Navigation Links
Sangart, Inc. Receives U.S. Orphan Drug Designation for use of MP4CO in Patients with Sickle Cell Disease

SAN DIEGO, Nov. 15, 2010 /PRNewswire-- Sangart, Inc., a global biopharmaceutical company dedicated to developing life-saving medicines specifically designed to enhance the perfusion and oxygenation of ischemic (oxygen deprived) tissues through targeted oxygen and other gas delivery, today announced that its investigational biopharmaceutical product, MP4CO, has been awarded orphan drug designation by the U.S. Food and Drug Administration (FDA) for use in treating acute painful sickling crises in patients with sickle cell disease.

Orphan drug designation is awarded to drugs and biologics which are being developed for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US. This designation provides companies with financial incentives that can help support development, as well as market exclusivity if the compound is ultimately approved for sale by the FDA. As with all biopharmaceutical products, MP4CO will only receive FDA marketing approval if it is first shown to be safe and effective in human clinical trials, which have yet to be performed.

MP4CO is designed to deliver therapeutic levels of carbon monoxide (CO) to patients suffering from a sickle cell crisis. CO stabilizes hemoglobin S, an abnormal type of hemoglobin, and prevents sickling of red blood cells. The addition of MP4CO to existing treatment protocols may alleviate pain associated with a sickle cell crisis and potentially reduce the duration of a crisis. Clinically, this could mean preventing hospitalization or shorter hospital stays, reducing the need for addictive narcotic analgesics, and an improved quality of life for patients with sickle cell disease.

"This orphan drug designation is another significant milestone in the development of the MP4CO product," said Brian O'Callaghan, President and Chief Executive Officer of Sangart. "We look forward to working closely with the FDA on our clinical program and advancing this new treatment option into clinical studies."

Sickle cell disease is an inherited hemoglobin disorder that affects red blood cell circulation in millions of people around the world. People with sickle cell disease have red blood cells that contain mostly hemoglobin S, an abnormal type of hemoglobin. Sometimes these red blood cells become crescent or sickle-shaped and have difficulty passing through small blood vessels. This is known as a "sickle crisis". When sickle-shaped cells block small blood vessels, less blood circulates through the body, causing damage to tissues that do not receive a normal blood flow. There are currently no approved medications to treat sickle cell crises, and only symptomatic relief is available.

About MP4Sangart's product platform is based on the MP4 molecule, an investigational biopharmaceutical product designed to enhance the perfusion of oxygen-deprived (ischemic) tissues and provide targeted oxygen delivery in the capillaries. Using a novel pegylation approach, Sangart produces the MP4 molecule designed at the optimal oxygen affinity, diffusion potential and molecular size to perfuse capillaries and target oxygen delivery to tissues specifically at risk of ischemia.

About SangartSangart is a global biopharmaceutical company dedicated to developing life-saving medicines specifically designed to enhance the perfusion and oxygenation of ischemic (oxygen deprived) tissues through targeted oxygen delivery. Based on more than a decade of research, Sangart has refined the pegylation of human hemoglobin to create a molecule, MP4, with the ability to carry oxygen through the circulatory system to prevent and treat ischemia.

To learn more about Sangart, please visit the company's website at Contact:Lauren HamiltonEdelman Public Relations

SOURCE Sangart, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Sangart, Inc. Initiates Dosing in Phase II Study of Hemospan(R) in Chronic Critical Limb Ischemia
2. Sangart, Inc. Initiates Phase IIa Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients With Hemorrhagic Shock
3. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
4. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
5. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
6. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
7. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
8. CryoCor Receives FDA Approval for Right Atrial Flutter
9. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
10. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
11. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
Post Your Comments:
(Date:11/26/2015)... 2015 ) has ... of High Viscosity Drugs" report to their ... the addition of the "Self Administration of ... --> Research and Markets ( ... "Self Administration of High Viscosity Drugs" report ...
(Date:11/25/2015)... , Nov. 25, 2015 ... addition of the "Global Brain Monitoring ... offering. --> ) has ... Brain Monitoring Devices Market 2015-2019" report ... and Markets ( ) has announced ...
(Date:11/25/2015)... WOODBURY, N.Y. , Nov. 25, 2015  Linden ... access and optimizing treatment outcomes for patients suffering from ... its request for a Temporary Restraining Order (TRO) enjoining ... between the two companies. --> ... aggressively pursuing all of its legal options. ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... 26, 2015 , ... Patients at Serenity Point Recovery, a ... on Thanksgiving Day to share the things that they are most grateful for ... YouTube channel, patients displayed what they wrote on index cards, describing the things ...
(Date:11/26/2015)... ... ... The Catalent Applied Drug Delivery Institute today announced a ... selection in early phase drug development. The first of these is to be ... UK’s emerging life sciences companies, corporate partners, and investors, at Milton Park, Oxford, ...
(Date:11/26/2015)... ... November 26, 2015 , ... Pixel ... self-animating trailer titles with ProTrailer: Vintage. This newly styled ProTrailer pack comes with ... work with any font, giving users limitless opportunities to stylize and create designs ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... Water For Empowerment ™ attracts volunteers together who want to combine talents ... women as key stakeholders in the process. The non-profit launched its first major ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... direct sauna parts and accessories. , Sauna accessories help improve the bather experience ... and personality. From basic styles for the purist looking for simplicity in design ...
Breaking Medicine News(10 mins):