Archive for the ‘TNI BioTech Inc. TNIB’ Category

TNI BioTech, Inc. (TNIB) Secures Exclusive License to Portfolio of Cancer Treatment and Prevention-Related Intellectual Property

Friday, February 1st, 2013

Today, TNI BioTech announced the signing of 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.

Covering methods and formulations related to the treatment and prevention of cancers, particularly gastrointestinal cancer, the patents 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 partly 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 is working to acquire the orphan drug designation (IND), and clinical data set from Dr. Jill Smith.

“TNI BioTech is extremely pleased to acquire the exclusive rights to the patent portfolio of the Penn State Research Foundation,” stated Dr. Ronald Herberman, Chief Medical Officer and Senior Vice President for Research and Development. “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.”

For a summary of a clinical trial demonstrating the benefits of OGF in the treatment of pancreatic cancer, view today’s full press release at the following link: http://dtg.fm/m9uX.

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TNI BioTech, Inc. (TNIB) to File Audited Financial Statements, Appoints New Chief Financial Officer

Tuesday, January 22nd, 2013

TNI BioTech, a biotech company working to combat chronic, life-threatening diseases through the activation modulating the body’s immune system, today announced the appointment of Mr. Peter Aronstam as the company’s Chief Financial Officer. He is replacing Mr. Christopher Pearce, who will now serve as the Chief Operating Officer.

“Mr. Aronstam’s broad-based experience as a finance professional in private and public companies gives him a solid platform for the job of Chief Financial Officer of TNI BioTech,” stated Ms. Noreen Griffin, Chief Executive Officer. “We welcome Peter and look forward to working with him as part of the TNI BioTech management team.”

“Mr. Pearce has done a tremendous job as Chief Financial Officer. He joined TNI BioTech nine months ago at its onset and has been a great asset to our operations throughout our period of growth and acquisition. I am pleased that Mr. Pearce will be available to assist TNI BioTech during the transition between CFOs, and will also assume the position as Chief Operating Officer. I also wish to thank him for his ongoing commitment to TNI BioTech,” added Ms. Griffin.

According to today’s press release, TNI BioTech made these changes in connection with the retention of Liggett, Vogt & Webb P.A. This accounting firm has been engaged to provide professionally audited financial statements for inclusion in a Form 10 filing with the SEC in approximately 45 days. This form is essential for TNI BioTech to become a fully reporting company.

Encompassing more than three decades of experience in accounting, finance, banking, international trade, and law to TNI BioTech, Mr. Aronstam’s career is noted by a progression of senior finance roles with growth and performance-driven enterprises, from startup technology and Internet companies to small service providers ($50 million) to very large international manufacturers ($25 billion) and global banks.

Peter has advised and/or served as CFO in both publicly held and privately owned businesses since 1978. These include startup venture-capital-backed entrepreneurial companies; manufacturing, technology, and service companies; and corporate and international banking. Other roles included human resources (HR) and Information Technology (IT) functions along with raising more than $500 million in debt and equity for his companies and their customers.

For more information on TNI BioTech, visit www.TNIBioTech.com

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TNI BioTech, Inc. (TNIB) Secures the Exclusive Rights to Low Dose Naltrexone and Other Opioid Antagonists

Tuesday, January 8th, 2013

Earlier today, TNI BioTech announced that it has entered into an agreement to acquire patent rights to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s Disease.

The patent acquired 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 obtained 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. Jill 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.

A development committee, consisting of independent scientific and technical leaders who are highly regarded by the scientific community, will monitor the clinical progress of the licensed products. This committee will include at least one representative from the licensor parties and one representative from TNI BioTech, 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. 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.

According to today’s press release, TNI BioTech plans to meet soon with the FDA to design and implement pivotal phase III trial(s) for treatment of 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.

For more information about TNI Biotech, visit www.TNIBiotech.com

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TNI BioTech, Inc. (TNIB) Scheduled to Present at 6th Annual OneMedForum Conference

Thursday, January 3rd, 2013

TNI BioTech, a biotech company utilizing patented immunotherapy to activate and mobilize the body’s immune system to combat fatal diseases, today announced that CEO Noreen McGurrin Griffin and CMO Dr. Ronald Herberman will be speaking at the 6th Annual OneMedForum taking place in San Francisco, CA, on January 7-9, 2013.

Ms. Griffin and Dr. Herberman will provide an update on the company’s business activities for 2012 as well as plans for 2013. TNI BioTech’s presentation is scheduled for Wednesday, January 9, 2013, at 11:20 am PST.

For more information on TNI BioTech, visit www.TNIBioTech.com

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Umbrella Research Initiates Coverage on TNI BioTech, Inc. (TNIB) and Sets $26 Price Target

Thursday, December 27th, 2012

Earlier today, TNI BioTech, a biotech company focused on utilizing patented immunotherapy to activate and mobilize the body’s immune system to combat fatal diseases, announced that Umbrella Research is now covering the company with a “buy” rating and $26 price target.

The entire 33-page report has been posted on the company’s Web site at http://www.tnibiotech.com/investor-relations/reports

The following is an excerpt of the report: “It is our opinion that TNI presents investors with significant upside from current prices based on a two-fold growth strategy including: the near term commercialization of its existing immunotherapies targeting cancer and HIV/AIDS; coupled with the potential contribution from the phase 3 study of low dose naltrexone (LDN) for use in Crohn’s disease, scheduled to begin in 2014. As the company enters 2013 it should be in a position where ramping revenue run rates not only allow it to be self-funding in regard to clinical development costs, but also for this to translate quickly into an earnings driven growth story for investors with significant potential upside from approvals.”

For more information on the company and its immunotherapies, visit www.tnibiotech.com

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TNI BioTech, Inc. (TNIB) and Immunotherapy

Wednesday, November 28th, 2012

Just as stem cell technology holds out the current best hope for the regeneration of healthy cells, immunotherapy is becoming the latest best hope for efficiently dealing with diseased cells. Although immunotherapy in its broadest form can be said to date back to the pioneering work of 18th century English physician Edward Jenner, who greatly advanced the ancient but dangerous practice of inoculation, the modern practice of manipulating the body’s own immune system to treat disease is often marked by American surgeon William Coley who developed a rudimentary cancer treatment based on provoking an immune response to bacteria around 1891.

Today, although it is still a developing science, immunotherapy has become an important tool for treating various types of cancer, as well as other diseases. It can be used to provide a general boost to the body’s immune system, or can be used to focus the immune response against specific types of cancer cells. In addition, immunotherapy can be used to suppress certain immune system reactions, which is important for preventing rejection of organ transplants or for treating various auto-immune diseases.

TNI BioTech is a Maryland based biotechnology company that uses their own patented immunotherapy technology to mobilize the body’s immune system and combat fatal diseases, including cancer and infectious diseases such as HIV/AIDS. The company’s most advanced clinical program works by isolating a patient’s lymphocytes and then incubating them together with Methionine Enkephalin (MENK) in an enriching external incubation system. The lymphocytes are then put back into the patient to destroy tumor cells.

The company is currently working with three primary products:

• IRT-101, an active immunotherapy that works by activating a patient’s immune system against infectious diseases and tumor cells
• IRT-102, an adaptive immunotherapy that works by isolating and enriching a patient’s own immune cells
• IRT-103, an active immunotherapy that works by activating a patient’s immune system against HIV/AIDS and tumor cells

For additional information, visit www.TNIBiotech.com

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TNI BioTech, Inc. (TNIB) Goes After the Magic Bullet

Wednesday, November 21st, 2012

TNI BioTech is combating fatal diseases by using the developing science of immunotherapy. By learning how to activate and manipulate the body’s own immune system, TNI has developed their own patented immunotherapy that promises new and better options for the treatment of cancer and infections such as HIV and autoimmune diseases. TNI’s most advanced clinical programs involve immunotherapy that isolates a patient’s lymphocytes and then incubates them together with Methionine Enkephalin (MENK). The lymphocytes are then reinfused back into the patient where they combat and destroy tumor cells.

A primary target for immunotherapy is cancer, and it’s an approach that has important advantages over standard cancer treatments. Although the use of non-immunotherapy cancer drugs, together with radiation, represents a major accomplishment in the war against various cancers, it has come with a price. Such traditional therapies, in spite of many improvements over the past decade, do not have the inherent complexity of a bio-based immune system, and thus have less of a capacity for the programmed identification of cancer cells. As a result, their use still involves appreciable collateral damage to normal cells, increasing the number of painful and sometimes dangerous side effects. Increasing the dosage to kill more cancer cells risks more serious damage to normal cells.

Immunotherapy, on the other hand, offers the potential of accurately targeting only the specified cancer cells, leaving normal cells untouched. The result is highly effective destruction of cancer, with minimal concerns for extraneous damage and unwanted side effects. It’s a situation that has been compared to a war, where the bad guys are imbedded within the civilian population. With conventional weapons, the bigger the bombs the more civilian damage. With so-called smart bombs, the intended targets can be completely destroyed without hurting anything else.

Whether called a smart bomb or magic bullet, immunotherapy is considered by many to be the next important step in the fight against cancers and other diseases, and TNI BioTech is on the leading edge.

For additional information, visit www.TNIBiotech.com

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TNI BioTech, Inc. (TNIB) Enters Exclusive Distributor Agreement with G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC

Thursday, November 15th, 2012

Today, shortly before the opening bell, TNI BioTech announced that it has signed an exclusive distributor agreement with G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC for the Federal Republic of Nigeria. As a result, G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC will have exclusive marketing and distribution rights to IRT-103 LDN and IRT-104 LDN cream in Nigeria. TNIB will be responsible for the manufacture and supply of IRT-103 LDN and IRT-104 LDN cream.

The therapies, developed as a treatment for cancer, HIV/AIDS, and other autoimmune diseases, are to be manufactured in the company’s facility in Managua, Nicaragua, under the supervision and quality control of Dr. Henry “Skip” Lenz. G-Ex Technologies/St. Maris Pharma have agreed to provide TNIB with a revolving letter of credit for the minimum purchase of 750,000 doses monthly of IRT-103 LDN or IRT-104 LDN cream beginning March 1, 2013, priced at $1.00 dollar per dose.

Under the terms of the agreement, G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC must purchase a minimum of 15,000,000 doses monthly within 24 months to maintain their exclusive agreement. Once G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC reach sales of 1,000,000 million doses per day, TNIB has agreed to joint venture a factory in the Federal Republic of Nigeria to meet local demands.

Noreen Griffin, CEO of TNI BioTech, Inc. stated, “This contract shows TNI BioTech’s commitment to generate revenue during our first year of operations.”

Frank Aribeana, the managing member of G-Ex Technologies/St Maris Pharma, commented, “We are delighted to enter into this agreement as we believe the introduction of IRT-103 LDN and IRT-104 LDN cream in this market will allow us to provide much needed treatment at an affordable price to the citizens of the Federal Republic of Nigeria.”

G.Ex Technologies/St. Maris Pharma is comprised of management consultant, general pharmaceutical, clinical pharmacy, and marketing executives, each with more than two decades of industry experience and well versed in the changing dynamics of the prescription and OTC drug international marketplace. Actively supported by medical practice professionals in business and academia who have been involved in the management of related drug therapies for many years, the consortium is well positioned to lead the successful introduction of IRT-103 LDN and IRT-104 LDN in Nigeria.

For more information on TNI Biotech, visit www.tnibiotech.com

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TNI BioTech, Inc. (TNIB) Helps Lead the Way to a New Africa

Monday, November 12th, 2012

When TNI BioTech recently signed an agreement to open an Oncology & Infectious Disease Clinic at Queen Elizabeth Central Hospital in Malawi, in southwestern Africa, it reflected an ongoing change in the attitude of the industrialized world toward Africa. Once largely ignored because of its troubled political history and lack of infrastructure and technology, Africa is suddenly rising on the world’s economic radar. The second largest land mass on the globe, with the second largest population of any continent, Africa has been seeing rapid economic growth, and has been compared to Asia in its potential.

In a Seeking Alpha article, “The Case For Investing In Africa”, Peter Thoms points out that Africa’s recent economic growth is just one of the reasons that investors should take a long look at the continent, and cites a number of other attractive factors:
• Africa’s immense natural wealth
• Africa’s youthful demographics
• Africa’s growing embrace of technology
• Africa’s developing integration with the global economy

Africa is made up of many diverse countries, each with its own challenges, but challenges that, for the above reasons, are now being viewed as early-game opportunities.

In the case of TNI BioTech’s agreement with Malawi to open a clinic, the new clinic will not only be important to the people of Malawi, through greatly improved cancer treatment, but will also allow TNIB, in conjunction with GB Oncology & Imaging Group, to study the interaction between infections and cancer by promoting cutting-edge research aimed at pathophysiology, prevention, diagnosis, and treatment of infection-related cancers in Africa. In particular, it is believed that IRT-103, TNIB’s active immunotherapy that works by activating a patient’s immune system against HIV/AIDS and tumor cells, can be demonstrated to be capable of saving millions of lives.

In short, as Africa rises, so can the companies and individuals with the foresight to invest early in this massive and rich part of the world that is no longer being called the dark continent.

For additional information, visit www.TNIBiotech.com

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TNI BioTech, Inc. (TNIB) Capitalizes on Rich Pharmaceutical Experience

Monday, November 5th, 2012

TNI BioTech is a leader in the activation and mobilization of the body’s immune system to fight fatal diseases. The company is directed by people who themselves have a history of leadership in the pharmaceutical industry, a fact that has helped the company establish important agreements around the world.

• Nicholas Plotnikoff, Ph.D. (Chairman) has over 20 years in the pharmaceutical industry, specifically in the fields of Pharmacology, Toxicology, and Clinical Research. Dr. Plotnikoff helped develop the immunological effects of MENK. He successfully managed the project teams that developed the N.D.A.’s on Traxene (Valium-like tranquilizer) and Cylert (non-amphetamine psychostimulant). He was the first to identify the central nervous system effects of hypothalamic releasing factors (brain hormones), resulting in clinical development for treatment of depression and Parkinson’s disease. He co-authored 25 publications with Dr. Andrew Schally covering basic research in the field of depression and Parkinson’s disease, and held a number of international patents.

• Dr. Eugene Youkilis, Ph.D. (Director & President) has over 25 years in the pharmaceutical and healthcare industry working in Toxicology, Pharmacology, and Clinical Research. He is a Diplomate of the American Board of Toxicology and former President and Founder of Clinical Bio-Tox Laboratories. He was Laboratory Section Chief and Director at Stroger Hospital (formerly Cook County Hospital), and was a Senior Research Investigator with G. D. Searle and Company. He is currently a Principal Associate with Toxicology Resource Associates, and was a Senior Research Investigator with G. D. Searle and Company.

• Noreen Griffin (Founder & CEO) has played a vital part in the acquisition of patents and therapies involving MENK and LDN, and was involved with the inventors and patent holders for over 5 years before deciding to join the team that formed TNI BioTech, Inc. She has over 25 years of industrial experience, and founded and led a number of startup companies. She has played an integral role in raising multiple rounds of private and venture capital funds on behalf of clients.

• Christopher Pearce (Director & CFO) is one of the founding principals of pH Pharmaceutical, Inc. (a pharmaceutical company focused on the commercial application and licensing of a patented technology) and its affiliated company, pH Solutions. He has over 30 years’ experience as Director and COO of a New York stock exchange listed company with more than 5,000 employees worldwide and $500 million revenue per annum.

• Dr. Ronald Herberman (Sr. VP R&D & Chief Medical Officer) served as the founding director of the University of Pittsburgh Cancer Institute (UPCI) and the UPMC Cancer Center. He was Associate Vice Chancellor for cancer research within the School of Medicine, Department of Health Sciences. Other appointments during his career included Chief of the Division of Hematology/Oncology and the Hillman Professor of Oncology, and Professor of Medicine and Pathology.

• Fengping Shan, Ph.D. (Director & Chief Science Officer) is the Professor of Immunology and Vice Director of the Institute of Immunology, China Medical University, Shenyang, China. He was the Senior Scientist for Penta Biotech and Chief Scientist for the Institute of Microbiological Science and Studies at the Nation Cancer Research in Paris, France. He Shan is an author of 50 Publications and 11 patents.

For additional information, visit www.TNIBiotech.com

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TNI BioTech, Inc. (TNIB) Enters Agreement to Open an Oncology & Infectious Disease Clinic at Queen Elizabeth Central Hospital

Wednesday, September 26th, 2012

Earlier today, Mrs. Joyce Banda, the President of the Republic of Malawi, announced that an agreement has been signed to open an outpatient’s clinic at Queen Elizabeth Central Hospital for the treatment of cancer and infectious diseases with US-based biotech firms TNI BioTech (TNIB) and GB Oncology & Imaging Group LLC (GBOIG).

Chronic infectious diseases are estimated to cause more than 20 percent of all cancers in the world, including liver, cervical, and gastric malignancies. Infection-related cancers are more frequent and often more severe in people infected with HIV. Cancer patient survival rates in Malawi are abysmal due to lack of access to early diagnosis and treatment.

President Banda is working to reverse this problem by signing an agreement with TNIB and GBOIG to open an outpatient clinic for the treatment of cancer, HIV/AIDS, and infectious diseases at Queen Elizabeth Central Hospital within the coming months. At the clinic TNIB and GBOIG will deliver both conventional and alternative therapies; including safer, more effective cancer therapies, new-targeted drug therapies, and minimally invasive surgical alternatives.

The new facility for outpatient cancer care, education, and research will allow TNIB and GBOIG to:

• Provide first-rate cancer care in Malawi, a country of about 16 million citizens suffering from one of the highest cancer rates in the world, in order to improve survival rates for most common cancers under the available therapies from 10 percent to 90 percent, saving an estimated 5,000 lives each year.
• Study the interaction between infections and cancer by promoting cutting-edge research aimed at pathophysiology, prevention, diagnosis, and treatment of infection-related cancers in Africa.
• Improve the quality of medical education in oncology and increase the number of cancer specialists in Malawi.

The Government of Malawi will make space available in the Queen Elizabeth Central Hospital where TNIB and GBOIG will retrofit the facility and start the operation of an outpatient oncology and infectious disease clinic. This first phase will begin in November of 2012 with the anticipation of the clinic being operational by March of 2013. This clinic will include a CT Scan, an X-Ray Room, a 10 chair infusion chemo-therapy and immune rehabilitating therapy clinic, a sterile room, all related medical supplies, an electronic medical record system, and other medical services. In an effort to provide treatment immediately, the companies will initiate the treatment of 10,000 women and children a day for cancer, HIV/AIDS, and infectious diseases using IRT-103 LDN, and then expand to 250,000-500,000 patients over time. The next phase is focused on adding the necessary Radiation Oncology treatments. The radiation department will be managed by an experienced radiation oncology team and will provide the most advanced technology they can offer to provide the highest chance for healing and recovery; the aim is to have Phase II within 12 months.

Dr. Gloria Herndon, President & Managing Member of GBOIG stated, “Though cultural change is achieved very slowly, we strongly believe that IRT-103 (LDN) can serve to literally save millions of lives within a relatively short time. We believe this is an important step forward as there is an urgent need in Malawi for readily available, safe and effective treatments that can hopefully increase the life span and improve the quality of life for millions of cancer and HIV/AIDS infected patients.”

“Having a healthy population is essential for the fabric and stability of the nation. It is imperative to provide care to the people of Malawi in need of care,” said President Banda. “It’s also the right thing to do. There can be no greater mandate in cancer treatment and research than to wage the fight by doing the right thing.”

To learn more about the company, visit www.tnibiotech.com

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TNI BioTech, Inc. (TNIB) Uses Immune System to Tackle Cancer, Infections, and Autoimmune Diseases

Tuesday, September 25th, 2012

Leveraging the body’s own immune system to fight disease is one of the hottest areas in medicine. The human immune system, by its nature, is able to identify and fight disease organisms in sophisticated ways that chemicals and other traditional interventions by themselves cannot. The first human vaccines, developed in the late 1700s, represented early steps in manipulating the human immune system, and resulted in the saving of countless lives over the past two centuries. Today newly developed technologies have again opened a door to a world of immune system potential.

Florida-based TNI BioTech is in the forefront of combating fatal diseases through the activation and mobilization of the body’s immune system. The company uses patented immunotherapy to harness the power of the immune system in the fight against cancer, infections, and autoimmune diseases. Methionine Enkephalin (MENK), for example, is a human hormone produced naturally by the human immune system. It is believed that MENK is toxic to tumor cells but does not hurt the human body.

TNI BioTech currently lists three primary products:

• IRT-101 is an active immunotherapy that stimulates a patient’s immune system against infectious diseases and tumor cells by increasing the number of T cells and NK cells, NKT and Gammadelta T cells, which destroy infective organisms and tumor cells while simultaneously inhibiting Treg cells.

• IRT-102 is an adaptive immunotherapy that isolates and enriches a patient’s own immune cells. Following an enriching external incubation, cells are transfused back into the patient, providing the patient with a passive immunity containing large amounts of auto-amplified immune cells that combat cancer cells.

• IRT- 103 is an active immunotherapy that activates a patient’s immune system against HIV/AIDS and tumor cells. This is accomplished by activating the enkephalin receptor system, resulting in an increased number of T cells and NK cells that destroy infective organisms and tumor cells.

TNI BioTech also intends to investigate the following areas of application:

• Autoimmune states such as rheumatoid arthritis and multiple sclerosis
• As an adjuvant to vaccines in the protection from getting infectious diseases
• In patients undergoing chemotherapy or radiation treatments in surgery
• In wound healing, herpes, and shingles in the elderly.

To learn more about the company, visit www.tnibiotech.com

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TNI BioTech, Inc. (TNIB) is “One to Watch”

Tuesday, September 18th, 2012

TNI BioTech is focused on utilizing patented immunotherapy to activate and mobilize the body’s immune system to combat fatal diseases. The company’s products and technologies improve the treatment and diagnosis of cancer, infections such as HIV/AIDS, and autoimmune diseases. Future initiatives include treatment for multiple sclerosis, herpes viral infections, and other conditions that result in altered-immune response.

The company’s product portfolio currently includes IRT-101, an active immunotherapy that works by activating a patient’s immune system against infectious diseases and tumor cells; IRT-102, an adaptive immunotherapy that works by isolating and enriching a patient’s own immune cells; and IRT-103, an active immunotherapy that works by activating a patient’s immune system against HIV/AIDS and tumor cells.

Leveraging the advantages of today’s cutting-edge treatment options, the company aims to meet the growing demand for quality healthcare with safer, more effective radiation therapy; new-targeted drug therapies; and minimally invasive surgical alternatives around the world. TNI BioTech most recently signed a letter of intent to open clinics in Africa that will provide advanced treatment for cancer, HIV/AIDS, and autoimmune diseases.

The company plans to continue clinical trials in China during 2012 and 2013, and anticipates starting trials in the United States by early 2013.The company is also in negotiations to acquire a number of other immunotherapy products, patents, and therapies. Led by a management team with decades of experience and solid business plan, TNI BioTech is poised to improve healthcare with active and adaptive forms of improved immunotherapies.

To learn more about the company and its immunotherapy technologies, visit www.tnibiotech.com

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TNI BioTech, Inc. (TNIB) Enters Memorandum of Agreement to Open Pharmaceutical Plant

Tuesday, September 11th, 2012

Today before the opening bell, TNI BioTech, a biotech company focused on combating fatal diseases through the activation and mobilization of the body’s immune system, reported that a Memorandum of Agreement has been signed involving the company and MOV-FAS S.A. to open a pharmaceutical plant in Managua, Nicaragua.

TNIB has acquired a portfolio patents involving Low-Dose Naltrexone (LDN) for the treatment of HIV/AIDS, cancer and other diseases. This acquisition includes more than two decades of data showing Low Dose Naltraxone (LDN) as an effective immune system modulator, without significant toxic side effects or addicting properties, and can be administered by a single capsule taken daily. In anticipation of meeting existing obligations, as well as contracts under negotiation, TNI BioTech reached an agreement with MOV-FAS S.A. to finance and construct a pharmaceutical plant for the production of IRT-103.

According to today’s press release, the new plant will occupy approximately 20,000m² of area in Managua, Nicaragua; an economic free zone designed to promote industrial growth and development in the Managua area. The company secured a lease on the premises with plenty of room for future expansion. Plant construction began in September of 2012 and is being built pursuant to international pharmaceutical GMP (Good Manufacturing Practice) standards. The TNI BioTech facility is expected to be fully operational by the end of next month.

LDN is to be manufactured under the trade name of IRT-103 with the intention of selling the product in Africa and nearby export markets. The plant has the capacity to manufacture approximately One Billion Four Hundred Thousand (1,400,000,000) capsules year.

A partially owned subsidiary was formed by TNI Biotech for this joint venture. The partners in this joint venture are TNI BioTech (which owns 55%); MOV-FAS S.A., the development company (which owns 35%); Pharmaceutical Care Consultant of South Florida, d/b/a Skips Pharmacy (which owns 5%); and GB Pharma Holdings LLC, a subsidiary of GB Oncology & Imaging Group LLC (which owns 5%). TNI BioTech anticipates providing most of the technology; Pharmaceutical Care Consulting will provide quality control and management; GB Oncology & Imagining Group, LLC has provided the initial contracts for the sale of IRT-103; and MOV-FAS will provide the initial capital, the land, and building, but more importantly, local relations to handle all permitting and approval for the venture.

Frank Owens, the managing member of MOV-FAS S.A., and a successful entrepreneur with over 30 years of experience in building and operating businesses in Central and South America, stated, “We are on target to open the new pharmaceutical facility October 15, 2012. The facility will be expanded from production for One Hundred Thousand (100,000) capsules a day to Four Million (4,000,000) capsules per day as demand for the product increases. MOV FAS entered this venture because it believes the project will be a financial success, and simultaneously allow us to provide low cost effective treatments for HIV/AIDS and autoimmune diseases to millions of people in developing nations.”

Christopher Pearce, CFO of TNI BioTech, Inc., added, “TNI BioTech looks forward to working with noted, successful and innovative businessmen such as Mr. Frank Owens and Robert E. Friedrich. Their extensive experience in the field of business development and manufacturing provides the company with a partner ensuring TNIB can meet its IRT-103 delivery contracts beginning the last quarter of 2012.”

Noreen Griffin, TNI BioTech, Inc. CEO, commented, “The opening of this facility is very important for TNIB, as it is a significant step in the company’s development of its licensed, patented, low cost effective treatment for a number of autoimmune diseases and will provide revenue for the company.”

To learn more about the company and its immunotherapy technologies, visit www.tnibiotech.com

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TNI BioTech Inc. (TNIB) Able to Target Numerous Fatal Diseases with Immunology Approach

Monday, September 10th, 2012

TNI BioTech aims for world leadership in the area of immunology. It plans to fight infectious diseases by using Methionine Enkephalin (MENK), a human hormone produced naturally by the human immune system. It is believed that MENK is toxic to tumor cells but does not hurt the human body. TNIB’s most advanced clinical programs involve immunotherapy that works by isolating a patient’s lymphocytes and then incubating them together with an enriching external incubation system. After incubation, the patient’s lymphocytes are reinfused back into the patient where they combat and destroy tumor cells.

Although TNIB considers any condition that results in altered-immune response a target for investigation, the company will most likely focus its efforts on using MENK in the treatment of 5 major types of illnesses: 1) Autoimmune states such as rheumatoid arthritis and multiple sclerosis; 2) As an adjunct to antibiotics in the treatment of infectious diseases; 3) In cancer patients undergoing chemotherapy, radiation treatments, or surgery; 4) Patients with AIDS, in combination with retroviral drug therapy; and 5) In wound healing or herpes viral infections.

To further its goal of prominence in the field of immunology, the company recently acquired certain technology developed by Dr. Bernard Bihari, a well-known AIDS researcher. The portfolio portfolio contains six patents and applications related to:
• Cancer of the prostate, lymphoproliferative syndrome, including such diseases as malignant lymphoma, chronic lymphocytic leukaemia, 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, chronic infections due to the Epstein-Barr virus, and chronic inflammatory conditions including chronic fatigue syndrome; and
• A treatment method for humans infected with HTLV-III (AIDS) virus, including patients clinically diagnosed as suffering from AIDS and those suffering from AIDS-related complex (ARC).

Dr. Bernard Bihari 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. TNIB intends to continue Dr. Bihari’s work on the use of LDN by conducting Phase III trials.

Asked for comment on the purchase of Dr. Bihari’s technology, Dr. Nicholas Plotnikoff, Chairman of TNI BioTech, Inc., said, “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.”

Another major step forward for the company was Dr. Ronald Herberman joining the company as Senior Vice President of Research and Development and Chief Medical Officer. Dr. Herberman’s responsibilities include leading the company’s global development, clinical research, and medical initiatives.

Dr. Herberman is widely recognized as a top researcher in the field of immunology. He has received many awards, including the Lifetime Science Award from the Institute for Advanced Studies in Immunology and Aging. During the period of 1981 to 1990, Dr. Herberman was recognized as one of the 100 most-cited research authors in the immunology area.

Dr. Nicholas Plotnikoff, TNI BioTech, Inc. Chairman, noted that the company’s hiring of Dr. Herberman reflects TNI BioTech’s highest priority: to become a world-class leader in groundbreaking therapeutics for patients who are afflicted with cancer, autoimmune, and infectious disease, including HIV/AIDS.

“In order to successfully become a world-class leader,” stated Dr. Plotnikoff, “we need significant expertise in clinical, regulatory and leadership development, along with a deep knowledge of immunology and Dr. Herberman brings demonstrated strengths in these areas having made major discoveries in his field and has fostered the application of this information to novel approaches to cancer therapy, diagnosis and prevention during his time as a leader at the National Cancer Institute and Founding Director of the University of Pittsburgh Cancer Institute.”

Dr. Plotnikoff added, “During his career, Dr. Herberman has been recognized as a leader in the field of immunology. The phenomenon of natural killer (NK) cell-mediated cytotoxicity against tumors was first discovered in Dr. Herberman’s laboratory at the National Cancer Institute in the early 1970s. In addition to his pioneering investigation of NK cells, Dr. Herberman has played a leading role in multiple areas of tumor immunology. TNI BioTech therapies and treatments draw upon the theory that medicine can enlist the body’s own immune system to combat cancer and autoimmune diseases that are Dr. Herberman’s specialty. His experience and strategic perspective precisely meet TNI BioTech’s needs today.”

Dr. Herberman commented: “I am very excited to assume a leadership position in TNI Biotech Inc. I have had the privilege to know Dr. Plotnikoff for about 30 years and I have been very impressed with his pioneering studies of the effects of opioid peptides on the immune system. I am convinced that TNI Biotech’s drugs have much potential for the treatment of not only cancer, but also a range of other diseases including multiple sclerosis, HIV/AIDS, and Crohn’s Disease. I intend to rapidly build on a pre-existing foundation of clinical research with low dose naltrexone and MENK, and develop innovative approaches to use them to stimulate the immune system to make an impact on these and other chronic diseases.”

In addition to his other duties, Dr. Herberman will be a member of the company’s executive leadership team. He will report to Dr. Eugene Youkilis, President and the Board of Directors. As the company’s Chief Medical Officer, Dr. Herberman will employee his extensive experience in all phases of drug development and drug portfolio management — including acquisition of new assets and relationships with regulators and government agencies. Dr. Herberman will also retain specific accountabilities relating to patient safety.

To learn more about the company and its immunotherapy technologies, visit www.tnibiotech.com

Let us hear your thoughts: TNI BioTech, Inc. Message Board

TNI BioTech, Inc. (TNIB) Appoints Dr. Ronald Herberman to Senior Vice President of Research and Development and Chief Medical Officer Positions

Thursday, September 6th, 2012

TNI BioTech, a biotech company focused on combating fatal diseases through the activation and mobilization of the body’s immune system, announced that effective immediately Dr. Ronald Herberman has joined the management team as Senior Vice President of Research and Development and Chief Medical Officer. Dr. Herberman’s will be responsible for leading the company’s global development, clinical research, and medical initiatives.

Dr. Herberman brings extensive experience in all phases of drug development and drug portfolio management — including acquisition of new assets, and in dealing with regulators and government agencies. Previously, he held the position of Chief Medical Officer at Intrexon Corporation where he was responsible for scientists and clinicians in discovery, clinical research and development, regulatory affairs, and medical affairs. He was also the founding director of the University of Pittsburgh Cancer Institute and Associate Vice Chancellor for Cancer Research, Hillman Professor of Oncology, and Professor of Medicine at the University of Pittsburgh School of Medicine.

An internationally recognized tumor immunologist, Dr. Herberman has made major discoveries in his field and has fostered the application of this information to novel approaches to cancer therapy, diagnosis, and prevention. Dr. Herberman has received numerous awards, including the Lifetime Science Award from the Institute for Advanced Studies in Immunology and Aging. The significance of Dr. Herberman’s foundational scientific discoveries is accentuated by his recognition as one of the 100 most-cited research authors during the 1980s.

Dr. Nicholas Plotnikoff, TNI BioTech, Inc. Chairman, stated, “In order to successfully become a world-class leader, we need significant expertise in clinical, regulatory and leadership development, along with a deep knowledge of immunology and Dr. Herberman brings demonstrated strengths in these areas having made major discoveries in his field and has fostered the application of this information to novel approaches to cancer therapy, diagnosis and prevention during his time as a leader at the National Cancer Institute and Founding Director of the University of Pittsburgh Cancer Institute.”

“During his career, Dr. Herberman has been recognized as a leader in the field of immunology,” Dr. Plotnikoff continued. “The phenomenon of natural killer (NK) cell-mediated cytotoxicity against tumors was first discovered in Dr. Herberman’s laboratory at the National Cancer Institute in the early 1970s. In addition to his pioneering investigation of NK cells, Dr. Herberman has played a leading role in multiple areas of tumor immunology. TNI BioTech therapies and treatments draw upon the theory that medicine can enlist the body’s own immune system to combat cancer and autoimmune diseases that are Dr. Herberman’s specialty. His experience and strategic perspective precisely meet TNI BioTech’s needs today.”

Dr. Herberman commented, “I am very excited to assume a leadership position in TNI Biotech Inc. I have had the privilege to know Dr. Plotnikoff for about 30 Years and I have been very impressed with his pioneering studies of the effects of opioid peptides on the immune system. I am convinced that TNI Biotech’s drugs have much potential for the treatment of not only cancer, but also a range of other diseases including multiple sclerosis, HIV/AIDS, and Crohn’s Disease. I intend to rapidly build on a pre-existing foundation of clinical research with low dose naltrexone and met-enkephalin, and develop innovative approaches to use them to stimulate the immune system to make an impact on these and other chronic diseases.”

To learn more about the company and its immunotherapy technologies, visit www.tnibiotech.com

Let us hear your thoughts: TNI BioTech, Inc. Message Board