Greffex Ebola Response
Denver -
(NewMediaWire) - October 29, 2014 - For the last four weeks we have been fielding questions regarding Ebola and the state of Ebola vaccines. Those who follow us know that we are advancing into the clinic with our H5N1 (Avian Flu) vaccine and that we have developed a MERS Co-V vaccine, both based on our proprietary technology, as well as vaccine candidates for a host of other potential threats.
In May, 2013, we released a report on our H7N9 Avian Flu vaccine candidate. In it we stated: "We believe
the world needs a 'plug-and-play'(TM) (universal interchangeable platform) method of creating vaccines."
Speed as well as flexibility is needed for vaccine design to combat emerged infectious threats. We had
already shown with an Anthrax vaccine that we can create any vaccine within one month." We created a
H7N9 Avian Flu vaccine from a dead stop to prove it could be done if an emerging threat occurred.
In June, 2013, we released information regarding our MERS Co-V vaccine. “Greffex unrivalled production
times resulted from its proprietary and patented GREVAX(TM) platform--a highly scalable process that also
safeguards vaccine purity. Developed with the support of the National Institutes of Health and the National
Institute of Standards and Technology, GREVAX(TM) vaccines are designed as small synthetic
nanoparticles of genes packaged in an adenoviral shell that can be modified to deliver their genetic
payloads wherever most beneficial. They can be administered in different ways, including injection and
nasal mist. Our vaccines target cells that kick start the immune system and do not need chemical adjuvants.
We have a clean product that does not expose you to contaminations…”
Now Ebola is ravaging Africa, and has raised its ugly head in Europe, the United States and Canada. Health
agencies are scrambling to find a vaccine solution. Millions of dollars have been thrown at systems to
develop a vaccine candidate; some will prove moderately successful as short-term solutions. We believe
these solutions will prove inadequate to stem the tide AND to create a platform from which other vaccine
candidates can be made should a new strain of Ebola or other threats appear. Buried in the messages from
health agencies is the fact that there is a great need for a trivalent vaccine that carries sequences for both
Ebola strains plus the Marburg virus. All vaccines presented as solutions only address a single Ebola strain
(sequence) while some include Marburg. Further, no mention of time of production and more importantly
cost of production has been made. Developers offering a limited vaccine candidate for Ebola within a
period of time without them addressing their clinical trial problems (at this writing the WHO and other
health agencies have not addressed the social, ethical and systemic problems of human clinical trials,
particularly Phase III human trials) and the burdensome costs and extraordinary length of time associated
with their production is simply irresponsible. It is also important to understand that scientists differ on
many issues with some vaccines being developed. In our White Paper we note that one current VSV Ebola
vaccine being developed has two significant issues. The first is that because it is a “replication efficient”
VSV, that is an infectious virus, it may cause serious side effects. There may be a better VSV Ebola virus
vaccine candidate but it has not been tested. With regard to the current VSV Ebola vaccine candidate,
Greffex believes there is potential for deleterious effects if given to undeveloped world populations that
have shaky immune systems due to food deprivation and pre existing diseases such AIDS, tuberculosis, and
malaria. The second problem is that the above-mentioned vaccine is based on an old Ebola sequence, not
the sequence of the current Ebola infection. Greffex believes that this is significant because these changes
(mutations) lie in a crucial area of the vaccine antigen. Some scientists incorrectly believe that they are not
important because they are "only" between 2% and 7%. We believe that the VSV Ebola vaccine being
presented does not address the “mutation actuality” that the immune system sees. Basically, the antibodies
made against the old Ebola antigen may not be fully protective against the new one. In our White Paper we
address these issues in specificity. I touch on them here to remind us all that science and solutions change
rapidly.
WE INVITE YOU TO READ OUR WHITE PAPER. IT COMPARES THE MAJOR PRESENTED
VACCINE SOLUTIONS. IT GENERALLY DESCRIBES OUR PROPRIETARY SYSTEM. We invite
comments, challenges and questions.
In non-scientific terms we at Greffex state:
1. Greffex is the only company that can make a trivalent Ebola-Marburg vaccine in a single vector based
on its fully deleted Ad platform,
2. The Greffex vector will be packaged into capsids of the Adenovirus serotype 2, as well as 5, (this
scientific statement tells readers that Greffex builds a vaccine on multiple serotypes-blood types).
3. The Greffex Ebola vaccine will be administered intranasally,
4. The Greffex Ebola vaccine by design allows prime boost immunization regimens with the same vaccine
construct, if required,
5. The Greffex vaccine can be delivered to ANY AGENCY within 4 weeks from start date,
6. Greffex production scheme allows the company to make 10,000 (ten thousand) doses of its Ebola
candidate in house under GMP conditions for testing within a month,
7. Upon completion of all testing, Greffex believes it can deliver the required number of trivalent Ebola
vaccine doses within the requested time period.
CONCLUSION:
A vaccine solution for Ebola that delivers exactly what is needed quickly IS available.
Greffex offered two additional components to its vaccine solution.
1. Greffex can deliver a testable Ebola vaccine candidate in one month from start date.
2. GREFFEX WILL FORGO ALL PROFITS FROM THE SALE AND DISTRIBUTION OF A
GREVAX EBOLA VACCINE TO AFRICAN COUNTRIES IN NEED.
Why would a small, often struggling Biotechnology Company give away its vaccine solution to Africa? It
is because those of us lucky enough to get up in the morning thinking that we probably won’t get Ebola
need to be part of the world health solution for those that are not that fortunate. Dr. Paul Farmer, cofounder
of Partners in Health writes that the “growing inequality in global healthcare is at the root of the
Ebola Crisis.” Dr. Farmer cannot do what we, a commercial company can: challenge itself and others to
reverse the challenges of “poverty diseases.” It is the right thing to do for Africa. Greffex faces many nonscientific
hurdles in its journey to make its Ebola vaccine. Developing an Ebola vaccine by Greffex is
inexpensive. Later testing is costly. But Greffex can, right now, start the conversation amongst
pharmaceutical manufacturers and vaccine developers to forgo profits from Ebola vaccines for use in
Africa!
Finally, one thing has remained constant. Since the Swine Flu epidemic of the 1970’s, the United States
has not developed an interchangeable vaccine platform to address these ever changing and mutating
diseases: one that is nimble and cost effective. Greffex has that solution. And Greffex believes that nature
is presenting us with challenges we must be equipped to overcome, because every wild spreading disease
is simply a test bed for the next one.
On a personal note, I am extremely grateful to our board of directors, my business partner, Dr. Uwe Staerz,
my Executive Vice President Bill Connolly and all the dedicated scientists and administrators at Greffex for
developing great science and for supporting the decision to give away all profits from Ebola vaccines for
use in Africa. Everything I learned can be summed up in this simple verse to which all at Greffex adhere:
“unto him to whom much is given, much is required.”
Contact us at either: john.price@greffex.com or uwe.staerz@greffex.com. In the coming weeks we
will post questions we receive and our responses on our website: www.greffex.com
John R. Price
President and Chief Executive Officer
October 2014
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