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Pharmaceuticals has developed a therapy that will allow oncologists to
shrink tumors without radiation, carcinogens chemicals or surgery
Provectus Pharmaceuticals, Inc.
7327 Oak Ridge Hwy.
Knoxville, TN 37931
Phone: (865) 769-4011
H. Craig Dees, PhD
Chief Executive Officer
Interview conducted by:
Lynn Fosse, Senior Editor
February 24, 2005
Craig Dees, Ph.D. Ė Chief Executive Officer
Craig Dees, Ph.D., has spent more than 20
years in senior management positions at Photogen Technologies, Inc.; the Oak
Ridge National Laboratory; LipoGen, Inc.; and TechAmerica, Inc. Dees was a
founder, senior scientist and founding director of Photogen before Provectus
was formed. His responsibilities have included product design and
development in the fields of ethical vaccines, cosmetics, human diagnostics
and over-the-counter pharmaceuticals. His development record includes the
first live viral vaccine produced by recombinant DNA technologies and the
first recombinant antigen human diagnostic assay. Dees has also successfully
licensed a number of proprietary cosmetic products. In addition to design
and development activities, Dees has been responsible for business and
market applications, regulatory affairs, and commercialization of human and
veterinary medical products. Awards include an R&D 100 for an industrial
enzyme, an Inventorís Forum New Product Award for a skincare product, and a
First Saber Award for outstanding research in virology. Dees holds a Ph.D.
in molecular virology from University of Wisconsin, Madison. He earned his
master of science degree in immunology from Auburn University, and his
bachelorís degree in microbiology from Brigham Young University.
Provectus Pharmaceuticals, Inc. (OTC Bulletin Board: PVCT) is a pioneering
pharmaceutical company actively engaged in the design, development and
marketing of a diverse portfolio of leading pharmaceutical technologies for
the treatment of liver, breast and prostate cancer. In addition, Provectus
has developed treatments for skin diseases and psoriasis, as well as
developed a variety of other over-the-counter skin care products. Provectus'
experienced management team, comprised of several leading scientists,
developed and own 12 U.S. patents, and currently are seeking approval for 19
CEOCFOinterviews: Dr. Dees, what was your vision when you started
Provectus, and where are you today?
Dr. Dees: "We are close to our strategic plan.
We are lucky enough to be working in an area where tremendous economic
returns are possible and we are also able to do good for people. We set out
to revise how medicines were built and to make them safer and improving
their efficacy and also be cost-effective. The companies strategic plan is a
little different; instead of going ten years before break-even, we have an
OTC division where we have the over-the-counter products, which will help
bring us to revenue-positive this year we hope and to stop further dilution
of stock and then we will support the longer term bigger ethical products. I
would say we are very much on track for that, so we are very excited."
CEOCFOinterviews: What are the areas you are working in today?
Dr. Dees: "We have a number of things; some
devices and biotech but those are not our core technologies. Our focus right
now is an anti-cancer drug, which has us very excited. What is very
different about it is that people have tried to fix the side-effect problems
and efficacy problems. Traditionally, the medical community has treated
cancer as we use to treat other diseases like Malaria. We would poison it
with something like arsenic and with about one out of a hundred patients; we
would get a miraculous cure. Nine we would kill with arsenic and the other
ninety we would make really sick and not help them. The cancer therapies
that are being used today are very primitive; we will hack off a part of
your body, mutilation, with loss of function, followed by poisoning with
radiation and chemicals. The problem with the chemicals and radiation is
that they are very horrific carcinogens; you may get cancer years later from
the treatments. The problem is they just donít target the disease. There has
been some unwieldy solutions attempted like using monoclonal antibodies or
encapsulation techniques. It is very limited and they donít work on all
tumors. What we do at Provectus Pharmaceuticals is make that a small
molecule that has virtually absolute specificity for diseased tissue, so you
have no pain, no side-effects. There may be a hole where the cancer used to
be but nothing else. It is amazing, side-effect free and painless."
CEOCFOinterviews: How did you decide to attack cancer from this
Dr. Dees: "People assume that cancer has a
unique marker and it really doesnít. When you go after a cancer it is not
like an alien space invader that is totally different in bi-chemistry like a
microbe. They may increase the number of lipo-protein receptors or folate
(vitamin) receptors, but there is generally no unique markers. We realized
that with a very different phenomenon what the sick cells were doing. At
Provectus we knew how we could make a chemical solution to it; a very
easy-fix solution. Since we know how it works, we have a very rapid
screening test; we can screen pre-existing compounds, I donít have to design
a new one, we can use one that the FDA approved for someone else and that
speeds up the process. We know something unique about the membranes of the
cancer cells. Its so specific that we can prevent cancer from occurring too.
We have data in mice that get colon cancer. They have been genetically
modified to do that. We let the mice drink the drug at high dosages. The
mice drinking it never get colon cancer and after 28 or 30 weeks, all the
others are dead. It is 100% too. Essentially, once you solve this problem,
at high dosage, it prevents cancer from happening. People think it is too
good to be true and when we have scientists fly down from New York and they
see this data, their mouths drop open. I say if you stayed all day or two
days you would only a fraction of the data and it will pass anybodyís
scrutiny once they look at it."
CEOCFOinterviews: Where are you in the process of getting it to
Dr. Dees: "We hope it is going to be a
relatively short process. People forget that the mandate of the FDA is
almost like the Hippocratic Oath; first is do no harm. Meaning that they
are first concerned for our safety, which is a good thing. Our very first
compound is an old drug or old compound, which was abandoned for use years
ago and we screened for it. The FDA has already approved it for IV
injections and use in the eyes, so that hurdle is already over. The quality
control tests to release it are done, the stability tests are done. All we
have to do is go to the FDA in the clinical trial process and say we are
going to use this drug for something different. We are working with in two
different areas. In oncology, we have just had and IND allowed for doing
breast cancer and melanoma. After that, we will add liver cancer. We just
signed a contract with Clinimetrics, a global, full-service contract
research firm that serves the pharmaceutical, biotechnology and medical
device industries and started the process that call for the first patients.
We will have the Phase I studies, the first humans, starting very shortly.
Interestingly enough, the first Phase I study is not only a dose escalation
safety study, but we have been allowed to increase the dose up to efficacy
levels, which normally you donít get to until Phase II. We will get efficacy
data in Phase I, so we are already compressing the process. In the first
half of the year, you will see the first human patients treated. It has
already been in human use in pre-clinical studies in Denmark, at Aarhus
University years ago with Peter Berry, a foremost dermatologist, and has
already completed pre-clinical with psoriasis with very nice results. Phase
I trials have been completed at multiple sites in the US. It is ready to go
to Phase II. That is where we are."
CEOCFOinterviews: Why breast cancer first?
Dr. Dees: "I have been in breast and womenís
cancer for years. If you look at the number of patients impacted in the U.S;
one in seven or one in eight are going to get breast cancer. I have walked
through a room at meetings and asked and numerous women will put up their
hand and say, ďI have already had breast cancer.Ē It is one of the major
killers behind heart disease and a tremendous impact on the health of woman
world wide. In the past there were huge radical mastectomies done. Now they
are attempting tissue-sparing surgeries after attempting to shrink the
tumors with radiation and chemotherapy before surgery. With Provectus
Pharmaceuticals' therapy, you can reach in, put the drug in the tumor and
shrinks the tumor. No chance of cancer from the drug.Ē
CEOCFOinterviews: In what other areas is Provectus involved?
Dr. Dees: "One of the questions people ask is
if it will work in humans, and we say will it work in spontaneous tumors.
The real question is will it work in spontaneously occurring tumors or
naturally occurring tumors and the answer is, yes, it will work. We have
already been over that hurdle, because it has been used in a number of
veterinary patients with spontaneous arising tumors. We have some pictures
of a mouse with some huge breast tumors on her and then a picture afterwards
where they are completely gone. About 5 years ago our first patient was
Rookie, a three-and-a-half year old Shepard that had a sarcoma up in her
nose. She had been treated with $8 thousand worth of surgery and radiation
nine months before we saw her. Her owners were told to take the dog home
because the tumor was back and she would not survive. However, after
treatment with our drug I have the oncologists discharge report that says
that it's a miracle. It really wasn't, because are drug was designed by a
smart chemist and chemical engineer and a biologist. The drug did what it
was designed to do that caused the tumor in Rookie to go away. She lived
another four or five years after that, to be a pretty old Shepard.
One of the really funny things is when the veterinarian used a very small
amount of our drug he kept apologizing and apologizing and I finally said,
'what's the matter'? He told me he used it all up. He was thinking that he
had used up a $100 thousand or $200 thousand experimental drug. I laughed
and told him that we were truly inventors in here, but we did not invent
something that only Bill Gates could use. I looked at the bottle, I had one
hundred milliliters of it, ten times more than he had used and I said, 'this
bottle cost 17 cents, the label costs a nickel, sterile fill might be a buck
total; so you may have used a tenth of a cent on that dog'. Now that's a
real invention, one that can actually bring down the cost of fighting breast
cancer. We hope it does just as well in the human trials. We also hope to do
liver cancer where with current therapies there is about a 30% survival rate
at five years. Those are not acceptable odds. We hope to do those where we
can reach in and directly ablate them. Outside of the U.S., they are using
direct ethanol, which we hope to make that way better. Most liver cancer is
outside the U.S. Cirrhosis from the U.S. is usually from drinking and
hepatitis. Most of the people outside the U.S. cannot pay $80 thousand or
$200 thousand dollars for surgery. However, our drug they can use."
CEOCFOinterviews: You talked about your over-the-counter product;
what is happening for you in this arena?
Dr. Dees: "We are excited with that and it has
really started to take off the. In the last quarter, we have probably
doubled the amount of stores we are in. We hope to get into a number of new
large chains this year."
CEOCFOinterviews: What are you selling?
Dr. Dees: "It is an anti-bacterial/anti-viral
hand spray. There is a major market out there for a gooey sort of gel. One
of the ways you can get a cold virus is to touch the phone headset where
others have picked up the phone, a television remote in a hotel room; the
toilet is actually cleaner. The amount of organisms around a hotel room will
astound you. It leaves a barrier to re-infection and from bacteria growing
back. We have taken a competitorís gooey gel put it on a surface, washed it
three times and did the same thing with our spray. I would put 500, 000
antibiotic resistant ďnasty, flesh-eating staphylococcus on the treated
surfaces. Where the competitorís gel was, I get all of them back, where our
stuff is, you get zero back."
CEOCFOinterviews: What are your challenges going forward?
Dr. Dees: "One challenge is the explosive
growth on the OTC side, being able to manage it, and the advertising. We are
negotiating with a big marketing company to take care of that. For example,
a very big chain store approached us for 4000 new stores in 2005. We are
adding on help to try and take advantage of these growth opportunities.
There is nothing worse than receiving the orders and not be able to get them
into the stores, or to get them into the stores and not have the advertising
in-place. We have already taken care of that, anticipating the growth. On
the ethical side, we are quite certain about the technical performance of
the drug. But there are potential problems outside of our control. For
example, you have to call for patients, what if nobody there has liver
cancer; there may be a delay that you donít have control of. You are going
to a regulatory agency and they have their own agendas and things they want
to see. We are very good at anticipating that. Even then, they may think of
something else that they want to see done. When you are doing diseases, it
is not like when you are doing animals here; I create the disease you canít
do that with humans, you have to wait for it to appear. Those are probably
the two biggest challenges."
CEOCFOinterviews: What would you like to say to potential investors?
Dr. Dees: "They approach us once they get a
good look at our analysis of the net worth of our properties. We have a
tremendously deep patent portfolio and its growing. We have thirteen issued
patents and a number of allowances as well as nineteen or twenty more in the
pipe in the process. We are deep in property. We had to do a survey of the
things we had on the books. Our external auditor had us prove it to them. We
had it booked at that time for $20.5 million. We did a very conservative
analysis of the business. We did not even put in any OTC. We did one cancer,
psoriasis, and we came up with the number of $406 million. That was before
multiple more patents had been issued and before we got the new IND. That is
now obsolete. If you look at our number of shares outstanding which is only
15.9 million, and divide it into 400-600 million, you immediately see that
we are one of the most undervalued stocks out there."
CEOCFOinterviews: In closing, do you do much outreach to investors?
"We speak to people all the time. We speak to the fund managers in New York
and other places. We will go to Europe to speak to them as well. People that
have seen what we are doing, know the under-value. People approach us all
the time. We just made a raise here of high net worth individuals. We
actually did it about 20 cents over the stock price. Once people do get a
look they agree with us on the under-value. They look at the data and at us
and realize we have two good old-fashioned values and that is making
products that people want and need and we have good margins. Plus, we are
tremendous believers in hard work and honesty.Ē
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