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Only down about 25% since the conference call.
Did you notice that the last PP shares went out at .10 cents?
(looks to me like that's where its headed)
Time to wake this sleeping beast up. With the good amount of volume, I’m going to go out on a limb say it reaches mid .30’s by Wednesday afternoon before the May 20th conference call.
Do note that in THIS POST
I stated: Next levels of significant support are around .13 cents and then .085
whadayaknow?
Lazaruswho???
Back to pivots which some have said are nonsense (along with charts) when applied to penny stocks, but as years of tracking this stock has proven, they work very well.
The upper pivot is now .41 cents and the lower is at .03
If I were a betting man, I would bet on the lower pivot being reached before the upper.
Just sayin'
As out previous poster noted, CTDH's redemption has been there ability to continually raise capital. Good luck with that one in this market.
10k is due out in about a week, and I see we're bidding .12 cents today. I'll pass and wait for prices that my charts dictate. Besides, at the present it only looks like their throwing out the dirty bathwater. I'll wait for the baby.
You were right, scam. You called it. Did you report to SEC yet? Been years now.
Nothing instills confidence in shareholders like a 50% drop in share price over 6 trading days.
Just missed on this one. Maybe get a second chance at sub teen.
I wonder if we're going to see Form 4's filed...and if so, by who????
I have someone in mind - but wont say.
https://ir.stockpr.com/ctd-holdings/company-news/detail/513 How? I thought it was a scam? Lmfao!
Cyclo Therapeutics Signs Master Services Agreement with Worldwide Clinical Trials
Press Release | 12/27/2019
Cyclo Therapeutics, Inc. (OTCQB: CTDH), a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C (NPC) and Alzheimer’s Disease, today announced that it has signed a Master Services Agreement with Worldwide Clinical Trials (Worldwide), a leading Contract Research Organization (CRO), to serve as CRO for the Company’s clinical programs evaluating Trappsol® Cyclo™, the Company’s proprietary hydroxypropyl beta cyclodextrin formulation, for the treatment of Niemann-Pick Disease Type C and Alzheimer’s Disease.
The Company currently supports a Phase I clinical trial for NPC in the United States, which recently completed enrollment (ClinicalTrials.gov NCT02939547); an Extension Protocol for the US study, which includes home-based infusions (NCT03893071); and a Phase I/II trial in Europe and Israel for NPC which is nearing completion of enrollment (NCT02912793). The Company will share its design of a pivotal trial in scientific advice meetings with regulators in the US and Europe in first and second quarters of 2020, respectively.
Cyclo Therapeutics is also developing a clinical program to address Alzheimer’s Disease, building on its Expanded Access program for a late onset patient (NCT03624842).
“We are very excited to take this next step in working with Worldwide, an industry leader in the rare disease and neurological disease space,” said N. Scott Fine, Company Chairman and CEO. “Worldwide will play a vital role as we build and execute our clinical programs in NPC and Alzheimer’s Disease.”
Worldwide Clinical Trials’ President and Chief Operating Officer, Peter Benton, said, “The scientific, medical and operational experts at Worldwide are privileged to be associated with Cyclo Therapeutics’ innovative clinical development program seeking to address the significant unmet clinical needs for NPC and Alzheimer’s patients.”
About Cyclo Therapeutics:
Cyclo Therapeutics, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease. The company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is in three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease (Clinical Trials.gov NCT02939547, NCT02912793 and NCT03893071), and in an Expanded Access program for late-onset Alzheimer’s Disease (NCT03624842). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development. For additional information, visit the company’s website: www.cyclotherapeutics.com
About Worldwide Clinical Trials:
Worldwide Clinical Trials employs more than 1,700 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs—in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services.
With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO.
For more information, visit http://www.worldwide.com.
Safe Harbor Statement:
This press release contains “forward-looking statements” about the company’s current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the company’s future performance include the company’s ability to obtain additional capital to expand operations as planned, success in achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the company’s biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food products. These and other risk factors are described from time to time in the company’s filings with the Securities and Exchange Commission, including, but not limited to, the company’s reports on Forms 10-K and 10-Q. Unless required by law, the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191227005025/en/
You say the stock is going to $2.00, again - we've heard this before - in fact, the last time you were touting two bucks the stock dropped from around .80 cents to ~ .15 cents.
So now the stock is supposed to go to $2.00 based ON "... a buy recommendation and $1.25 price target from ThinkEquity, a division of Fordham Financial Management."
Hmmmm....
Note that FORDHAM IS LISTED HERE:
Fraud Warnings Fraud Alerts From Financial Authorities
16/04/2019
https://isog.org/fraud-warnings-and-alerts/fraud-warnings-fraud-alerts-f/
And then there's this:
Dean Kajouras of Fordham Financial Management, Inc. Involved in $1.6 Million Customer Lawsuit
August 14, 2019 | by Fitapelli Kurta
HERE'S THE LINK TO THE ARTICLE
BUT --- SHOULDN'T THAT ARTICLE CONTAIN A DISCLOSURE?
'CUZ THERE'S THIS sec filing
Please read and post the paragraph that starts with "Cyclo Therapeutics (OTCQB: CTDH) is a client of RedChip Companies, Inc..."
*********************
Thanks in advance.
Disclaimer: I am a shareholder.
How? I thought this was a scam? Lmfao!
Kabooom! $2 coming! Told you! https://ir.stockpr.com/ctd-holdings/company-news/detail/512
To my knowledge, "conditional approval" does not exist. Certainly not after phase one. The idea behind conditional approval is that drug might be approved after phase 3, on the grounds that it seems effective but the FDA would like to see long-term data.
By nature, rare disease trials have two problems. One, not many patients and two, not enough time. NPC1 takes years to progress. It is different for every kid. Some kids have very bad mutations and die in a few years after birth. Others have less aggressive mutations and progression may take decades. I read an article about a women that was diagnosed with NPC1 at 60 years old.
So...an NPC1 trial only looks at a few patients( MNK and Orphazyme had 50-something patients, CTDH has less than that). The trials are for 52 weeks. In the FDA's opinion, 52 weeks is very small window into the disease progression. The idea behind conditional approval is to approve the drug on 52 week data if it seems positive. However, the trial participates would be monitored for the years to follow. If it appears after 3-5 years the drug actually does not work, approval is withdrawn.
I have heard many people lobby for this approach. My understanding is, as of now, it does not exist. I am not an expert. If you know otherwise please, direct me to that information. That would be very helpful!
I did hear a company argue that if a treatment is a re-purposed drug, with safety data already established, Phase one should be skipped. They argue in favor "conditional approval" with a short trial and few patients, as safety, theoretically, is not an issue.
Dear NPC1Parent,
my post has completely differnt meaning but you gave a way out to someone who was completed quite for 2 days...
I appreciate your posts.
Includes a lot valuable info. the most of them are known to me.
i have just one addition regarding the approval process
for rear deceases are 2 ways.
The safe one, if we can say this, to go step by step fase 1 ...face 2 ...face 3 etc
and the more risky way. to run something for more solid results and to chase a conditional approval from the FDA after face 1.
of course nobody knows what will happen at the end of the day and what the managment of CTDH have in mind...
for your situation i wish you all the best and hopefully a treatment to work for you after all
sent from mobile
please excuse eany bad spelling or typos
I believe they are in Phase I, so not a chance in Hell. It takes a long time to get a drug approved. Even "Fast Track" drugs.
That said, CTDH success does not depend drug approval by September. It depends on their ability to raise money. So far, they have been pretty resourceful. I wouldn't count them out.
In terms of FDA approval, it looks like the Orphazyme drug will approved before either CTDH or MNK. This came out yesterday.
https://www.globenewswire.com/news-release/2019/11/19/1949080/0/en/Orphazyme-receives-Breakthrough-Therapy-Designation-for-arimoclomol-in-Niemann-Pick-Disease-Type-C-NPC.html
I don't know what effect that will have on CTDH or MNK. Hopefully no effect. I want every company treating NPC1 to succeed.
Thanks for that. What would you put the odd of CTDH getting approval on one of their cyclo therapies before, say Sept of next year (when it looks like-at least to me- they will be out of cash again)?
Well...If you really want to know. This is old news.
The problem with VTS270 has to do with the trial design as required by the FDA. MNK sent out a video a few weeks ago explaining the problem. The trial was a 2/1. That is, for every 3 people in the trial , 2 get the drug and one gets sham. The trial also had a "rescue protocol". That is, if someone in the sham group declined rapidly, they could be "rescued" and given the drug. Decline (disease progression) was based on a point system.
I don't know the point system, but I will give an example. Lets say for description purposes, a decline of 20 points triggered the rescue protocol. If the patient dropped 20 points, they were taken out of the sham group and put "on drug".
Here is the problem: The FDA treats the patients on the rescue protocol as "missing data". As such, they assigned the patient a universal decline in points (for this example, 5 points). So... If a patient fell 22 points and was put "on drug", the data would reflect that the patient fell only 5 points. Essentially, that data was treated as "missing". Let's say the patient dropped 30 points before the rescue protocol...same result, the data would show only a drop of 5 points. 25 point decline...5 points. 35 point decline...5 points. And so forth.
Bottom-line result: The patients that dropped the most points, showing decline while not on the drug, is hidden. While decline was significant, it only shows up as a minor drop. Because the data on the rescue protocol is buried, it looks as if there is no difference between the sham and the "on drug" group. NPC1 progresses in a stair-up fashion. That is, you progress rapidly, then stabilize for a while (sometimes years), the you progress rapidly again. The trial was not design to capture this.
This system put rare disease drug developers in a very difficult situation. They can chose not to have a rescue protocol, so that their data is true. However, they would have to watch trial participates sustain additional disease progression or worse, death. "Sorry your kid can't talk any more, but we got good data!". The other option, and more moral option, is to include a rescue protocol but risk that your data will not be perfect.
If VTS270 doesn't work, neither does CTDH's drug. If you believe this, you should sell both stocks immediately.
My child is on VTS270. The drug works. CTDH's drug works.
If CTDH was smart, they stop focusing on very difficult to prove claims of neurological benefit from IV cyclo. Instead, they should focus on the benefit to the liver and other organs. Make neurological benefit a secondary endpoint. They can prove liver benefit without a sham group. If they want to prove neurological benefit, they will be in the same boat as MNK.
No comments on VTS-270?
So quite... most probably because you talk too much about it
•VTS-270, a cyclodextrin-based drug candidate in clinical development by Mallinckrodt, did not meet its primary objective in the pivotal Phase 2b/3 trial.
https://seekingalpha.com/article/4307548-mallinckrodt-vtsminus-270-niemann-pick-disease-type-c-competition
In our recently completed registration trial, the product did not show a statistically significant separation from placebo. But importantly, neither the VTS-270 nor the placebo arm showed disease progression as would have been anticipated in a neurodegenerative condition over 52 weeks of observation.
The expectation was that both treatment groups in the study would worsen over the trial period but that the VTS-270 treated group might show an attenuated course based on an accrued benefit.
Accordingly, our review of the data from the Phase 2b/3 trial has required substantial effort and still continues. We expect a better understanding of the potential benefit of VTS-270 to emerge as we carefully consider the totality of data available to us. This is an important step.
No mention of the recent Q?
Funny how so many posters here who are long never mention filings when they come out.
Why do you suppose.
Got comments on this 10Q?
How? People here say it’s a scam. Still, no one has reported it. https://ir.stockpr.com/ctd-holdings/company-news/detail/504
my next downside pivot is ~ .12 cents.
(just the mention of my tiny token position brought this to a 14 day low)
next Q due in around 3 weeks.
Q and year end tax loss selling could take it down further.
In the mean time, fingers crossed for cure for NPD (and Alzheimer's)
I took a small tracking position today, not to be construed as a vote of confidence; rather, now that I have shares in an account every trade of CTDH is posted on my portfolio tracker in real time which helps me to better follow the stock.
ARPO and IMUC - two biotechs both heading up - but not because of their drugs. Looks like they've pretty much thrown in the towel but they both have double the cash per share than their current trading prices.
Biotechs in a funk
Well the good news here is that CTDH is holding up better than Mallinckrodt
Do you realized that since Mallinckrodt bought out Sucampo for $1.2 billion dollars that the stock is down 90% -- It was around $23.00 at the time of the buyout.
Mallinckrodt [MNK] just hit a new all time low recently of $1.98 (has been has high as $134+)
Probably no one has reported it because there are so few that have a financial interest in the stock anymore. Wouldn't you think that most have likely licked their financial wounds long ago and moved on?
Pat
You were right. How is this not reported?
Consider this
Do note that Fordham is listed HERE in the SEC filing regarding the private placement.
Well, as the CEO of one public company (now defunct) once told me, the first ones to get into private placements are the THREE F's
FAMILY
FRIENDS
& FOOLS
That article just means that stock is now in their portfolio and they're talking their book.
LOOKS LIKE THEY MOVE IN AND OUT OF POSITIONS A LOT
Name change hasn't done much for the price. Lets see what the next Q looks like.
If you want to get an idea of how turdly the biotech space is -- just look at ARPO. That company has
less than 41 million shares outstanding
48 million in cash (around $1.18 per share in cash)
and trading at ~ .48 cents per share.
So quit your ridiculous yapping and say your hail Marys and pray your stock goes back up to .80 cents where you were shooting your mouth off about how it was headed to $2.00, easy.
I said .25 cents before $2.00
AND MY TARGET WAS OVERSHOT BY ~ 35%
What kind of genuinely helpful information are you trying to convey?
How do you change the name of a scam? Hmmm. Huh?
CTD Holdings Inc. changed to Cyclo Therapeutics Inc.:
https://otce.finra.org/otce/dailyList?viewType=Symbol%2FName%20Changes
Name/CUSIP Change - Effective 10/3/2019
A buy rating? How? Some here say scam! Did they report it to SEC? Um, nope. https://ir.stockpr.com/ctd-holdings/company-news/detail/500
Agreed. Substantive posts only are welcomed!
You really should just STFU! You were touting this at .80 - 1.00 -- telling us how it was soon to be $2.00. Since then its lost over 75% of its value and I'm sure there's a lot of unhappy people who are underwater here.
As for insider purchases...SO WHAT?
Insider buying or company share buybacks ARE NO GUARANTEE that the stock is a good deal / going to go higher.
read this article
How Retailers Like Bed Bath & Beyond Dug Their Own Graves
You really should just STFU!
You were touting this at .80 - 1.00 -- telling us how it was soon to be $2.00. Since then its lost over 75% of its value and I'm sure there's a lot of unhappy people who are underwater here. You should be ashamed of yourself.
As for insider purchases...SO WHAT?
Insider buying or company share buybacks ARE NO GUARANTEE that the stock is a good deal / going to go higher.
read this article
How Retailers Like Bed Bath & Beyond Dug Their Own Graves
Why would management buy tons of shares if scam? He was right, said scam, but why doesn’t he report it? He should, hmmm, weird.
H1 means first half of the year. H2 means second half of the year.
I am familiar with Orphazyme. However, there are very few kids in the US on Arimoclomol. Quick history. Cyclodextrin was available in the US quickly, in part, thanks to the work of the Hempels. The US Patients quickly tried to get into a trial or get the drug via compassionate use. However, the drug was not available in Europe. When my child was diagnosed, Orphazyme/arimoclomol did not exist. At this point, the EU kids were kind of screwed.
Orphazyme stepped in with Arimoclomol and signed up the EU population. In a strange way, this has been a blessing. We have been able to test two different drugs at the same time, which is very difficult in a small patient population. There are a few US kids on Airmoclomol, but I don't personally know any of the families.
Cyclodextrin and Airmoclomol work completely differently. This is a very simplistic explanation but, Cyclo removes cholesterol. Airmoclmol makes the misfolded NPC1 protein work better. You can't really compare the drugs. They do very different things. Each have their advantages and disadvantages.
As I said, Airmoclomol chaperones the NPC1 protein. However, if a child has a mutation that produces too few NPC1 proteins, airmoclomol will likely have no effect. It is very possible that overall 74% reduction in disease progression was because some patients produced enough NPC1 protein and experienced 100% reduction in disease progression. On the flip side, patients that produce too few proteins were non responders and experienced 0% reduction in disease progression. As a result, the total average fell in the 74% range. So...this is good news for some, bad news for others. It also highlights the fact that cyclodextrin remains a need treatment option, even if airmoclomol is a approved. Regardless of mutation, cyclodextrin removes cholesterol. Thus, there will be patients that MUST have cyclodextrin.
There is speculation that airmoclmol may be approved first. The FDA is afraid of averse events and side effects. Cyclo requires a medical procedure (IV and/or lumbar puncture). Added risk. Cyclo causes hearing loss, side effect. Airmoclomol is a pill with no side effects. Just from a safety perspective, the FDA may be inclined to approve airmoclomol first rather than cyclodextrin. However, as I said, this does not mean cyclodextrin will not be approved. It is not a "this or that" situation. It's a "this and that" situation. But I am starting to think Airmoclomol will be first. In fact, Orphazyme is talking with NORD and C-Path right now. I am not sure if CTDH or MNK were invited to this event. Foreshadowing?
https://finance.yahoo.com/news/orphazyme-cmo-speak-fda-funded-122232119.html
As I have posted before, long term, I think CTDH and MNK both face a lot competition. If those other companies are successful with more effective and less risky treatments, cyclodextrin will become irrelevant. However, this all speculation.
As parent with a child with NPC1, I want all the companies to succeed. CTDH, MNK, Orphazyme, and all the rest.
And ESPECIALLY would appreciate if you can provide any input on THIS from their latest press release:
Pivotal trial primary endpoint with arimoclomol for NPC showed 74% reduction in disease progression after 12 months, subgroups showed statistically significant efficacy. Anticipated H1 2020 filing submission in Europe and USA, following positive meetings with regulatory authorities
....as they indicate commercialization of their drug IN 2021 on the illustration of their pipeline HERE
Are you familiar with the work of Orphazyme?
(specifically, I would like to know what the term H1 & H2 mean)
and can you comment on this from their website:
that should read: "beat out the competition"
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If you have any questions about cyclodextrins or our company, feel free to email us, or contact Dr. Jeffrey Tate at 386-418-8060.
The mission of CTD Holdings Inc. is to develop, manufacture, and distribute cyclodextrin-based high value products. Our products treat disease, improve quality of life, and provide solutions in a broad range of applications including pharmaceutical formulation, medical diagnostics, cosmetics, nutraceuticals, and nutrition.
CTD Holdings Inc. provides the world’s widest range of cyclodextrin-based fine chemicals available from a single source. Through its Sphingo Biotechnology division it develops biopharmaceuticals using cyclodextrins as the active ingredient. The NanoSonic Products division provides industrial quantities of cyclodextrins for high value biotechnology manufacturing applications. The CTD division provides research quantities of cyclodextrins to biotechnology laboratories world-wide.
Substantially all of our revenues are derived from the sales of cyclodextrins, bio-pharmaceuticals containing cyclodextrins, cyclodextrin complexes, resale of cyclodextrins manufactured by others for our clients to their specifications, and our own licensed cyclodextrin products. We currently sell our products directly to customers in the diagnostics, pharmaceutical, and industrial chemical industries, and to chemical supply distributors. In 2012, we began offering pulse drying services.
Our core business has transitioned to a biotech drug development company from a business which had been primarily reselling basic cyclodextrin products, which have the least value-added attributes. Our strategy going forward is to pursue opportunities in healthcare where cyclodextrin applications have maximum value.
We market and sell bio-pharmaceuticals containing cyclodextrins, and cyclodextrins and related products to the pharmaceutical and other industries. Our revenues are principally from the sales of chemically modified cyclodextrins. For the year ended December 31, 2014, our revenues consisted of 58% biopharmaceuticals, 40% basic natural and chemically modified cyclodextrins, and 2% cyclodextrin complexes represented. Our business strategy is to increase sales by transitioning to the more value-added biopharmaceuticals and complexes and maintaining profitability for these products.
Our cyclodextrin sales historically involve small quantities (i.e., less than 1.0 Kg). We sell directly to our customers, package the orders at our facility and ship using common carriers.
The majority of our revenues are from five to ten customers who have historically been repeat purchasers. In 2014, one customer (UNO Healthcare, Inc.) accounted for more than 57% of our total revenue. In 2013, two customers (UNO Healthcare, Inc. and Sigma-Aldrich Fine Chemical, Inc.) accounted for more than 10% each of our total revenue, and collectively for 60% of our total revenue. Sigma-Aldrich Fine Chemical, Inc. accounts for almost 100% of our annual sales of Aquaplex®. In a year we typically sell to fewer than 200 individual customers.
We anticipate our customer trend to be moving to long-term or sole source contracts with our customers. In 2012, we signed a four-year supplier agreement for Trappsol® HPB with Siemens Corporation. Our customers buy products from us as needed primarily for product research and development purposes. Therefore, it is difficult to predict future sales, as it is dependent on the current cyclodextrin related research and development activities of others, which we have monitored in the past by following the issuance and applications of patents in the US and elsewhere.
We have identified pulse drying as a technology that promises benefits for turning commercial quantities of aqueous (liquid) solutions of Trappsol® cyclodextrins and Active Pharmaceutical Ingredients and other ingredients into a powdered solid. Pulse drying does this more economically and with less degradation to the materials than the traditional drying processes. The cyclodextrin and active ingredient come out in a complexed powder form that can be readily used by our customers to mix into their specific product formulations. In 2012 we completed construction of a c-GMP (current Good Manufacturing Practice) facility and installed a pulse drying system to manufacture commercial quantities of cyclodextrin complexes. These products will meet current food and Active Pharmaceutical Ingredient (“API”) production standards and will be sold using our Trappsol® and Aquaplex® product marks. API production quality standards are higher than those for foods but somewhat less stringent than those for finished pharmaceutical dosage manufacturers. We expect to expand and diversify our product offerings. We expect over time this will result in less volatility in our sales due to lower dependence on our cyclical research and development customers.
Share Structure:
Outstanding: 57,476,820
(as of August 11, 2015)
Sitrick and Company
Wendy Tanaka
11999 San Vicente Blvd
Los Angeles, CA 90049
415-369-8447
DD Links:
CTD Holdings Fact Sheet
March 31, 2012 - http://content.stockpr.com/ctdholdings/media/747eeebeb6c96b81d74eee2eecff9687.pdf
WSR Equity Research Report
February 21, 2012 - http://www.wallstreetresources.net/pdf/fc/CTDH.pdf
CTD Holdings - Nanosonic Uses USDA Grant to Install Solar Energy System
October 19, 2011 - http://www.gainesville.com/article/20111019/ARTICLES/111019423?tc=ar
FDA Orphan Drug Status Designation - Trappsol
May 17, 2010 - http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=303910
Dateline Story on Addi & Cassi Hempel - Using Trappsol to Treat Niemann Pick Type C
January 5, 2010 - http://www.youtube.com/watch?feature=player_embedded&v=se1Pzqjh26o
Cyclodextrin As A Therapeutic "Drug" For HIV AIDS, Niemann Pick Type C and other Viruses
April 16th, 2009 - http://webofhope.com/2009/04/cyclodextrin-as-a-theraputic-drug-for-hiv-aids-niemann-pick-type-c-and-other-viruses/
Mentioned in a Wall Street Journal Article:
http://online.wsj.com/article/SB123871183055784317.html
Cyclodextrin - Wikipedia:
http://en.wikipedia.org/wiki/Cyclodextrin
CEO Rick Strattan - Personally thanked following FDA Approval:
http://fightnpc.wordpress.com/2009/03/18/fda-approves-novel-cyclodextrin-treatment-for-addi-cassi/
Cyclodextrins are donut shaped circles of glucose (sugar) molecules that bring together oil and water and have potential applications anywhere oil and water must be used together. Successful applications have been made in the areas of agriculture, analytical chemistry, biotechnology, cosmetics, diagnostics, electronics, foodstuffs, pharmaceuticals and toxic waste treatment. Stabilization of food flavors and fragrances is the largest current worldwide market for Cyclodextrin applications. We and others have developed Cyclodextrin-based applications in stabilization of flavors for food products; elimination of undesirable tastes and odors; preparation of antifungal complexes for foods and toiletries; stabilization of fragrances and dyes; reduction of foaming in foods; cosmetics and toiletries; and the improvement of quality, stability and storability of foods.
Cyclodextrins can improve the solubility and stability of a wide range of drugs. Many promising drug compounds are unusable or have serious side effects because they are either too unstable or too insoluble in water. Strategies for administering currently approved compounds involve injection of formulations requiring pH adjustment and/or the use of organic solvents. The result is frequently painful, irritating, or damaging to the patient. These side effects can be ameliorated by Cyclodextrins. Cyclodextrins also have many potential uses in drug delivery for topical applications to the eyes and skin.
Cyclodextrins are formed naturally by the action of bacterial enzymes on starch. They were first noticed and isolated in 1891 by a French scientist, Villiers, as he studied rotting potatoes. The bacterial enzyme naturally creates a mixture of at least three different Cyclodextrins depending on how many glucose units are included in the molecular circle; six glucose units yield Alpha Cyclodextrin (“ACD”); seven units, Beta Cyclodextrin (“BCD”); eight units, Gamma Cyclodextrin (“GCD”). The more glucose units in the molecular circle, the greater the volume of the toroid. The inside of this “donut” provides an excellent resting place for “oily” molecules while the outside of the donut is significantly compatible with water enabling clear stable solutions of Cyclodextrins to exist in aqueous environments even when an “oily” molecule is carried within the donut hole. The net result is a molecular carrier that comes in small, medium, and large sizes with the ability to transport and deliver “oily” materials using water as the primary vehicle.
Cyclodextrins are manufactured in large quantities by mixing appropriate enzymes with starch solutions, thereby reproducing the natural process. ACD, BCD and GCD can be manufactured by an entirely natural process and therefore are considered to be natural products. Additional processing is required to isolate and separate the Cyclodextrins. The purified ACD, BCD, and GCD are referred to collectively as “natural” Cyclodextrins (NCDs).
The chemical groups on each glucose unit in a Cyclodextrin molecule provide chemists with ways to modify the properties of the Cyclodextrins, i.e. to make them more water soluble or less water soluble, thereby making them better carriers for a specific chemical. The Cyclodextrins that result from chemical modifications are no longer considered “natural” and are referred to as chemically modified Cyclodextrins. Since the property modifications achieved are often so advantageous to a specific application, the Company does not believe the loss of the “natural” product categorization will prevent its ultimate commercial use. It does, however, create a greater regulatory burden.
One of the premises that CTD based its future success on was the endless (literally) applications available to Cyclodextrin's. Wherever water and water insoluble or immiscible materials need to be brought together, one of the Cyclodextrin's is likely to make it possible and/or more efficiently accomplished.
The following table will give you an idea of the variety of the applications possible.
TABLE 4: Approved & Marketed Drugs Formulated with Cyclodextrins
COMPONENT | TRADE NAME | FORMULATION | INDICATION | COMPANY/ COUNTRY |
---|---|---|---|---|
PGE-1/alpha Cyclodextrin | Prostandin | Intra-arterial infusion | Chronic arterial occlusive disease, etc. | Ono/Japan |
PGE-1/alpha Cyclodextrin | Prostandin 500 | Intra-arterial infusion | Controls hypotension during surgery | Ono/Japan |
PGE-2/beta Cyclodextrin | Prostarmon E | Sublingual tablet | Induction of labor | Ono/Japan |
OP-1206/alpha Cyclodextrin | Opalmon | Tablet | Buerger's disease | Ono/Japan |
Benexate/beta Cyclodextrin | Ulgut | Capsules | Antiulcerant | Teikoku/Japan |
Benexate/beta Cyclodextrin | Lonmiel | Capsules | Antiulcerant | Shionogi/Japan |
Iodine/beta Cyclodextrin | Mena-Gargle | Gargling | Throat disinfectant | Kyushin/Japan |
Dexamethasone Glyteer/beta Cyclodextrin | Glymesason ointment | Ointment | Analgesic, anti-inflammatory | Fujinaga/Japan |
Nitroglycerin/beta Cyclodextrin | Nitropen | Sublingual tablet | Coronary dilator | Nippon Kayaku/Japan |
Cefotiam hexatil hydrochloride/alpha Cyclodextrin | Pansporin T | Tablet | Antibiotic | Takeda/Japan |
Oral Cephalosporin/beta Cyclodextrin | Meiact | Tablet | Antibiotic | Meiji Seika/Japan |
PGE-1/alpha Cyclodextrin | Prostavasin | Intra-arterial | Vasodilator | Schwarz/Germany |
Piroxicam/beta Cyclodextrin | Brexin | Tablet | Analgesic & antiphlogistic | Chiesi/Italy |
Itraconazole/hyroxypropyl beta Cyclodextrin | Sporanox Liquid | Oral liquid | Antifungal | Janssen/Belgium |
The global market demand for cyclodextrins continues to grow. A recent study (by QY Research Cyclodextrin Research Center) cites global demand as having almost doubled between 2009 and 2013 from 191,900 metric tons to 353,160 metric tons. Within the last 10 years, many more European countries have approved the use of cyclodextrins in food products. In the United States, major starch companies are renewing their earlier interest in cyclodextrins as food and nutraceutical additives. We believe the food additive industry world-wide will continue to increase its use of cyclodextrins.
Natural cyclodextrins have been confirmed to be generally recognized as safe (GRAS) in most of the world, now including the U.S. Moreover, approvals of products containing cyclodextrins by the U.S. Food and Drug Administration (FDA) since 2001 suggest that regulatory approval for new products may be easier in the future. In 2001, Janssen Pharmaceutica, now a subsidiary of Johnson & Johnson, received FDA approval to market Sporanox®, an antifungal which contained hydroxypropyl beta cyclodextrin as an excipient. In 2008, one of our clients used our product, Trappsol® hydroxypropyl beta cyclodextrin, in an FDA approved compassionate use investigational new drug protocol for the treatment of Niemann-Pick Type C disease. We now sell this product under our trademark Trappsol® Cyclo™. Our customer successfully applied to the FDA to designate Trappsol® Cyclo™ as an orphan drug in the treatment of Niemann Pick Type C disease in support of an Investigational New Drug protocol. Under the Orphan Drug Act, companies that develop a drug for a disorder affecting fewer than 200,000 people in the United States may seek designation as an orphan drug and, if such application is approved, they have the ability to sell it exclusively for seven years, and may get clinical trial tax incentives. On May 17, 2010, the FDA designated Trappsol® Cyclo™ as an orphan drug for the treatment of Niemann-Pick Type C disease.
Applications of cyclodextrins in personal products and for industrial uses have appeared in many patents and patent applications. Cyclodextrins are used in numerous brand-name household goods, including fabric softeners and air fresheners. With increased manufacturing capacity and supply the prices of the natural cyclodextrins have decreased to the point that use of these materials is considered in even the most price sensitive goods. We believe this will result in increasing demand for commercial uses of cyclodextrins.
In Japan, at least twelve pharmaceutical preparations are now marketed which contain cyclodextrins; there are also multiple products in Europe and the United States. The cyclodextrins permit the use of all routes of administration. Ease of delivery and improved bioavailability of such well-known drugs as nitroglycerin, dexamethasone, PGE(1&2), and cephalosporin permit these “old” drugs to command new market share and sometimes new patent lives. Because of the value added, it is management’s opinion that the dollar value of the worldwide market for products containing cyclodextrins and for complexes of cyclodextrins can be a hundred times that of the market sales of the cyclodextrin itself. This value increment portends opportunities for company growth in the pharmaceutical grade cyclodextrins and in custom cyclodextrin complexes.
Trappsol® Cyclo™ is a parenteral grade of hydroxypropyl beta cyclodextrin available in either a powdered or sterile liquid presentation. It has been designated an orphan drug by both the U.S. FDA and the European EMA. Trappsol® Cyclo™ is being developed in the Sphingo Biotechnology division for the treatment of Niemann Pick Type C disease, a rare and fatal illness tied to an autosomal recessive genetic defect.
Trappsol® is the trade name given to the Cyclodextrins CTD, Inc. provides to its customers. The Trappsol® name assures you the cyclodextrin you purchase is of the finest possible quality. The letter designations after the Trappsol® (T) name indicate the actual Cyclodextrin (Cyclodextrin); e.g. "B" is for Beta (β). THPG stands for Trappsol® Hydroxypropyl Gamma. Whenever possible, the catalog number will correspond to the cyclodextrin's name. Trappsol® products are organized by commercial category of Cyclodextrin: Alpha (α), Beta (β), and Gamma (γ).
While all of CTD's products are of Fine Chemical quality, CTD is also pleased to provide materials suitable for exacting Chromatographic procedures that are listed as Capillary Electrophoresis grade material. Therefore, the same catalog number may have two pricing levels referred to as FC-Grade and CE-Grade. The chemical entity is the same, but the isomeric purity and/or the level of impurities will be different for the CE-Grade, which is reflected in the higher pricing.
Within the Fine Chemical category, CTD is also pleased to be able to provide different grades of material, such as Pharmaceutical, Technical, Food, etc. These grade designations are primarily intended for Cyclodextrin's that are produced in bulk. The grade classification for these materials results from the manufacturing standards met by the manufacturer in terms of testing the bulk product before it is released. The different industries (Pharmaceutical, Food, Packaging, Adhesives, etc.) often require different kinds of testing; hence the grade designation is more an indication of the testing that has been done rather than differences in physical or chemical properties.
CAUTION
The Trappsol® and Aquaplex® products described on this site are intended for research and investigational uses only. They are not for human, veterinary or household use. (Since the pharmacological properties of the compounds described in this brochure are incompletely characterized, due care should be exercised in their use.) Material Safety Data Sheets and Certificates of Analysis are available upon request.
CTD offers a line of chemicals already complexed with Trappsol® cyclodextrins. They are categorized as Drugs, Flavors, and Miscellaneous chemicals. Their catalog numbers begin with AP to designate that they are Aquaplex complexes. The AP is followed by a four or five letter abbreviation of the active ingredient, ending with a number designating the type of Trappsol® cyclodextrin used in their manufacture as listed below.
1 | THPB | Trappsol® Hydroxypropyl Beta | ||
2 | TRMB | Trappsol® (Randomly) Methyl Beta | ||
3 | TBCD | Trappsol® Beta | ||
4 | TDMB | Trappsol® (2,6-di-O) Methyl Beta | ||
5 | TACD | Trappsol® Alpha | ||
6 | TGCD | Trappsol® Gamma | ||
7 | TG2BM | Trappsol® Maltosyl Mixture |
Management:
N. Scott Fine
Chairman of the Board and Chief Executive Officer
Mr. Fine has been involved in Investment Banking for more than 35 years working on a multitude of debt and equity financings, buy and sell side M & A, strategic advisory work and corporate restructurings. The majority of his time has been focused on transactions in the healthcare and consumer products area, including time with the Tempo Group of Jakarta, Indonesia when Mr. Fine and his family resided in Jakarta for two years.
Mr. Fine was the lead investment banker on the Initial Public Offering for Med-Design Corporation, a specialty medical device company, Keurig Green Mountain Coffee Roasters, and Central European Distribution Corporation, a multi-billion dollar alcohol company. He continued his involvement with CEDC serving as a director from 1996 until 2014, during which time he led the CEDC Board's successful efforts in 2013 to restructure the company through a pre-packaged Chapter 11 process whereby CEDC was acquired by the Russian Standard alcohol group.
Presently, Mr. Fine serves as Chairman and CEO of CTD Holdings Inc., a Biotechnology/Healthcare Company. He also serves on a number of Boards of Directors including: Better Place, Inc., where he is sole Director; Kenon Holdings Ltd, a spin-off from the Israel Corporation Ltd.; Global Virus Network where he is Chairman; and Forward Industries, where he serves as Chairman of the Audit Committee.
In addition to his business activities, Mr. Fine is an active participant with the Medal of Honor Foundation, the Intrepid Museum Foundation and is involved with the New York City Army Birthday Gala. He is also a director of Operation Respect, an anti-bullying education non-profit organization.
Mr. Fine has been a guest lecturer at Ohio State University's Moritz School of Law.
Dr. Jeffrey L. Tate
Director, Chief Operating Officer and Chief Scientific Officer
Dr. Tate is a seasoned executive with more than 30 years of experience in the biotechnology, pharmaceutical and nutritional supplements industries including: branded generic drugs, intellectual property strategy, product development, and cGMP manufacturing. He is intimately familiar with food and drug marketing approval procedures, documentation and strategy in U.S. and foreign markets, experienced in implementation of all aspects of regulatory compliance and in successfully communicating with regulatory agency representatives.
Dr. Tate has successfully established integrated regulatory compliance programs resulting in timely, cost effective corporate-wide compliance, meeting regulatory agency requirements and customer expectations. He closely monitors developments in U.S. and international regulations to maintain compliance and identify regulatory and intellectual property strategies for new products and markets. He holds patents and trademarks in material processing and food formulation.
C.E. "Rick" Strattan
Director and Founder
Mr. Strattan was with Pharmatec, Inc. where he became Director of Marketing and Business Development for CDs. He was responsible for CD sales and related business development efforts. From November, 1985 through May, 1987 he served as Chief Technical Officer for Boots-Celltech Diagnostics, Inc. He also served as Product Sales Manager for American Bio-Science Laboratories, a Division of American Hospital Supply Corporation.
Mr. Strattan is a graduate of the University of Florida with a BS degree in chemistry and mathematics and has also received an MS degree in Pharmacology and an MBA degree in Marketing/Computer Information Sciences from the same institution. Mr. Strattan has written and published numerous journal and white paper articles and a book chapter on the subject of cyclodextrins.
George L. Fails
Director, Vice President
Mr. Fails has served as Director of Operations for CTD Holdings Inc. since 2000 and was appointed president of CTD Inc. (a wholly owned subsidiary of CTDH) in 2008. From 1965 until his retirement in 1986, Mr. Fails served with the US Army Special Forces reaching the rank of Sergeant Major. Mr. Fails received his BA from the University of the Philippines, and also received degrees from 43 Military schools and the Federal Police Academy in Little Rock, Arkansas. Prior to joining the Company, Mr. Fails served as a Detective Sergeant with the Veterans Administration Hospital in Gainesville, Florida; and had special duties as an Officer with the US Marshall's Service.
Markus W. Sieger
Lead Director
Mr. Sieger advises companies in the pharmaceutical and media industries in Central and Eastern Europe. He is a Member of the Supervisory Board of Z.F. Polpharma S.A., the largest manufacturer of pharmaceuticals in Poland, and supervises the company’s operations. He also holds supervisory and board of director seats on other European and U.S. companies. For nearly two decades, Mr. Sieger was Managing Partner of fincoord, a company that advises entrepreneurs on business and financial strategies in emerging markets. At fincoord, Mr. Sieger focused on the media, pharmaceutical, engineering and food industries.
F. Patrick Ostronic
Director
Mr. Ostronic is an officer of US Pharmacia International, Inc., a subsidiary of USP, and also serves as the Chief Financial Officer of The USP Group. Mr. Ostronic is also a director of Novit US, Inc., the general partner of Novit
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