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Key factors for Rexahn Pharmaceuticals are innovation, speed to
development and innovation in their clinical trial design and a lean management team to
focus the majority of their available capital on product development
Healthcare
Biotechnology
(RXHN.OB)
Rexahn Pharmaceuticals, Inc.
9620 Medical Center Drive
Rockville, MD 20850
Phone: 240-268-5300
George F. Steinfels, Ph.D., M.B.A.
Chief Business Officer and
Senior V.P. Clinical Development
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
June 1, 2006
BIO:
George F. Steinfels, Ph.D., M.B.A., Chief Business Officer
and Senior Vice President Clinical Development
Dr. Steinfels has served as Chief Business Officer and Senior Vice President, Clinical
Development since June 2004. Prior to coming to Rexahn, Dr. Steinfels since 2000 has
served as President of Genomic Strategies, a medical technology consulting firm that
provided client solutions in the areas of regulatory, clinical development, and product
launch and marketing. From 2001 to 2002, Dr. Steinfels was Chief Science Officer and
General Manager of QNOME at QED Solutions. From 1994 to 1998, Dr. Steinfels was Vice
President at The Lewin Group (which was acquired by Quintiles) where he started Lewin's
Strategic Marketing Practice. In 1999 he was Chief Operating Officer for the
Pharmacogenomics Business Unit of Quintiles, Inc. Dr Steinfels began his career in
pharmaceuticals at E.I. DuPont and later Dupont/Merck where he was Research Manager in
Central Nervous System Research. Dr. Steinfels received a B.A. in Biology from The Johns
Hopkins University, an M.S. and a Ph.D. in pharmacology from the University of Maryland,
and an M.B.A. from The Wharton School of the University of Pennsylvania.
Company Profile:
Rexahn is a pharmaceutical company dedicated to the discovery, development, and
commercialization of innovative products for the treatment of cancer and disorders of the
central nervous system.
Our therapeutic focus in
oncology is signal inhibitors, which are drugs that target the communication systems of
cancer cells. Disrupting the signals responsible for disease progression and/or metastasis
offers a more targeted approach with fewer side effects than traditional chemotherapy
drugs. Our current clinical development focus in neuroscience is anxiety and depression.
Our lead candidate has demonstrated activity in behavioral and biochemical models that
appear related to elevated serotonin and dopamine but unrelated to direct actions on
monoamine receptors or transporters.
CEOCFO: Dr. Steinfels,
what attracted you to the company?
Dr. Steinfels: “The thing that attracted me to Rexahn
was that it was a company of about three years of age,; they started in 2001 and it was
2004 when I started. There was a need for someone with the diverse background of skills
that I have. Although I wear the title of chief business officer, I manage the clinical
trials, I do much in the area of investors relations and communications, as well I am
responsible for the preclinical discovery work that is ongoing in our neuroscience area.
When I look back over my 25 years in its history, and look at the varied experiences that
I had, this was an opportunity for me to spread my wings and utilize every facet of my
career. It was an exciting opportunity to come into an organization and make a difference
as opposed to being pigeon-holed into one specific responsibility.”
CEOCFO: What is Rexahn
working on now?
Dr. Steinfels: “Rexahn has two major therapeutic
focuses; one is oncology, specifically treatment of solid tumors and the second is
treatment of central nervous system disease, and disorders, specifically anxiety and
depression. On the oncology side, we are pursuing unique molecules that are referred to as
signal transduction inhibitors. Since cells communicate by release of chemicals such as
proteins, and if you turn off the flow of protein production, a cell cannot communicate to
another cell. In the case of cancer, if cancer cells are not able to communicate with
cells within the tumor, bad things happen to the cancer cells such as they no longer can
divide. They can be sent back into a normal cell life cycle, which includes cell death.
They are unable to grow internal vasculatures so that there is no way to feed them with
nutrients and other things. Thus, turning off protein communications with a potent signal
transduction inhibitor, is a way to kill cancer cells and we believe that this method has
a high likelihood of producing fewer side effects compared with the old-line cyto-toxics
such as the platinum and the taxols. On the central nervous system (CNS) disease side, our
pursuit is in novel mechanisms to treat anxiety and depression, and it has been well
established over the last forty and nearly fifty years, that the most efficacious drugs
that treat depression and anxiety are those that work through the neurotransmitter
serotonin. The last several years, we have seen the Selective serotonin Reuptake
Inhibitors (SSIRs) such as ProzacŪ (Eli Lilly and Company - NYSE: LLY), which is perhaps
the most famous. The SSRIs have all generated significant revenue, despite competition,
but at the same time, these products produce side-effects, which influence patient
compliance and even efficacy. We were not certainly going to enter this market with a
‘me-too’ product, but instead wanted to have a product that was unique in its
mechanism, as well as having a pharmacology profile that included serotonin. Our lead
compound RX-10100, meets these criteria. We are bringing this into its Phase I clinical
process in hopes of seeing some activity that will be not only efficacious, but devoid of
side-effects.”
CEOCFO: Is there common thread between the two?
Dr. Steinfels: “No, there is not a common thread between
the two therapeutic areas. On the marketing side, there is a huge link, which is both are
areas where unmet medical need is high and the markets are significant worldwide; we
haven’t cured cancer and we haven’t cured anxiety and depression. From talking
to physicians and caregivers in the area, these diseases are still wanting for better
therapy. Therefore, the common link between our oncology and our anxiety and depression
therapies is on the marketing side rather than the technology side.”
CEOCFO: Where are you in
the process of the oncology project?
Dr. Steinfels: “Our most advanced oncology product;
RX-0201, is currently completing Phase I trial at the University of Alabama in Birmingham
and Georgetown. We are nearing the end of this Phase I clinical trial and right now, have
initiated the planning of our Phase II trial, which we plan to initiate later this
year.”
CEOCFO: I understand
this is indicated for a fair number of cancers. Will you tell us about the orphan drug
status and the benefits for Rexahn?
Dr. Steinfels: “The orphan drug act which was passed by
Congress in 1983, was passed to encourage research, development and commercialization in
disease areas where the patient population in the U.S. was less than 200,000 new cases
annually; and there are numerous cancers that fall in this category. Rexahn received
orphan designation at the beginning of 2005, for stomach, pancreatic, renal, ovarian and
brain tumors. All of these cancers fall well under the 200,000 patient limit. This
designation provides us with an opportunity to pursue an earlier stage of approval with
the FDA. Potentially, if we can demonstrate efficacy in a Phase 2 trial, we can go to the
FDA earlier, apply for accelerated review, approval. This is our go-to-market strategy for
the company. Along those lines, the other attractive avenue of oncology is that these
products are traditionally administered by oncologists and selling to this group can be
accomplished using a small specialty sales force. We are looking at specialty sales as the
avenue to generate revenue in Rexahn.”
CEOCFO: You have this
figured out from beginning to end!
Dr. Steinfels: “Our plan all along has been to sell
products with the Rexahn label. Our plans also call for Rexahn to develop co-development,
co-promotion relationships with partners for territories outside the U.S. For example, on
the CNS side, products for anxiety/depression are prescribed both by psychiatrists and by
general practitioners or internists. We foresee the potential of a co-marketing
co-development relationship where Rexahn will handle the specialty to the psychiatrist and
our partner would work with the larger group of general practitioners and internists.
Thus, the CNS area is likely to see co-promotion partnerships within the U.S.”
CEOCFO: You recently
entered into an agreement with the University of Maryland; will you tell us about that?
Dr. Steinfels: “The University of Maryland has a School
of Pharmacy. In the Pharmacy school’s Department of Pharmaceutics there have been
some very exciting research in areas of drug delivery. Drug delivery means different
things to different people; for us it is more than just an extended or sustained release
of a product. It is a way of targeting a product for a particular tumor type or taking a
product inside a cell, which is an objective for one of our products. Given the proximity
between Rexahn and the University of Maryland, we felt we could take advantage of a nearby
asset; in fact what we did is create a post doctoral program here at the company where we
have a Rexahn Post-Doctoral student, but the Post-Docs will also have joint appointments
at the University where they will work closely with university faculty. We hope to apply
some of the unique technology that these faculty are developing to Rexahn products now and
in the future.”
CEOCFO: Would this be
involved with NANO medicine?
Dr. Steinfels: “Nano is the great catch-all term that
people are using today, but it could relate to a whole variety of different technologies,
whether they be liposomes or polymers or a whole host of different technologies.”
CEOCFO: What is the
financial picture like at Rexahn today?
Dr. Steinfels: “In 2005, we had two very critical
events; we went public through a reverse merger in May and raised a total of nearly $13
million during the last calendar year. We have a healthy treasury to move us through the
year and allow us to move our RX from a one into a Phase II trial, brings our RX-10100
into Phase I, and even advance one of our small molecules into a pre-IMD toxicology. Our
plans this year are to raise additional capital and make a move from the bulletin board
NASDAQ location, which is where we are now, over to the Amex.”
CEOCFO: How do you
encourage the investment community to take notice?
Dr. Steinfels: “We are initially financed by several
groups in South Korea, and that is through our CEO and CFO who have very close ties into
the financial communities there, but importantly as we move forward, we are speaking to
investors, investment banks in the U.S. and telling them the Rexahn story, which is one of
a diverse pipeline and therapeutic area. While recognizing that drug discovery development
has successes and failures, a company should diversify or at least have multiple ways to
bring products through the pipeline. A company with a single product in development is
likely to fail—that is just based on statistics. Our product and portfolio strategy
is aimed at diversifying risk. We feel that we are diversifying our portfolio with
therapeutic areas of high need, high market areas, and high visibility. We are also
bringing up products that are not “me-toos” these are products that have targets
and endpoints that are measurable, not only in the pre-clinical situation, but in the
clinical situation. We are using these attributes to make ourselves noticed.”
CEOCFO: Do you need to
add to your management or research team?
Dr. Steinfels: “We have been operating on a very lean
format for the past several years. As we grow our clinical pipeline, we will be adding key
personnel, in the clinical and regulatory areas. As our products come closer to market, we
will bring in and establish a sales and marketing team here. As we see opportunities
develop further into drug delivery, we will expand the pharmaceutics group, which is
already under development here. Expansion is a key part of our plan.”
CEOCFO: Why should the
investment community be interested and is there anything that is overlooked about the
company that investors should realize?
Dr. Steinfels: “It is an exciting opportunity in an area
of strong markets, and a need for novel therapy. In the cancer area, we are looking at
targets that are unique for Rexahn, but validated targets. In the area of CNS, we are
pursuing novel ways to evaluate and treat anxiety and depression. Our key factors are
innovation, speed to development and innovation in our clinical trial design and a lean
management team to focus the majority of our available capital on development.”
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“Rexahn
has two major therapeutic focuses; one is oncology, specifically treatment of solid tumors
and the second is treatment of central nervous system disease, and disorders, specifically
anxiety and depression. On the oncology side, we are pursuing unique molecules that are
referred to as signal transduction inhibitors. Since cells communicate by release of
chemicals such as proteins, and if you turn off the flow of protein production, a cell
cannot communicate to another cell. In the case of cancer, if cancer cells are not able to
communicate with cells within the tumor, bad things happen to the cancer cells such as
they no longer can divide. They can be sent back into a normal cell life cycle, which
includes cell death. They are unable to grow internal vasculatures so that there is no way
to feed them with nutrients and other things. Thus, turning off protein communications
with a potent signal transduction inhibitor, is a way to kill cancer cells and we believe
that this method has a high likelihood of producing fewer side effects compared with the
old-line cyto-toxics such as the platinum and the taxols. On the central nervous system
(CNS) disease side, our pursuit is in novel mechanisms to treat anxiety and depression,
and it has been well established over the last forty and nearly fifty years, that the most
efficacious drugs that treat depression and anxiety are those that work through the
neurotransmitter serotonin.” - George F. Steinfels, Ph.D., M.B.A.
“It is an exciting opportunity in an area of strong markets, and a need for novel
therapy. In the cancer area, we are looking at targets that are unique for Rexahn, but
validated targets. In the area of CNS, we are pursuing novel ways to evaluate and treat
anxiety and depression. Our key factors are innovation, speed to development and
innovation in our clinical trial design and a lean management team to focus the majority
of our available capital on development.” - George F. Steinfels, Ph.D., M.B.A. |
