Navigation Links
FREEDOM-C(2) Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Does Not Meet Primary Endpoint
Date:8/24/2011

ce daily in the oral treprostinil group. Discontinuations due to adverse events were 18 (11%) and 5 (3%) in the treprostinil and placebo groups, respectively. Adverse events associated with discontinuations were typically prostacyclin-related effects including headache, nausea and vomiting.

Preliminary analysis of other secondary efficacy measures, including time to clinical worsening, change in combined 6MWD and Borg Dyspnea Score rating (shortness of breath test) and Dyspnea-Fatigue index, WHO functional class, and PAH signs and symptoms, did not differ significantly between oral treprostinil and placebo (p>0.05).

Further review and analysis of the FREEDOM-C(2) preliminary results are ongoing.  A summary of the preliminary analysis conducted thus far can be accessed via United Therapeutics' website at http://ir.unither.com/events.cfm beginning at 5:00 a.m. Eastern Time on August 24, 2011.  Full data from FREEDOM-C(2) will be presented at an upcoming medical meeting and will also be available through the publication of peer-reviewed journal articles.

"While we did not achieve a statistically significant result for this trial, we believe the positive results from our previously-announced FREEDOM-M study support an NDA filing of oral treprostinil in treatment naive patients," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "Given that treprostinil is already approved for use in PAH by subcutaneous, intravenous and inhaled routes of administration, we believe the data obtained from all FREEDOM trials support an NDA for oral treprostinil in this indication," added Dr. Jeffs. "We will now focus on completing the NDA for filing by the first half of 2012."

Conference Call

On Wednesday, August 24, 2011 at 9:00 a.m. United Therapeutics will host a one-hour conference call to answer questions related to FREEDOM-C(2).

<
'/>"/>
SOURCE United Therapeutics Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. United Therapeutics Corporation Completes Enrollment of FREEDOM-C(2) Trial
2. Oncolytics Biotech Inc. Completes Dose Escalation in Combination REOLYSIN(R)/Docetaxel Trial
3. BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis
4. Dendreon Initiates Second of Two New Phase 2 Trials of PROVENGE for Prostate Cancer
5. NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients
6. Landmark SYNTAX Trial Reports Comparable Safety Outcomes for Complex Patients Treated With TAXUS(R) Express2(TM) Stents or Bypass Surgery
7. Oncolytics Biotech Inc. Announces U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours
8. /R E P E A T -- Oncolytics Biotech Inc. Announces U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours/
9. CV Therapeutics Initiates Phase 1 Clinical Trial of CVT-3619, a Novel Potential Treatment for Cardiometabolic Diseases
10. Atrial Fibrillation Month - StopAfib.org Announces September Focus on Life-Threatening Irregular Heartbeat
11. Ondine Announces Presentation of Positive Clinical Trial Results at the American Academy of Periodontologys 94th Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Freeslate, Inc ., the leading provider ... Limited, one of India’s top five pharmaceutical companies, has ... for high throughput solid form screening. , ... wide range of quality, affordable generic and branded formulations ...
(Date:1/14/2014)... Date: Friday, April 11, 2014 , Time: ... 1360 Almshouse Road, Warrington, Pa. , Details: The ... to finding a cure for hepatitis B and improving the ... annual Crystal Ball on Friday, April 11 at Warrington Country ...
(Date:1/14/2014)... Communications, a leading provider of strategic communications services to corporations and ... the United States and Europe ... JD, is returning to the firm,s Washington, D.C. ... more than two years of service as Associate Commissioner for the ...
(Date:1/14/2014)... Jan. 14, 2014 The largest international professional ... plants and therapeutic derivatives thereof has endorsed an ... researchers about the challenges of adulterated herb and ... The Society for Medicinal Plant ...
Breaking Biology Technology:Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 2Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 3Hepatitis B Foundation to Host Annual Crystal Ball Gala 2Former FDA Associate Commissioner Returns To 3D Communications 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 3World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 4World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 5World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 6World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 7World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 8
... ... three Fast Track SBIR grants from the National Institutes of Health to develop original in ... model the reaction rates of DNA and RNA experiments. , ... (Vocus) July 22, 2009 -- DNA Software, Inc. has been ...
... , PHILADELPHIA, July 22 ERT (Nasdaq: ... ePRO, and other services to the biopharmaceutical, medical device, and related ... Management, Tammy Miller. Ms. Miller will report to the Executive Vice ... Miller will be responsible for the global implementation and delivery of ...
... GOTHENBURG, Sweden, July 22 Cellectricon, a ... discovery,today announced its collaboration with University of Lodz, Poland. ... world,s first,system for high throughput transfection enabling reagent-free delivery ... To view the Multimedia News Release, please click: ...
Cached Biology Technology:DNA Software, Inc. Awarded $2.5 M in NIH Funding to Develop Pioneering Nucleic Acid-based Technologies 2DNA Software, Inc. Awarded $2.5 M in NIH Funding to Develop Pioneering Nucleic Acid-based Technologies 3DNA Software, Inc. Awarded $2.5 M in NIH Funding to Develop Pioneering Nucleic Acid-based Technologies 4ERT Appoints New Vice President of Project Management 2ERT Appoints New Vice President of Project Management 3University of Lodz Invests in the Unique Cellaxess(R)HT System for Research on Multidrug Resistance Genes in Cancer 2
(Date:4/17/2014)... Professor Luca Razzari of the nergie Matriaux Tlcommunications ... from the John R. Evans Leaders Fund of ... acquisition of state-of-the-art biotech and nanophotonics equipment. To ... the Ministre de l,Enseignement suprieur, de la Recherche, ... These new laboratories will help us develop new ...
(Date:4/17/2014)... MANHATTAN, KAN. A Kansas State University engineer ... security and remotely detects improvised explosive devices. The ... , William Dunn, the Steven M. and Kay ... of mechanical and nuclear engineering, and his research ... explosives hidden underground or in car trunks. The ...
(Date:4/17/2014)... . If a ... him, he can expect his premises to be trashed. Warnings ... consequences is enough to make restaurant owners pay up. Similarly, ... eggs in other birds, nests. If the host birds throw ... by destroying the entire nest. Consequently, it is beneficial for ...
Breaking Biology News(10 mins):New state-of-the-art biotech and nanotech equipment for INRS 2Patented research remotely detects nitrogen-rich explosives 2Fear of the cuckoo mafia 2Fear of the cuckoo mafia 3
... help to protect against some food allergies. Kefir, a traditional ... food, and is often used to wean babies, as it ... children under the age of three, with around 5-8% of ... the problematic food. , "Friendly" bacteria in kefir may play ...
... Small but remarkable fossils found in New Zealand will prompt a ... the so-called "land of birds" was once home to mammals as ... and a leg - belonged to a unique, mouse-sized land animal ... St Bathans fossil bed, in the Central Otago region of South ...
... Columbia University's Mailman School of Public Health, the Centers ... Research Center have discovered a key mechanism by which ... identification of an amino acid sequence in Filoviruses that ... described in the December 2006 issue of The FASEB ...
Cached Biology News:Friendly bacteria in alcoholic milkshake could fight food allergies 2Tiny bones rewrite textbooks 2Researchers discover key mechanism by which lethal viruses Ebola and Marburg cause disease 2
Phospho- (Ser) 14-3-3 Binding Motif (4E2) Mouse mAb...
Rat polyclonal to acetyl Salicylic Acid ( Abpromise for all tested applications)....
Drugs and NO-drug Rat Anti-conjugated Acetyl Salicylic Acid Polyclonal Antibody...
Rabbit polyclonal to UBC12 (rating: ****) ( Abpromise for all tested applications). Antigen: Synthetic peptide: RGGYIGSTYFER, corresponding to amino acids 169-180 of UBC12 Entrez Gene ID: 90...
Biology Products: