Immune Therapeutics, Inc. (OTCQB:IMUN), a specialty
pharmaceutical company focused on developing and commercializing its novel
patented, affordable, non-toxic therapy for the treatment of cancer, HIV,
autoimmune disease, and other inflammatory conditions, today announced that it
has received NAFDAC (National Agency for Food and Drug Administration and
Control) approval to market and distribute LodonalTM, the Company’s
breakthrough treatment for HIV/AIDS in Nigeria. The Company and its strategic
partners plan to immediately initiate sales activities of this first-to-market
opportunity.
The approval is for a one-day Immune System Regulator for
the management of HIV/AIDS, which is based on the results of the Company’s
90-Day bridging trial in Nigeria that resulted in a 44% increase in CD4 Count
versus an 11% increase for standard of care patients. Additionally, there was a reduction in
opportunistic infections plus several Phase II multi-center, randomized studies
that demonstrated improvements for patients treated with Lodonal when compared
to placebo or standard of care.
"Receiving regulatory approval from one of Africa’s
most stringent regulatory bodies is a resounding endorsement for Lodonal,
Immune Therapeutics’ breakthrough therapy for patients with life-threatening
diseases such as HIV/AIDS,” said Noreen Griffin, Chief Executive Officer of
Immune Therapeutics, Inc. “We thank our
partners in Africa – our exclusive agent, GB Pharma Holdings and AHAR Pharma
Limited – for working with Immune Therapeutics to achieve this critical and
exciting milestone and look forward to their ongoing support and guidance as we
prepare to enter into commercialization.”
Dr. Gloria B. Herndon, President and CEO of GB Pharma
Holdings, noted at the annual Global Health Catalyst Summit at Harvard Medical
School, “GB Pharma believes in the importance of introducing a non-toxic,
innovative and medically viable solution within a country’s national health
policy and believes that it is imperative to develop treatments that can
improve immunological function and offset the toxic side effects of antiviral
therapies. We believe that Lodonal can be that therapy and look forward to
supporting Immune Therapeutics as it launches its highly-anticipated commercialization
plan beginning with Nigeria,” concluded Dr. Herndon.
Culled from the Internet
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