TNI BioTech, Inc. Acquires the Exclusive Rights to Low Dose Naltrexone and Other Opioid Antagonists for the Treatment of Inflammatory and Ulcerative Diseases of the Bowel
TNI BioTech, Inc. (PINKSHEETS: TNIB) announced 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 Disease.
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 diseases
•Patients with HIV/AIDS, in combination with retroviral drug therapy
Over on the big Low Dose Naltrexone forum, folks voiced concerns about a price increase because of this news. I was wondering about the cost issue too with this TNI Biotec deal. But according to what is on the Low Dose Naltrexone site, Dr. Gluck posted this:
When our Latest News for October went online, it understandably led to a number of vocal concerns about the possibility that, following any successful Phase III trial and subsequent FDA approval, the price for LDN would skyrocket.
Since then, we were delighted to receive a statement from the CEO of TNI BioTech, Noreen Griffin, that her company is committed to charging no more than $1.00 a day for LDN, because it does not want to undermine LDN’s use as an affordable treatment. Kudos to TNIB!
Fears of a potential increase in LDN’s price are unwarranted. The FDA and any pharmaceutical company making an application for new drug approval are quite limited under the law. A clinical trial, by its very nature, can focus on only one disease. Such trials are very expensive—often at the level of tens of millions of dollars. Therefore, in the event that TNIB does receive FDA approval and patent rights for LDN treatment of Disease XYZ with a brand-named product, the pharmaceutical company is strictly limited to advertising and marketing that new brand as only for patients with Disease XYZ. Doubtless, there will be many people with XYZ who, with good reason, will insist on purchasing that new brand-name drug for their personal care.
However, totally unaffected will be the right of every physician to continue prescribing appropriate off-label uses of the FDA-approved generic medication naltrexone (in the form of LDN) for all of its many medical uses (other than Disease XYZ). Also unaffected will be the right of compounding pharmacies to fill such prescriptions requesting LDN and to do so at the accustomed price.
Most importantly, should the research efforts of TNI BioTech prove successful, FDA-approval of any one of LDN’s special uses could open up a whole world of recognition for LDN and, for the first time, considerable understanding and acceptance by both the media and the medical community. With that, the ability for anyone to receive an Rx of LDN (either as the brand or as a compounded off-label generic) for any of the great numbers of medical problems for which it is beneficial should then become a matter of course.
As a result, I dream of a subsequent decline, in the US alone, in both the annual rates of general morbidity/mortality and of health care costs of a whopping 15% to 20%. And beyond that, perhaps we will eventually live to see LDN sold over-the-counter at pharmacies around the world.