|
Cardium Therapeutics And Its Subsidiary, Tissue Repair Company (TRC), Extend
Their Relationship With OmniComm Systems Inc. As Their Preferred Web-Based Data
Collection And Management Solution
Phase 2b clinical trial of Excellarate™ for Diabetic Ulcers to use OmniComm's
First in Functionality™ electronic data capture (EDC) solution, TrialMasterTM
FT. LAUDERDALE, FL - November 28, 2007 - /MarketWire/ - OmniComm Systems, Inc. (OTC
Bulletin Board: OMCM.OB), a leader in integrated electronic data capture (EDC) solutions
for clinical trials, today announced that they will provide EDC services to Tissue
Repair Company for a randomized, double-blind, placebo-controlled, comparator arm
clinical trial to evaluate the safety and efficacy of Excellarate for the potential
treatment of non-healing diabetic foot ulcers. Excellarate is a DNA-based topical
gel that is being developed to stimulate wound healing. The study is currently enrolling
patients diagnosed with Type I or II diabetes with a non-healing foot ulcer present
that has failed standard of care therapy. The study will enroll approximately 210
patients at 25 U.S. medical clinics.
"After successful completion of a Phase 1/2 clinical trial that proved Excellarate
to be safe and well tolerated and resulted in a high rate of complete wound closure,
we are excited to be underway with our Phase 2b study. We believe that Excellarate
has the potential to be a best-in-class product compared to currently marketed products,"
said Barbara Sosnowski, Vice President of Operations for Tissue Repair Company.
"We chose to use EDC and specifically TrialMaster in this study for the innate benefits
that EDC provides such as ease of use, better access to the data, shorter study
timelines and quicker study completion."
Cardium's Tissue Repair Company (TRC) subsidiary is focused on the development of
growth factor therapeutics that promote tissue repair and regeneration. TRC's lead
product candidate, Excellarate is being developed as a potential treatment of non-healing
diabetic foot ulcers. The Excellarate topical gel uses TRC's Gene Activated Matrix™
(GAM) technology that is designed to provide localized and sustained cellular release
of platelet-derived growth factor-BB protein.
"OmniComm is very proud to be chosen by Tissue Repair Company for this important
diabetic wound healing trial. It gives us great satisfaction to know that Cardium
and its subsidiaries recognize TrialMaster as a superior EDC solution for their
trials," said Cornelis F. Wit, CEO of OmniComm. "The fact that Cardium chose us
once again for EDC for their clinical trials proves that we are delivering on our
promise to provide a product that is easy to use, flexible and cost effective along
with the dedicated support services that our clients need and expect."
About OmniComm
OmniComm Systems, Inc. (www.OmniComm.com) provides customer-driven Internet solutions
to pharmaceutical, biotechnology, research and medical device organizations that
conduct life changing clinical trial research. OmniComm's growing base of satisfied
customers is a direct result of the company's commitment to deliver products and
services that ensure ease of use, faster study build, ease of integration and better
performance. OmniComm's client intuitive pricing model allows companies that range
from small to mid-size to large scale institutions to safely and efficiently capitalize
on their clinical research investments.
OmniComm ranked in the top 150 as one of the fastest revenue growth technology companies
in North America during the last 5 years. OmniComm Systems Inc. has corporate headquarters
in Ft. Lauderdale, Florida with offices in Bonn, Germany, California, Maryland,
New York, North Carolina and Texas.
PRESS RELEASE
for Immediate Release
Lizanne Kelley
OmniComm Systems, Inc.
954-473-1254 Extension 283
lkelley@omnicomm.com
Back
|
