Thought to have originated in Africa, the acquired
immunodeficiency syndrome (AIDS) has undoubtedly become a scourge of the
continent, particularly south of the Sahara. According to AVERT, the U.K.-based
international charity, in sub-Saharan Africa, 24.7 million people, or about
4.7% of the continental population, were living with the human immunodeficiency
virus (HIV) in 2013, the last year for which data is available. Over one
million of those individuals have died every year since. South Africa, with 5.9
million, has the highest number of infected persons. Swaziland’s HIV infection
rate of 27.4% (2013) is the highest worldwide. In Nigeria, although the HIV
rate is comparably low (3.2%), this translates into 3.2 million persons because
of the country’s huge population. Thus, the recently concluded 90-day bridging
trial of HIV-positive patients in Nigeria by Immune Therapeutics, Inc. (OTCQB:
IMUN) was most welcome.
In January 2016, on completion of the bridging trial, the
company announced it had submitted data to Nigeria’s National Agency for Food
and Drug Administration and Control (NAFDAC). The company expects that the
Nigerian authorities will approve Lodonal™ as a treatment for those with
compromised immune systems, such as occurs in HIV infection. The bridging study
sought to examine the effectiveness of Lodonal as a treatment to stabilize and
improve CD4 count. The parameters of stabilization were set at 10% either side
of the mean. A 25% increase in CD4 count, in the infected group over the
control group, was set as the target for Lodonal’s effectiveness in improving
CD4 cell count.
A CD4 count is a lab test that measures the number of CD4 T
lymphocytes (CD4 cells) in a sample of blood. In people with HIV, it is the
most important laboratory indicator of how well the immune system is working
and the strongest predictor of HIV progression. CD4 cells (often called T-cells
or T-helper cells) are a type of white blood cells that play a major role in
protecting your body from infection. They send signals to activate your body’s
immune response when they detect invasion from viruses or bacteria. The CD4
count of a healthy individual typically ranges from 500 cells per cubic
millimeter to 1,200 cells per cubic millimeter. When the count falls below 200
cells per cubic millimeter, it may indicate that a person living with HIV has
progressed to stage 3 infection (AIDS).
The progression of an HIV infection typically follows three
stages. Acute HIV infection is the first stage. It is characterized by symptoms
similar to a very bad attack of influenza and usually occurs some two to four
weeks after contraction of the virus. Also referred to as acute retroviral
syndrome (ARS) or primary HIV infection, these flu-like symptoms are signs of
the body’s natural response to the HIV infection.
After the acute stage of HIV infection, the disease moves
into a stage called the clinical latency stage, during which the virus
continues to live and reproduce at very low levels but produces no or very mild
symptoms. This period is also referred to as the asymptomatic HIV infection or
chronic HIV infection stage. AIDS is the third and final stage, when the immune
system has been so greatly compromised that the body can no longer ward off
opportunistic infections. An individual is also considered to have progressed
to AIDS if he or she develops one or more opportunistic illnesses, regardless
of the CD4 count. Without treatment, people who progress to AIDS typically
survive about three years. If a dangerous opportunistic illness is contracted,
life-expectancy without treatment falls to about one year.
Immune Therapeutics, Inc. is a specialty pharmaceutical
company involved in the manufacturing, distribution and marketing of novel
patented therapies to combat chronic, life-threatening diseases through the
activation and modulation of the body’s immune system. The company’s technology
platform is built on two different immunotherapies, Low Dose Naltrexone (LDN),
known internationally as Lodonal, and Methionine-Enkephalin (MENK). Both therapies
have been decades in the making at institutions such as the Pennsylvania State
University Medical School at Hershey, University of Chicago, State University
of New York, and Multiple Sclerosis Center at UCSF. These efforts were
pioneered by leading immunologists, including Dr. Nicholas Plotnikoff, Dr.
Ronald Herberman, Dr. Bernard Bihari, Ian S. Zagon, Dr. Jill Smith, Patricia
McLaughlin, and Dr. Jaquelyn McCandless.
Learn more by visiting www.immunetherapeutics.com
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