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Grant Life Sciences may be the first company to bring a simple
blood test to the market that can determine the presence of cervical cancer or cervical
cancer pre-cursors
Healthcare
Diagnostics
(GLIF – OTC: BB)
Grant Life Sciences, Inc.
5511 Capital Contor Drive, Suite 223
Raleigh, NC 27606
Phone: 786-229-9795
Stan Yakatan
Chief Executive Officer
and President
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
March 24, 2005
BIO:
Stan Yakatan, MBA, is Chairman and CEO of Grant Life Sciences, Inc. He has over 30
years experience as a chief executive, entrepreneur, and operational manager for biotech
and medical companies. He served as an executive and in several instances as CEO
with New England Nuclear, EI Dupont, ICN Pharma, New Brunswick Scientific and Biosearch.
He has founded or co-founded more than 15 companies in the United States, Canada, Israel,
France and Germany and in many cases served as the initial CEO, and Chairman of these
companies. He sits on the board of directors of several public and private companies, and
has served as an advisor to a number of the world's leading venture capital firms
including TVM (Germany), Ventana (USA), MSP (USA) and Biocapital (Canada) as well as to
the governments of Australia and Canada.
Company Profile:
Grant Life Sciences, Inc. develops products to improve the efficiency of diagnosing
cervical cancer. The Company is developing protein-based screening tests to screen woman
for cervical cancer and pre-cancerous conditions. These screening tests analyze blood for
the presence of certain antibodies that appear only when cervical cancer or certain
pre-cancerous conditions are present. Invasive cervical cancer kills approximately 300,000
women annually world-wide. There are more than 120 million cervical screening tests
administered annually in the United States and Europe. But more than 120 million eligible
women 20+ years old in developed nations still do not get Pap smears. Globally, more than
1.7 billion women over the age of 20 do not undergo any cervical cancer screening.
CEOCFOinterviews: Mr.
Yakatan, please give us a little background on Grant Life Sciences.
Mr. Yakatan: “The technology behind Grant was begun over
two years ago when a scientist from China, working with the University of Utah, teamed up
with Dr. Mark Rosenfeld to do some work in cervical cancer. As a result of their initial
activities they filed a patent for the use of various amino acids to identify the
antibodies that surface when a woman has cervical cancer. They looked at blood and body
fluids as opposed to the traditional Pap smear. With their patent applied for, they
connected with a local entrepreneur named Michael Ahlin, who today is our Vice President
of Development and a Director with Grant, and he provided some initial capital. When the
venture capital route proved to be too dilutive, they began working with a brokerage firm
here in New York to facilitate a reverse merger with a publicly traded entity to raise
capital, which was done quickly and successfully. Then I and several others with a lot of
experience were recruited to be the management team, which is where we are today.”
CEOCFOinterviews: What is it that your test can do that
others can’t?
Mr. Yakatan: “Normally to check cervical cancer, women
generally go for a Pap smear, which is considered in the industry to be highly inaccurate.
Currently, there is no simple test, where you can just take the blood from a patient and
determine by measuring antibodies in the blood whether cervical cancer or cervical cancer
pre-cursors are present. We have developed what we believe is the first blood test
that does this, and the initial data is extremely compelling.”
CEOCFOinterviews: What
is it that your scientists have discovered that hasn’t been done before?
Mr. Yakatan: “We’ve discovered in the literature
five or six attempts to identify precursors to cervical cancer through various methods.
What our group did is developed a series of oncogenic amino acid sequences. We have
characterized them in a way that can be utilized in a standard screening test where the
amino acid sequences would truly identify the presence of cervical cancer or cervical
cancer pre-cursors in blood or bodily fluid samples. I don’t think it’s
any trick or black magic; I think that we’ve just been able to do a lot of laboratory
work in terms of screening hundreds of different amino acid sequences. We have discovered
that a test that we would make for the U.S. market may have a different sequence than a
test that we would make for the Indian or Chinese markets because the makeup of the
oncogenes that show cervical cancer activity vary in different geographical areas of the
world. What we are doing now is working very closely with a partner, Allogen, which is a
part of the Cleveland Clinic Foundation, in trying to characterize all of these amino
acids. We think that within three to six months, we’ll be able to have our initial
characterization completed and a product essentially ready to go into clinical trials,
both in the United States and in other places in the world.”
CEOCFOinterviews:
What’s the process and about how long does it take?
Mr. Yakatan: “We think that the longest process for us
is the amino acid characterization. What we want to do is a sample collection before
we go to any regulatory agency; we then test these samples from thousands of patients in
what we call institutional review board programs. We have a few of them already set-up at
USC, UCLA, Johns Hopkins and a local hospital in Utah. We’ve begun an active program
to identify 4,000 samples within a six-month period to do the characterization program. So
we think it may take two to three months to characterize the amino acids; another four to
six months to do the sample collection and process those samples. Then we would begin a
regulatory submission. If we are lucky, and I say lucky is the key word, we will be able
to file a 510K with the US FDA (Food and Drug Administration) as an adjunct to Pap smears
and that process could take three to six months. However, if we have to do a complete
product disclosure process, it could take as much as eighteen months to two years. We
believe that in the rest of the world we can get a swift approval of our rapid test. We
think that once the nine months to a year of laboratory development time and amino acid
characterization is completed, we could put a product on the market outside of the U.S.
within a year.”
CEOCFOinterviews: Where do you go from here?
Mr. Yakatan: “We’re continuing to characterize the
amino acid sequences to make sure that we have the right sequences. We are currently
developing two products, the first of which is an ELISA (Enzyme Linked Immunosorbent
Assay) test which we would file as an adjunct in the United States through the FDA.
The second is a rapid test-- a point-of-care test that would be low cost and could serve
the more than 1.7 billion women outside of the United States and Europe who normally
don’t get any type of cervical screening. This probably accounts for over half
the world and can be due to religious or economic reasons or just some type of taboo where
women don’t feel comfortable getting a cervical exam from a physician.”
CEOCFOinterviews: Is there a market for rapid test in the United
States?
Mr. Yakatan: “The issue is how imbedded the Pap smear is
in the U.S. and whether or not we would be able to get the community to accept a
blood test after 50 years of doing traditional Paps. In our early discussions with people
in the marketplace as well as the FDA, it’s been suggested to us that the best way to
get a new cancer test approved is as an adjunct. So, we think that strategically it makes
sense to develop an adjunct test for the U.S. market and develop an inexpensive rapid test
for the global market.”
CEOCFOinterviews: Do you have enough funding going forward?
Mr. Yakatan: “Our initial capitalization was through a
reverse merger were we raised about $1.8 million total. We are now looking for another $3
to $5 million and we think that with that second round of financing, we should be able to
complete all of the pre-market activities and get the products on the market.”
CEOCFOinterviews: What is the market potential for your test?
Mr. Yakatan: “In the United States, there are 60 million
women who receive routine Paps of some form. Out of that, about 20% get false positives or
false negatives, which lead to about 9 million colposcopy procedures; of that, 7 million
turn out to be negative. So, we want to focus on an adjunct test where we could reduce the
number of colposcopies and save the American health care system over $1.5 billion
annually, not to mention eliminating the unnecessary mental anguish some of the false
negatives create for our mothers and daughters. We think that the U.S. market alone
is about 7 to 10 million tests annually at $25.00 to $30.00 a test. As I said
before, the world market outside of the U.S. consists of over 1.7 billion women that have
never been screened. We think that for those women, we can develop a test that would cost
under $5.00, which is our goal. Then, we would ultimately put that same test on the market
in the United States. I was retired for many years from being a CEO in
biotech and when the opportunity came to me to look at a novel patented technology that
serves an unmet market of over 1.7 billion people, that was enough excitement to get me to
come back to work again.”
CEOCFOinterviews: Can you give us an idea of what you are up
against in the medical community to gain acceptance for your new approach?
Mr. Yakatan: “The issue is that Dr. George Papanicolaou
developed this test about 68 years ago. If you talk to any medical pathologist they
will tell you that this is an archaic test that is highly inaccurate. However, it has
become well accepted in the community. It is completely reimbursed by the insurance
community and if they get a false positive, the patient would then go for a colposcopy,
another reimbursable procedure. Unfortunately false negatives are more problematic of
course. Just to give an idea of how well entrenched the Pap smear is in the United States,
there was a recent article in the N.Y. Times that pointed out that about 12% of the women
receiving Pap smears have had hysterectomies. They don’t even have a cervix any
longer to take a Pap sample from!. Our new medical director, David Bolick, MD, FCAP,
MIAC, is one of the most well-known spokesmen in the world for the replacement of the Pap
smear. It’s one of the reasons we brought David into our fold and he will be speaking
at meetings all around the United States on our technology.”
CEOCFOinterviews: What about going directly to women and
women’s groups?
Mr. Yakatan: “We plan to do exactly that. One of our
founders, Michael Ahlin, has been given the responsibility to look into women’s
groups around the United States and see if we can generate support. It is common knowledge
among the medical community that the current process of the cervical examination a very
negative and highly invasive experience.”
CEOCFOinterviews: Could you address potential investors; what
should they know about the background of the management and the company that would make
them want to invest it Grant Life Sciences?
Mr. Yakatan: “We have a very experienced management
team. I have 35 years of experience in the biotech world. There are people who consider me
part of the old guard. I’ve run companies like this before and much of the investment
community knows who I am and my track record. We have a CFO, John Wilson, who has a
similar background and a strong financial pedigree. He was senior banker at Credit Suisse
First Boston and prior to that, served as CFO for Hardee’s Food Systems, Perrier USA
and Bell Canada International. John has served on numerous boards, both public and
private. In many of these cases, he was their CFO and did tremendous things for them. We
have someone who has 20 years experience in product development ready to join us. In
diagnostics we are working with the man who actually developed the rapid test program for
Hoffmann-La Roche in terms of developing our rapid test program. We are working directly
with the cancer center in China and that’s important because China has the highest
incidence of cervical cancer in the world. There are approximately 100,000 deaths there a
year because of the lack of screening and we are the only company that is working directly
with the center. One of our founders, and a continuing consultant to the Company, is
a scientific advisor to the center in China and has about ten years experience in the
Chinese market. We brought on as a consultant to the company a former high level executive
at the National Cancer Institute and he is working with us in terms of government funding
and grants. We believe that within the next 2 to 3 months we will solidify a major
relationship with an institute in the United States that has the largest W.H.O. grant in
the world for this type of work. So, we think that the combination of the experience of
the management team, plus the market size and viability of the market are excellent
opportunities for investors.”
CEOCFOinterviews: In closing, could you tell us how long do
you anticipate it will take for acceptance?
Mr. Yakatan: “The acceptance will be very rapid.
We’ve actually had discussions with the Gates Foundation and other organizations that
specialize in finding funding for third world countries and we are just in the early
stages of those discussions. In reality, the company as it exists now is essentially two
months old. The management team has worked very closely with the founders to pull together
all the work that has been done to date and that has been a harmonious relationship.”
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