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Press Release: Immunosyn Releases Wound Healing Photographs From the First Phase 'Proof of Concept Trial' in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019
Quote:
Immunosyn Corporation received permission from Argyll
Biotechnologies, LLC to release before and after wound healing photographs
resulting from subcutaneous injections of the biopharmaceutical SF-1019
from the first phase of a formal "Proof of Concept Trial" which has been
successfully completed in Europe for treatment of Diabetic Ulcers with
SF-1019.
The primary purpose of the "Proof of Concept Trial" is to further
evaluate the safety and efficacy of SF-1019 in the treatment of Diabetic
Ulceration and its effect on Diabetic Polyneuropathy in Type 1 Diabetes
Mellitus by both subcutaneous injection and by topical application. The
first phase, which is now complete, involved an extremely small cohort of
patients.
"Seldom is it possible to demonstrate the efficacy of a
biopharmaceutical such as SF-1019 in a media that people can actually see,"
said Stephen D. Ferrone, President and CEO of Immunosyn. "Photographic
evidence such as this is indeed significant."
The images seen below as well as additional images are also available
for viewing at http://www.immunosyn.com/du-beforeandafter.html. A
specialized grid referenced Polaroid camera was used for photographic
documentation in order to prevent digital manipulation and to substantiate
authenticity of the images.
"This first very important phase in the development of SF-1019, which
was undertaken at a European venue by Argyll Biotechnologies, has indicated
that SF-1019 promotes wound healing and almost certainly induces growth
factors. When systemically delivered (subcutaneously), SF-1019 has shown
the resolution of long standing chronic lesions which is very impressive,"
stated Professor Angus Dalgleish, MBBS, BSc, MD, FRCP, RACP, FRCPath,
FMedSci, Chief Scientist and Consultant Medical Officer for Argyll
Biotechnologies, LLC. Professor Dalgleish is also a member of Immunosyn's
Scientific Advisory Board.
"Because of the positive results, which both the independent clinical
team and I have observed during the first phase of the 'Proof of Concept
Trial' and with the absence of any adverse side effects, the trial will go
forward to the next phase and will be expanded to cover a wider group of
patients," advised Clinical Director for Argyll Biotechnologies, David
Maizels, MD, MSc, MRCS, LRCP.
It is expected that the next phase will be completed during the first
half of 2008 and if successful larger-scale independently-managed formal
Clinical Trials, leading to a licensed product in Europe, will take place
shortly thereafter at a world-renowned specialist wound healing clinic.
According to the International Diabetes Federation (IDF), globally, an
approximated 246 million people have Diabetes Mellitus, of which one in six
will develop a diabetic foot ulcer. Also according to IDF, extensive
epidemiological surveys indicate that between 40% and 70% of all lower
extremity amputations are related to diabetes and that every 30 seconds a
leg is lost to diabetes somewhere in the world.
Argyll Biotechnologies, LLC is Immunosyn's strategic partner and
largest shareholder, as well as the developer and licensor of SF-1019 for
which Immunosyn has been granted the world-wide rights to market, sell and
distribute under an exclusive license agreement.
Proof of concept study on the biopharmaceutical SF-1019 for diabetic foot ulcers
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