Before the opening bell, Immune Therapeutics, Inc. (OTCQB:
IMUN) offered shareholders an update of the status of its ongoing drug
development program in China. Recently, Chinese Peptide Company (CPC), one of
only a handful of companies in the world that can claim both ISO Certification
and cGMP licensing, completed the formulation and required Chemistry,
Manufacturing and Controls (CMC) for Methionine-Enkelphine (MENK). IMUN’s
long-term partner, Hubei Qianjiang Pharmaceutical Co. Ltd. (Qianjiang), is
expected to provide formulation and CMC data to Cytocom, Inc., a subsidiary of
IMUN, within 30 days. With this data in hand, Cytocom will take the necessary
steps to present final protocols to the FDA for the treatment of pancreatic,
pediatric and adult hepatic cancer.
In addition to CMC data, preclinical studies have also been
conducted evaluating the pharmacological properties of MENK and tumor response
in mice with transplanted cancers. These trials determined a favorable response
to MENK against a number of different cancer tumors. Following translation, the
results from these studies will also be included in Cytocom’s upcoming FDA
briefing package for pediatric and adult hepatic cancer.
IMUN’s efforts to obtain FDA approval for MENK in the United
States are also playing a role in efforts to obtain approval for the drug
candidate in China. As of April 1, 2016, the company provided Qianjiang all
correspondence between IMUN and the FDA regarding the MENK drug development
program. MENK, sometimes referred to as opioid growth factor, has been studied
by a number of scientists, but the most published of these are Dr. Ian Zagon
and his team from Pennsylvania State Medical Center at Hershey. According to
Zagon’s research, MENK has been show to regulate the growth of cancer cells,
effectively delaying the replication of cells and allowing immunological
mechanisms to accomplish the task of destroying cancerous cells.
By seeking clinical approval of MENK in both the U.S. and
China, IMUN is well-positioned to enter two of the largest pharmaceutical
markets in the world. According to the Economist Intelligence Unit, drug sales
in China are expects to top $166 billion by 2017, providing a recognized market
to further growth. Despite its tremendous size, China’s pharmaceutical industry
is not yet fully mature. Within the next decade, economic and demographic
development, government stimulus, enhanced health awareness among the public,
market consolidation and improved R&D capabilities are expected to
transform the Chinese pharmaceutical industry into a sophisticated market.
Learn more by visiting www.immunetherapeutics.com
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