Navigation Links
Grifols Initiates Safety Study of Inhaled Alpha1-Proteinase Inhibitor (Human) Following Orphan Drug Designation for Cystic Fibrosis
Date:7/17/2012

RESEARCH TRIANGLE PARK, N.C., July 17, 2012 /PRNewswire/ -- Grifols, a global healthcare company based in Barcelona, Spain, today announced plans to initiate a safety trial of a novel, inhaled formulation of alpha1-proteinase inhibitor [Human] later this year.  In April, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for Grifols' inhaled alpha1 formulation as a treatment for cystic fibrosis, an inherited disease that can cause life-threatening lung infections. Orphan drug designation is granted to encourage the development of treatments that prevent, diagnose or treat rare diseases that affect fewer than 200,000 people per year in the U.S.

"Grifols is committed to developing new therapies that address the debilitating symptoms of chronic lung disease," said Kim Hanna, vice president of clinical research development at Grifols. "The orphan drug designation represents another milestone in the growth of our alpha1 program, and we're excited to pursue clinical trials with an aerosol formulation of this important therapy."

Grifols currently leads the market in alpha1-proteinase inhibitors with its intravenous therapy PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human])(A1-PI), indicated for the treatment of alpha1-antitrypsin (AAT) deficiency. This rare, genetic disorder can result in the development of emphysema due to low circulating levels of the alpha1 protein in the lungs.

PROLASTIN®, the predecessor to PROLASTIN-C, was the first FDA-approved product to treat AAT deficiency and remained so for nearly 17 years. Grifols is developing its next-generation alpha­1-proteinase inhibitor as an inhaled formulation.

About Orphan Drug Designation

Orphan drug designation is granted to companies to encourage the development of treatments that prevent, diagnose or treat rare conditions that affect fewer than 200,000 people per year in the U.S. The designation provides incentives such as t
'/>"/>

SOURCE Grifols
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Asubio Initiates Landmark Clinical Study in Spinal Cord Injury
2. CSL Behring Initiates Study of Subcutaneous Administration of C1-esterase Inhibitor in Patients with Hereditary Angioedema
3. Isis Initiates Phase 2 Study of ISIS-APOCIIIRx in Patients with Hypertriglyceridemia
4. Alder BioPharmaceuticals Inc. Initiates Phase 1 Clinical Study of Antibody Therapeutic Candidate for Treatment of Migraine, ALD403
5. Oncos Therapeutics Initiates Phase I Clinical Study of CGTG-102, an Oncolytic Adenovirus for the Treatment of Solid Tumor Cancers
6. MAQUET Initiates Class I Recall of the FLOW-i Anesthesia System
7. Stryker Initiates Voluntary Product Recall of Modular-Neck Stems
8. Inovio Initiates H1N1 Universal Influenza Vaccine Clinical Trial Targeting Over-65 Population, Which Represents 90% of Flu Deaths
9. Senate HELP Committee OKs Food and Drug Administration Safety And Innovation Act
10. PDR and the iHealth Alliance Announce New Drug Safety Certification for EHRs
11. Physician-Patient Alliance for Health & Safety: Monitoring Technology for PCA Pumps Can Prevent Adverse Events: So Why Are Hospitals Not Using It?
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2014)... According to a new market ... Market (Neurosurgical Navigation Systems, ENT Navigation Systems and Orthopedic ... Trends and Forecast, 2014 - 2020", the global surgical ... in 2013 and is expected to grow at a ... an estimated value of USD 295.5 million in 2020. ...
(Date:7/29/2014)... 2014 Numotion,s Board of Directors has announced that ... be the company,s new Chief Executive Officer. ... GE where he worked primarily for GE Healthcare Services, running ... $5 billion. His most recent position was as President and ... am thrilled to join Numotion," said Mike Swinford . ...
(Date:7/29/2014)... 29, 2014 McGraw-Hill Education Professional, a leading ... technical, and medical communities, has announced the launch of ... application of the world-renowned medical education platform. ... App , available for download onto all iOS and ... to gain access to valuable AccessMedicine diagnostic ...
Breaking Medicine Technology:Surgical Navigation Systems Market Expected to Reach USD 295.5 Million Globally in 2020: Transparency Market Research 2Surgical Navigation Systems Market Expected to Reach USD 295.5 Million Globally in 2020: Transparency Market Research 3Surgical Navigation Systems Market Expected to Reach USD 295.5 Million Globally in 2020: Transparency Market Research 4Numotion Names Mike Swinford CEO 2McGraw-Hill Education Professional's AccessMedicine App Delivers Instant Access to Essential Diagnostic Tools 2McGraw-Hill Education Professional's AccessMedicine App Delivers Instant Access to Essential Diagnostic Tools 3
... GARDEN CITY, New York, Oct. 7 ... Merkin recognize and congratulate seniors enrolled with HCP, IPA ... concern, health care reform, directly to members of Congress, ... http://www.newscom.com/cgi-bin/prnh/20091007/LA89266 ) , Dr. John Gastright, Senior ...
... , WALTHAM, Mass., Oct. 7 Nova Biomedical Corporation, ... that the company,s independent, wholly owned subsidiary, Sanvita CBGM, ... Sanvita, Inc., a subsidiary of CCS Medical, Inc. ... through this transaction, Nova,s Consumer Blood Glucose Monitoring (CBGM) ...
Cached Medicine Technology:HealthCare Partners, IPA, Dr. Richard Merkin, CEO, Recognize Seniors Taking Their Healthcare Concerns Directly to Lawmakers in Washington, DC 2HealthCare Partners, IPA, Dr. Richard Merkin, CEO, Recognize Seniors Taking Their Healthcare Concerns Directly to Lawmakers in Washington, DC 3Subsidiary of Nova Biomedical Completes Acquisition of Assets of CCS Medical's Subsidiary, Sanvita, Inc. 2
(Date:7/29/2014)... HealthDay Reporter TUESDAY, July ... on a task, various brain connections fire up. But ... with autism, according to a small new study. ... even less of this "brain flexibility," the researchers found. ... when children with autism are faced with new situations," ...
(Date:7/29/2014)... The Board of Governors of the State Bar ... Connie Akridge to serve as a trustee of ... the Foundation. Akridge served as President of the State Bar ... Holland & Hart in Las Vegas, providing tailored counsel on ... and healthcare clients for more than 25 years. She regularly ...
(Date:7/29/2014)... 2014 New high priced hepatitis C ... by a projected $2.9 to $5.8 billion next year, ... Milliman released today by the Pharmaceutical Care Management Association ... increase by as much as 8.6 percent in 2015 ... Sovaldi and Olysio. , The study finds that the ...
(Date:7/29/2014)... The Law Offices of Michael Cordova is proud to ... organization providing grief camps for kids, teens, adults, and families. ... clients experience from the death of a loved one. ... Stepping Stones of Hope, as they provide hope and healing ... also includes a monthly support group and a variety of ...
(Date:7/29/2014)... headache sufferers to record the severity and regularity of ... Griffith research study. , A new approach to the ... with their triggers and is being led by Professor ... Health program. , He has developed an approach designed ... their headaches called Learning to Cope with Triggers (LCT). ...
Breaking Medicine News(10 mins):Health News:Less Flexibility Seen in Brain Wiring of Kids With Autism: Study 2Health News:Less Flexibility Seen in Brain Wiring of Kids With Autism: Study 3Health News:Holland & Hart LLP Attorney Connie Akridge Reappointed Trustee of the Nevada Bar Foundation 2Health News:New Milliman Study: Hepatitis C Drugs Could Increase Medicare Part D Spending by $2.9 to $5.8 Billion in 2015 2Health News:The Law Offices of Michael Cordova is Sponsoring Stepping Stones of Hope, a Non-Profit Organization Providing Grief Camps for Kids, Teens, Adults, and Families 2
... April 27 BioTrends is pleased to announce the ... SIMPONI (R) . Cenotcor ... for SIMPONI (R) (generic name: golimumab) ... anti-TNF-alpha therapy, SIMPONI is approved for the treatment of ...
... WASHINGTON, April 27 Speaker Nancy ... virus: "This afternoon, Majority Leader Hoyer and I were ... Obama Administration,s preparations to deal with the public health ... briefed us on the efforts that are being made ...
... 27 Speaker Nancy Pelosi released the following statement ... serve as Ambassador at Large and Global AIDS Coordinator:"President ... Ambassador at Large and Global AIDS Coordinator signals the ... Dr. Goosby is an excellent choice and is uniquely ...
... April 27 Young Innovations, Inc. (Nasdaq: YDNT ... 2009. Sales for the first quarter of 2009 were ... the $24.4 million reported in the first quarter of 2008. ... first quarter of 2009 from $4.6 million in the first ...
... BAX ), will host its annual shareholders meeting ... (10:30 a.m. Central Time)This call is being webcast by Thomson/CCBN ... http://www.baxter.com/ . The conference call ... It cannot be recorded or rebroadcast without Baxter,s permission.The webcast ...
... HSKA ) announces the following Webcast: (Logo: ... to Its Annual Meeting of Stockholders on the WebWhen: ... www.heska.com (click on the Annual Meeting of ... Live over the Internet -- Simply log on ...
Cached Medicine News:Health News:Young Innovations, Inc. Announces Results for the Quarter Ended March 31, 2009 2Health News:Young Innovations, Inc. Announces Results for the Quarter Ended March 31, 2009 3Health News:Young Innovations, Inc. Announces Results for the Quarter Ended March 31, 2009 4Health News:Young Innovations, Inc. Announces Results for the Quarter Ended March 31, 2009 5Health News:Young Innovations, Inc. Announces Results for the Quarter Ended March 31, 2009 6Health News:Webcast Alert: Heska Corporation's Annual Meeting of Stockholders Webcast 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: