Navigation Links
Following Encouraging Results Anthera to Continue IMPACTS Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
Date:3/24/2009

HAYWARD, Calif., March 24 /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 from the first cohort of 30 patients, 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 based on favorable interim results.

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 or sPLA2). Acute chest syndrome is a life-threatening complication of sickle cell disease and one of the most common causes of death in this population.

"We 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. "We believe a drug that is deemed to be safe and able to suppress inflammation by inhibiting sPLA2 provides an opportunity for early intervention for patients where current treatment options are limited."

"Today's announcement marks an exciting milestone for Anthera and more importantly, the sickle cell patient population," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "We are pleased with the continued progress of our varespladib clinical programs for cardiovascular and sickle cell disease where inflammation plays a fundamental role in patient outcomes. We look forward to reviewing data from our FRANCIS clinical trial in the second quarter that will provide further insight into the potential role of varespladib's anti-inflammatory activity in preventing secondary major adverse cardiovascular events following an Acute Coronary Syndrome (ACS) event."

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 varespladib (A-002) and Acute Coronary Syndrome

A-002 (varespladib) is a potent inhibitor of secretory phospholipase A2(sPLA2) activity, which in two previously completed studies demonstrated benefits to a variety of biomarkers, including those typically indicative of inflammation. Presently A-002 is being examined in patients with acute coronary syndrome (ACS) for a reduction in secondary MACE. ACS is a heart condition characterized by chest pain occurring at rest or upon minimal exertion. This condition is also referred to as unstable angina. If the chest pain is associated with heart muscle damage and heart tracing abnormalities, it is typically classified as a heart attack or myocardial infarction.

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©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback
2. Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
3. Zevalin(R) Following Short-Course Chemotherapy with CHOP + Rituximab (CHOP-R) Doubles Complete Remission Rate in First-Line Treatment of Follicular Non- Hodgkins Lymphoma
4. Recent Study Demonstrated VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Improvements in Behavior, Inattention, and Math Test Scores from 1.5 Hours up to 13 Hours following Administration in Children with ADHD
5. IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)
6. High Intensity Focused Ultrasound for Locally Recurrent Prostate Cancer Following External Beam Radiation Therapy Investigated in Phase III Clinical Study
7. Prasugrel Significantly Reduced New or Recurrent Heart Attacks in Both Acute and Longer-Term Settings Following PCI, Compared with Clopidogrel
8. New Data Support Role for Monitoring of Cell-Mediated Immunity in Adult Patients Following Renal Transplantation
9. Applisonix Announces Breakthrough in Ultrasound Technology for Hair Removal - Average Hair Reduction of 38% Following Initial Treatment
10. IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following June Meeting of European Committee for Medicinal Products for Human Use (CHMP)
11. CPR Data Debriefing by Hospital Responders Improves CPR Performance and Increases Initial Survival Rate Following Cardiac Arrest
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2017)... , Pa. and KALAMAZOO, Mich. , ... Allentown, Penn. , and OptiMed Specialty Pharmacy of ... business partnership to offer a strategic hub service that ... Healthcare,s highly sought-after personal spirometer, Spiro PD 2.0, and ... A spirometer is a medical device used to ...
(Date:9/12/2017)... Sept. 12, 2017   EcoVadis , the leading platform for environmental, ... first annual edition of its Global CSR Risk and Performance Index. The ... EcoVadis, based on Scorecard Ratings that analyzed nearly 800,000 data points across ... ... ...
(Date:9/9/2017)... ... to Washington DC ... September 12 th – Monday, September 18 th .The Brain Tumor ... brain scans to the public.Where:  BTF,s Mobile MRI ... K Street NW, Washington, D.C.What:BTF brings its nationwide initiative, the Road to ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has ... least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a ... centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a ... “The Journey: From the Mountains to the Mission Field” is the creation of published ... all ages and currently teaches a class of ladies at her church, which she ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... treating sleep apnea using cutting-edge Oventus O2Vent technology. As many as ... disorder characterized by frequent cessation in breathing. Oral appliances can offer significant relief ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), ... of an innovative new design of the shoulder pad. The shoulder pad provides ... while controlling your pain while using cold therapy. By utilizing ice and water that ...
(Date:10/12/2017)... Rockville, Maryland (PRWEB) , ... October 12, 2017 ... ... a magnetic drug delivery system that we intend to develop to enable prevention ... regimens can lead to severe hearing loss, especially in pediatric patients. For cisplatin, ...
Breaking Medicine News(10 mins):