Item 8.01
Other Events
Investor
Presentation
Below
is
a copy of the press release dated, February 26, 2008, and photos 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
RELEASES WOUND HEALING PHOTOGRAPHS
FROM
THE FIRST PHASE “PROOF OF CONCEPT TRIAL” IN EUROPE
FOR
TREATMENT OF DIABETIC ULCERS WITH BIOPHARMECEUTICAL
SF-1019
February
26, 2008
LA
JOLLA,
Calif., Feb. 26, 2008 /PRNewswire-FirstCall/ -- Immunosyn Corporation (OTC
Bulletin Board:
IMYN
)
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
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.
|
99.1
|
Additional Wound Healing Photographs
of
the First Phase. “Proof of Concept” in Europe For Treatment of Diabetic
Ulcers with 1.5ML Subcutaneous Injections of the Biopharmaceutical
SF-1019.
|
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.