Immunosyn Corporation (IMYN)

 

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Immunosyn is a development stage marketing and distribution company headquartered in La Jolla, CA, with a regional office in Chicago, IL and a Scientific Advisory Board that is globally positioned.  Our first product to be introduced, currently called SF-1019, is believed by our Scientific Advisory Board to be one of a new class of therapeutics made from mammalian cells that may have the ability to dramatically affect many auto-immune, neurological and demyelinating conditions resulting in a rapid reduction of symptoms.  SF-1019 will be marketable upon receipt of potential regulatory approval in the appropriate jurisdictions.

SF-1019 was developed from extensive research into Biological Response Modifiers (BRM’s) undertaken at Mississippi State University; St. George’s, University of London (formerly St. George’s Hospital Medical School); Ohio University; and Methodist Hospital.  The first group of BRM’s was designated as Immune Cell Potentiating Factors (ICPF) and has been extensively evaluated in a number of veterinary treatments, including animal studies relating to human disease.  This collaborative approach brought the thorough and unbiased scrutiny of the scientific and medical community upon the related research and particularly SF-1019.  It is the opinion of Argyll Biotechnologies, LLC, that these data collectively support the conclusion that SF-1019, as a BRM, may point the way for the future development and refinement of many promising innovative and cutting-edge therapeutics, which are also included in our exclusive license agreement.

SF-1019 is believed to be one of a new class of therapeutics made from mammalian cells.  As an isolated compound, SF-1019 is comprised of low molecular weight lipo-peptides.  Pre-clinical human studies and clinical trials in animals have shown SF-1019 to provide therapeutic benefits without toxic or pyrogenic (fever-causing) effects at therapeutically effective dosages.  In pre-clinical human studies, it appears to create a therapeutic affective response over a range of demyelinating conditions of the peripheral nervous system (PNS) resulting in rapid reduction of symptoms. 

A major benefit of SF-1019 is its perceived ability to simultaneously target, activate and support the modulation of both the innate and adaptive immune systems, having a dramatic effect on many neurological and demyelinating conditions.  Research suggests the current product has additional developmental potential as it also possesses analgesic properties with an ability to substantially reduce the inflammation attending a number of clinical conditions including Multiply Sclerosis (MS), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Reflex Sympathetic Dystrophy Syndrome, (RSD and RSDS) and other auto-immune and neurological disorders.

Recent Key Announcements

January 18, 2007 – Steven D. Ferron, CEO of Immunosyn, to Present at Flaherty Financial News/Wall Street Research Conference - LA JOLLA, Calif., - Stephen D. Ferrone, President and CEO of Immunosyn Corporation (OTC Bulletin Board: IMYN), will present to a diverse group of investors, portfolio managers and analysts at the Flaherty Financial/Wall Street Research Small Cap Conference on January 22, 2008 at The Penn Club in New York City.

"We are privileged to present Immunosyn to the elite group of investors, industry experts and analysts at the Flaherty Financial News/Wall Street Research Small Cap Conference," says Ferrone. "This is a great opportunity to increase market awareness for Immunosyn, to articulate our vision and goals and to show the ways in which we are moving closer to achieving them."

Immunosyn's objectives, overview and product information will be communicated to target audiences at select conferences such as the Flaherty Financial/Wall Street Research Small Cap Conference. Presentations will be made which include market data, research information and milestones achieved. As part of Immunosyn's presentation, Ferrone will focus on the biopharmaceutical SF-1019, including information about the steps being taken toward regulatory approvals and results of a recent trial.

January 17, 2008 – Immunosyn Announces the Successful Completion of First Phase ‘Proof of Concept Trial’ in Europe for Treatment of Diabetic Ulcers with Biopharmaceutical SF-1019 - Immunosyn Corporation (OTC Bulletin Board: IMYN) announced today 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 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.

"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.

November 28, 2007 – Immunosyn Announces Biozyme Lab’s Receipt of MHRA Manufacturing License Approval in Europe for the Biopharmaceutical SF-1019 - Immunosyn Corporation (OTC Bulletin Board: IMYN) today announced that Biozyme Laboratories has received approval from the MHRA to import base material and manufacture SF-1019 for human use in clinical trials. SF-1019 is a biopharmaceutical for which Immunosyn holds the exclusive license for worldwide marketing rights.

The "Medicines and Healthcare products Regulatory Agency," more commonly known as the MHRA, functions in the United Kingdom on behalf of the European Medicines Agency (EMEA) much like the FDA does in the United States. MHRA regulates which drugs are safe and effective for use in humans to treat specific ailments and conditions. The license approvals currently granted by the MHRA include a "Manufacturer's Authorisation -- Investigational Medicinal Products" (MIA (IMP)) as well as "Manufacturer's / Importer's Licence" (MIA) for manufacturing investigational medicinal products for use in humans for phase I, II and III clinical trials. If a company successfully completes these trials it can apply for a full license to distribute throughout the European Union.

"The fact that SF-1019 has garnered manufacturing and import approval from the MHRA so rapidly is exciting news," says Stephen D. Ferrone, CEO and President of Immunosyn, "as every milestone we achieve in this process brings us that much closer to producing revenue for our shareholders."

"This is another example whereby Immunosyn's shareholders strongly benefit from our unique relationship with our largest shareholder, Argyll Biotechnologies," stated David Criner, CFO of Immunosyn. "Under the terms of our exclusive license agreement, Argyll Biotechnologies is responsible for all regulatory approvals and clinical trials including those required by the MHRA and FDA together with their associated costs."

Under EMEA requirements, in order to obtain approval to manufacture a drug for use in humans, whether for clinical trials or for general use, an approved manufacturer must be able to demonstrate its ability to comply with the rules governing "Good Manufacturing Practice" (GMP) and apply directly to the MHRA for license approval. Following a series of manufacturing "scale-up" studies, Argyll Biotechnologies entered into an agreement with Biozyme Laboratories Limited to manufacture SF-1019. As a result of this agreement, Biozyme applied for and received manufacturing and base materials import approval from MHRA for clinical trials of SF-1019.

Green Baron Conclusion

We are fortunate to have found a biotech with overwhelming positive clinical data to support its discovery of a whole new class of bioresponse modifiers.  SF-1019 appears to modulate and regulate the auto-immune system at indication with no negative side effects seen to date.  This is breakthrough science and will not go unnoticed long.

The Green Baron Report recognizes the mammoth potential for SF-1019, and we believe current shareholders of IMYN made up primarily of insiders and Argyll Biotechnologies are holding out for much bigger numbers.  Limited approvals outside the United States could still bring huge revenues to Immunosyn even in the current year.

IMYN stock tends to rally strongly on good news, and we are confident there is plenty to come.  We suggest members pick off shares below $4 for a move to double digits over the next few months, and don’t be surprised if you hear this company’s story on your local news or talk show soon.

For Further Information Contact:

Bill Kraus / Lisa Baker / Devon Blaine

The Blaine Group

Phone: (310)360-1499

Fax: (310)360-1498

Email: blaine@blainegroupinc.com

 
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