CIGX - Science, Law and Credentials and Unfathomable Market Potential - Comments after reading Star’s Patent Application
Dr. John L. Faessel
ON THE MARKET
Commentary and Insights
Dr.Faessel@onthemar.com
Science, Law and Credentials
Unfathomable Market Potential
Star Scientific Inc. (CIGX) Nasdaq
Some Comments after reading Star’s 223 page Patent Application
Part A
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.
THE SUMMARY:
“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)
Before 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 industry.
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”.
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I 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.
Because 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.
Accordingly, 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 these conditions?
CRP
You 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. [100] Anatabine can be used to reduce elevated blood levels of inflammatory markers such as CRP. [103] 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.
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Thyroiditis
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.
[216] 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.”
Additionally, 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.
Claim
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
sclerosis.
(Claim 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.
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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...
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What 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.
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.
If you 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: Dr.Faessel@onthemar.com
To view the new Anatabloc™ website; http://anatabloc.com/
Disclosure: I am long CIGX
Additional 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.
