Immunosyn Releases Wound Healing Photographs From the First Phase 'Proof of Concept Trial' in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019
LA JOLLA, Calif., February 26, 2008 /PRNewswire-FirstCall/ -- 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.
About Immunosyn Corporation
La Jolla, CA-headquartered Immunosyn Corporation (IMYN.OTC.BB) plans to market and distribute life enhancing therapeutics. Currently, the company has exclusive worldwide rights from its largest shareholder, Argyll Biotechnologies, LLC, to market, sell and distribute SF-1019, a compound that was developed from extensive research into Biological Response Modifiers (BRMs). Argyll Biotechnologies, LLC has initiated the process for regulatory approval of SF-1019 in several countries and preparations for clinical trials are underway in both the US and Europe. Research suggests that SF-1019 has the potential to affect a number of clinical conditions including complications from Diabetic Mellitus such as Diabetic Neuropathy (DN) and diabetic ulcers (DU), auto-immune disorders such as Multiple Sclerosis (MS) and neurological disorders such as Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Reflex Sympathetic Dystrophy Syndrome (RSD or RSDS). (For more information on Immunosyn and SF-1019 go to http://www.immunosyn.com)
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Posted: February 2008