ORLANDO, Fla. and DUBLIN, May 4,
2015 /PRNewswire/ -- Immune Therapeutics Inc
(IMUN) "Immune Therapeutics", through its fully owned
subsidiary, TNI Biotech International, today announced the dosing
of the first patient with Lodonal™ (Once-daily Oral
Treatment) for the 90-Day bridging clinical trial of Immune
Therapeutics' proprietary patented therapy (Lodonal™)
as an adjunct treatment for HIV/AIDS and opportunistic
infections.
The Bridging Trial has met all parameters of the Nigerian Trial
Clinical Research Health [NTCR] & Nigerian Health
Research Ethics Committee [NHREC] as confirmed on their official
website and stated below: 89519615
A Bridging study to Evaluate the Effects of LODONAL as an
Immune-System Regulating Agent in Subjects in Which
their Immune System is Compromised. The primary
objective of this clinical trial is to confirm that LODONAL has a
beneficial effect on the immune system of patients in Nigeria with a compromised immune system
(refer to Inclusion/Exclusion Criteria). This will be determined
by: The number of subjects with CD4 count stabilization (less than
10% change from baseline mean values) or 25% increase in CD4 counts
on LODONAL compared to observation group from baseline to Days 30,
60 and 90. 2015-03-31
http://nctr.nhrec.net/search.php?search=lodonal&submit=Search
Dr. Abayomi Oni, Principal
Investigator and Lead Consultant on this trial at State Hospital
Asubiaro, stated "I am excited about the possibility of Low Dose
Naltrexone (Lodonal™) being of immense benefit to our
local population of patients with HIV/AIDS in Osun State, Nigeria as has been proven with other
populations."
AIDS is a chronic, potentially life-threatening condition caused
by the human immunodeficiency virus (HIV). By damaging your immune
system, HIV interferes with your body's ability to fight the
organisms that cause disease. NAFDAC determined that using
Lodonal™ as an immune adjunct could provide a
tremendous catalyst in enhancing the resistance to the
proliferation of HIV/AIDS virus. This 90-Day bridging trial simply
provides the verification and legitimization of this precept on
this population. Upon completion of this trial,
Lodonal™ will be available and could provide positive
solutions to millions of HIV/AIDS sufferers.
"With the total population in Africa of 1.111 billion (2013) and the
incidence and prevalence of HIV and other non-HIV immune
compromised states, Lodonal™, being affordable, well
tolerated and efficacious in boosting the immune status of
individuals at risk is novel and revolutionary. Early deaths due to
opportunistic infections would be reduced thereby increasing the
labor force in the continent which is essential to the much-awaited
economic boom in Africa!" said Dr.
Richards Afonja, MD, of American Hospitals and Resorts.
The bridging trial for Lodonal™ is a single center
90-Day, double-blind, placebo-controlled trial. The trial has
enrolled over 200 patients consisting of a one a day oral treatment
with Lodonal™ or placebo, followed by a 60-day open
label extension in which all participants will receive
Lodonal™. The superiority of Lodonal™ vs.
placebo during the double blind period will be evaluated in terms
CD4 count (primary endpoint), while key secondary endpoints include
the reduction in the number of opportunist infections and
improvements in the quality of life measures.
"The start of this bridging trial for HIV/AIDS is marking the
accomplishment of a critical milestone for Immune Therapeutics,"
said Noreen Griffin, CEO of Immune
Therapeutics. "We are grateful for the opportunity to launch
Lodonal™ in Nigeria
via this trial, as well as the support we have received from the
medical community in Nigeria."
There's no cure for HIV/AIDS, but there are medications that can
dramatically slow disease progression. These drugs have reduced
AIDS deaths in many developed nations. But HIV/AIDS continues to
decimate populations worldwide. It is such a devastating health
challenge that the US Department of State through its PEPFAR
[Presidential Emergency Program for AIDS Recovery] program provides
emergency assistance for more than 21 partners, one of which is
Nigeria. We believe LDN could be
an answer; LDN is safe, easy to administer and affordable.
President & CEO GB Pharma Holdings, Dr. Gloria B. Herndon, said " Nigeria has once again assumed its leadership
position by undertaking a bridging trial that will allow
Lodonal™ to be available to its population and
ultimately the rest of Africa.
This will revolutionize the concept of health security in
Africa by providing an immune
booster that offers solutions that are non evasive and reactive.
After my forty-five [45] years experience in Africa, this initiative has the potential of
being the most far reaching and impactful I have yet to
witness.
About the Company
The Company is a biotechnology company working to combat
chronic, life-threatening diseases through the activation and
modulation 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 include the
treatment of a wide range of cancers. Our most advanced clinical
programs involve immunotherapy with met-enkephalin ("MENK")
(sometimes referred to as opioid growth factor) and our Low Dose
Naltrexone product ("LDN") or Lodonal™, which have been shown to
stimulate the immune system even in patients with advanced
cancer.
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 and LDN
as valuable candidates in the treatment of autoimmune states such
as rheumatoid arthritis and multiple sclerosis; as an adjunct in
cancer patients undergoing chemotherapy, radiation treatments or
surgery; and as a complement to antibiotics in the treatment of a
variety of infectious diseases, including patients with HIV/AIDS,
in combination with retroviral drug therapy.
About Airmed Biopharma Limited
Airmed Biopharma Limited, a wholly owned Irish company, is the
pharmaceutical sales division of the Company. Airmed
Biopharma Limited is responsible for servicing sales orders for
Lodonal™ where the Company has received sales approval in
Latin America and Africa.
About Cytocom Inc.
Cytocom Inc. is a biotechnology company that will initially
focus on developing LDN (Lodonal™) and MENK in the investigation of
unmet medical needs in the areas of oncological and inflammatory
diseases.
About GB Pharma Holdings
GB Pharma Holdings is a Washington
D.C. global Pharmaceutical company with expertise in
defining policies, facilitating approvals, distribution and cGMP
(Good Manufacturing Practices) and introducing innovative therapies
to Africa. GB Pharma Holdings was
established in order to be on the forefront of change and
"providing innovative and sustainable solutions" GB Pharma Holdings
is dedicated to bringing cost effective and quality products to
Africa. We are able to link new
technologies, science and education together to be a cause for
good. GB Pharma Holdings core focus is twofold; manufacturing cGMP
quality pharmaceuticals and helping existing government agencies
develop testing and regulations to purge counterfeit and sub-potent
products out of their respective countries.GB Pharma Holdings
sources products directly from manufacturers able to provide
quality pharmaceuticals and medical products. We are able to
provide pedigree of any products we provide. Quality of products we
distribute is guaranteed through testing reports, closed loop
network and meticulous tracking from acquisition to final delivery
on every product we provide. Our relationship with several
universities in the United States
and teaching Hospitals keeps us on the cutting edge of proven new
trends & technologies. Additionally, we have an excellent
relationship with international agencies and regulatory bodies.
This link helps us develop cost effective therapies and
products.
About America Hospitals and AHAR Pharma
Dr. Richards Afonja, a Hematologist/Oncologist, living and
working in New Jersey and
Nigeria with over 28 years of
experience, is the founder of AHAR Pharma. Dr. Afonja is the CEO of
Paterson Medical Services Corp, Colfax Oncology, Inc. and Princeton
Health Care, which is an HMO that has been operating in
Nigeria since 2000. He is also the
founder of American Hospitals and Resorts Limited, a cancer and
blood disorder treatment center (americanhospitals.org) that has
been delivering high quality healthcare in Nigeria since 2007.
AHAR Pharma is a pharmaceutical company, which operates in the
West and East Africa markets. AHAR
specializes in branded medicines and seeks to improve the lives of
patients suffering from infectious diseases.
Cautionary Note Regarding Forward-Looking Statements
This document includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include, but are not limited to,
statements about the plans, objectives, expectations and intentions
of the Company, including the benefits of the spin-off of Cytocom
Inc. from the Company, and other statements that are not historical
facts. These statements are based on the current expectations and
beliefs of our management and are subject to uncertainty and
changes in circumstances. We caution readers that any
forward-looking information is not a guarantee of future
performance and that actual results may vary materially from those
expressed or implied by the statements herein due to the conditions
to the consummation of the spin-off of Cytocom Inc. from the
Company, and changes in economic, business, competitive,
technological, strategic and/or regulatory factors, as well as
other factors affecting the operation of the other businesses of
the Company and Cytocom Inc. More detailed information about these
factors may be found in our filings with the Securities and
Exchange Commission, including our most recent Annual Report on
Form 10-K in the sections entitled "Cautionary Note Regarding
Forward-Looking Statements" and "Risk Factors." Various other
factors could cause actual results to differ from those set forth
in the forward-looking statements, including, without limitation,
the risk that the anticipated benefits from the spin-off may not be
fully realized or may take longer to realize than expected. We are
under no obligation to, and expressly disclaim any such obligation
to, update or alter our forward-looking statements, whether as a
result of new information, future events, or otherwise. The Company
undertakes no obligation to publicly release any revisions to such
forward-looking statements to reflect events or circumstances after
the date hereof. For further information, please
http://www.immunetherapeutics.com
Contact: Dennis S. Dobson,
203-258-0159
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SOURCE Immune Therapeutics Inc.