, attributed to current trends of globalization, ... these trends is an increase in movement, which ...
(Date:6/19/2013)... June 18, 2013 A new look ... costs and other trends will highlight technical sessions at ... this fall. In its 33rd year, the three-day event ... exhibition of key suppliers, approximately 100 technical presentations and ... the international society for optics and photonics , the ...
Breaking Biology Technology:Beckman Coulter Announces FDA Clearance of New Access AccuTnI+3 Troponin I Assay for the Access 2 Immunoassay System 2Beckman Coulter Announces FDA Clearance of New Access AccuTnI+3 Troponin I Assay for the Access 2 Immunoassay System 3DuPont Leader Calls for New Generation of Food Visionaries to Fight Hunger 2BioConvergence® Presents at BioLogistics Summit on Risk Matrix for Biosamples during Shipment 2‘Big Glass’ and Visions for the Future are on the Program for SPIE Photomask Technology 2‘Big Glass’ and Visions for the Future are on the Program for SPIE Photomask Technology 3
... Calif.) Smaller. Faster. More efficient. These are the ... nanoscale structures that will help to speed up computers. ... have made a major contribution to this field by ... computers smaller, faster, and more efficient. The new process ...
... VANCOUVER, Sept. 25 /PRNewswire-FirstCall/ - Dragon Pharmaceutical Inc.,("Dragon ... BBSE: DRP), a,leading international pharmaceutical company, today announced ... Garry Wong, Chief Financial,Officer will present at 9:30 ... Quebec 2008 at the Chateau Frontenac hotel in ...
... U.S. Senate to Take Similar Action, WASHINGTON, ... (ATA), the industry trade organization for the,leading U.S. ... taking action that if adopted by the Senate, ... (DHS) US-VISIT,Exit program., The House-approved language would ...
Cached Biology Technology:New nanoscale process created by UCSB scientists will help computers run faster and more efficiently 2New nanoscale process created by UCSB scientists will help computers run faster and more efficiently 3New nanoscale process created by UCSB scientists will help computers run faster and more efficiently 4New nanoscale process created by UCSB scientists will help computers run faster and more efficiently 5
(Date:6/19/2013)... 2012, the European Medicines Agency (EMA) approved the ... ever gene therapy for clinical use in the ... developed AAV-LPL S447X for the treatment of a ... (LPLD) which affects approximately one or two out ... life-threatening inflammations of the pancreas. Afflicted individuals carry ...
(Date:6/18/2013)... awarded a $394,300 grant from the Tarrant Regional ... in the new facilities of the 150-mile Integrated ... professor of civil engineering, will investigate the best ... water in an effort to eliminate biological growths ... monochloramine is widely practiced throughout the United States. ...
(Date:6/18/2013)... June 18, 2013 Joshua Obar, Ph.D., Department ... been honored with a 2013 ICAAC Young Investigator Award ... of immunological memory responses to infection. , Obar ... in 2001 and went on to complete his Ph.D. ... He performed his Ph.D. thesis research in Edward ...
Breaking Biology News(10 mins):No danger of cancer through gene therapy virus 2UT Arlington research to benefit quality, flow in 150-mile Integrated Pipeline 2The American Society for Microbiology honors Joshua Obar 2
... is a simple blood test for serum creatinine, but it ... accumulate to levels that are significant enough to indicate kidney ... to intervene. To close the gap between injury and ... Dr. Jonathan Barasch, M.D., Ph.D., associate professor of medicine and ...
... cell biologists there are few better-known proteins than nestin, whose ... "stem cell," such as a neural stem cell. As helpful ... which purpose nestin serves in a cell. In a ... of Nature Neuroscience , Salk Institute of Biological Studies ...
... developed a new laser sensing technology that may allow ... scientists to better measure airborne environmental pollutants and greenhouse ... pulse out and get another pulse back from the ... and aerospace engineering at Princeton, the research group leader ...
Cached Biology News:Seeing kidney injury, as it happens 2Salk researchers discover that stem cell marker regulates synapse formation 2Salk researchers discover that stem cell marker regulates synapse formation 3'Air laser' may sniff bombs, pollutants from a distance 2'Air laser' may sniff bombs, pollutants from a distance 3
Alexa Fluor 647 anti-mouse Qa-2...
... is ideal for developing single and multi-analyte ... contains the new, improved, and user friendly ... can design specific templates for commercial or ... integrated graphing and data regression capabilities; the ...
... System is ideal for developing single ... reagents. The Luminex 100 Instrument System ... version 1.7, the XY platform and ... $2000 in free Beadlyte products if ...
Peptide-affinity Purified Polyclonal Antibody to ICEBERG Peptide with sequence EEDPQLASKMGLH, from C Terminus of the protein sequence according to NP_067546...
Biology Products: