DEPARTMENT OF DEFENSE REPORT SHOWS BACH PHARMA DRUG GVT REVERSES BRAIN DYSFUNCTION

GVT Repairs Hippocampal Dysfunction by Stem Cell Regeneration

NORTH ANDOVER, Massachusetts: August 1, 2017 – Bach Pharma, Inc. (BACH), a global leader in the discovery and commercialization of revolutionary therapeutics to treat life threatening diseases, announced that recent studies show GVT® reverses astrocyte hypertrophy and supports generation of new stem cells and neurons in the hippocampus, indicating that the drug could be an effective treatment for victims of Gulf War Illness (GWI).
GWI is a chronic, multi-symptom illness affecting approximately 250,000 of the nearly 700,000 U.S. servicemen and women who served in the Gulf War from August 1990 through February 1991. Veterans of allied forces, including those from the US, United Kingdom and Australia, continue to suffer from GWI symptoms including brain dysfunction, memory impairment, depression, and anxiety.

The study, conducted by Ashok K. Shetty, PhD, Associate Director and Professor at the Institute for Regenerative Medicine at the College of Medicine at Texas A&M University System, confirmed that exposure to chemicals and stress caused astrocytic hypertrophy and neuronal stem cell inactivity in the hippocampus of the brain. Ashok K. Shetty, PhD, is a world-renowned expert in modeling Gulf War Illness. The study, prepared under a grant from the Department of Defense (DOD) for the U.S. Army Medical Research and Material Command, Fort Detrick, Maryland, demonstrated that treatment with BACH’s lead drug compound, GVT, normalized the production of neurons in the hippocampus by stem cell proliferation.

According to the results of Dr. Shetty’s report, GVT reverses astrocyte hypertrophy, a condition that makes the astrocyte incapable of protecting neurons. Astrocyte hypertrophy is a contributing factor in the progression of Gulf War Illness. Specifically, GVT was found to regenerate stem cells and neurons. GVT treatment improved cognitive function and reversed mood impairment, particularly anhedonia, while modulating oxidative stress in the hippocampus of GWI animals.

GVT treatment was shown to reverse recognition and location memory dysfunction and improve cognitive ability while normalizing oxidative stress in the hippocampus and cerebral cortex. In addition to normalizing astrocytic hypertrophy, GVT treatment also normalized neuronal stem cell activity in the hippocampus, and reduced the numbers of activated microglia/macrophages in the hippocampus.

The chemicals troops were exposed to in the Persian Gulf included pyridostigmine bromide, which was used as prophylaxis to prevent death in an attack with nerve gas agents. In addition, mosquito repellants, such as DEET, and pesticides, such as permethrin, were sprayed on their clothes and tents to keep potentially disease-carrying insects and rodents at bay. Some troops were also likely exposed to low levels of chemical warfare agents, due to demolition of Iraqi facilities storing those agents, and smoke from oil well fires.

Chemicals such as DEET and permethrin can enter the brain through disruption of the blood-brain barrier, where they can inhibit the breakdown of a neurotransmitter called acetylcholine. “Essentially, they cause acetylcholine to build up in the brain, causing hyperexcitability of neurons as well as the death of some neurons, which leads to inflammation in the brain,” said Ashok K. Shetty, PhD.

“Our data in animal models matches very well with what has been seen in patients,” Shetty said. They both had considerable systemic inflammation, which can be measured by levels of multiple pro-inflammatory cytokines in the blood serum. Pro-inflammatory cytokines circulate all over the body and cause systemic inflammation, which, in turn, can cause considerable problems in certain vulnerable regions of the brain such as the hippocampus. These problems include declined production of new neurons important for making new memories.

“GVT is not only neuro-protective, but also neuro-generative,” according to Mark O. Henry, CFO of BACH. “We have now shown in two different animal models that GVT can regenerate neurons. The fact that GVT regenerates stem cells and neurons was an unexpected finding.” Based on the results announced today, Dr. Shetty has established a collaboration with Dena Davidson, PhD, deputy director of research at the Veterans Integrated Service Network (VISN) 17 Center of Excellence for Research on Returning War Veterans in Waco, Texas, to pursue clinical trials in GWI patients.
“Poisoning of the brain due to chemicals widely used in modern industrial societies is a widespread issue around the world. We believe GVT has potential as a therapeutic treatment for disorders associated with a wide range of chemical poisoning,” noted BACH’s Chairman of the Board, Dr. Steven L. Stroup, MD, who also stated: “In the U.S. alone, it is believed that 30 percent of the U.S. population suffers some form of brain poisoning related to chemicals and stress.”

About Bach Pharma, Inc.: Bach Pharma, Inc. (BACH), a privately held research and development pharmaceutical company, directs the development of therapies for degenerative neurological illnesses. The company’s lead candidate GVT is a novel cytoprotective agent that has powerful anti-oxidant and anti-inflammatory properties, which research has shown can reverse oxidative stress, restore intracellular redox homeostasis and quell inflammation. Due to its strong safety profile along with its ability to cross the retinal and the blood-brain barriers and enter cells of the central nervous system, GVT has the potential to treat serious diseases of the central nervous and immune systems and dramatically reduce the cost of global health care.

BACH is a proud member of the Massachusetts Biotechnology Council and a host company for the Massachusetts Life Science Center Internship Challenge.

For more information, contact Mark O. Henry, CFO, 978-794-5510, mhenry@bachpharma.com.
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