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LDN news

From lowdosenaltrexone.org

As of October 2012:

TNI Acquires Bihari’s Patents; Phase III Trial Planned. Dr. Nicholas Plotnikoff, Chairman of TNI BioTech, recently announced that his company has acquired all of Dr. Bernard Bihari's use-patents for low dose naltrexone. This will enable TNI to proceed with its plans for a phase III clinical trial within the next 12 months, as well as plans to manufacture and sell the drug. Dr. Plotnikoff, quoted on the TNI BioTech website, said:

“I worked with Dr. Bernard Bihari for many years. I believe acquiring all of the technology of Dr. Bihari will allow the company, we hope, to move forward to Phase III clinical trials in both the United States and Africa within the next 12 months. In our opinion, LDN holds great promise for the millions of people worldwide with autoimmune diseases or central nervous system disorders or who face a deadly cancer. It could prove to be the first low-cost, easy to administer, and side-effect-free therapy for cancer, HIV/AIDS, MS and Crohn’s disease.”​
TNI BioTech has begun construction of a large pharmaceutical plant in Managua, Nicaragua for the production of LDN, under the trade name of IRT-103. It expects to be in operation by the end of this month and it is said to be capable of manufacturing well over one billion of the capsules annually. According to their website, the goal of TNI BioTech is “to enable mankind...to combat fatal disease by...mobilizing the body’s own immune system using TNI’s patented compound(s)”.

Dr. Plotnikoff, Emeritus Professor of Pharmacology and Psychoneuroimmunology, College of Pharmacy and College of Medicine, at the University of Illinois in Chicago, holds a PhD in Pharmacology. Prior to TNI, Dr. Plotnikoff helped direct research for Abbott Labs.

[Editor's Note: Some readers have expressed concern that the patenting and manufacture of LDN by a pharmaceutical company would increase the price of LDN for all users. Although a manufactured brand would initially have an increased price, it is probable that the price of LDN as an off-label, compounded drug should not be substantially affected. To explain why, later this month we will be posting a new entry on the LDN Editor's Blog.]

From tnibiotech.com

Dr. Henry “Skip” Lenz, Pharm.D, Joins TNI BioTech, Inc., as Quality Control Officer


I don't understand how it can be patented at this point. I'd rather pay more for a patented drug than take it from a compounding pharmacy. Less manipulation equals safer.
I don't understand how it can be patented at this point. I'd rather pay more for a patented drug than take it from a compounding pharmacy. Less manipulation equals safer.
Well, if your only problem with taking LDN is the fact that it is compounded, then you should trust Skip's Pharmacy. He is the one they hired to do quality control for this and he has a great reputation for quality. I get mine from his pharmacy and I think several others here do too.
I don't understand how it can be patented at this point. I'd rather pay more for a patented drug than take it from a compounding pharmacy. Less manipulation equals safer.
You would rather take LDN made from a plant in Nicaragua, than take it from a known national compounding pharmacy in the US?

My opinion is this is just more manipulation, with cheaper standards to keep cost down, that would if anything be more volatile in consistency/purity. I hate Pham companies... They are the reason we have not had this drug approved for decades
Ever tried to get the CCFA to disclose their top funders? Off topic I know.
I think CCFA + phar companies = scum. They keep each other alive by keeping drugs like this hidden, so that the big boys can stay alive(remicade ect)

CCFA = scum
Pham companies = scum

NO reason CCFA should of let this go unnoticed for so long!! All LDN needed for years was funding for a second double blinded study to get it on its way to be approved for crohns. You trying to tell me that CCFA really looked at the study of 73% success rate, with NO side effects, NO risk of cancer, cheap enough for everyone to afford it, and thought it wasn't worth a $100k study of donated money to get it started and find out??? How long went by, 11 years? Bullshit. I'll never donate a penny to them. And we've asked for a funders list for YEARS. There are 3 meds all with studies better results than remicade, still awaiting more trials for approval, after years...

Ok I'm done now...
Ziggy - I appreciate your rant, for one. There's big business in drugs. Just like there's big business in treating cancer. They are all in each others' pockets. If you "cure" Crohn's, or cure cancer, where does that leave all of them? Bingo.

Out of curiosity, what are the 3 medications with better results than Remicade?


Senior Member
I've heard (but this is all anecdotal, and could be inaccurate) that a Phase III study would cost millions. (Please, anyone will bona fide info on this please jump in). I also understood that Naltrexone is off patent protection, and available in a number of generic forms. If this is also accurate, then why haven't the generic makers offered a 5 mg pill? Does offering the pill in a smaller dosage require clinical trials? I can understand why advertising 5 mg (or 4.5 mg) pills of Naltrexone or its generic equivalent to treat IBD would require clinical trials, but I can't fathom why (or how) offering a known/registered and patented (even if off patent protection) product of a company in a non standard dose CAN be patented. You know what I mean? Or am I showing my total ignorance?
Like, if I developed a product... got it tested, approved, patented, etc.. lets call this product "Insane Glue"... and I marketed it in 75ml tubes. Another fellow comes along, reverse engineering gives him my formula, and he makes an identical product. Although it is chemically identical, he puts it on store shelves in 50ml tubes and calls it Idiot Glue.
Is that legal? Nothing has changed except the size it is available/distributed in. Sounds to my limited intelligence exactly what is purportedly happening with low dose Naltrexone. Mind you, if someone comes out with a patented, DIN registered 4.5 mg pill that does for me what LDN does for me, I'll be the first to jump on board. Once someone puts a DIN on this drug, drug plans have to cover it, and ANY pharmacy can offer it.
Exciting news. I think? I'm not sure I understand it all I know is LDN seems to really help a lot of people yet most doctors seem to poo poo it so maybe this will help change it?

As for the CCFA, all I know is that one of their directors is part of the (separate) company that processes the CCFAs donations and takes a cut. A larger cut than pretty much every other payment processing company out there would. :lol:

Its what is called a utility patent. i.e. if the existing known use is for drug addiction, and someone else discovers its good for crohn's or MS or arthritis, then they can file a patent for those uses.

Anyone who then sells it for those uses is infringing a patent. Many such patients get developed by drug companies, and yes, it costs a fortune to do a Phase 3 trial - in the vicinity of over $100 million (in the US at least). Actually the drug company figures how it costs over $1 billion to get a drug approved.


Senior Member
Hey Hopeful.. Thank you, thank you, for jumping in with real info. So, this group is hoping for a utility patent. On a drug that is off patent protection (otherwise the generic versions would be patent infringement, correct?).. So, if there is no patent protection left on the original Naltrexone, if this group is awarded a utility patent, they aren't infringing on any still existing patents anyway. I dunno.... somewhere in the middle of this my poor old head starting spinning. Right now, I spend about $300 per year for my Naltrexone. If they patent this (utility or otherwise) and start making pills in the right dosage for treating Crohns, and those pills have a DIN, my insurance company will pay for them.... AND.. hopefully the issue with 'stale' compounded pills will be fixed. And, even better, more doctors will get their thumbs out of their scope apertures and prescribe it.
Actually, they have the patent, its been granted. But they are not enforcing it (otherwise no compounding pharmacy could sell to Crohn's patients). So far they have not found a drug company interesting in investing in it - it will cost many millions to do a phase 3 trial. So meanwhile we can enjoy its benefits and hope that one day insurance will pay for it.


Senior Member
Now I'm really confused. There is a patent... for what? 4.5 mg of Naltrexone? Whoever makes Naltrexone sells it in bulk powder... and there are generic equivalents... so how is it possible to patent a dosage? Or enforce that patent? I could lay my hands on a script for 50mg Naltrexone pills and compound my own dosage... or do the same with a generic.

I mean... like, I recall being on pred... and ramping up... tapering off.. all that nightmarish stuff.... And at times it required me (with my handy dandy little pill splitter) taking 1/2 a pill. The makers of pred didn't make/sell 1/2 pills, so was I infringing on their patent? Or did I accidentally discover a new medication? You see what I'm saying?
Yes, it sounds strange. basically, they have the patent on the use of low dose naltrexone fro Crohn's.

So in theory you could file a patent for high dose naltrexone (if it worked) for Crohn's.

If a drug company sold LDN for Crohn's, they would be infringing that patent. if they sold it for another use, they would not be.

If a compounding pharmacy knew you were buying LDN for Crohn's, they would be infringing the patent by selling to you. But luckily the scripts don't mention what its for.
Its granted to the 3 listed - Smith, Zagon and Rogosnitzky. It does not show assignment to anyone, so I don't believe it is owned by TNI.
They have Bihari's patents.

I don't think Bihari patented use for IBD.

I'm looking them up now but the .gov site is SLLLOOOOOWWW.
From HERE:

The acquired portfolio contains six patents and applications related to:

  • Cancer of the prostate, lymphoproliferative syndrome, including such diseases as malignant lymphoma, chronic lymphocytic leukemia, Hodgkin's lymphoma, and non-Hodgkin's lymphoma

  • Infectious diseases such as 
chronic herpes virus infections, including chronic genital herpes caused by the herpes simplex virus, Type 2, and chronic infections due to the Epstein-Barr virus, and chronic inflammatory conditions including chronic fatigue syndrome

  • A treatment method for humans infected with HTLV-III (AIDS) virus, including patients clinically diagnosed as suffering from AIDS, those suffering from AIDS-related complex (ARC)

The portfolio includes all reissues or modification, reexaminations, or other related U.S. patent filings directed to the same subject matter. Licensed Patents refer to U.S. Patent No. U.S. Patent Number 6,586,443, U.S. Patent Number 6,384,044, U.S. Patent Number 6,288,074, U.S. Patent Number 5,356,900, U.S. Patent Number 5,013,739, U.S. Patent Number 4,888,346.

Its what is called a utility patent. i.e. if the existing known use is for drug addiction, and someone else discovers its good for crohn's or MS or arthritis, then they can file a patent for those uses.

Anyone who then sells it for those uses is infringing a patent. Many such patients get developed by drug companies, and yes, it costs a fortune to do a Phase 3 trial - in the vicinity of over $100 million (in the US at least). Actually the drug company figures how it costs over $1 billion to get a drug approved.
Yes but we were waiting for just phase 2 trials all those years that's the point. We couldn't even get phase 2 attention which cost a lot less than the phase three trials.
I think they did the Phase 2 trials - either in children or adults - those have been published.
Yes they have correct. The point was it took 11 years for them to do so!
CCFA should have been first in line a decade ago! I was the first kid to do remicade. You should of seen how fast that thing was fast tracked once they saw the $$ potential. And initial study on remicade was not as good as LDN. So why the 11 year lapse??

Only reason we are seeing LDN now is because of dr Jill and zagon. Only reason...


Senior Member
Well, if what is listed in part two of their patent applications (chronic inflammatory) applies to the myriad forms of IBD, then once their trials are successfull (which I expect they will be) then we are all a step closer to LDN going mainstream. However, if these patents do not include treatment for IBD ,and hence no specific Phase III trials, we are stuck where we are... a genuine treatment that remains outside the considered 'mainstream, normal' course of treatment for IBD despite it offering some.... significant advantages. The only upside I would derive from this latter scenario (if it is the case) is that even the most... close minded (I was going to go with pig headed) doctor would be hard pressed to dismiss LDN as 'proverbial snake oil' a treatment where highly respected researchers are investing the money for Phase III trials.
LDN for Crohn's gets licensed by TNI

For best results when printing this announcement, please click on the link


NEW YORK and BETHESDA, Md., Jan. 8, 2013 /PRNewswire/ -- TNI BioTech, Inc.
(PINKSHEETS: TNIB) announced today that it has signed an agreement for the
acquisition of patent rights and orphan drug designation by the FDA to a novel
late-stage drug, trademarked "LDN," for the treatment of Pediatric Crohn's

TNI BioTech has signed a licensing agreement to acquire the exclusive patent
rights for the intellectual property of Dr. Jill Smith and LDN Research LLC,
whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe
Rogosnitzky. The patent covers methods and formulations for treatment of the
inflammatory and ulcerative diseases of the bowel, using naltrexone in low dose
as an opioid antagonist. Endogenous opioids and opioid antagonists have been
shown to play a role in stimulating and rebalancing the immune system and the
healing and repair of tissues.

As part of the Agreement, TNI BioTech has the right to apply to the Food and
Drug Administration (FDA) for the transfer of the orphan drug status, the
investigational new drug applications (INDs), and the right to acquire the
relevant clinical data set from Dr. Smith. The FDA has designated orphan drug
status for the use of low dose naltrexone in the treatment of pediatric patients
with Crohn's disease and ulcerative colitis.

The agreement calls for the formation of a Development Committee to monitor the
clinical progress of the Licensed Products and will consist of independent
scientific and technical leaders who are highly regarded by the scientific
community in the Field of Use of each Licensed Product. The development
committee will consist of at least one representative from the Licensor Parties
and one representative from the Company in addition to outside experts in the
field. The inventors input will be highly valued due to their history and
expertise with the therapies.

"TNI BioTech is extremely pleased to acquire the exclusive rights to low dose
naltrexone and other opioid antagonists for the treatment of inflammatory and
ulcerative diseases of the bowel," stated Noreen Griffin, CEO of TNI BioTech.
"We believe that low dose naltrexone has the potential to provide significant
relief to those who suffer from Crohn's disease or other auto-immune disorders
of the bowel." Low dose naltrexone has already been evaluated in two randomized
placebo-controlled phase II trials, one for adult patients with Crohn's disease
and the other for children with Crohn's disease by Dr. Jill Smith. Naltrexone
in low dose has been well tolerated in almost all patients, and it showed
significantly greater treatment efficacy than the control group in both trials.
TNI BioTech is now planning to meet soon with the FDA to design and implement
pivotal phase III trial(s) for treatment for patients with Crohn's disease using
naltrexone in low dose. A platform immunomodulatory technology, naltrexone in
low dose also is expected to be clinically tested for treatment of other
immune-mediated or immune-deficient diseases, for which the company has
previously acquired additional patents.

About TNI BioTech, Inc.

TNI BioTech, Inc. is a biotech company working to combat chronic,
life-threatening diseases through the activation and modulation the body's
immune system using our patented immunotherapy. Our products and immunotherapy
technologies are designed to harness the power of the immune system to improve
the treatment of cancer, chronic inflammatory diseases and autoimmune diseases,
such as HIV/AIDS.

Our proprietary technology, therapies and patents include the treatment of a
wide range of cancers. Our most advanced clinical program involves immunotherapy
with Methionine Enkephalin (MENK) also termed Opioid Growth Factor (OGF), which
has been shown to stimulate the immune system even in patients with advanced
cancer. Management considers any condition that results in altered-immune
response as a target for investigation, and the Company will most likely pursue
additional investigations for low dose naltrexone and/or MENK as valuable
candidates in the treatment of the following:

* Autoimmune disorders such as rheumatoid arthritis and multiple sclerosis
* As an adjunct in cancer patients undergoing chemotherapy, radiation treatments
or surgery
* As an adjunct to antibiotics in the treatment of a variety of infectious
* Patients with HIV/AIDS, in combination with retroviral drug therapy

various "forward-looking statements" within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, which represent the Company's expectations or beliefs
concerning future events. Statements containing expressions such as "believes,"
"anticipates," "intends," or "expects," used in the Company's press releases and
in Disclosure Statements and Reports filed with the Over The Counter Markets
through the OTC Disclosure and News Service are intended to identify
forward-looking statements. All forward-looking statements involve risks and
uncertainties. Although the Company believes its expectations are based upon
reasonable assumptions within the bounds of its knowledge of its business and
operations, there can be no assurances that actual results will not differ
materially from expected results. The Company cautions that these and similar
statements included in this report are further qualified by important factors
that could cause actual results to differ materially from those in the
forward-looking statements. Readers are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date thereof. The Company
undertakes no obligation to publicly release any revisions to such
forward-looking statements to reflect events or circumstances after the date

See http://www.tnibiotech.com for more information.

Contact: Global Investment Media
Phone: 310-353-6277

SOURCE TNI BioTech, Inc.
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Does anyone know of a GI doc near Cincinnati, Ohio that would be willing to consider prescribing LDN? My son, 20 was just diagnosed last month after having to have surgery/resection. This is all very new to us and they are trying to start him on Remicade. He doesn't want it and neither do I. Based on the short time I have had to research, LDN is the safest option with little to no side effects. He has an appt with his GI on the 15th and we are running out of time. She was assigned to us in the hospital after surgery and seems nice, but basically did not give us a choice for treatment. She simply stated that he needs to start with the Remicade because he has surgery which makes his disease considered "aggressive and severe". He will only be allowed on our insurance for another 5 years...and then what?! Even if the Remicade works, he won't be able to pay for that kind of continued treatment when he is no longer allowed on our health insurance.