Dr. John L. Faessel
ON THE MARKET
Commentary and Insights
Science, Law and Credentials
Unfathomable Market Potential
Star Scientific Inc. (CIGX) Nasdaq
Some Comments after reading Star’s 223 page Patent Application
International Publication Number - WO 2011/119722 A2
For applicant Rock Creek Pharmaceuticals Inc a subsidiary of Star Scientific.
Title: “Use of Anatabine to Treat Inflammation and Methods of Synthesizing Anatabine”
To begin with, this patent application claims priority over 5 of Stars other patents...
Read below, verbatim, some of the “astonishing” summary and the essence of what is claimed in the application.
“A pharmaceutical composition comprising a therapeutically effective dose of an isolated form of anatabine or a pharmaceutically acceptable salt thereof can be administered to an individual to
reduce a symptom of a disorder comprising an NF-kB mediated
inflammatory component or to reduce the risk of developing such a
disorder.” (My emphasis)
going further, let’s first recognize and understand some crucial
backdrop re the development and production of the document and the
credentials of some of the key institutions / players in this
extraordinary developing mosaic that is Star Scientific Inc. First, another key quote:
1. “Making false patent claims
could mean big fines for companies found liable under the false patent
marking statute. The Federal Circuit has distinguished a century old
precedent, and now every article falsely marked with a patent number is
subject to the maximum fine, rather than each decision to falsely mark.1 By
law the maximum fine is $500 for each item. This means a batch of
100,000 falsely marked products could face fines of $50,000,000, with
qui tam litigants eligible to collect half.2” (source: Bracewell & Giuliani LLP)
2. Stars Chairman of the Board, President, Chief Operating Officer Paul L. Perito
graduated from Harvard Law School (LLB/JD) as an Edward John Noble
Scholar in 1964. Mr. Perito was the President of the Harvard Law School
Association of the District of Columbia, a member of the Executive
Committee of the Harvard Law School Association, and Secretary to the
Harvard Law School Association. He is also a member of the International
Board of Overseers of Tufts University where he graduated Magna Cum
Laude and Phi Beta Kappa.
3. Shepherding Stars patent is the law firm Banner & Witcoff Ltd.
which was established in 1920. Its specialty is the practice of
intellectual property law in the United States and abroad with expertise
in biotechnology sciences issues. The firm is famous for successful
representation of the inventor in the Diamond v. Chakrabarty case that
held for the first time that a living, genetically-altered microorganism
constituted patentable subject matter; this decision spurred new
interest in patents, particularly in the then-nascent biotechnology
Next for more
essential backdrop, we quickly review the storied credentials of the
scientists and institutions surrounding the testing of anatabine / Anatabloc™. Don’t fail to peruse their full resumes via hyperlink.
1. The Roskamp Institute’s main goal is to discover new and effective treatments for Alzheimer's disease. Roskamp is funded by the National Institutes of Health and private donations, and is conducting research using anatabine / (RCP-006) / Anatabloc™ on Alzheimer’s
disease, gastroenterology, rheumatology, cancer, auto-immune diseases
(lupus), and cardio-atherogenesis (the process of atheromatous plaque
development in arteries), among other conditions.
2. Michael Mullan, M.D. PhD,
is Director of Roskamp Institute, His degrees include LMSSA (Medicine),
MRCP (Psychiatry), and Ph.D. (Molecular Genetics) from the University
of London, England. It is he who along with Roskamp’s Associate Director
Dr. Fiona Crawford, found that the genetic cause of Alzheimer’s disease
and its onset were directly related to the accumulation of a protein
called beta-amyloid, which makes up the telltale plaque that accumulates in the brains of people with Alzheimer’s.
3. Paul W. Ladenson M.D., was trained at Oxford University and Harvard Medical School, and is now Director of Endocrinology and Metabolism at Johns Hopkins Medical School where he is Professor of Medicine, Pathology, Oncology, and Radiology & Radiological Sciences.
4. Mr. Richard L. Sharp is member of the Johns Hopkins Medicine Board of Advisors and the founder and a board member of Crocs Inc. (CROX), as well as former Chairman of Circuit City and Carmax. Mr. Sharp is a former board member of Star Scientific. It was just reported that Mr. Sharp bought 100,000 shares of Star in the open market, see; http://secfilings.nasdaq.com/filingFrame...
Of note: Dr. Ladenson and Dr. David S. Cooper,
another notable professor of medicine and Director of the Johns Hopkins
Thyroid Clinic, presented the “feature” Paul Starr Award Lecture at the
recent 81st annual meeting of the American Thyroid Association
conference. The lecture was entitled, “The Medical Treatment of Hyperthyroidism: Past, Present, and Future”.
could go on, but I’m sure you get my drift: Star is lawyer’d up to the
gills in both management and eminent counsel and it is extremely
unlikely that they would knowingly make false patent claims that can
incur such stupendous fines (per above). Obviously this fact should be
held in mind when reading the claims and embodiments in the patent
application. And where would these claims originate? Try an assemblage
of renown scientists and institutions involved in anatabines development
and testing, some of it already concluded that focus bottom-line on one far-reaching theme: the use of anatabine in “reducing a symptom of a disorder comprising an NF-kB mediated inflammatory component” (as quoted in the summary above ) ― that is, reducing and quieting NF-kB ’s, a blood protein that acts as a first immune system responder to harmful cellular stimuli.
NF-kB controls many genes involved in inflammation, it is not
surprising that NF-kB is found to be chronically active in many
inflammatory diseases, such as, arthritis, sepsis, gastritis,
inflammatory bowel disease, asthma, among others. It is important to
understand that the key biological regulators of NF-kB happen to be
associated with elevated mortality, especially from cardiovascular diseases.
The study of inflammation has moved to a place of preeminence in
medical research and there are thousands of articles now referencing
this “first” response of the immune system. A quick Google search of
NF-kB brought up 3,260,000 results.
Many scientists now believe that cancer is caused by NF-kB’s gone “haywire,” and further believe that a product that would suppress NF-kB’s would have potential in both the prevention and treatment of cancer. See: Inflammation and cancer: How hot is the link? (The
University of Texas M.D. Anderson Cancer Center) Striking is that page
11 of the patent application mentions 130 different types of cancer that
may be addressed with anatabine.
Star believes―and is willing to state in the patent application and
make claims to the effect (54 claims made) that NF-kB’s are inhibited /
reduced / mediated / moderated in hundreds of conditions referred to as
embodiments in the patent. Would any law firm in their right mind make
the listing of 100’s of embodiments and claims relative to treating
may know that Star Scientific and the Roskamp Institute are in the
midst of a 300 person multi-site human clinical trial referred to as the
“Flint” study, examining the effect of anatabine / Anatabloc on C-reactive Protein [CRP].
This testing involves the treatment of neurological conditions as well
as conditions associated with elevated blood levels of C-reactive
protein [CRP], a marker of disease due to inflammation. It should be
noted that testing for CRP requires a simple blood test and the results
are generally included in blood panels of individuals over 30-years old
when the testing for cholesterol usually begins. The American Heart
Association website says that, “individuals with elevated levels of CRP
have a risk about 2 to 3 times higher than the risk of those with low
levels. Over a dozen major studies demonstrate that baseline levels of
CRP in apparently healthy men and women are highly predictive of future
risk of heart attack, stroke, sudden cardiac death, and the development
of peripheral arterial disease.”
The provisional patent application discloses that, “S-(-)-anatabine positively correlates with reduction of the inflammatory activity.” (My emphasis again)
Here for example, is how the new patent application treats the CRP embodiments and claims.  Anatabine can be used to reduce elevated blood levels of inflammatory markers such as CRP.  which is associated both with cardiovascular disease and cancer such as colon cancer... (Numbers in brackets taken directly from the numerical progression in the patent application)
Claim (numbers from the patent application)
7. Use of an isolated form of anatabine or a pharmaceutically acceptable salt
thereof in the manufacture of a medicament for reducing blood serum levels of Creactive
protein [CRP] in an individual.
8. Use according to claim 7 wherein the individual IS at risk for a disorder
comprising an NFKB-mediated inflammatory component.
9. Use according to claim 7 wherein the individual has a disorder comprising an
NFKB-mediated inflammatory component.
10. Use according to claim 7 wherein the NFKB-mediated inflammatory
component is chronic inflammation.
11. Use according to claim 7 wherein the individual is at risk for a disorder
selected from the group consisting of cardiovascular disease, cancer, and diabetes.
12. Use according to claim 7 wherein the individual has a disorder selected from
the group consisting of cardiovascular disease, cancer, and diabetes.
A Google search of C-reactive protein [CRP] brought up 5,520,000 results.
Let’s also recall that at a meeting on June 1st
at the Roskamp Institute Dr. Ladenson, the Johns Hopkins
endocrinologist, stated that, “aside from (RCP-006) there is no known
compound that stops thyroiditis.” Now see what the patent application
said about the autoimmune based condition:
Example 6. Treatment of thyroiditis.
this example illustrates administering anatabine for treating
thyroiditis. A female patient, aged approximately 52, has been afflicted
with Hashimoto’s thyroiditis for approximately 5 years. The patient’s
condition had advanced to a state where the treating physician
recommended a thyroid lobectomy. The patient orally ingested a tablet
containing 600 ug anatabine citrate, 20 times daily over a period of 30
days. At the conclusion of the treatment, inflammation of the thyroid
was reduced to normal levels, such that the patient was no longer in
need of a thyroid lobectomy. The patient continued the treatment for an
additional 30 days, after which time the patient’s voice distortion
associated with thyroiditis was no longer present.”
Johns Hopkins is shepherding a study involving about 500 thyroid
disease subjects being treated with anatabine at the University of Pisa
Medical School, Pisa, Italy.
4. Use according to claim 1 or claim 2 (below) wherein the disorder is selected from the
group consisting of thyroiditis, cancer, arthritis, Alzheimer's disease, and multiple
1or 2) Use of an isolated form of anatabine or a pharmaceutically
acceptable salt thereof in the manufacture of a medicament for reducing a
symptom or “risk” as mentioned in claim #2 in an individual of a
disorder comprising an NFKB-mediated inflammatory component.
View a CBS news affiliate WNEM-TV video about Anatabloc™ and inflammation shown in the Flint/Tri-Cities
market in Michigan that features Dale Wilson MD, one of the principal
investigators in the clinical trial being conducted in the Flint area.
In the video Dr. Wilson states that, “Anatabloc™ turns chronic low grade
inflammation off.” Link available at: http://www.youtube.com/watch?v=StVre96Vz...
they say in this patent application is staggering in its importance in
lowering / mitigating / suppressing NF-kB’s in nearly 200 conditions and
present in a multitude of bodily woes; present in a number
of coronary and vascular diseases, and in auto-immune diseases such as
thyroid disease, diabetes asthma, Crohn’s, Alzheimer’s, Parkinson’s,
Irritable Bowel Syndrome, cancers, arthritis and numerous other
conditions―and that includes ageing.* We
now know that over 190,000 people have taken anatabine / Anatabloc™ and
the anecdotal stories of wonderful results continue to pour in and the
peer review process is now well underway. I suggest that readers of this
report avail themselves of a serious examination of the patent
application. Link at: http://www.youtube.com/watch?v=StVre96Vzr8
* Re Part B: I’m saving my comments re ageing, telomeres and their effect on the Hayflick limit for a subsequent report.
Aging, or senescence, is the major cause of suffering, disease, and death in Western civilization. Gerontology,
also called biogerontology, is the science that studies the aging
process to prevent age-related disease and degeneration, preserve
health, and prolong human life.
I'm an investor in Star Scientific shares and have bought shares on the
open market and have no other affiliation with the company other than
as a shareholder.
missed my previous reports—more specific in detail and scope on each of
these themes—or wish to receive my Best Ideas for 2012, send a request
To view the new Anatabloc™ website; http://anatabloc.com/
Disclosure: I am long CIGXAdditional disclosure:
Disclosure: I'm an investor in Star Scientific shares and have bought
shares on the open market and have no other affiliation with the company
other than as a shareholder.