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Flying into Boston today from a week long trip in the Azores. Snow or not, life goes on in New England. Things might get thrown off by a day or two, but not much more.
Awesome. Thanks Karin.
As someone has pointed out in the past, these always seem to come out on Fridays or at least very late during the week.
If you really don't know, then I have some advice for you...
Buy some more. At some point in the future when all the rest of the puzzle pieces fall into place and you see the whole picture, you will be astounded.
Today is slow, so I will remind everyone...
Signs of stabilization across multiple cancer types at 75mg or below
In one case tumor shrinkage has been noted at 110mg or below
In one case a cancer lesion disappeared at 350mg
We are currently dosing at 450mg
In future trials, we may dose twice per week.
Do you know what you own?
When I decided to invest here, I knew I'd be in it for the long haul. I honestly don't get the flipping. I sleep better knowing my money is invested here, so I won't miss any surprise gaps up. If CTIX gets a poster for ASCO this year, watch out...
Mine have
BK - I know you've been busy, just wanted to check if you saw my post # 89841. Nothing big, just more confirmation.
That was the long shot, and I think he answered perfectly.
You are welcome!
redwing - I think you hit the nail on the head. Also, cohort 10 dosing is "continuing" and that is an encouraging sigh for cohort 10.
Those were my two take-aways.
Email from Leo. Sent today at 9:56, response 10:08am
Me:
Hello Mr. Ehrlich,
I couldn't be more excited about reaching these latter stages of the Kevetrin Phase 1 trial. With the incredible results PRd the other week (and presented at Biotech Showcase), I'm even more excited about cohort 10. If you have a chance, I was wondering if you could answer a few questions:
1) has dosing in cohort 10 at 450mg begun?
2) is Cellceutix planning on being at ASCO 2015?
If you choose to respond, I will post it on IHUB.
PS. I appreciate your efforts to stave off the short attack we recently went through. In March, I will celebrating my two year anniversary of being invested in your company. While my 27K shares may not have much influence on share price, it is a lot for me. I look forward to my next two years of being invested here.
Sincerely,
Jeff
Reponse:
Hi Jeff,
Regarding your question as to the 10th cohort at 450mg/m2, the answer is yes. Patients have been dosed and it is continuing. Dr Alexander the other week in San Francisco mentioned that it was starting.
As to ASCO, we will issue a press release at a later date as to our plans.
Best,
Leo Ehrlich
Someone contact Biohedge and let him know...
he can buy that beach house again.
4.20 hit! No one calls them like TD...
I was going to respond with the same thing. I think their merlot is great and their cab is a close second for me.
TOB - I'm at work so I can't replay the presentation, but I don't recall how they characterized the patient to suggest what dose she was receiving. If I recall, they stated a patient that started in Oct, received 2nd round of dosing in Nov...is there any reason why this wasn't Cohort 9 @350? Is there some reason to think this patient was from Oct. 2013? Thanks.
Because of B or because of K?
LR, he was speaking to the last time this happened. He was not speaking to market activity this morning.
HA! nice.
Not from what I see...
Edit...oh, sorry I see you mentioned 4.69.
Just wanted to share an article about an Amgen cancer drug getting unexpectedly approved early. Bodes well for our K timeline...
http://finance.yahoo.com/news/u-fda-approves-amgen-leukemia-184519112.html
Okay, thanks. My ctix stock in my scottrade account has been down 90% multiple times this morning. I will just ignore it.
So, it looks like all $3.00 trades come through as $0.30? Is that what is going on today?
I posted this back in June...
Hi Jeff,
The simple answer is we believe Kevetrin in some situations would be quite complementary in combination with immunotherapy to produce synergistic anti tumor activity. Once the phase 1 is over I can explain it more in depth.
Leo Ehrlich
On Thu, Jun 12, 2014 at 9:54 AM,
Hello Mr. Ehrlich,
I have read a lot a articles recently referencing immunotherapy cancer treatments. Is it your position that immunotherapy treatments would be competition for Kevetrin or do you see the two types of treatments as complementary which would support future research for combination trials?
Thank you,
Jeff
10-Q out
Thanks for sharing.
I recall a conference/partner meeting CTIX was scheduled for in November (something like 18-20th). Does anyone have that link?
I think the link is dead, but I found the text online...
The green baron stock newsletter has an excellent profile of Cellceutix and it's auspicious new drug, Kevetrin.
A must read! (Reprinted below. )
We always focus on low priced stock investments that are worth holding for
an extended period of time. Our team digs hard and long to uncover stocks
that can feel comfortable sitting in your portfolio and letting the
mathematics of exponential portfolio growth do its work.
Well, as I was preparing to choose this month’s company, I sorted through
the usual. My bin of notes, notebooks, websites, browser bookmarks,
magazine articles, correspondences, news, charts and…, well you get the
picture. Then something caught my eye and captured my attention to the
point that I was completely enraptured in research and didn’t even realize I
was still having at it at 4:00 a.m.
It all started while surfing the financial news and I came across a
Bloomberg story that Pharmasset Inc.’s (NASDAQ:VRUS) experimental
hepatitis C drug PSI-7977 was effective when added to standard therapy in
98 percent of patients in a 121-person clinical trial. Being that I LOVE
biotechs because of the enormous growth potential they present, I started
looking at them and was, admittedly, a bit turned off by the high price tag,
but enamored by the fact that they were so pricey without any drugs on
the market. I watched the stock action the next day and was glued to
watching it drive north of $100 per share to push its market cap near $4
Billion!
Quite an impressive run-up considering it was only about $8 in March
2009.
In my due diligence I was, of course, reading Pharmasset’s releases.
Recently they had announced “that screening has begun in a Phase IIb
study of PSI-7977, a nucleotide analog polymerase inhibitor for the
treatment of chronic hepatitis C (HCV). The trial will evaluate PSI-7977
400mg QD with pegylated interferon and ribavirin in patients with HCV
genotype 1, 4, 5 or 6 who have not been treated previously.” Now, finding
untreated patients and filling a clinical trial with them is often more
difficult then it seems and takes quite a bit of time. But, that market cap of
over$3.7 BILLION would not leave my mind.
Is there a company can that achieve this in breaking speed and even pass
them in clinical studies? My hunt was on and I was not stopping until I
found one that fit the mold perfectly. Believe me, it wasn’t easy as, quite
honestly, there are a number of good developmental biotechs out there, but
they all paled in comparison to the gem I finally dug into.
Not Just Another Biotech
I must concede that I have been involved in the biotechnology investing
community for many years and spoken with countless developmental
biotechs (and device manufacturers) claiming to have the “greatest
discovery of all time.” Anyone that has spent any time at all around the
stock market has heard the story a thousand times, so immediate
skepticism is triggered and perhaps followed by a quick read on the given
company at best. I have been trained over the years to be a cynic first, and
to perform extensive due diligence.
I have to admit that I am extremely impressed as to what I see with this
biotech that I like to refer to as a “NYSE company donning an OTC suit.”
As such, I implore readers to take their time and explore what I have to
say. I urge readers to compound upon my findings with their own research
to challenge anything I bring forth to rebut the massive potential of this
company.
History of Cancer Therapies
Cancer therapies have come a long way, but are still relatively new in the
grand scheme of things, believe it or not. It was less than 70 years ago that
Dr. Sidney Farber, a pathologist at Harvard Medical School, was ridiculed
by many for his research and use of the analogues aminopterin and
amethopterin to treat children with acute lymphoblastic leukemia.
Incidentally, amethopterin is now called methotrexate and commonly used
today, Dr. Farber is now regarded as the “Father of Chemotherapy” and
Harvard’s world-renown cancer hospital is now called the “Dana-Farber
Cancer Institute” (The Charles A. Dana Foundation, a long-term supporter
the Institute, was acknowledged in 1983 with the name change).
It was not until 1965, that a major breakthrough was demonstrated
through the pioneering efforts of James Holland, Emil Freireich, and Emil
Frei. The three doctors hypothesized that cancer therapies should include
a multi-pronged approach of combining drugs that each had a separate
mechanism of action. The result was the ultimate cure for childhood
leukemia and a new approach to developing chemotherapy that is still used
and researched today. Without going into too much more detail, the point
is that a plethora of avenues are now being explored by countless
companies to develop cancer treatments, but the majority of it has only
been ongoing for the last few decades. Okay, enough with the history
lesson, let’s get to the meat and potatoes.
By the way, please note the name Emil Frei, as he appears again in this
report.
Not Just Another Biotech
I must concede that I have been involved in the biotechnology investing
community for many years and spoken with countless developmental
biotechs (and device manufacturers) claiming to have the “greatest
discovery of all time.” Anyone that has spent any time at all around the
stock market has heard the story a thousand times, so immediate
skepticism is triggered and perhaps followed by a quick read on the given
company at best. I have been trained over the years to be a cynic first, and
to perform extensive due diligence.
I have to admit that I am extremely impressed as to what I see with this
biotech that I like to refer to as a “NYSE company donning an OTC suit.”
As such, I implore readers to take their time and explore what I have to
say. I urge readers to compound upon my findings with their own research
to challenge anything I bring forth to rebut the massive potential of this
company.
History of Cancer Therapies
Cancer therapies have come a long way, but are still relatively new in the
grand scheme of things, believe it or not. It was less than 70 years ago that
Dr. Sidney Farber, a pathologist at Harvard Medical School, was ridiculed
by many for his research and use of the analogues aminopterin and
amethopterin to treat children with acute lymphoblastic leukemia.
Incidentally, amethopterin is now called methotrexate and commonly used
today, Dr. Farber is now regarded as the “Father of Chemotherapy” and
Harvard’s world-renown cancer hospital is now called the “Dana-Farber
Cancer Institute” (The Charles A. Dana Foundation, a long-term supporter
the Institute, was acknowledged in 1983 with the name change).
It was not until 1965, that a major breakthrough was demonstrated
through the pioneering efforts of James Holland, Emil Freireich, and Emil
Frei. The three doctors hypothesized that cancer therapies should include
a multi-pronged approach of combining drugs that each had a separate
mechanism of action. The result was the ultimate cure for childhood
leukemia and a new approach to developing chemotherapy that is still used
and researched today. Without going into too much more detail, the point
is that a plethora of avenues are now being explored by countless
companies to develop cancer treatments, but the majority of it has only
been ongoing for the last few decades. Okay, enough with the history
lesson, let’s get to the meat and potatoes.
By the way, please note the name Emil Frei, as he appears again in this
report.
The Mystery of p53: “The Guardian Angel of the Human
Genome”
Officially, p53 is a tumor suppressor protein that in humans is encoded by
the TP53 gene. In case you were wondering, p stands for protein and the 53
refers to the molecular weight in kiloDaltons. It is crucial to good health as
it regulates the cell cycle and, consequently, is critical in preventing cancer
because cancer tumors are nothing more than cells that are out of control
(maybe a little primitive in description, but you get the point). Because of
its regulatory duties, p53 has been appropriately dubbed “the Guardian
Angel of the Human Genome” and “The Guardian Angel Gene” amongst a
variety of other names that are descriptive of its protective nature to our
body’s well-being and controlling effects of cell mutations.
Now, I could recite a whole bunch of “white lab coat” sort of documentation
about the genetic structure and composition of p53, but the majority of the
population is not going to truly understand it from a scientific standpoint
and those that would, probably already know how important p53 is to cell
cycles. For the most part, I have learned over the years from speaking with
scientists and then conveying the message in “layman’s terms” to others to
speak with plenty of easily understood terms and analogies. What may
seem as idle prattle amongst a group of researchers with PhD’s is often a
daunting task to understand by the general population, myself
notwithstanding. The point is to understand is that p53 regulates cell
division and “speaks” to other proteins to perform their responsibilities.
Think of it as a General commanding his troops in day-to-day duties as
well as to methodically attack should the enemy invade upon the soil he
protects.
While p53 is the ultimate master of its craft in performing a wide array of
duties, with specificity to cancer, it acts through several mechanisms of
action. These include activating DNA repair, activating cell cycle arrest
(which means that it will stop the division of a cell at a specific stage to
allow proteins to repair the damaged cell) and inducing apoptosis, an
occurrence of “programmed cell death” should the cell not be able to be
repaired.
So, let’s look at this for what it really is and is doing for a moment. If the
DNA is damaged, “the Guardian Angel” triggers the mechanisms to fix the
DNA. If it is not a quick repair and the cell continues further with mitosis
(the cell division process), p53 tells other proteins to hit the brakes on the
cell division so the cell can be repaired to normal status. If the cell is not
repairable, then p53 orders for the cancer cell to be destroyed. Now,
obviously, I have simplified things to the extreme for explanation purposes,
but this is the long-and-short of what happens and demonstrates the
regulatory control of p53 and why it has been aptly given its title.
Nutlin
The oncology community has known about p53 for about 30 years with its
role and anti-tumor activities extensively researched. It has been proven
that in over 50 percent of all cancer cases, p53 is mutated and not
succinctly performing its duties as master regulator. As such, there has
been a concerted effort to discern how to repair damaged p53 to maintain
cellular and genetic stability.
At this point, I must inject one more piece of biotechnology/chemistry
information, but I will keep it as simple as possible. p53 is found in small
amounts, as that is all that is necessary to accurately perform its function,
and it is regulated by molecule MDM2 (“Murine Double Minute” – a
reference to the mouse chromosome in which it was discovered). In
humans, both p53 and MDM2 are on the short arm of chromosome 17.
Researchers have known that disruption of p53/MDM2 interaction leads
to activation of p53 and tumor suppression, but were unable to create the
disruption until a few years ago when scientists at Roche made what many
thought was going to be the biggest breakthrough in cancer research ever
with a series of molecules called cis-imidazolines analogs which they
named “Nutlins”.
The Nutlins demonstrated the ability to activate the p53 pathway and to
have anti-tumor effects in tumor cell lines, especially in those that overexpress MDM2. Everything was going as planned and people were dancing as apoptosis was happening, cell cycle arrest was shown and tumors were
being suppressed. The grins were turned upside down, however, when it
was determined that Nutlins were genotoxic, a term that refers to the
destruction of surrounding healthy cells and subsequently DNA. Again, to
put it in simple terms, think of it as napalming a whole area of your own
land to destroy a few intruders. The class of drugs still exists and is still
being researched to make modifications as the oncology world knows that
p53 activation holds the key to a new breed of chemotherapy, but is still
unsuccessful at this point to the best of my knowledge.
The Overlooked Headline of a Lifetime
In my research on p53, I stumbled across Cellceutix Corporation (OTCQB:
CTIX). This is where things started to get interesting and I had to dig
deeper. A press release issued by the Company on February 28, 2011
seemed to slip past the majority of the investment community; an
oversight that could turn out to be the best thing possible for those
reading this right now.
The PR titled ‘Cellceutix Makes Breakthrough in Cancer Research by
Activating p53, the ‘Guardian Angel of the Human Genome’ may have been
overlooked by people due to the fact that so many biotechs regularly throw
around the terms glorifying their research to simply try to generate
attention to their company. I don’t know if that is the case, nor does it
really matter to me. What I do know is that a closer look at what is going
on with Cellceutix combined with knowledge of the history of p53 research
and an overall understanding of FDA procedures has my generally cynical
nature being overwhelmed by the potential.
My basic questions had to be answered: “Is this developmental drug
Kevetrin™, which claims to reactivate p53, for real?”, and “Is it just
another Nutlin?” I first had to take a look at the source Company.
The Cellceutix Story
Outwardly, Cellceutix Corp is still relatively new to the scene; only being
founded less than four years ago. But, a look at the scientific and advisory
team reveals a strategic assembly of forces in the industry. Without
dragging complete resumés into this, I will hit the highlights of credentials:
? CSO/President/Board Member Dr. Krishna Menon: Nearly 30
highly-relevant years in the drug development industry including
being a recipient of the President’s Award during his time as a
Research Associate at Eli Lilly for his instrumental role in choosing
Alimta and Gemzar for development as cancer therapies. These
blockbuster chemotherapies are still two of the most widely used
drugs today and generated more than $3.3 billion in sales last year
alone.
? Scientific Advisory Board Member Dr. Emil Frei: Widely regarded as
one of the world’s leading oncologists with more than 40 years’
experience. His accomplishments include former Physician-in-Chief
at the Dana-Farber Cancer Institute (where he still resides as
Physician-in-Chief, Emeritus) and Chief of Medicine at the National
Cancer Institute. If the name rings a bell, it’s because he was
mentioned earlier for his role in the cure for childhood leukemia.
? Scientific Advisory Board Member Dr. Samuel Danishefsky: Widely
regarded as one of the world's leading chemists in cancer research,
PhD in Chemistry from Harvard, recipient of the First Annual
AACR-CICR Award for Outstanding Achievement in Chemistry in
Cancer Research and Chairman of the Laboratory for Cancer
Research Bioorganic Chemistry for Memorial Sloan-Kettering
Cancer Center
? Consultant Dr. Ashok Kumar: Dr. Kumar is a highly-regarded
Molecular Biologist who received his Ph.D. from Jawaharlal Nehru
University, one of the most prestigious schools in India, recipient of
a Japan Society of Promotion of Sciences fellowship from the
Government of Japan, extensively published in top scientific
journals in the area of Immunology and Molecular Biology and until
just recently, a faculty member in the Dept. of Immunology, Mayo
Clinic, Rochester, MN.
? Advisor Dr. Paul Ginsberg: Dr. Ginsberg is the former Head of the
New York Patent Department at Pfizer, Inc. where he represented
Pfizer and their blockbuster drugs Viagra and Chantix on the
intellectual property committees of the National Association of
Manufacturers, the Chemical Manufacturers Association and the
Biotechnology Industry Organization. He is perhaps most wellknown as the author of the patent covering Schering-Plough's
hugely successful product Claritin.
Normally, I wouldn’t go into any real length about the management of a
company, but this list was so impressive that I felt it had to be mentioned.
When a company has this many big names in the industry standing
behind its developments, it tends to swing open doors of opportunity to
“Big Pharma” due to their connections and industry recognition.
Kevetrin™ and p53: Going Where No Cancer Drug has Gone
Before
Solid management…check. Now it was time to dig into Kevetrin™. Given
the explanations above, readers should have a pretty good understanding
of p53, its critical roles in the homeostatic health of our bodies and the
quest of pharmas to figure out a way to restore damaged p53 to unleash
its wrath on cancer cells without damaging DNA. This could indeed by the
“Holy Grail” of chemotherapy and be worth billions and billions of dollars.
Being the research nerd that I am, I had to keep digging into Cellceutix
and their drug, Kevetrin™.
My research began by hitting the basics and speaking with the Company
about the compound. While I cannot provide direct quotations at this time
regarding my conversations with Cellceutix (I wanted to get this out
quickly and I always wait for approval of direct quotes), I am at liberty to
paraphrase a combination of my research with my discussions. Direct
quotes will be provided at a later time upon the Company’s approval.
Officially, Kevetrin is a salt of an isothiourea nitrile derivative that was
discovered by Cellceutix to have unique medicinal properties and appears
to be acceptable pharmaceutically for use in patients. Kevetrin™, a
completely novel compound (meaning that it is not a derivative of any
other drug), is a small molecule that had been in existence for quite some
time, but never considered independently for use in medicine and
definitely not as a chemotherapy. The compound is, however, used as a
chemical intermediate to making more complex compounds, but the
proprietary application now known as Kevetrin™ was the brainchild of Dr.
Menon and patented as such. Obviously, given his history, the good doctor
has a nose for innovative uses for compounds. Furthermore, being that
this class of chemistry was never used in medicine, the patent literally
covers tens of thousands of possible future chemical combinations for new
drugs; a potentially very valuable proposition for multiple drug
development.
Further due diligence revealed that early research on Kevetrin™ by
Cellceutix displayed a broad spectrum anti-cancer activity in xenograft
tumor models (lung, breast, colon, prostate, squamous cell, and leukemia),
while being well tolerated with low toxicity. There are many cancer drugs
that possess anti-tumor activities, but most also demonstrate high levels of
toxicity that often leads to necrosis and other actions which release toxic
contents into the body. Obviously, just by the word itself, it is not a
desirable attribute. Cytotoxicity assays for Kevetrin™ demonstrated a
relatively low potency in vitro and yet Kevetrin™ was efficacious against
multi-drug resistant tumors. Kevetrin™ was also shown to inhibit tumor
growth by arresting cells in the G2/M stage of cell division together with
increased apoptosis. Cell cycle arrest was associated with a change in
levels of G2/M proteins (CDK1, cdc25B and WEE1) and cell death was
promoted by pro-apoptotic signaling (p53, MDM2, p21 and PUMA) that
together affect the metabolic pathways in cancer cells. In short, Kevetrin™
was hitting on all cylinders with slowing and/or stopping tumor growth
and doing it in a non-toxic manner.
At this point, the Cellceutix team knew that they were on to something;
perhaps something very big. While searching for the Method of Action
(MOA) as to why Kevetrin™ was performing so effectively, that’s when the
p53 connection was discovered. Now it was known that this was something
big, but “just how big?” was the question presented to the team of
researchers.
Remember, genotoxicity is what crippled hope with Nutlins, so I looked for
evidence as to if Kevetrin™ affected nucleic acids or was found to bind and
alter DNA. Per the Cellceutix website, “Kevetrin™ did not induce
phosphorylation of H2A.X protein; whereas, other chemotherapy drugs,
such as Adriamycin, did induce the phosphorylation of H2A.X as shown by
Western blot assay.”
In layman’s terms, Kevetrin™ is shown to be non-genotoxic. I remember
thinking to myself, “Holy cow, this actually could be the Holy Grail of
cancer research.”
Kevetrin and Leukemia
When a biotechnology company starts to have the pieces of the puzzle
fitting together, it is logical that they are going to start testing it for a wide
array of possible uses. It only makes sense. Cellceutix, as announced
nearly two years ago, was targeting the most difficult cases of cancers that
had proven to be unaffected by present therapies. Cancer cells are
extremely resilient and have the ability to modify and adapt to their
environment through spontaneous mutation. As a result, in many cancer
patients, it does not matter what therapy is used, the tumors will continue
to mutate and thrive. These cases are called “multi-drug resistant cancers”
and inevitably lead to death of the patient.
“Multi-drug resistant cancers” may seem a bit complicated, but really it is
not. Every person that dies of cancer is an example of a victim of the term.
Think about it. A therapy (or a combination of therapies) may be effective
for a while in slowing tumor growth or seeing the cancer disappear for a
while (“going into remission”), but this could just be a latent stage and
when it returns, the cancer cells may have mutated and the therapy no
longer works. Subsequent therapies often prove to be ineffective as well
and the cancer can then run rampant. Hence, the cancer is “resistant to
multiple drugs.”
Kevetrin™ has already shown to have an impact in animal studies on some
of the most drug-resistant cancers today including breast, lung and colon
cancers. With the recently discovered confirmation of p53 rejuvenation, a
leukemia strain was tested. Amazingly enough, (or perhaps not so
amazingly given the positive effect the drug has had on everything else that
it’s been tested on), Kevetrin™ demonstrated potent anti-tumor activity in
the treatment of leukemia cells in a hematopoietic xenograft tumor model.
The results weren’t that Kevetrin™ had a mild impact; it had a huge
impact on the leukemia cells. After three weeks of treatment, Kevetrintreated mice saw a reduction in the average tumor volume by 84%.
Tumors in mice treated with Kevetrin took a median of 32 days to reach 1000 mm3
in volume whereas control mice took only 15 days, resulting in a Tumor
Growth Delay of 110%. In addition, after Kevetrin treatment, the tumors in
14% of the mice completely regressed for a period of 3 weeks. I will be
looking for confirmation from the Company, but I would imagine that the
three week period was the remaining time in the testing, which would
mean that the cancer never resurfaced. In my experience, a Company will
typically not state it in that manner as it sounds as if they are using the
word “cure,” which is completely taboo in the industry and never done.
Further validating the data, Dr. Emil Frei, the man who epitomizes
knowledge of leukemia research, reviewed the statistics and gave his
stamp of approval in a Cellceutix press release. He stated, “The p53
mechanism of Kevetrin as a possible new therapy for leukemia is very
exciting and holds significant promise. After Dr. Menon's years of hard
work, I am impressed with the progress of this novel compound. I look
forward to the commencement of human trials and the realization of
Kevetrin's potential as a new therapy for a wide array of cancers.”
You have to read into this kind of statement. Scientists speak in a very dry
manner the vast majority of the time and are very cautious to never say
even a syllable that could possibly be construed as a prediction of success.
That being understood, Dr. Frei’s comments carry a lot of weight as for the
possibilities of Kevetrin. Believe me, I have talked with a lot of scientists
over the years and these guys at Cellceutix seem to barely be able to hold
back their enthusiasm even though professional etiquette forces them to;
but I can read between the lines.
I even asked Dr. Menon if he was this excited with Gemzar and Alimta and
he assured me that he was not and that Kevetrin™ could be much, much
bigger (he had to reiterate “could” as a matter of course of conduct). From
a different perspective, each conversation with the Cellceutix staff was a
real pleasure because of the honest-to-goodness excitement in the air.
They never seem to leave the lab. They’re there 12 to 14 hours a day, 7
days a week grinding away at more at more tests almost just so they can
say “Yup, Kevetrin™ worked on that too!”
What cancer will be tested next has not been released by Cellceutix, nor
would they speak to me about it for disclosure reasons, but there was
some “dancing around the bush” that it could be huge news if the ongoing
research is successful. I wish that I could offer more information as they
have already hit the “big dogs” of cancers: breast, lung, colon and
leukemia. Pancreatic cancer, if not caught early, is a death sentence, so
perhaps that is on the agenda, but that is purely a speculative guess on
my part.
Clinical Trials for Kevetrin™ Cellceutix is nearing the targeted date of filing their Investigational New
Drug (IND) application with the U.S. Food and Drug Administration and
reported that it should be submitted in May 2011. Barring any
complications, Kevetrin™ should be in humans as a cancer treatment
sometime around August 2011. Confidentiality has kept the hospital
location from being released, but it has been stated that the trials will be
held at one of the world’s most prominent cancer centers.
Put your thinking cap on and pay attention as here is the most important
thing to understand about Phase I clinical trials for Cellceutix. Typically,
Phase I trials address safety for a new drug. For obvious reasons, the FDA,
the hospital and the biotech firm have to make sure that giving their new
drug to a human isn’t going to kill them and they have to evaluate
tolerable dosage levels.
This process will not be true in the same manner for Cellceutix. Their
patients will consist of the worst of the worst cancer patients; patients that
have late stage or terminal cancer. This is EXACTLY what a Company like
Cellceutix wants to see. Remember, they are targeting extreme, drugresistant cancers with Kevetrin™. There will obviously be an evaluation of safety component to the trials, but efficacy, although not the intent of the
study, will be noted. If Kevetrin™ demonstrates efficacy on any level, it’s
not a window of opportunity opening for Cellceutix, it’s a set of barn doors
flying open as they will have a drug that can be of benefit to a terminal
patient. It will need to be moved as quickly as possible to be tested as a
front-line defense.
While most people believe that the FDA review process is extremely slow
and that it takes nine to eleven years to bring a drug to market, this is not
true on every occasion. The FDA has programs in place to expedite new
drugs to advanced clinical stages that meet an area of great unmet medical
need. The “Accelerated Approval” and “Priority Review” programs are
exactly what Cellceutix will be focused upon should efficacy should be
demonstrated which could literally mean a jump straight to Phase III
clinical trials after a very minimal time in Phase I. Per standard protocol,
when Phase III is completed, a New Drug Application (NDA) is filed, which
also can be moved through at an expeditious pace. Abbot Laboratories,
Inc. is a prime example as their HIV infection drug, Norvir, received NDA
approved in 72 days from the date of submittal.
Why is Kevetrin™ a strong candidate for this sort of fast-tracking? Because
Kevetrin™ is like nothing else. It is, in fact, classified as a completely new
chemical entity in medicine. Read that again. It’s a “completely new
chemical entity in medicine.” That’s how unique it is. It also is being
developed to treat diseases that kill over 100,000 people annually. If
Kevetrin™ proves safe in humans and eliminates cancer as is has in
animal studies, it should move rapidly through the FDA approval process.
What normally would take years and years of clinical trials could be
slashed to as little as 24 or 30 months for Kevetrin™.
Direction and Potential
The foundation is laid as pre-clinical research has exceeded what could
have been considered lofty aspirations to begin with for Cellceutix and
Kevetrin™. As mentioned, any efficacy in Phase I trials later this year
should be a catalyst for the Company to soar. Although for obvious
reasons names were not disclosed, major pharmaceutical companies have
been in contact with Cellceutix with at least one multi-billion dollar drug
maker already signing a Confidential Disclosure Agreement (CDA).
Once again, Cellceutix is the exception to the rule as big pharmas just
aren’t typically interested in pre-clinical companies. It seems apparent that
Cellceutix has something extremely special with enormous revenue
potential and “Big Pharma” is already starting to move in on it. Take a look
at a just a few examples of a major pharma pouncing on drugs in
development:
? Astellas Pharma Inc. said it will pay Aveo Pharmaceuticals Inc. as
much as $1.3 billion for the rights to develop and sell an
experimental cancer drug that may compete with medicines from
Pfizer Inc. and Bayer AG. The drug, tivozanib, is now being tested
for kidney cancer in the last of three phases normally required for
U.S. approval (that means it’s only just completed Phase II clinical
trials).
? Proteolix, Inc. signed a definitive agreement to be acquired by Onyx
Pharmaceuticals, Inc. (Nasdaq: ONXX). Onyx will make a $276
million cash payment upon closing of the transaction. Additional
payments include $40 million payable in 2010 based on the
achievement of a development milestone and up to $535 million
contingent upon the achievement of anticipated approvals for
carfilzomib in the U.S. and Europe. Of the potential $535 million, a
payment of $170 million is based upon the achievement of
accelerated U.S. Food and Drug Administration approval.
? Sanofi-Aventis signed a research alliance with Ascenta Therapeutics
to develop Ascenta’s cancer drugs targeting p53-HDM2 proteinprotein interaction. Sanofi will pay Ascenta an undisclosed upfront
fee with Ascenta being eligible for development, regulatory and
commercial milestone payments that could reach $398 million as
well as receiving tiered royalty payments. None of the drugs are even industry as major pharma’s pipelines are running thin and a whole series
of patents are expiring soon (including Pfizer’s monster, Lipitor), the big
boys are going to be on the hunt for strong drug candidates and willing to
pay top dollar. Partnering offers, buy-out offers, etc. could all be on the
Company’s plate by the year’s end. Being in the driver’s seat by holding a
drug with quite possibly one of the greatest potential’s ever is certainly an
admirable position and Cellceutix is working their way into that slot.
The Whole Epiphany
Since this epiphany that I had started with the huge market cap of
Pharmasset, I had to look a bit closer at them. I saw that their trailing
twelve month revenue was less than $1 million and that they don’t have
any drugs approved by the FDA at this point nor does their pipeline have a
slew of drugs even close to a final review for marketing. It is notable that
they have $100 million in cash on their balance sheet, but other than that,
the rest of their value (currently trading at over $100 per share) appears to
be based upon the potential of the hepatitis C drug PSI-7977 and their
partnership with Roche for the development of PSI-6130 and its prodrugs,
including RG7128.
Willing to give credit where it is due, I certainly cannot knock Pharmasset
for all of their accomplishments and that is by no means my nature in
general. Running across Cellceutix Corporation and its tiny market cap of
$80 million and 85 cent share price may actually leave me owing
Pharmasset a debt of gratitude as it is theoretically possible that Cellceutix
will leapfrog past Pharmasset’s lead compound in the overall FDA approval
process in the next 18 months. Not only possible, but perhaps likely, as
Cellceutix will be getting their target patients in a Phase 1 trial, while I
assume Pharmasset was not able to as they needed to do a phase IIa trial.
Pharmasset now needs to recruit Hepatitis C patients who have never been
treated for its Phase IIb trial, a time consuming task. I believe Cellceutix
will be able to skip this phase if they are able to show efficacy against a
resistant cancer during its Phase 1 clinical trial. Let’s call this the “low
hanging fruit strategy.” Otherwise they can do a combined Phase 2/3.
Considering that Pharmasset’s market cap is 46 times CTIX; that leaves a
lot of potential upside in short order. Even though Kevetrin™ is addressing
a much larger target population and potential revenue would far exceed a
$3.75 billion market cap (market cap is typically valued at 4 to 5 times
potential sales), a valuation comparable to Phamasset’s market cap would
place the cost of a share of Cellceutix around $42. I think that the point is
pretty clear about the Company’s potential being severely overlooked by
the investment community. And I haven’t given one cent of value for the
other seven compounds in their pipeline, including their drug for autism,
which could also be a game changer as another disruptive technology.
in pre-clinical stages at this point and research shows that they will
target a much smaller cancer population than Kevetrin™.
Most notable is that none of those drugs comes close to addressing the
overall realm of potential therapies that Kevetrin™ does. If Astellas will pay
$1.3 billion for an experimental drug for only kidney cancer (which
reported 58,240 new cases in 2010), what would that make Kevetrin™
worth considering it addresses the more than 5 million total patients in the
United States alone that suffer from breast, lung, head & neck, and colon
cancer? Honestly, for all we know at this point, Kevetrin™ may work on
kidney cancer as well; it just hasn’t been tested against it yet.
When all things are considered and if things continue to stay their course
for the development of Kevetrin™, Cellceutix could very well be considering
the direction that they take in the near future. Given the state of the
industry as major pharma’s pipelines are running thin and a whole series
of patents are expiring soon (including Pfizer’s monster, Lipitor), the big
boys are going to be on the hunt for strong drug candidates and willing to
pay top dollar. Partnering offers, buy-out offers, etc. could all be on the
Company’s plate by the year’s end. Being in the driver’s seat by holding a
drug with quite possibly one of the greatest potential’s ever is certainly an
admirable position and Cellceutix is working their way into that slot.
The Whole Epiphany
Since this epiphany that I had started with the huge market cap of
Pharmasset, I had to look a bit closer at them. I saw that their trailing
twelve month revenue was less than $1 million and that they don’t have
any drugs approved by the FDA at this point nor does their pipeline have a
slew of drugs even close to a final review for marketing. It is notable that
they have $100 million in cash on their balance sheet, but other than that,
the rest of their value (currently trading at over $100 per share) appears to
be based upon the potential of the hepatitis C drug PSI-7977 and their
partnership with Roche for the development of PSI-6130 and its prodrugs,
including RG7128.
Willing to give credit where it is due, I certainly cannot knock Pharmasset
for all of their accomplishments and that is by no means my nature in
general. Running across Cellceutix Corporation and its tiny market cap of
$80 million and 85 cent share price may actually leave me owing
Pharmasset a debt of gratitude as it is theoretically possible that Cellceutix
will leapfrog past Pharmasset’s lead compound in the overall FDA approval
process in the next 18 months. Not only possible, but perhaps likely, as
Cellceutix will be getting their target patients in a Phase 1 trial, while I
assume Pharmasset was not able to as they needed to do a phase IIa trial.
Pharmasset now needs to recruit Hepatitis C patients who have never been
treated for its Phase IIb trial, a time consuming task. I believe Cellceutix
will be able to skip this phase if they are able to show efficacy against a
resistant cancer during its Phase 1 clinical trial. Let’s call this the “low
hanging fruit strategy.” Otherwise they can do a combined Phase 2/3.
Considering that Pharmasset’s market cap is 46 times CTIX; that leaves a
lot of potential upside in short order. Even though Kevetrin™ is addressing
a much larger target population and potential revenue would far exceed a
$3.75 billion market cap (market cap is typically valued at 4 to 5 times
potential sales), a valuation comparable to Phamasset’s market cap would
place the cost of a share of Cellceutix around $42. I think that the point is
pretty clear about the Company’s potential being severely overlooked by
the investment community. And I haven’t given one cent of value for the
other seven compounds in their pipeline, including their drug for autism,
which could also be a game changer as another disruptive technology
Read more at http://www.stockhouse.com/blogs/cellceutix-ctix/june-2011/the-green-baron-says-cellceutix-guardian-angel-wil#ClKAQzVVJ8FgFjkb.99
I love the simplicity of this post. I will save as part of my personal collection of great posts.
CTIX specifically mentions the possibility of a box warning in its SEC documents (I want to say this was revealed last summer). Overall side effects should be greatly reduced as the dose for psoriasis is much lower than what is used for HIV, but the hypersensitivity issue still remains. The box warning is still probable because of the hypersensitivity issue, but Prurisol patients will get a test to determine if they are hypersensitive before the drug is administered (If I recall correctly, dmattingly posted an email from Leo on this very item, I could look it up if you want...). While the test does greatly reduce the incidence of adverse reactions, it does not eliminate it. It will be interesting to see after the trials, whether or not the adverse reactions continue to occur or if the incidence is low enough to not warrant the warning. This will only be knows after trial data is released.
He also gave us the very vague "October/November" which gives him some leeway..
I thought the exact same thing. Thanks for posting this.
You might have to call some of your friends again
Great, thanks TOB. So, Leo may already have all the B 2b results.
things bug me in the back of my mind, I stew on them for a while...
NR, just wanted to clarify something. Do you understand this response from Leo to mean there are two separate things here...
1) unblinding
2) top-line data
Are these not one and the same?
Thanks!
HA! I used to have money on the sidelines, then I bought more CTIX, then I bought some more, then more, now I'm all in.
I'm probably averaging about 1.70/share, so it is nice to be in the black by a healthy margin. Within the next six months (maybe as soon as 1 month) we will all be referring to that "silly SAE that never amounted to anything" with our shares floating around $5.
I have most of (95%+) of my investment money anchored here for over 18 months - 25K shares. I have a house and two young kids.
If you look at my post from yesterday, I stated my favorite part of the PR was EXACTLY the line that he changed with the 8K. I almost want to say I took the change personally (Leo are you reading IHUB?).
Leo mocked the critics after this line on top of that. I have been carefully reading each PR, SEC doc and even attended the R@R conference in NY and we haven't got a single mention of any SAEs since the all clear at 80%. I guessed he was aware of something and therefore not mentioning it. I hope the SAE is either something not normally associated with B (like a Dapto SAE) or some other SAE that is common but can be explained by looking at the person's medical history etc...
I'm glad he corrected it swiftly and as I stated in my prior post, I've cooled down a bit and have come to my senses.
BK - the other possibility is that it was just some random SAE that can't be attributed to either drug... I recall an SAE from B 2a regarding a single platelet count SAE. No one (us, CTIX or POLY) seems to care at all about it.
After some frustrating thoughts yesterday, I too have come to my senses and think this is NOT going to be black-eye on the trial results. I just hope that it isn't a BP SAE when the data is unblinded.