Navigation Links
DSMB Supports Continuation of Anthera Phase II Impacts Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
Date:4/16/2008

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 http://www.anthera.com.

MEDIA CONTACT:

Anne Bowdidge (650) 218-6900

pr@anthera.com


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:5/8/2017)... 8, 2017 MACRA replaces the outdated ... for service reimbursement. Black Book Research crowdsource-surveyed 8,845 physician ... 1.       The Market for MIPS Compliance Technology is Booming ... practices with 3 or more clinicians seek to buy ... "Given the magnitude of the changes, the hunt is ...
(Date:5/6/2017)... IRVING, Texas , May 5, 2017   Provista ... 1994 with more than 200,000 customers, today announced Jim ... brings a wealth of executive and business experience to Provista, ... a compounding pharmacy in California . He ... "Jim is a great fit for Provista," says ...
(Date:5/6/2017)... 5, 2017  Hill-Rom Holdings, Inc. (NYSE: HRC), has ... square feet to its Welch Allyn campus. ... to bring more than 100 new jobs to ... has maintained a significant presence for more than 100 ... positions, a large portion of which will be R&D ...
Breaking Medicine Technology:
(Date:5/23/2017)... ... May 23, 2017 , ... New England Journal Of Medicine Confirms Viability of ... Response”, -The Rory Staunton Foundation Calls on Health & Human Services, Tom Price to ... ( http://www.rorystauntonfoundation.org ) today reported on a new study released on May 21, 2017 ...
(Date:5/23/2017)... ... May 23, 2017 , ... The National Council on ... to announce the organization’s Certified Strength Coach credential has earned accreditation from the ... program validates the competency of qualified candidates for jobs in the Strength and ...
(Date:5/23/2017)... ... 23, 2017 , ... The Gallery of Cosmetic Surgery, founded ... to announce a new treatment option called Vivace Microneedling. This treatment option is ... body through a virtually pain-free, non-surgical treatment. Vivace Microneedling combines a state-of-the-art, best-in-class ...
(Date:5/23/2017)... ... May 23, 2017 , ... Drs. Allen Huang and ... in Las Vegas, NV, and the importance of treating it immediately. They ... leading care for peri-implantitis, with or without a referral. As experienced periodontists and ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... chat as a standard feature on its secure clinical communication platform. The platform ... to video depending on the type and urgency of a situation. , ...
Breaking Medicine News(10 mins):