Navigation Links
Anthera Updates Phase 3 Plans Following Results from the Phase 2b PEARL-SC Dose Ranging Study of Blisibimod
Date:6/27/2012

ients from our Phase 2 study clearly identifies those patients most in need of therapy and most likely to benefit from our potent BAFF inhibitor blisibimod," said Paul F. Truex, Anthera's President and Chief Executive Officer. "Feedback from the EMA Scientific Advice process combined with an End of Phase 2 meeting in the third quarter will form the basis of our final phase 3 study designs."

Table 1:  Response rates for 200mg weekly subcutaneous blisibimod versus placeboEndpoint (Subgroup)12 Week ResponsePlacebo / Active16 Week Response Placebo / Active 20 Week Response Placebo / Active24 Week Response Placebo / ActiveSRI-5

(mITT*)

27.1% / 29.3%

26.8% / 34.8%

31.6% / 44.6%

35.3% / 43.5%SRI-5

(Moderate*)

24.1% / 30.0%

29.3% / 36.0%

31.0% / 44.0%

34.5% / 48.0%SRI-5

(Severe*)

27.7% / 37.5%

34.0% / 41.7%

36.2% / 52.1%

40.4% / 54.2%* mITT:  Lupus, SELENA/SLEDAI >6, seropositive* Moderate Subgroup:  Lupus, SELENA/SLEDAI >8, seropositive, receiving steroids* Severe Subgroup:  Lupus, SELENA/SLEDAI >10, seropositive, receiving steroidsThe pre-specified primary efficacy endpoint, clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose groups, was not met due to a lack of clinical efficacy in the 100mg weekly and 200mg monthly dose groups.  All doses of blisibimod demonstrated consistent serological response including reductions of B-cells, ds-DNA and improvements in both complement C3 and C4.  Blisibimod was safe and well-tolerated at all dose levels with no meaningful imbalances in serious adverse events.  A single suicide attempt and a non-fatal single tuberculosis infection were seen in the placebo group.  There were seven deaths during the study - three in placebo and four blisibimod. 

Following a submission in April of 2012 the Company r
'/>"/>

SOURCE Anthera Pharmaceuticals
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
2. Anthera Announces First Quarter 2012 Financial Report and Conference Call
3. Anthera Pharmaceuticals Reports 2012 First Quarter Financial Results And Provides Clinical Progress Update
4. Neuralstem Updates ALS Stem Cell Trial Progress
5. Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
6. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
7. Retrospective Study Suggests that Stereotactic Ablative Radiotherapy (SABR) Can be a Viable Option for Treating Early-Stage Lung Cancer in Operable as well as Inoperable Patients; Phase III Randomized Trial Now Under Way
8. Ultragenyx Announces Phase 1 Results of UX001 in Hereditary Inclusion Body Myopathy (HIBM), a Rare Neuromuscular Disease
9. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
10. Isis Initiates Phase 2 Study of ISIS-APOCIIIRx in Patients with Hypertriglyceridemia
11. Alder BioPharmaceuticals Inc. Initiates Phase 1 Clinical Study of Antibody Therapeutic Candidate for Treatment of Migraine, ALD403
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... July 25, 2014  Acsis Inc., the market ... serialization solutions, has recently posted an article, ... current and future needs for companies, extended supply ... supply chain model no longer work today.  The ... the growth of mobile technology, machine to machine ...
(Date:7/25/2014)... , N.Y. and MEXICO CITY , ... today announced that PLM, a Latin American healthcare sciences ... to deliver medical information on conditions such as cancer ... can now access the most up-to-date information to deliver ... medical professionals is growing rapidly, with many relying on ...
(Date:7/25/2014)...  AMETEK, Inc. (NYSE: AME ) today ... as Vice President and General Manager, Engineered Medical Components, ... "I am pleased that Kurt has joined ... experience, especially in the medical device industry, and we ... growth and success of our medical components businesses," commented ...
Breaking Medicine Technology:Acsis Addresses Questions on the Modern Supply Chain 2Healthcare Sciences Publisher PLM and IBM Speed Access to Medical Information to Deliver Better Patient Care with Mobile 2Healthcare Sciences Publisher PLM and IBM Speed Access to Medical Information to Deliver Better Patient Care with Mobile 3Healthcare Sciences Publisher PLM and IBM Speed Access to Medical Information to Deliver Better Patient Care with Mobile 4AMETEK Names Kurtis L. Goos, Vice President & General Manager, Engineered Medical Components 2
... July 22, and OSAKA, Japan, July 23 ... Takeda Global Research & Development Center, Inc., a wholly ... U.S. Food and Drug Administration (FDA) that the FDA ... for the fixed-dose combination (FDC) of alogliptin and ACTOS((R)) ...
... , MENLO PARK, Calif., July 22 Apieron, ... positive coverage policy for the measurement of exhaled nitric oxide ... peer-reviewed evidence is sufficient to support benefit coverage for the ... the measurement of exhaled nitric oxide is considered medically necessary ...
Cached Medicine Technology:Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl) 2Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl) 3CareFirst BCBS Covers eNO Measurement for Diagnosis, Asthma Treatment 2
(Date:7/25/2014)... Lake City, UT (PRWEB) July 25, 2014 ... basketball court surfaces for the recent Nike National ... and the current United States Junior National Tournament ... through July 25. , The flooring for these prestigious ... totaling more than 300,000 square feet of playing surface ...
(Date:7/25/2014)... 25, 2014 Florida Hospital and MOSI officially ... organizations for years to come and make a difference in ... $2 million dollar check to provide the support needed to ... enable MOSI to transform the IMAX Dome Theatre from film ... the only IMAX Dome Theatre in the state of Florida, ...
(Date:7/25/2014)... AttorneyOne.com, a recognized authority on law, update the website ... Ibuprofen and Oxcarbazepine Tablets . , The FDA ... one lot of Oxcarbazepine Tablets, by American Health Packaging (AHP), ... used for the treatment of certain types of seizures in ... recall is that Lot #142588, Expiration Date, 01/2016 of Ibuprofen ...
(Date:7/25/2014)... 2014 A new study of participants in ... are published today in Cancer , found evidence that ... who had an abnormal finding on a lung cancer screening ... life than did those who were screened and found to ... to the researchers. “We expected that participants with an abnormal ...
(Date:7/25/2014)... This is a professional and ... Galactooligosaccharides (GOS) industry in Global and China. ... industry, including definitions, applications and industry chain structure. ... are provided with a focus on history, developments, ... comparison between the international and Chinese situation is ...
Breaking Medicine News(10 mins):Health News:Sport Court Provides All Sports Flooring for Basketball Events in Chicago and Washington D.C. 2Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 2Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 3Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 4Health News:Ibuprofen and Oxcarbazepine Tablets Recalled: AttorneyOne Monitors and Keep Consumers Informed 2Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 2Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 3Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 4Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 5Health News:GOS Market (Galacto-oligosaccharides) Development in Global & China Regions Now Available at DeepResearchReports.com 2Health News:GOS Market (Galacto-oligosaccharides) Development in Global & China Regions Now Available at DeepResearchReports.com 3
... , TIANJIN, China, June 3 ... by Pfizer Inc. as the 2008 Top Intermediates CMO,Award, ... and drug product,facility, despite the current challenging economic environment. ... of Chemical,Development and is ready to help expand and ...
... It, Too! , , ATLANTA, June 3 We,ve all ... magazines ... celebrity moms flaunting their beautiful beach bodies in bikinis. ... which leaves the rest of us wondering how they got so ... trainer Susie Shina gained weight after having kids. The extra pounds ...
... 3 Gene Network Sciences, Inc. (GNS) today announced ... The University of Connecticut Health Center,s Carole ... parties will incorporate genetic, genomic and clinical data ("3-D ... be used to identify the best treatments for individual ...
... MINNEAPOLIS, June 3 ATS Medical, Inc. (Nasdaq: ... surgery products and services, today announced participation in the ... Meeting in San Francisco on June 3-6, 2009. ... surgeons from around the world whose interests include the ...
... ... , ... (Vocus) June 3, 2009 -- Morehead Associates will host a webinar on ... , ,Retaining skilled, engaged physicians is critical to the success of health systems across ...
... ... products and other services. , ... San Jose, Calif. (PRWEB) June 3, 2009 -- The Glowan Consulting Group, ... a new on-line store allowing clients and partners to purchase their suite of Leadership ...
Cached Medicine News:Health News:Asymchem Continues to Maintain a Good Running Posture, Despite Economic Crisis 2Health News:Asymchem Continues to Maintain a Good Running Posture, Despite Economic Crisis 3Health News:Asymchem Continues to Maintain a Good Running Posture, Despite Economic Crisis 4Health News:Celebrity Moms Make Headlines in Their New Bikinis 2Health News:Gene Network Sciences Announces Cancer Collaboration with University of Connecticut Health Center's Neag Comprehensive Cancer Center 2Health News:Gene Network Sciences Announces Cancer Collaboration with University of Connecticut Health Center's Neag Comprehensive Cancer Center 3Health News:ATS Medical Announces Participation in the International Society for Minimally Invasive Cardiothoracic Surgery Meeting 2Health News:ATS Medical Announces Participation in the International Society for Minimally Invasive Cardiothoracic Surgery Meeting 3Health News:ATS Medical Announces Participation in the International Society for Minimally Invasive Cardiothoracic Surgery Meeting 4Health News:Morehead Webinar on Driving Physician Retention through Engagement 2Health News:Glowan Consulting Announces New On-Line E-Commerce Site 2
Use the Mo Bio Vortex Adapter in conjunction with the Vortex Genie 2 for rapid bead beating procedures. Using the Mo Bio Vortex Adapter is an inexpensive alternative to other bead beating and Fast Pr...
... Combines BchiVac V-500, water-cooled secondary condenser ... housing Model V-500 is a powerful PTFE ... vacuum applications. Applications Ideally ... rotary evaporators Laboratory vacuum source ...
... secondary condenser to trap residual solvent vapors ... vacuum pump designed to handle most vacuum ... for use with up to two rotary ... instruments including vacuum ovens, concentrators, gel dryers, ...
Universal vacuum pump (capacity 34 L/min, 8 mbar vacuum abs.)...
Medicine Products: