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(Photo: http://www.newscom.com/cgi-bin/prnh/20080226/LATU104)
The primary purpose of the "Proof of Concept Trial" is to further evaluatethe safety and efficacy of SF-1019 in the treatment of Diabetic Ulceration andits effect on Diabetic Polyneuropathy in Type 1 Diabetes Mellitus by bothsubcutaneous injection and by topical application. The first phase, which isnow complete, involved an extremely small cohort of patients.
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"Seldom is it possible to demonstrate the efficacy of a biopharmaceuticalsuch as SF-1019 in a media that people can actually see," said Stephen D.Ferrone, President and CEO of Immunosyn. "Photographic evidence such as thisis indeed significant."
The images seen below as well as additional images are also available forviewing at http://www.immunosyn.com/du-beforeandafter.html. A specializedgrid referenced Polaroid camera was used for photographic documentation inorder to prevent digital manipulation and to substantiate authenticity of theimages.
"This first very important phase in the development of SF-1019, which wasundertaken at a European venue by Argyll Biotechnologies, has indicated thatSF-1019 promotes wound healing and almost certainly induces growth factors.When systemically delivered (subcutaneously), SF-1019 has shown the resolutionof long standing chronic lesions which is very impressive," stated ProfessorAngus Dalgleish, MBBS, BSc, MD, FRCP, RACP, FRCPath, FMedSci, Chief Scientistand Consultant Medical Officer for Argyll Biotechnologies, LLC. ProfessorDalgleish is also a member of Immunosyn's Scientific Advisory Board.
"Because of the positive results, which both the independent clinical teamand I have observed during the first phase of the 'Proof of Concept Trial' andwith the absence of any adverse side effects, the trial will go forward to thenext phase and will be expanded to cover a wider group of patients," advisedClinical Director for Argyll Biotechnologies, David Maizels, MD, MSc, MRCS,LRCP.
It is expected that the next phase will be completed during the first halfof 2008 and if successful larger-scale independently-managed formal ClinicalTrials, leading to a licensed product in Europe, will take place shortlythereafter at a world-renowned specialist wound healing clinic.
According to the International Diabetes Federation (IDF), globally, anapproximated 246 million people have Diabetes Mellitus, of which one in sixwill develop a diabetic foot ulcer. Also according to IDF, extensiveepidemiological surveys indicate that between 40% and 70% of all lowerextremity amputations are related to diabetes and that every 30 seconds a legis lost to diabetes somewhere in the world.
Argyll Biotechnologies, LLC is Immunosyn's strategic partner and largestshareholder, as well as the developer and licensor of SF-1019 for whichImmunosyn has been granted the world-wide rights to market, sell anddistribute under an exclusive license agreement.
About Immunosyn Corporation
La Jolla, CA-headquartered Immunosyn Corporation (IMYN.OTC.BB) plans tomarket and distribute life enhancing therapeutics. Currently, the company hasexclusive worldwide rights from its largest shareholder, ArgyllBiotechnologies, LLC, to market, sell and distribute SF-1019, a compound thatwas developed from extensive research into Biological Response Modifiers(BRMs). Argyll Biotechnologies, LLC has initiated the process for regulatoryapproval of SF-1019 in several countries and preparations fo
