Navigation Links
Pearl Therapeutics Announces Successful Completion of Phase 2b Safety and Efficacy Studies of COPD Combination, PT003
Date:1/6/2012

REDWOOD CITY, Calif., Jan. 6, 2012 /PRNewswire/ -- Pearl Therapeutics Inc. today announced the completion of two Phase 2b clinical studies of PT003, the Company's investigational inhaled combination bronchodilator product for the treatment of patients with moderate-to-severe COPD. The first of these two trials (NCT01349803) was a 237-subject cardiovascular safety study designed to measure the change in mean heart rate following twice-daily (BID) chronic administration of the combination PT003, and its components PT001 and PT005. The second (NCT01349816) was a 185-patient, randomized, double-blind dose-confirmation study of different doses of PT003 compared with its components. PT003, PT001 and PT005 were shown to be safe, effective and well tolerated, with no meaningful changes in heart rate or other cardiovascular safety parameters relative to baseline as measured by Holter monitor over two weeks. Pearl plans to present results of these trials at appropriate medical meetings in 2012.

"We were able to conduct these two studies, as well as the previously announced Phase 2b dose-ranging studies of PT001 and PT005 in approximately six months, which is a testament to both the skill and commitment of our clinical team, and the efficacy and safety profiles of our combination bronchodilator observed to date," said Chuck Bramlage, chief executive officer for Pearl Therapeutics. "With this operational excellence, along with the continued safety and efficacy of our bronchodilator combination, we are confident in our plan to advance PT003, PT001 and PT005 into the rigor of late-stage clinical scrutiny."

These two clinical trials are part of the Company's five-study Phase 2b program that included three previously completed, randomized, double-blind trials: one dose-ranging trial each of PT005 and PT001, plus a placebo- and active-controlled
'/>"/>

SOURCE Pearl Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Asante Solutions, Inc. Receives CE Mark for Pearl™ Insulin Pump
2. Pearl Therapeutics to Present Complete PT003 Results from Phase 2b COPD Study in a Late-Breaker Session at the American Thoracic Society Annual Meeting
3. Pearl Therapeutics Highlights Its Porous Particle Cosuspension Platform, Demonstrating Universal Applicability Across Multiple Drug Classes and Combination Products
4. Asante Solutions Receives FDA Clearance for Pearl™ Insulin Pump
5. Pearl Therapeutics Phase 2b Results Show a 50% Improvement in Lung Function with PT003 Compared to Spiriva® and Foradil® in Patients with COPD
6. Pearl Therapeutics Advances Its Long-Acting Bronchodilator Combination Product Candidate into Four Additional Phase 2 Studies
7. Pearl Therapeutics Announces Positive Results for Phase 2b Dose-Ranging Study of Formoterol MDI
8. Pearl Therapeutics Bronchodilator Combination PT003 Provides Superior Inspiratory Capacity Compared to Spiriva®
9. Anthera Announces Last Patient Enrolled in PEARL-SC Study
10. Pearl Therapeutics Presents New Scientific Evidence Supporting Versatility of Its Novel Cosuspension MDI Platform
11. Pearl Therapeutics Reports Positive Phase 2b Results of PT001 in Patients With COPD
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... 2014  United Therapeutics Corporation (NASDAQ: UTHR ... the District of New Jersey ... against Sandoz, Inc. regarding United Therapeutics, Remodulin ® ... that U.S. Patent No. 6,765,117 is both valid and ... its generic product until the expiration of that patent ...
(Date:8/29/2014)... Aug. 29, 2014 Diseases largely eradicated in ... ago are returning. Measles was declared eliminated in 2000, ... as of August 15—the highest incidence in 20 years. ... department declared whooping cough a problem of "epidemic ... sick and dying from these preventable diseases—in part because ...
(Date:8/29/2014)... 2014 Research and Markets has ... Drugs Market 2014-2018" report to their offering. ... condition that results in demyelination, axonal transection, and neurodegeneration. ... response by the immune system, which targets neurons within ... debilitating disease in which the damage of the myelin ...
Breaking Medicine Technology:District Court Decision Received In Remodulin Patent Case 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 3Global Multiple Sclerosis Drugs Market 2014-2018: Key Vendors are Bayer, Biogen Idec, Merck Serono, Novartis and Teva Pharmaceutical 2Global Multiple Sclerosis Drugs Market 2014-2018: Key Vendors are Bayer, Biogen Idec, Merck Serono, Novartis and Teva Pharmaceutical 3
... China, April 16, 2011 China Medical Equipment ... provider of ultrasound and MRI systems in China, ... portable ultrasound machine. The iuStar100 utilizes Samplify,s high-performance, ... SAM1600 analog to digital converter (ADC) to deliver ...
... Md., April 15, 2011 The U.S. Food and ... or in combination with methotrexate, for the treatment ... children ages 2 years and older. ... Still,s disease, is a rare, potentially life-threatening disorder ...
Cached Medicine Technology:United Imaging Healthcare Leverages Samplify's Analog Front-End Solutions to Deliver New Portable Ultrasound System with Superior Image Quality 2FDA Approves Actemra to Treat Rare Form of Juvenile Arthritis 2FDA Approves Actemra to Treat Rare Form of Juvenile Arthritis 3
(Date:9/2/2014)... (PRWEB) September 02, 2014 Developers and ... announced a new ProIntro Lesson from Pixel Film Studios. ... easy and fresh-looking titles,” said Christina Austin, CEO of ... armature, ProIntro is a definite game changer.” , Learn ... ProIntro Lesson from Pixel Film Studios. ProIntro is a ...
(Date:9/2/2014)... (PRWEB) September 02, 2014 NOVAtime ... Management solution development company, announced today that Avon ... 2009, has upgraded to NOVAtime 4000 Time ... conjunction with NOVAtime’s latest smart clock, the ... Farmington Valley of Connecticut is an award-winning nursing ...
(Date:9/2/2014)... 02, 2014 “Harmonicas have been ... decade, primarily to help people with COPD or ... three developed systems,” says Dana Keller, PhD, co-inventor ... the goals are much the same – improved ... type of harmonica.” , The three approaches to ...
(Date:9/2/2014)... (PRWEB) September 02, 2014 September 2014 – ... long gone. But even though men shave daily – and ... – rough and irritated skin isn’t inevitable, according to ... P.C. , For decades, skin care was something in ... a surge in men of all ages who realize that ...
(Date:9/2/2014)... AURO the enterprise Canadian Public ... expansion of its leadership team with the appointment of ... Liang joins AURO in conjunction with his current role ... with the operations, product management and engineering teams to ... well as ensuring effective internal and external controls are ...
Breaking Medicine News(10 mins):Health News:Pixel Film Studios Released a New ProIntro Lesson Exclusively for Final Cut Pro X 2Health News:Pixel Film Studios Released a New ProIntro Lesson Exclusively for Final Cut Pro X 3Health News:Avon Healthcare Upgrades to NOVAtime 4000 Time and Attendance / Workforce Management Solution with NT7000 Smart Clocks 2Health News:Avon Healthcare Upgrades to NOVAtime 4000 Time and Attendance / Workforce Management Solution with NT7000 Smart Clocks 3Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 2Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 3Health News:Rough Isn’t Rugged in Men’s Skin: Dermatology specialist Dr. Joshua Fox with Advanced Dermatology PC offers tips on easy skin maintenance for men 2Health News:Rough Isn’t Rugged in Men’s Skin: Dermatology specialist Dr. Joshua Fox with Advanced Dermatology PC offers tips on easy skin maintenance for men 3Health News:AURO Appoints Kevin Liang as New Chief Financial Officer for Canadian Enterprise Public Cloud 2Health News:AURO Appoints Kevin Liang as New Chief Financial Officer for Canadian Enterprise Public Cloud 3
... following Hurricane Katrina, the health of survivors 65 and ... sample of older adults not affected by the disaster, ... Johns Hopkins Bloomberg School of Public Health. The August ... deadliest hurricanes in U.S. history. Hurricane Katrina displaced thousands ...
... This release is available in French . ... study of its kind on preschoolers has demonstrated that ... effective in reducing the severity and duration of asthma ... of clinical research at the Sainte-Justine Hospital Research Center ...
... -- Stern Communications, a public ... its new client www.healthcarebluebook.com . The start-up ... their zip code for healthcare services. Stern Communications ... into strategic communications resources and campaigns aimed at ...
... Jan. 22 Hillenbrand, Inc.,(NYSE: HI ) ... Thursday, Feb. 5, 2009. The full text of the ... site at www.HillenbrandInc.com . , ... simultaneous webcast with,investors and financial analysts that day at ...
... - Engineers at Purdue and Stanford universities have created ... and other cells react to mechanical stresses from heart ... devices are made by injecting a liquid alloy made ... sheets of a plastic polymer, said Babak Ziaie, a ...
... release is available in Spanish . , ... for detecting the presence of Salmonella spp. and ... time than current systems. Unlike others, this project used clinical ... new diagnostic device is effectively a miniature conventional laboratory inside ...
Cached Medicine News:Health News:Decline in health among older adults affected by Hurricane Katrina 2Health News:New treatment reduces severity of asthma attacks in preschoolers 2Health News:Stern Communications Wins and Helps Launch Healthcarebluebook.com 2Health News:New stretchable electrodes created to study stresses on cardiac cells 2Health News:IK4 develops a portable device for detecting Salmonella in under an hour 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: