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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, TrialMaster®
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
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