Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Pearl Therapeutics Advances Its Long-Acting Bronchodilator Combination Product Candidate into Four Additional Phase 2 Studies

June 16, 2011 By Bio-Medicine.Org

REDWOOD CITY, Calif., June 16, 2011 /PRNewswire/ — Pearl
Therapeutics Inc. today announced the advancement of its dual
combination product candidate, PT003 and its individual components,
PT001 and PT005 into a series of planned Phase 2 studies in
patients with moderate-to-severe COPD. PT003 (GFF MDI) is an
investigational inhaled combination bronchodilator product
comprising glycopyrrolate (GP), a long-acting muscarinic antagonist
(LAMA), and formoterol (FF), a well-known, established, long-acting
beta-2 agonist (LABA), delivered together for the first time via a
hydrofluoroalkane metered dose inhaler (HFA MDI), using a
proprietary cosuspension formulation approach. These Phase 2
studies are designed to expand findings from the Company’s recently
concluded Phase 2b study of PT003 and strengthen the safety and
efficacy foundation of the Company’s Phase 3 program, which is
expected to start in late 2012. Specifically they will provide
further insight into the individual component doses, compare
clinical activity to that of a short-acting anticholinergic agent
and assess any cardiovascular effects.

The Phase 2 studies in this series include:

  1. A randomized, double-blind study of four doses of PT001 (GP
    MDI) compared to placebo and Atrovent® HFA inhalation aerosol,
    a short-acting muscarinic antagonist;
  2. A randomized, double-blind study of three doses of PT005 (FF
    MDI) compared to placebo and Foradil® Aerolizer®;
  3. A randomized, double-blind cardiovascular safety study of
    PT003, PT005, PT001 and Foradil® Aerolizer®; and
  4. A randomized, double-blind study of four doses of PT003
    compared with its components, PT001 and PT005.

“With the success of our first Phase 2b study behind us, we are
advancing PT003 and its components without delay into this planned
series of four Phase 2 studies,” said Chuck
Bramlage, P

‘/>”/>

SOURCE

Related Articles Read More >

Johnson & Johnson Office of Digital Innovation Leader Peter Schulam
Imagining the future of cloud-connected medical devices with Johnson & Johnson leaders
Withings Body Scan
Withings plans launch for Body Scan smart scale platform
BinaxNow COVID-19 Ag Card
Time recognizes Abbott offerings among this year’s 100 best inventions
Koya Medical’s Dayspring device
Koya Medical reports positive early results in Dayspring lymphedema trial

DeviceTalks Weekly.

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech