Home Set as Homepage Add to Favorite Contact Submit  
           07 November, 2009
 
 
search for
 
 


Categories
Agriculture »
Arts »
Automotive »
Business »
Career »
Computers »
Education »
Entertainment »
Fashion »
Finances »
Food & Drinks »
Health & Fitness »
Hobbies & Crafts »
Home & Family »
Industry »
Internet »
Kids & Teens »
Legal »
Machinery »
Marketing »
Miscellaneous »
Music »
Nanotechnology »
Non-profit »
Politics & Government »
Real Estate »
Recreation & Sports »
Religion & Faith »
Science »
Shopping »
Society »
Software »
Technology »
Telecommunications »
Transportation »
Travel & Leisure »
    
Category:  Press » Health & Fitness

 
DSMB Supports Continuation of Anthera Phase II Impacts Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease Popularity:
         Views: 130
2008-04-16 05:15:26     
Anthera Pharmaceuticals, Inc.

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 .

MEDIA CONTACT:

Anne Bowdidge (650) 218-6900

Specialized in: Anthera - Anthera Pharmaceuticals - A-001 - A-002 - Pharmaceutical - Biopharmaceutical - Antibiotic - Antibacterial - Clinical - Life Science - Anti Infective - Medicine - Medical - Acute Chest Syndrome - Ali - Ards - Asthma - Atherosclerosis - Psoriasis
URL:
Print press release      Send to a friend      Bookmark this page
Related Press releases 
AARP Calls On Idaho's U.S. Reps To Back House Health Care Reform Bill (Popularity: ): As the debate over health care reform reaches a fevered pitch and the House readies to vote on critical health care reform legislation in the coming days - AARP is calling on Idaho's U.S. Representatives to support the bill. The AARP-backed Affordable Health Care for America Act (H.R. 3962), which will close the Medicare prescription drug "doughnut hole" and tackle soaring insurance premiums, serves to help hundreds of thousands of ...
FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus (Popularity: ): The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national public ...
National Alliance for Hispanic Health Applauds Confirmation of Dr. Regina Benjamin as the 18th Surgeon General of the United States (Popularity: ): "The Senate has done the right thing for the nation's health in confirming Dr. Regina Benjamin as our nation's 18th U.S. Surgeon General," said Dr. Jane L. Delgado, President and CEO of the National Alliance for Hispanic Health, the nation's leading Hispanic health advocacy group. "As a woman in the field of health I am proud that she will become the third woman to serve as Surgeon General of the ...
Complete Prenatal Multivitamin plus 300mg life's DHA (Popularity: ): vitaMedMD™ Complete Prenatal Multivitamin + 300mg life’sDHA™ is a doctor formulated vegetarian dietary supplement that provides 20 important vitamins and minerals plus life'sDHA™ in a 300mg vegetarian-certified, single-dose prenatal tablet and softgel.
Experience the best Sky Diving services with Go Sky Dive (Popularity: ): Sky diving is really a breathtaking sport and it is really important that is has to be performed under trained professionals. But, you not have to worry when you are with Go Sky Dive; it was established by a small group of passionate and dedicated skydiving professionals. They work with an aim to make the people tandem skydiving experience the best and most memorable one. The press release organized by ...

Press release home snapshot 


Related Business 
eMedicine - Acute Coronary Syndrome (Popularity: ): Serious condition that may occur in heart disease and angina patients. Symptoms may include chest pain and palpitations caused by myocardial ischemia.
My Sickle Cell Homepage (Popularity: ): Provides a first hand look at Sickle Cell Anemia, built by a person suffering from the disease. Frequently asked questions and a personal diary of the owner's own battle with this disease.
The Sickle Cell Foundation of Alberta (Popularity: ): Educates the public about sickle cell disease and provides support for carriers of the trait and their families.
Sickle Cell Disease: Practical Tips for Preventing a Sickle Cell Crisis (Popularity: ): Advice from FamilyDoctor.org.
Secondhand Smoke Increases Complications in Children with Sickle Cell Disease (Popularity: ): Research finds hat children with sickle cell disease who are exposed to tobacco smoke in the home have more complications from the disease than those who live in a smokefree environment.
Joint Center for Sickle Cell and Thalassemic Disorders (Popularity: ): Gives an evaluation of the causes and treatments of sickle cell disease as well as current research. Information is available both for lay persons as well as health care providers.
Sickle Cell Kids (Popularity: ): Animated site with information, games, letters from celebrities and a quiz show to keep kids with sickle cell disease healthy.
Sickle Cell Information Center (Popularity: ): Current information for health care providers, patients, the public, teachers and others with online treatment guideline books, a tutorial, multiple links to other sickle cell sites and a directory of clinics in the US.
eMedicine - Angina Pectoris (Popularity: ): Cardiologist offers a clinical overview of this condition that often leads to chest pain in patients with coronary artery disease. Includes emergency care information and prevention tips.
Devastation of sickle cell disease chronicled (Popularity: ): [CNN]


 
 
Home | Top | Set as Homepage | Bookmark this Page | Privacy | Contact | Submit Press Release
© 2003-2008 ABC Directory.Com. All Rights Reserved