$$$ Seeking FDA Approval $$$
IMMUNOSYN ANNOUNCES THE SUCCESSFUL COMPLETION
OF FIRST PHASE “PROOF OF CONCEPT TRIAL” IN EUROPE
FOR TREATMENT OF DIABETIC ULCERS WITH BIOPHARMECEUTICAL SF-1019
Immunosyn Corporation announced that the first phase of a formal "Proof of Concept Trial" for
the biopharmaceutical SF-1019 has been successfully completed in Europe for treatment of
Diabetic Ulcers.
The Board of Immunosyn was advised as to the success of this important phase of the “Proof of
Concept Trial" by Argyll Biotechnologies, LLC its strategic partner and largest shareholder. Argyll
Biotechnologies is 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.
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.
Regarding the "Proof of Concept Trial,” Professor Angus Dalgleish, MBBS, BSc, MD, FRCP, RACP,
FRCPath, FMedSci, Chief Scientist and Consultant Medical Officer for Argyll Biotechnologies, LLC
stated that, “This first very important phase in the development of SF-1019, which was
undertaken at a European venue, has indicated that SF-1019 promotes wound healing and almost
certainly induces growth factors.” “When systemically delivered, SF-1019 has shown the rapid
resolution of long standing chronic lesions which is very impressive. And the topical application of
SF-1019, while showing promise, in that a 5mm deep wound became closed, needs, as expected,
unlike the subcutaneous method, more short-term development in order to improve the delivery
methodology,” he added.
Clinical Director for Argyll Biotechnologies, David Maizels, MD, MSc, MRCS, LRCP, has also advised
that, “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.”
It is expected that the next phase will be completed during the first half of 2008 and that largerscale
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.
“The success of this phase of the trial is yet another substantial milestone in moving toward
approval of SF-1019 in Europe for use with Diabetic Ulcers,” said Stephen D. Ferrone, President
and CEO of Immunosyn. “We feel that beyond whatever the potential revenue might be for
Immunosyn, from possible future approval and sales of SF-1019, is the significant and
compassionate role that SF-1019 could eventually play in filling an unmet need in the arena of
wound healing. According to the International Diabetes Federation (IDF), of the 250 million
people globally who suffer from Diabetes Mellitus one out of six will develop a Diabetic Ulcer. To
put that into perspective, currently, worldwide, one person every 30 seconds has a limb
amputated due to Diabetes, 85% of which are preceded by a Diabetic Ulcer; and, as unbelievable
as it seems, until now there have been no known therapies to remedy this tragic condition,”
concluded Mr. Ferrone.
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