LA JOLLA, Calif.,
(Photo: http://www.newscom.com/cgi-bin/prnh/20080226/LATU104)
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
"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
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
The above news release contains forward-looking statements. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance, and are subject to a wide range of business risks, external factors and uncertainties. Actual results may differ materially from those indicated by such forward-looking statements. For additional information, please consult the Company's most recent public filings and Annual Report on Form 10-K for its most recent fiscal year. The Company assumes no obligation to update the information contained in this press release, whether as a result of new information, future events or otherwise.
CONTACT: Bill Kraus/Lisa Baker/Devon Blaine The Blaine Group 310/360-1499 310/360-1498 (FAX) blaine@blainegroupinc.com
SOURCE Immunosyn Corporation