Applications are currently underway with the Food and Drug Administration (FDA) for clinical trial approval of SF-1019 relating to Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Reflex Sympathetic Dystrophy Syndrome, (RSD or RSDS). In Europe, similar applications are also being prepared for the European Medicines Agency (EMEA) for further trials relating to diabetic ulcers and other wound healing.
IMMUNOSYN ANNOUNCES THE SUCCESSFUL COMPLETION OF FIRST PHASE “PROOF OF CONCEPT TRIAL” IN EUROPE FOR TREATMENT OF DIABETIC ULCERS WITH BIOPHARMECEUTICAL SF-1019
mmunosyn 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.