Dr. John L.
ON THE MARKET
Report from the
Harvard Club Meeting
Inc. (CIGX) Nasdaq
is no humbug!”*
What, sir, is no humbug? This
time, we refer to reputable opinion that;
1. “it is
‘overwhelmingly likely’ that multiple sclerosis [MS] is
fundamentally an inflammatory disease, and not a neurodegenerative Alzheimer-like
disease.” ** (quotation
source: the Mayo Clinic and Cleveland Clinic study published in the December 8,
2011 issue of the New England Journal of Medicine).
reduces the incidence of hind limb paralysis in the standard mice model of
Multiple Sclerosis and reduces the levels of peripheral cytokines associated
with the model maintaining them at normal levels. (See Dr. Mullan’s summary
* I have always loved the epic
proclamation enunciated back in 1846 when a surgeon, Professor John Warren, the
first dean of the Harvard Medical School (and previous
naysayer) on seeing ether first successfully demonstrated as an
anesthetic, exclaimed to the assembled scientists and doctors: “Gentlemen,
this is no humbug!”
So in a way it was providential that
Star Scientific Inc, found its way to the Harvard Club to bring interested parties up to date
on the fast-developing, multi-sided story of people, research, patents, and
snowballing progress. The awesome setting of the meeting, in which there
were approximately 125 participants, is worthy of a little ballyhoo itself, as
it is somehow a propos of where Star generally finds itself at this
The Harvard Club website says this about
their Harvard Hall: "Many architectural observers
consider Harvard Hall to be the finest clubroom in the Western Hemisphere, if
not the world.” The atmosphere is thick with regency, power and prestige, and
the crowd at the meeting looked the part. Food and bar were commensurate with
the setting. Did I mention the string trio? I’ve been in a few of the world’s
fine rooms, but this place spun my head around, to put it mildly.
To introduce the day’s agenda, Star’s
new Vice President for Communications, Ms. Talhia Tuck, led off with opening
remarks and introduced the speakers that would follow. Of note: Ms. Tuck
received her Bachelor of Arts cum laude from Harvard University and graduated
from Harvard Law School. While at Harvard she was a member of the Editorial
Staff of the Harvard Law and Policy Review. Ms. Tuck has also
worked in the financial sector at Goldman Sachs as a financial analyst and in
higher education administration as an admissions officer for Harvard
University. For Ms. Tucks complete and exceptional bio link here.
The first speaker was
Jonnie Williams, Star’s Chief Executive Officer, who gave a bit about the
company’s development, its history, and its tobacco roots. Mr. Williams
mentioned that Harvard had done research on Anatabine for two years before the
Anatabloc™ product was released. He spoke briefly about the re-emergence of
Star’s “ambassador,” pro golfer great Fred Couples, in the highly competitive
PGA tour and mentioned that Fred’s C-reactive protein [CRP] has dropped from
6.5 to 0.5. He noted that Anatabloc is now sold in 26 foreign countries
and the company gets international orders daily. Williams went on to say how
pleased he was with the sales response from General Nutrition centers (GNC) and that it
won't be long before the product is carried in many more of its stores. GNC has
over 7,600 locations in 53 countries.
Mr. Williams spoke briefly about the
Star vs. Reynolds Tobacco (RAI) lawsuit and mentioned the petition to be heard
by the US Supreme Court is in motion and will be responded to by Star by May
29, 2012 and be ruled on by the court sometime in June or after the courts
summer recess. (Specifically, The US Supreme Court decision will not impact the
mediation / settlement process that is ongoing in the Federal District Court in
Williams went on the say that Mr.
Chairman of the Board, President and Chief Operating Officer of Star
Scientific, Inc. is acting as “gatekeeper” to all things related to the
lawsuit. (Mr. Perito is the new president of the Harvard Law Alumni
Association; he was Secretary of the Harvard Law School Association [HLSA] for
the past 14 years, until 2010, when he was named First Vice President of the
Williams said that the day’s main focus would be on Anatabloc and the
recent work at the Roskamp Institute on the beneficial effects of nutritional
supplementation with anatabine in an animal model of Multiple Sclerosis [MS]
that was announced by the company on Tuesday. Link here for the press release.
The next speaker was Michael Mullan
M.D., Director of Roskamp Institute. His degrees include LMSSA (Medicine), MRCP
(Psychiatry), and Ph.D. (Molecular Genetics) from the University of London,
Dr. Mullan and the Roskamp Institute
have conducted research relating to the company's anatabine compound for a
number of years. To set the stage for his comments, here is the summary from
the patent claim (International Publication Number - WO 2011/119722 A2):
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.” (A Google search
of NF-kB brought up 3,350,000 results.)
believes—and is willing to state in the patent application and make claims (54
claims made) to the effect—that NF-kB’s are inhibited / reduced / mediated /
moderated in hundreds of conditions referred to as embodiments in the patent. Striking is
that page 11 of the patent application mentions 130 different types of cancer
that may be addressed with anatabine.
Dr. Mullan first
spoke to and thoroughly reprised with the supporting graphs the research that the
Roskamp Institute has performed, essentially what he presented last June at a
Roskamp Institute meeting. Mullan again played the videos that showed standard
Alzheimer’s-afflicted mice beginning not only to remember again, but
becoming able to add critical new information to the cognitive equation and,
thus, to change behavior so as even to improve their lot after the
administration of anatabine. That’s impossible for a “demented” mouse. A split
screen video depicted for comparison a mouse fully impaired with the disease.
He went on to say that CRP* levels also fell 50% in these test animals,
indicating less inflammation. Dr. Mullan called the research “profound.”
Dr. Mullan then
went into the new research that Roskamp released on Tuesday (May 8, 2012). Roskamp
used a standard mouse model of MS (multiple sclerosis), and the news was
that the Institute had completed a successful animal study of nutritional
supplementation with Star’s / Rock Creek's specially formulated anatabine. The
mice used in this testing were vaccinated to
induce a severe inflammatory process in the brain, which has the effect of
destroying neurons and causing progressive paralysis. The disease model looks
very similar to that which occurs in human multiple sclerosis. Profound is that
the anatabine dietary supplementation resulted in a dramatic reduction in
the rate of paralysis of hind limbs. In addition to the better motor
performance of the mice, there was evidence of suppression of the normal
inflammatory response that accompanies neuronal destruction in this model.
graphs and hearing Dr. Mullan present on the treatment with anatabine etc. is
one thing, but watching the videos of the mice—with and without anatabine on
board—was quite eye-opening, to say the least. Prominently, in the last part of
the presentation Mullan showed a video of mice with paralyzed hind quarters
that were in fact nearly immobile. The second part of the video showed
anatabine-treated mice startlingly having a huge degree of mobility and
demonstrated that the mice were able to move in what appeared to be an almost
normal manner except that their tails were still quite flaccid.
If you would
like to see two videos taken from my iPhone, send an email request to Dr.Faessel@onthemar.com. I will send
the videos in two segments due to their size.
The videos are
rather rudimentary, shot from the audience seating, however, you can see those
anatabine-treated mice scoot around in Technicolor. Amazing...
*** Mullan’s summary:
Anatabine reduces the incidence of hind limb paralysis in the standard mice
model of Multiple Sclerosis by about 66% and reduces the levels of peripheral
cytokines associated with the model maintaining them at normal levels. These
data are consistent with the reduction of NFK-B regulated inflammation seen in
the Alzheimer mouse model and suggests the overall mechanism is one of
reduced cytokine production secondary to reduced NFK-B activity.
Roskamp report is available on the Institute’s website at http://www.rfdn.org/ms_anatabine.html.
Dale A. Wilson
MD was the next speaker. Dr. Wilson practices obstetrics & gynecology in
Flint, Michigan and is one of the principal investigators in the clinical
trials being conducted in the Flint area (and now elsewhere in the state).
Participants in the study need to have elevated CRP levels in order to take
part. Dr. Wilson explained that the process is a single blind study involving
simply drawing blood and sending it to Roskamp for an analysis tracking
high-sensitivity C-reactive protein [hs-CRP] levels. He went on to state that
while he knows of no definitive or official results, he has heard numerous
anecdotal stories from the clinic relating to the results of taking Anatabloc,
which he characterizes as “very, very, very encouraging.” It should be noted
that Dr. Wilson has had a serious lung cancer (a Stage 3 adenocarcinoma), and
in the talk he mentioned that he is now cancer free after taking Anatabloc. It
is thought that results of the Flint Study will be released this summer.
and the Roskamp Institute had obtained institutional review board approval for
the multi-site human clinical trial referred to as the above-mentioned “Flint”
study related to 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. My cardiologist tells me that a high CRP is
actually predictive of a heart attack. The New England Journal of Medicine
says that, “C-reactive protein is an inflammatory marker believed to be of
value in the prediction of coronary events.” 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.” A Google
search of C-reactive protein [CRP] brought up 5,520,000 results.
mentioned that conditions that raise CRP such as coronary artery disease,
cancers, autoimmune diseases allergies, thyroiditis, arthritis, asthma, macular
degeneration, Crones, ulcerative disease of the bowel, fibromyalgia, lupus,
ulcers, neurodegenerative disease such as Alzheimer's disease, multiple
sclerosis and Parkinson's disease, and many other medical conditions are
candidates for treatment with anatabine.
In January Star announced that it had
completed a successful human clinical trial showing that Anatabloc lowers CRP
levels in subjects' blood.
In a video Dr.
Wilson states that, "Anatabloc turns chronic low grade inflammation
off." The video link: http://www.youtube.com/watch?v=StVre96Vzr88
talk Jonnie Williams held a “question and answer” session in which he and Dr.
Mullan fielded a variety of questions. Williams obviously didn’t want to talk
about the “Anatabloc™ skin cream,” but he mentioned that Johns
has nine studies now underway testing Anatabloc and said that several of the
ongoing studies would finish up this summer. He likened Anatabloc to a ferry
boat, as opposed to a cruise ship, meaning that the cruise ship will be the
eventual prescription drug that is derived from the isomer of anatabine while
the ferry boat represents the Anatabloc product now already available. “So why
wait for the cruise ship that’s in construction?” he suggested. Other questions
related to thyroid and the multiple Johns Hopkins studies. Williams talked
about how his wife is cured of thyroid disease; let us recall that the
distinguished Johns Hopkins professor, Dr. Paul Ladenson, has stated that, “aside from
RCP-006 (now Anatabloc) there is no known compound that stops thyroiditis.”
Over twenty (20)
million Americans suffer from thyroiditis. I believe media impact will be great
when the thyroid research is published.
If there was any
“new” news mentioned it was probably during the Q&A, when CEO Jonnie
Williams mentioned that he expected a global entity would be the first
to license the company’s technology to produce tobacco below detectable levels
of nitrosamines (i.e., the cancer causing agents in tobacco) “this summer.”
Underscore global—in other words, not necessarily US Big Tobacco.
As I said in my last report on Star: “somebody ‘out there’ is going to come in
with a substantive down payment plus a licensing or royalty deal, and I think
it's going to be sooner rather than later. It's going to happen.”
observation before I close. Throughout the Harvard Club evening it was
especially captivating to hear the assembled interested parties speak to their
own, their families’, and their friends’ experiences using Anatabloc. Williams
and Wilson both said that their families are taking Anatabloc, including some
young kids, even grand kids. It seemed to be a major theme in nearly every
conversation. The anecdotal stories of improvements in such a large quantity of
varied health conditions were really quite remarkable.
All in all it
was a heck of an evening.
To close, a factoid that’s more than
notable; Harvard numbers 17 Medal of Honor recipients among its alumni. The
quote below captures the essence of the sacrifice of the Harvard warriors:
So nigh is grandeur to our dust
So near to God is man
When duty whispers low, thou must.
The youth replies I can
-- Ralph Waldo Emerson – Harvard
** The Mayo Clinic and the Cleveland
study was published in the December 8, 2011, issue of the New England Journal of Medicine by co-lead
authors Drs. Lucchinetti and Ransohoff. Their findings support the
understanding that MS is primarily a disease of inflammation, not
neurodegeneration as some studies have recently suggested. Indeed, the authors
conclude that it is "overwhelmingly likely" that MS is fundamentally
an inflammatory disease.
To view the new
Anatabloc™ website that includes a link to buy the product online or by phone: http://anatabloc.com/
I'm an investor
in Star Scientific shares and have bought shares 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 the Star
Scientific (CIGX) themes—or wish to receive my Best Ideas for 2012, send a
request to: Dr.Faessel@onthemar.com