Navigation Links
Celladon Corporation Receives FDA Fast Track Designation for Its Investigational Agent MYDICAR® for the Treatment of Heart Failure
Date:12/12/2011

LA JOLLA, Calif., Dec. 12, 2011 /PRNewswire/ -- Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced today that its investigational product candidate MYDICAR® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced heart failure.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

"The positive results of the phase 2 CUPID Trial demonstrated the potential of MYDICAR® to become an important treatment for patients with chronic, advanced heart failure," said Krisztina Zsebo Ph.D., President and CEO of Celladon Corp.  Dr. Zsebo continued, "Today we are pleased that the FDA recognizes the potential benefit of MYDICAR® to address the enormous unmet medical need for additional therapeutics to treat advanced heart failure patients by granting the program Fast Track Status."

About the CUPID Trial

The previously announced results of the phase 2 CUPID Trial met its primary safety and efficacy endpoints at 6 months for high dose MYDICAR® versus placebo. Additionally, 12 months after receiving a single infusion of MYDICAR®, patients treated with the highest dose versus placebo had an 88 percent risk reduction (Hazard Ratio = 0.12, P=0.003) of major cardiovascular events such as death, need for left ventricular assist device (LVAD) or cardiac transplant, episodes of worsening heart failure and number of heart failure-related hospitalizations.

The mean duration of hospitalization in the MYDICAR® high dose group during the 12-month period was 0.4 days per patient compared with 4.5 days per patient in the placebo group. This finding is especially n
'/>"/>

SOURCE Celladon Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Celladon Corporation Announces MYDICAR® Enzyme Replacement Therapy for Advanced Heart Failure Provides Sustained Reduction in Clinical Events in Patients for 18 Months Compared with Placebo
2. Celladon Provides MYDICAR(R) Program Update of First-In-Human Trial for Advanced Heart Failure at American Society of Gene Therapy Annual Meeting
3. Celladon Corporation Announces Presentation of First-in-Human Gene Transfer to Treat Heart Failure at the 12th Annual Meeting of the American Society of Gene Therapy
4. Celladon Announces Presentation of Clinical Data From First-in-Human MYDICAR(R) Trial for Advanced Heart Failure at American Heart Association Scientific Sessions
5. Leatt Corporation Announces 2011 Annual Shareholders Meeting
6. Angeion Corporation to Report Fourth Quarter and Fiscal Year 2011 Financial Results on Friday, December 16, 2011
7. Radient Pharmaceuticals Corporation Receives $500,000 in New Capital
8. Radient Pharmaceuticals Corporation Completes Restructurings with Institutional Investors to Limit Conversions and Stock Sales and Provide for Potential Additional Capital
9. China Cord Blood Corporation Reports Financial Results for the Second Quarter and First Half of Fiscal 2012
10. Ansell Limited Acquires a Minority Share in Yulex Corporation
11. The Female Health Companys Distributor, Sekunjalo Investments Corporation (PTY) Ltd., Receives Order for 5 Million FC2 Female Condoms From the Republic of South Africa Department of Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... 17, 2014 Research and Markets ... Cancer Market 2014-2018" report to their offering. ... growth of cancerous cells in the breast tissue. It ... cancer is rare. Histologically, breast cancer can be classified ... undifferentiated carcinoma. Ductal carcinoma is the form of breast ...
(Date:9/16/2014)... , 17. September 2014 ... ), hat heute die Markteinführung des ... Probenverarbeitung, in Europa bekannt gegeben. Der ... Universalplattform zur Vereinfachung der präanalytischen Probenverarbeitung. ... und fehlerbehaftete Arbeitsschritte bei der manuellen ...
(Date:9/16/2014)... 2014 3SBio Inc., ("3SBio") a leading ... focusing on researching, developing, manufacturing and marketing ... into an exclusive license agreement with JenKem Technology ... marketing in Mainland China of PEG-irinotecan, a long-acting ... is over-expressed in many solid tumors, including colorectal, ...
Breaking Medicine Technology:Global Breast Cancer Market 2014-2018: Key Vendors are Astrazeneca, Eli Lilly and Company and F. Hoffmann-La Roche, Novartis and Sanofi-Aventis 2Global Breast Cancer Market 2014-2018: Key Vendors are Astrazeneca, Eli Lilly and Company and F. Hoffmann-La Roche, Novartis and Sanofi-Aventis 3Hologic stellt in Europa den Tomcat vor, ein neues Gerät zur präanalytischen Probenverarbeitung 2Hologic stellt in Europa den Tomcat vor, ein neues Gerät zur präanalytischen Probenverarbeitung 33SBio Inc. obtains exclusive licenses to develop and market JenKem's PEG-Irinotecan in China 23SBio Inc. obtains exclusive licenses to develop and market JenKem's PEG-Irinotecan in China 33SBio Inc. obtains exclusive licenses to develop and market JenKem's PEG-Irinotecan in China 43SBio Inc. obtains exclusive licenses to develop and market JenKem's PEG-Irinotecan in China 5
... N.J., Oct. 27 Watson Pharmaceuticals, Inc. (NYSE: ... Laboratories, Inc., filed a new drug application under Section ... (FFDCA) with the U.S. Food and Drug Administration (FDA) ... and 40 mg tablets.  Watson,s rosuvastatin zinc tablets are ...
... Oct. 27 Intrinsic Bioprobes today announced that ... issued US Patent 7,816,095 covering novel blood protein ... first of a series of patent applications that ... clinical utility. "The biomarkers were discovered ...
Cached Medicine Technology:Watson Confirms Crestor® Patent Challenge 2Intrinsic Bioprobes Announces Issuance of US Patent for Novel Biomarkers and Assays for Myocardial Infarction 2
(Date:9/17/2014)... With the development of China’s economy, ... human body physiology, preventing diseases, promoting health, prolonging ... variety of specific populations. In 2013, the market ... billion, up 12.0% year on year, recording a ... product industry is composed of many extremely scattered ...
(Date:9/17/2014)... 2014 U.S. News and World ... country, and three mesothelioma treatment centers made the ... mesothelioma law firm Baron and Budd ... of Texas MD Anderson Cancer Center and Brigham ... ( http://health.usnews.com/best-hospitals/rankings/cancer ) , U.S. News and World ...
(Date:9/17/2014)... DMG Productions announces the upcoming airing ... broadcast on Wednesday, September 24, 2014 at 7:30 ... episode, Innovations will go behind the scenes to ... each client the opportunity to achieve the highest ... principles of Care, Compassion, and Commitment. , Audiences ...
(Date:9/17/2014)... 17, 2014 Experienced dress company, Discount-Dress.com, ... new selection of trendy black bridesmaid dresses. Furthermore, the ... its beautiful bridesmaid outfits. Readers can view more ... Discount-Dress.com is a famous brand of special ... additions as well as revamped old editions, the supplier ...
(Date:9/17/2014)... 17, 2014 Headquartered in Baltimore, Maryland, ... reach across the country. , “The past two ... “We have grown to over 400 evaluators in 46 ... evaluators in the Midwest and South Dakota and Vermont. ... facilities where our volunteers can visit.” , TPU provides ...
Breaking Medicine News(10 mins):Health News:China Health Food Industry Report 2014-2017 Now Available at ChinaMarketResearchReports.com 2Health News:China Health Food Industry Report 2014-2017 Now Available at ChinaMarketResearchReports.com 3Health News:China Health Food Industry Report 2014-2017 Now Available at ChinaMarketResearchReports.com 4Health News:Three Mesothelioma Treatment Centers Make U.S. News and World Report’s List of Top Cancer Care Facilities, Baron and Budd Reports 2Health News:Three Mesothelioma Treatment Centers Make U.S. News and World Report’s List of Top Cancer Care Facilities, Baron and Budd Reports 3Health News:Innovations to Explore Substance Abuse and Mental Health in Upcoming Episode Airing Wednesday, September 24, 2014 via Discovery Channel. 2Health News:Discount-Dress.com’s Top Designers Are Now Busy Making Its New Black Bridesmaid Dresses 2Health News:Therapy Pets Unlimited is Expanding 2Health News:Therapy Pets Unlimited is Expanding 3
... An alert over potential outbreak of 'Legionnaires Disease' has ... visited the Grand Atlantic Hotel before 10 Nov in ... samples tested positive for Legionelle Bacteria. The hotel which ... out a thorough disinfection. ,The Legionnaires disease ...
... OF HIGH BLOOD PRESSURE DOES NOT PREDICT EFFECT ON HEART ... blood pressure can lead to a potentially dangerous enlargement of ... at the Johns Hopkins Children's Center and the Children's Hospital ... not true for children, at least, that the higher the ...
... Britain has revealed that almost 59,000 Brits have an HIV ... cases were diagnosed last year. //,70 per cent of the ... Eastern Europe. Bulgaria and Romania are among the nations with ... ,It has been found that almost none of ...
... contributed to the health ratings of the famous spirit, known ... in much the same way as mice on a normal ... conducted by Harvard Scientists. ,Delving more into the ... blessings, following a second study conducted on mice. The compound ...
... fight the stigma of the disease. // ,According to ... fallen to 1.56 percent in 2005, from 14.7 percent in 2001. ... the cured are called, have been roped in since leprosy is ... in Ranchi has gone up to 1.60 percent between April and ...
... revelation, some researchers have discerned a thread of similarity ... likeness of character. //For instance, it was observed that ... had a past criminal record compared to owners of ... ,During a study of 355 dog owners in Ohio, ...
Cached Medicine News:Health News:Children and Chronic Kidney Disease 2Health News:Children and Chronic Kidney Disease 3
... developed the world's first 8-channel ... completely AC powered in 1951. ... a number of standard setting ... systems, such as a Windows ...
... you're getting an ambulatory and a clinical EEG ... Mobee O2 can be used for ambulatory EEG ... or in-lab sleep studies. And both feature 32 ... placement. The Mobee O2 includes the additional enhancement ...
... The VISULAS 690s is the ... the instrument of choice for ... clinical trials, Carl Zeiss has ... in laser manufacturing to create ...
... Humphrey Lens Analyzers Model 350 and ... most comprehensive lensometry for your practice. ... Analyzer (LA) gives fast and accurate ... lenses, prism lenses, contact lenses, polycarbonate ...
Medicine Products: