TNI BioTech, Inc. Acquires Portfolio of Exclusive Licenses to the Portfolio of Patents of Dr. Bernard Bihari

NEW YORK, NY--(Marketwire - August 28, 2012) -

TNI BioTech, Inc. (PINKSHEETS: TNIB) announced that it acquired exclusive licensing rights to all of the proprietary technical information, know-how, procedures, IND, protocols, methods, prototypes, designs, data and reports, which are not readily available to others through public means, and which are owned, generated or developed through experiments or testing by Dr. Bernard Bihari.

TNI BioTech, Inc. acquired the portfolio for 500,000 shares of the company’s stock and other consideration. As part of the agreement, the company agreed to maintain the patents and, in cases where additional patents have not been maintained in the last two years, TNI BioTech, Inc. plans to petition the United States Patent and Trademark Office to revive them immediately.

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.

Bernard Bihari, MD, was the discoverer of the clinical effects of Low Dose Naltrexone (LDN) in humans. In his groundbreaking clinical trial of patients with HIV/AIDS at Downstate Medical Center in 1985-86, Dr. Bihari discovered the significant effectiveness of LDN in protecting the battered immune systems of those who were infected. Equipped with the clinical trial knowledge, he entered private practice in an attempt to counter the then untreatable disease by using LDN -- and did so in some cases dramatically.

Dr. Bihari, by 2003, had been treating 350 AIDS patients using LDN in conjunction with accepted AIDS therapies. During 7 years of treatments, between 1996 and 2003, over 85% of his patients showed no detectable levels of the HIV virus -- a much higher success rate than most current AIDS treatments, and with no significant side effects. It is also worth noting that many HIV/AIDS patients have been living symptom-free for years, while taking only LDN with no other medications. Two studies in the African country of Mali, demonstrated LDN’s successful use in HIV/AIDS, as published in October, 2011 in the Journal of AIDS and HIV Research.

Additionally, in the mid-1990s, Dr. Bihari found that patients in his practice with cancer, such as lymphoma or pancreatic cancer, also benefited from LDN. People with autoimmune diseases, such as lupus, also often showed prompt control of disease activity while taking LDN.

There have been a number of Phase I and Phase II trials involving the use of LDN and it is important now for TNI BioTech, Inc. to complete the work of Dr. Bernard Bihari and others. The company believes, with the acquisition of the portfolio, it will be able to move forward with Phase III trials involving LDN, which will be marketed under the trade name IRT-103.

Dr. Nicholas Plotnikoff, Chairman of TNI BioTech, Inc., states, “I worked with Dr. Bernard Bihari for many years and 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.”

About TNI Biotech, Inc.

TNI BioTech, Inc., is a biotech company combating fatal diseases through the activation and mobilization of 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, infections such as HIV/AIDS, chronic inflammatory diseases, and autoimmune diseases.

Our proprietary technology, therapies and patents, will be used to treat a wide range of cancers. Our most advanced clinical programs involve immunotherapy that works by isolating a patient’s lymphocytes and then incubating them together with Methionine Enkephalin (MENK) in an enriching external incubation system. After incubation the patient’s lymphocytes are re-infused back into the patient where they combat and destroy tumor cells.

However, even though Management considers any condition that results in altered-immune response a target for investigation, the Company will most likely pursue additional investigations for MENK as a valuable candidate in the treatment of the following:

  • Autoimmune states such as rheumatoid arthritis and multiple sclerosis;
  • As an adjunct to antibiotics in the treatment of infectious diseases;
  • In cancer patients undergoing chemotherapy, radiation treatments or surgery;
  • Patients with AIDS, in combination with retroviral drug therapy; and
  • In wound healing or herpes viral infections.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS: This press release includes 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 hereof.

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


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