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Technology Has Demonstrated That It May Up-Regulate The Innate Immune
System, Modulate The Adaptive Immune System And Has Demonstrated No Toxic
Affects In Animal Trials And Pre-Clinical Human Studies
4225 Executive Square, Suite 260
La Jolla, CA 92037
Phone: s/b 888-853-3663
Stephen D. Ferrone
President and CEO
Interview conducted by:
Lynn Fosse, Senior Editor
Published - January 25, 2008
Stephen D. Ferrone
CEO, President and Board Member
Mr. Ferrone is a
veteran marketing and sales executive with demonstrated national leadership
of strategic and tactical distribution initiatives through intermediary
channels. He has a proven career of growing and managing businesses
including nine years of service with ABN AMRO Asset Management as genesis
architect of its marketing strategy and responsibility for its mutual fund
and separate accounts distribution network.
Mr. Ferrone is a graduate of Northwestern University and Loyola School of
Law and began his professional career in Chicago, Illinois as a felony trial
prosecutor for Cook County. He later transitioned into the field of
comprehensive wealth management as a principal in a successful fee-based
money management practice, a concept that was still new at that time. He
sold his interest in that business to become Regional Marketing Director at
Schwab Institutional where he opened the Midwest office. He built and led a
team providing technology solutions to asset managers, achieving a 76% per
year increase in sales with consistent top ranked profitability.
Subsequently, as the National Sales Director for ABN AMRO, Mr. Ferrone set
the strategic marketing plan and led the sales team he created to raise net
new investment sales of over $9 billion dollars over his nine-year tenure.
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).
CEOCFO: Mr. Ferrone, you are new as CEO at
Immunosyn; what attracted you, and what is the vision?
Mr. Ferrone: “What attracted me was the
science; there are so many unmet needs in the world with respect to treating
diseases and the science behind SF-1019 was tremendously compelling. As a
biological response modifier, SF-1019 interacts with the autoimmune system.
Autoimmune related diseases account for about half of the diseases on the
planet. If there is a potentially effective treatment for this area of
disease, it offers great opportunity.”
Would you tell us more about SF-1019?
Mr. Ferrone: “The scientists involved
believe, and it is our opinion, that SF-1019 is a scientific breakthrough.
The reason for this is that SF-1019 up-regulates the innate immune system
and modulates the adaptive immune system. This is particularly unique. Many
biological response modifiers will do one or the other but not both and
unfortunately most have toxic effects, whereas SF-1019 has demonstrated in
animal trials and pre-clinical human studies not to have those toxic
you doing this in partnership?
Mr. Ferrone: “Yes. Immunosyn, the public
company, is a developmental distribution company awaiting the approval of
the biopharmaceutical SF-1019. Argyll Biotechnologies, LLC, Immunosyn’s
strategic partner and largest shareholder, is the company who has brought
this biopharmaceutical through its ten-year period of development to the
point where it is a fully-developed drug.” It is now Argyll Biotechnologies’
responsibility to move SF-1019 through the clinical trials and through the
various jurisdictional approval processes.”
Where are you in the process of getting it to people?
Mr. Ferrone: “Regulatory approval
processes for SF-1019 have been initiated by Argyll Biotechnologies, LLC in
several countries. Additionally, in both the US and Europe preparations for
clinical trials are underway. Research indicates that SF-1019 has the
potential to affect neurological disorders such as Chronic Inflammatory
Demyelinating Polyneuropathy (CIDP) and Reflex Sympathetic Dystrophy
Syndrome (RSD or RSDS), autoimmune disorders such as Multiple Sclerosis
(MS), and a number of clinical conditions including complications from
Diabetic Mellitus such as Diabetic Neuropathy (DN) and diabetic ulcers (DU).”
it a lot easier in Europe?
Mr. Ferrone: “It is a process wherever
you go. Certainly, the EMEA in the European Union
has their protocol just as the FDA does
here. The standards are equally rigorous and stringent as to safety &
efficacy in both the US and the EU. So really, the question is not whether
it is easier or harder; but one of choosing the most efficient and timely
strategy for each given jurisdiction.”
What is the financial picture of the company?
Mr. Ferrone: “Under the terms of our
exclusive license agreement, Argyll Biotechnologies is responsible for all
regulatory approvals and clinical trials including those required by the
EMEA and FDA together with their associated costs. However, we are working
on the capitalization of Immunosyn now. We hope to be able to make an
announcement about that soon.”
What is the plan going forward?
Mr. Ferrone: “Our job is to raise
awareness in the patient, medical and investor communities as to the
potential of SF-1019. We will be setting up distribution protocols for
anticipated approvals as they come from their respective jurisdictions. It
is also our responsibility to communicate with Argyll Biotechnologies, to
monitor their progress and to update our stakeholders as milestone
accomplishments occur along the way.”
There are many new ideas that are fighting for attention; how do you get the
various components that you need for the public and investors to pay
Mr. Ferrone: “It is top down, bottom up;
attending conferences, speaking engagements and reaching out to
intermediaries and individual investors who might be interested in Immunosyn.
In addition, we are proactively creating a face and increasing visibility in
the market place. Those reading this article who would like more information
can contact us through our website.”
you planning to add other technologies and products?
Mr. Ferrone: “Yes. Certainly, our
immediate focus is on preparing for the achievement of successful clinical
trials and the approval to distribute SF-1019 worldwide, as is our right
through our exclusive license agreement with Argyll Biotechnologies.
SF-1019 is the platform technology that may point the way for the future
development and refinement of many promising innovative and cutting-edge
therapeutics. However, as we develop a revenue stream it will also allow for
are looking at prescription veterinary treatments, why is that an area of
Mr. Ferrone: “There are certain
autoimmune related indications from which animals suffer. Our Scientific
Advisory Board believes that there are potential applications for iterations
of SF-1019 to be developed for use in the veterinary arena.”
you looking at marketing and distribution?
Mr. Ferrone: “That is the second step.
We are at the awareness stage, creating a foundation and developing
awareness for Immunoysn and SF-1019 now. On an operational basis, as
milestones with SF-1019 are achieved and we get closer to distribution, then
marketing and distribution plans for SF-1019 will become our primary focus.”
should potential investors pick you out of the crowd?
Mr. Ferrone: “I read in a magazine
recently an article about a very well-known drug company and it included a
comment about the industry at large. Many of the major drug companies are
seeing their patents and their exclusive distribution rights running out.
This is with respect to some of the key medications that they have been
selling for a long period of time. Secondly, the whole perception of how to
create drugs is shifting from what it has been over the last hundred years,
which was lab driven, to something that is more biologically friendly. The
role of Immunosyn really is to seek biopharmaceutical solutions that work
with the body, not against it. It is our vision to market & distribute
treatments that are non-toxic in consequence and that will help the body do
what it does naturally, only better. The potential here is to relieve pain
and suffering throughout the world, as well as create revenue streams.
Companies such as Immunosyn that are striving to market biologically
friendly, cutting edge biopharmaceutical products such as SF-1019 are going
to get visibility.”
What should people take away from reading this interview?
Mr. Ferrone: “We have a drug that is
fully developed, which our Scientific Advisory Board believes has
demonstrated safety and efficacy for indications for which we hope the
treatment will be approved. We are in the marketplace raising awareness and
are cognizant of the need to set up a viable distribution system. With
respect to SF-1019, we are at the cutting-edge of where drug development and
therapies are today. The two Orphan Diseases for which Argyll
Biotechnologies plans to seek FDA approval in the US are Chronic
Inflammatory Demyelinating Polyneuropathy (CIDP) and Reflex Sympathetic
Dystrophy (RSD or RSDS). However, the overall target market is potentially
broader. It could include indications such as Multiple Sclerosis (MS), from
which an estimated 2.5 million people suffer worldwide. There is also the
potential for SF-1019 to be used in treating complications from Diabetic
Mellitus such as Diabetic Neuropathy (DN) and diabetic ulcers (DU).
Worldwide, approximately 246 million people have Diabetes Mellitus, of
those, 1 in 6 will develop a foot ulcer and an estimated 50% have a Diabetic
Neuropathy (DN). Therefore, there is certainly a large potential market for
SF-1019. From a business standpoint as well as a humanitarian standpoint, we
feel there is great potential.”
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