Navigation Links
DSMB Supports Continuation of Anthera Phase II Impacts Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease

SAN MATEO, Calif., April 16 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has recommended that Anthera's Phase II clinical trial, known as the IMPACTS (Investigation of the Modulation of Phospholipase in Acute ChesT Syndrome) Study can continue under the current protocol, without change.

IMPACTS is a Phase II multi-center clinical trial evaluating the safety and effectiveness of intravenous A-001 (varespladib sodium) in preventing the development of acute chest syndrome in hospitalized sickle cell disease patients. Enrolled patients are at-risk for acute chest syndrome based on the combination of pain (vaso-occlusive crisis), fever, and elevated serum level of the enzyme (secretory phospholipase).

"We are pleased with the DSMB's response and look forward to continuing the A-001 trial under our original protocol," said Dr. James E. Pennington, M.D., Executive Vice President and Chief Medical Officer of Anthera Pharmaceuticals, Inc. "Treatment options are limited for this important patient population and we believe a drug that provides an opportunity for early intervention would help address a significant unmet medical need."

"Today's announcement marks another exciting milestone for Anthera," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "Over the past few months, we've also made significant progress in our A-002 program for cardiovascular disease. In February, we completed our end of Phase II meeting with the FDA. In early April, we completed a pre-submission meeting with European Medicines Agency (EMEA). Presently, we are preparing to submit our registration protocols to FDA as part of the Special Protocol Assessment process."

About A-001

A-001 is a potent inhibitor of secretory phospholipase A2(sPLA2) activity, including groups IIA, V, and X. The U.S. Food and Drug Administration granted A-001 orphan drug status for the prevention of acute chest syndrome in patients with sickle cell disease in December 2007.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Company has acquired from Eli Lilly and Company and Shionogi & Co., Ltd. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase (PLA2) family - a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes, prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel, upstream steps in the inflammation cascade and have the potential to address a variety of diseases. The company has also acquired exclusive and worldwide rights to a peptide fusion protein, A-623, for the treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases from Amgen. For more information, please visit


Anne Bowdidge (650) 218-6900

SOURCE Anthera Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Fifth DSMB Meeting Supports Neurobiological Technologies Continuation of Phase 3 Stroke Trials With Viprinex(TM) (ancrod)
2. Karmanos Cancer Institute Research Supports Role of Inflammation to Determine Lung Cancer Risk, Particularly in African-American Women
3. DSMB Supports Continuation of Phase 3 AGENDA Trial of Genasense(R) in Advanced Melanoma
4. DSMB Again Supports Continuation of the Phase III Clinical Trial of Medidur(TM) FA for the Treatment of DME
5. Evanston Northwestern Healthcare Researchers Explain Effects of Large-Scale, Universal MRSA Surveillance Program That Supports Expanded Intervention
6. ACR Supports American Cancer Society Inclusion of CT Colonography (Virtual Colonoscopy) as Recommended Screening Tool for Colorectal Cancer in New Screening Guidelines
7. New Clinical Data Further Supports Chromium Picolinates Role in Enhancing Brain Activity in Older Adults
8. HUYA Bioscience Intl Announces Clinical Trial Milestones in China for Promising New Anti-Arrhythmic Compound; Data Supports Desirable Safety Profile
9. FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
10. Interim Analysis Supports Continuation of Cell Genesys VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
11. Interim Safety Analysis Supports Continuation of Allos Therapeutics Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-cell Lymphoma
Post Your Comments:
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, the ... by Walgreens and pharmacy benefit manager Prime Therapeutics LLC ... brand, which included the unveiling of new signage at ... as well as at a few other company-owned facilities ... brand to patients, some of whom will begin to ...
(Date:10/2/2017)... 2017 The Rebound mobile app is poised to ... the tide of prescription drug addiction. The app empowers users ... and stepping down their dosage in a safe, controlled manner ... 2017; the first 100,000 people to sign up will enjoy ... ...
(Date:9/28/2017)... 2017 Cohen Veterans Bioscience and Early Signal ... wearable and home sensors for real-time monitoring of patients ... a nonprofit organization focused on disruptive health solutions for ... analytical system to record and integrate behavioral, cognitive, physiological ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest Insurance Group, a ... Miami, and Raleigh regions, is organizing an extended charity drive to benefit the ... chromosome abnormality. , After struggling since birth with several health challenges, T.J. was ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... The American ... to become its next President and Chief Executive Officer, succeeding Dr. James C. Puffer ... Elect beginning July 1, 2018 until Dr. Puffer’s retirement at the end of 2018. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the Law ... organization of elder law and special needs planning attorneys. “Membership in ElderCounsel helps our ... a forum to network with elder law attorneys nationwide,” said Somekh. , ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... Fairfax, VA (PRWEB) , ... October 13, 2017 ... ... provider of DevOps and Agile Software Development, has been awarded a contract by ... (EATS) Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile ...
Breaking Medicine News(10 mins):