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With an experienced
management team and a novel and unique platform technology, Protox Therapeutics is focused
on creating new and improved therapies for prostate cancer and BPH
Healthcare
Protein Toxin Therapies
(PRX-TSXV)
Protox Therapeutics Inc.
1210-885 West Georgia Street
Vancouver, BC V6C 3E8
Phone: 604-688-0199
Fahar Merchant, Ph.D.
President and CEO
Leonard Cox
CFO and Vice President, Operations
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
May 18, 2006
BIO:
Fahar Merchant, Ph.D.
Chief Executive Officer
Dr. Merchant has over 18 years of progressive experience as a scientist, consultant,
entrepreneur and senior biotech executive. His entrepreneurial activities commenced in
1992 with the establishment of a consulting firm, Avicenna Medica, Inc. In 1994, he
co-founded a spin-off contract manufacturing company (INTELLIgene Expressions) and built
it into one of the fastest growing companies in Alberta. In 1999 the City of Edmonton
awarded Dr Merchant the Ambassadors Award for his contributions to the high tech industry.
By strategic in-licensing of targeted toxins he transformed Avicenna from a small
consulting firm to a $90 million company. He sold Avicenna in 2001 to KS Biomedix plc
(LSE) where he was their Chief Technology Officer (until 2002) and a Board member until
its subsequent sale to Xenova (LSE and Nasdaq). Dr. Merchant’s educational background
includes a Ph.D. in Biochemical Engineering from the University of Western Ontario.
Leonard Cox, BSc., CA
Chief Financial Officer and Vice President, Operations
Mr. Cox obtained his Chartered Accountant designation in 1994 and has held roles of
increasing responsibility in the biotechnology, high technology and manufacturing
industries. Prior to joining Protox, he was Vice President, Finance at Xenon
Pharmaceuticals Inc. During his five year tenure at Xenon, Mr. Cox was actively involved
in negotiating a US$157 million partnership and equity investment with Novartis AG,
completing a CDN$87 million collaboration and licensing agreement with Pfizer Inc. and
raising over CDN$100 million in VC and institutional financings. Prior to Xenon, Mr. Cox
held the position of Corporate Controller at Avcorp Industries. He holds a B.Sc. in
Biochemistry and Genetics from the University of Witwatersrand in South Africa and is a
member of the Institute of Chartered Accountants of British Columbia.
Company Profile:
Protox Therapeutics is a product-focused development stage company and a leader in
advancing novel, targeted protein toxin therapeutics for treatment of cancer and other
diseases. The company’s PORxin™ platform is based on engineered proaerolysin, a
naturally-occurring pore-forming protoxin. Product candidates generated using the
PORxin™ platform are inactive prodrugs that are activated at the tumor site into
potent toxins by cancer specific proteases, thereby causing cancer cell death. PRX302, the
company’s lead product candidate for localized prostate cancer and benign prostatic
hyperplasia, is a first-in-class pore-forming targeted toxin for cancer therapy.
CEOCFO: Mr. Merchant, will you tell us about your background
with the company?
Dr. Merchant: “I initially joined Protox Therapeutics as
Vice President of Corporate Development almost a year ago, but six weeks after I started,
the board asked me to take over as President and CEO because our former CEO had to step
down for health reasons. Prior to joining Protox, I was President and Chief Technology
Officer of a publicly traded company, KS Biomedix plc (LSE), which was a UK based company
that has now been bought by privately owned Xenova (LSE and Nasdaq). Previously to that, I
had started a biotech company in Edmonton, which was initially focused on manufacturing
clinical materials for various companies. I eventually transitioned the company into a
biopharma company by in-licensing targeted toxins for the treatment of brain tumors. Over
the past twelve years, I have been actively involved in the area of targeted therapeutics,
and specifically with targeted toxins.”
CEOCFO: What are
targeted toxins?
Dr. Merchant: “Targeted toxins are very potent drugs
comprised of naturally occurring proteins. Protox uses genetic engineering to transform
these proteins into novel targeted cancer therapeutics that destroy cancer cells by
creating pores, or holes, in the cell membrane.”
CEOCFO: How do you do that?
Dr. Merchant: “Our lead compound, called PRX302, is
based on a protein that is produced naturally by the bacteria Aeromonas hydrophilia. This protein is called
proaerolysin, and contains two important regions that allow it to exert its effect. The
first is a binding site that allows the molecule to attach to the surface of a cell and
the second is an “activation tail” that must be removed before it is able to
form a pore. Protox has engineered the tail on PRX302 so it can be cut off and activated
by prostate specific antigen or PSA, which is an enzyme that is produced at high levels by
prostate cancer cells. Once bound and activated, PRX302 combines with other activated
PRX302 molecules to form a mushroom shaped structure that is able to perforate the cell
membrane. The cell contents leak through the resulting pore and the cell dies. We are
currently conducting a Phase I clinical trial with PRX302 in patients with local recurrent
prostate cancer. The compound is injected locally into the prostate and reduces the tumor
size using a form of molecular surgery, which is much less invasive and more sophisticated
than traditional surgery.”
CEOCFO: Will you tell us about the advantages of your
technology?
Dr. Merchant: “PRX302 is essentially an engineered
version of proaerolysin. In the case of PRX302, we have engineered proaerolysin in such a
way that it becomes activated by an enzyme called PSA (prostate specific antigen). PSA is
produced by the prostate gland itself, and the level produced increases substantially when
a person has prostate cancer. We administer the drug locally into the prostate where it
becomes activated by the PSA. Once activated, PRX302 turns into a very potent toxin that
destroys the prostate cancer tumor.”
CEOCFO: Why did you
choose prostate cancer as your first target?
Dr. Merchant: “Mainly because of the ready availability
of the engineered version of proaerolysin that is activated by PSA, making it suitable for
prostate cancer. Our core inventors of the technology were at the University of Victoria
and Johns Hopkins University, where they had a great deal of expertise in the area of
prostate cancer. Prostate cancer is one of the leading causes of cancer death in men. One
in every six men will be diagnosed with prostate cancer during his lifetime. It is a large
market and although there are a number of existing treatments, all of them have serious
side effects such as impotence, urinary and bowel problems as well as emotional and social
issues that go along with the physical effects.”
CEOCFO: What happens
after Phase I?
Dr. Merchant: “Phase I studies are typically safety
studies done in healthy volunteers. What we are doing however is treating patients who
have localized recurrent prostate cancer, meaning they have already been treated for their
cancer with radiation but their cancer has come back. The prostate cancer also has to be
localized which means it has to be contained within the prostate and not have spread or
metastasized to other parts of the body. The Phase I study is a dose escalating study, so
we have started with a very low dose for our first group of patients, and then will
gradually increase the dosage in subsequent patients. We are monitoring the safety of the
drug in order to determine how high a dose we can go until we begin to see some toxicity.
Secondly, we hope to see some therapeutic effect of the drug in this study as well since
we will be also measuring PSA levels and performing biopsies following treatment. We hope
to see some tumor shrinkage and a decrease in PSA levels. We will be treating between 20
and 30 patients in this particular clinical trial. Our lead center and principal
investigator is from Scott and White Cancer Research Institute in Texas, which is part of
Texas A &M University. We plan to add two or perhaps three additional sites to this
trial as well. We expect to complete patient enrollment by the end of this year and even
have reported interim results by then, so it is a very exciting and transitional year for
us.”
CEOCFO: Are there other indications, products or therapies in
the future?
Dr. Merchant: “The second indication we are pursuing is
called benign prostatic hyperplasia (BPH) or what is commonly referred to as an enlarged
prostate. BPH is not itself a life threatening disease like prostate cancer, but it
affects a great number of men with bothersome and debilitating symptoms. Approximately 40
million men in Japan, Europe and the United States suffer from this condition. By the time
a man reaches the age of 60, he has a 50% chance of developing symptoms of BPH and that
number increases to 90% by the time he is 70 years. The prostate is a walnut shaped gland
located between the bladder and the rectum and wraps around the urethra, which is the tube
that carries urine through the penis. Symptoms consist of mainly lower urinary tract
difficulties caused by the growing prostate, which squeezes or exerts pressure on the
urethra thereby reducing urinary flow. Other symptoms include difficulty in initiating a
urinary stream, an interrupted or weak stream, a sense of urgency, leaking, dribbling and
even blood in the urine. As the urethra becomes narrower, the bladder wall becomes thicker
and the bladder itself becomes smaller causing more frequent urination, particularly at
night. Ultimately acute urinary retention occurs when a man can no longer pass any urine.
Because PSA levels are also elevated in the case of BPH, we plan to use the same drug,
PRX302 for this second indication as well, which is even larger than prostate cancer.
We plan to inject the drug directly into the prostate right in the doctor’s office so
it can be treated quite easily. These are the first two indications that we are pursuing.
We will file an IND (Investigational New Drug) application for BPH this year, and be ready
to start another Phase I clinical trial by the end of this year. The two indications,
prostate cancer, which affects every year about a quarter of a million North Americans and
takes the lives of about 30,000 males every year is a big indication. A much larger
indication is BPH--combined, the two indications have a market of about $14 billion and
the current therapies are not meeting the needs of the patients. We also have additional
research going on at Johns Hopkins University and the University of Victoria to create
other engineered proaerolysin drugs that can be used for other types of cancer or
proliferative diseases by engineering them to be activated by different proteases. We hope
that before the end of this year, we will have proof-of-concept data on a new compound for
treating another cancer.”
CEOCFO: What is the
financial picture at Protox?
Mr. Cox: “In 2004, the company went public on the
Toronto Venture exchange. At that time, we raised some public funds to finance the
preclinical studies for the prostate cancer program. Towards the end of last year, in
November of 2005, we completed another transaction, a private placement, raising just
short of $6 million, and that financing will be sufficient to fund the Phase I prostate
cancer trial as well as allow us to file the IND for BPH in preparation for our second
clinical trial.”
CEOCFO: Why should
people be investing in Protox Therapeutics as opposed to some of the other biotech
companies?
Dr. Merchant: “There are three reasons why investors
should invest in Protox Therapeutics. First, by focusing on prostate cancer and BPH, the
markets we are addressing are of substantial size and current therapies for these diseases
of simply do not measure up. They are unsatisfactory given the undesirable and
debilitating side effects such as impotence, incontinence, and so on. We are offering a
technology, which uses a very potent therapeutic agent and it, is administered using a
technique that is well established for prostate cancer as well as BPH. We are actually
performing a type of “molecular surgery” which is more sophisticated and less
invasive than other current therapies, so our technology offers huge advantages. Secondly,
these indications continue to grow as the population ages and the baby boomers hit their
sixties. There is continued increase in life expectancy in males and unlike other
therapies for BPH, which you have to take for the rest of your life; we are using a more
curative approach as we are destroying sections of the prostate. Those three things, the
market size, the minimally invasive and novel nature of our therapeutic approach, and the
fact that we offer a more curative approach are important reasons to invest in and support
our development.”
CEOCFO: In closing,
please tell us about the experience of your management team?
Dr. Merchant: “We, as a company have assembled a very
strong management team, particularly for an early stage company and despite remaining a
lean organization. We have amassed a considerable amount of experience in the biotech and
pharmaceutical sector. We have individuals that have taken products all the way into
late-stage clinical trials and we have a team that has worked extensively with targeted
toxins. We have a board of directors with a strong track record of success and who have
been part of a number of very successful companies in Canada. Combined with the very
exciting technology, we believe we are well positioned for success.”
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