TNIB ROIDAL PENN STATE PATENT NEWZZZ // TNI BioTe

[b]TNIB >>> ROIDAL PENN STATE PATENT NEWZZZ // TNI BioTech Acquires Exclusive License To The Portfilio Of Patents Of Dr Ian S. Zagon, Dr. Patricia J. McLauglin And Dr. Jill Smith From The Penn State Research Foundation[/b]

2013-02-01 07:45 ET - News Release


BETHESDA, Md., Feb. 1, 2013 /PRNewswire/ -- TNI BioTech, Inc. (OTCPINK: TNIB) has signed an exclusive licensing agreement for all of the intellectual property developed at Pennsylvania State by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of cancer. The patents cover methods and formulations related to the treatment and prevention of cancers, particularly gastrointestinal cancer. More specifically, the present inventions describe the use of drugs that interact with opioid receptors (naltrexone, naloxone and the pentapeptide growth factor Met-enkephalin) to inhibit and arrest the growth of cancer. Such efficacy has been discovered to be partially due to the functional manipulation of the zeta opioid receptor through exogenous and endogenous Met-enkephalin. This receptor has been determined to be present in a variety of cancers, including pancreatic and colon cancer.

As part of this agreement, TNI BioTech, Inc. is working to acquire the orphan drug designation (IND), and clinical data set from Dr. Jill Smith.

Dr. Ronald Herberman, Chief Medical Officer and Senior Vice President for Research and Development stated, "TNI BioTech is extremely pleased to acquire the exclusive rights to the patent portfolio of the Penn State Research Foundation. Based on the pioneering work of Drs. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith, these patents are related to the therapeutic efficacy and mechanism of action of Met-enkephalin, referred to as opioid growth factor. These patent acquisitions will help TNI BioTech develop our pipeline for therapy of cancer in conjunction with our other cancer therapies revolving around Met-enkephalin."

Summary of Clinical Trial on the Benefits of OGF in the Treatment of Pancreatic Cancer

In a prospective phase II open-labeled clinical trial performed by Dr. Jill Smith and her colleagues in the Departments of Medicine, Public Health Sciences, Pathology, and Neurosciences and Anatomy at the Pennsylvania State University School of Medicine in Hershey, PA, patients with very advanced pancreatic cancer were treated. These patients had failed prior chemotherapy regimens and were either treated weekly with opioid growth factor (OGF) or entered a hospice program.

Results: Clinical benefit response was experienced by 53% of OGF-treated patients compared to historical controls of 23.8% and 4.8% for gemcitabine and 5-fluorouracil (5-FU), respectively. Of the OGF-treated patients surviving more than eight weeks, 62% showed either a decrease or stabilization in tumor size by computed tomography. The median survival time for the OGF-treated patients was three times that of the untreated hospice patients (65.5 versus 21 days, p < 0.001). No adverse effects on hematologic or chemistry parameters were noted, and quality of life surveys suggested improvement with OGF.

Limitations: Measurements other than survival were not allowed in the control hospice patients, and clinical benefit comparisons were made to historical controls.

Conclusion: OGF biotherapy improves the clinical benefit and prolongs survival in patients with pancreatic cancer by stabilizing disease or slowing progression. The effects of OGF did not adversely alter the patients' quality of life. The use of OGF biotherapy at earlier stages of disease or in combination with chemotherapeutic agents may further improve the outcome of this malignancy.

About TNI BioTech, Inc.

TNI BioTech, Inc., is a biotech company working to combat chronic, life-threatening diseases through the activation modulating 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.

TNI BioTech's proprietary technology, therapies and patents include the treatment of a wide range of cancers. Their 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.

Even though TNI BioTech considers any condition that results in altered-immune response a target for investigation, they plan to pursue additional investigations for low dose naltrexone and/or MENK as valuable candidates in the treatment of the following:

Autoimmune states such as Crohn's disease, multiple sclerosis and rheumatoid arthritis
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, including patients with HIV or patients with AIDS, in combination with retroviral drug therapy
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.

Contact: Global Investment Media

Phone: 310-353-6277

SOURCE TNI BioTech, Inc.