Item 8.01
Other Events
Investor
Presentation
Below
is
a copy of the press release dated, January 17, 2008, relating to the results
of
the first phase of a formal “Proof of Concept Trial” for the biopharmaceutical
SF-1019 in Europe for treatment of Diabetic Ulcers.
IMMUNOSYN
ANNOUNCES THE SUCCESSFUL COMPLETION
OF
FIRST PHASE “PROOF OF CONCEPT TRIAL” IN EUROPE
FOR
TREATMENT OF DIABETIC ULCERS WITH BIOPHARMECEUTICAL
SF-1019
January
17, 2008
LA
JOLLA,
Calif., Jan. ____ /PRNewswire-FirstCall/ -- Immunosyn Corporation (OTC Bulletin
Board:
IMYN
-
News
)
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,” said Mr.
Ferrone.
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
)
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.