Duo for diagnostics
Startup company Breakthrough Diagnostics performs clinical testing of LymPro test for Alzheimer’s disease
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REHOVOT, Israel & NEW YORK—Alzheimer’s disease, which first destroys higher brain functions and then progressively destroys lower ones, is widely associated with amyloid proliferation in the brain. Worldwide, around 35.6 million people are Alzheimer’s patients, and this population will double every two decades. By 2050 there will be 115.4 million Alzheimer’s patients.
More than 5.4 million people in the United States are believed to have Alzheimer’s. More than half a million new cases occur every year, and nearly one in eight of the elderly fall victim to it. It is actually the third leading cause of death. The total cost for all forms of Alzheimer’s care is more than $200 billion per year and will grow to $1.2 trillion by 2050.
Todos Medical Ltd., a diagnostics developer that specializes in blood tests for cancer and neurologic diseases, and Amarantus Bioscience Holdings, which focuses on development of neurologic and ophthalmic tests and drugs, have formed the joint subsidiary Breakthrough Diagnostics Inc., for research into diagnosis for Alzheimer’s disease. Breakthrough Diagnostics has licensed intellectual property rights to the Alzheimer’s blood diagnostic LymPro test that was originally developed by Dr. Thomas Arendt from Leipzig University, as well as certain rights to multiple sclerosis diagnostic MSPrecise and Parkinson’s diagnostic NuroPro.
Breakthrough Diagnostics now has a full quota of subjects for a second clinical trial of its lymphocytic proliferation tests called Lympro PET 2. This diagnostic blood test for Alzheimer’s disease charts the disruption in the developmental cycle of peripheral lymphocyte cells and will examine the correlation between Lympro and amyloid PET imaging. An earlier study in 2018, Lympro PET 1, found a significant relationship between LymPro results and amyloid PET imaging, which the new trial seeks to confirm.
Dr. Herman Weiss, president of Todos Medical, says, “LymPro is a unique, immune system-based Alzheimer’s blood test. LymPro could prove to be a major breakthrough for Alzheimer’s disease diagnosis by measuring cell cycle disruption and amyloid together, conveniently as part of a blood workup in routing clinical practice. The therapeutic field in Alzheimer’s has begun to see some renewed hope based upon recent Aducanab data announced by Biogen that is directly related to the amyloid hyphothesis, as well as conditional approval by the National Medical Products Administration in China for the first new Alzheimer’s drug in over 20 years, called Oligomannate, from Shanghai Green Valley Pharmaceuticals, that is based on gut-brain biology of the microbiome and its effects on the immune system.”
He added, “We believe this renewed optimism and broadening of pathophysiological hypotheses relevant to Alzheimer’s disease being evaluated in the clinic significantly increases the scope for LymPro pharma services collaborations and begins to refine LymPro’s clinical utility profile for primary care physicians as strategies to correct cell cycle dysregulation emerge.”
Todos has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancer’s influence on the immune system, which triggers biochemical changes in peripheral blood mononuclear cells and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The company’s two cancer screening tests, TM-B1 and TM-B2, have received the CE mark.
Amarantus’ subsidiary, Elto Pharma Inc., has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson’s disease levodopa-induced dyskinesia, Alzheimer’s aggression and adult attention deficit hyperactivity disorder. Another Amarantus subsidiary, Cutanogen Corp., is preparing for pivotal studies with Engineered Skin Substitute for the treatment of pediatric life-threatening severe burns. ESS is a regenerative medicine-based, autologous full-thickness skin graft technology originally developed by the Shriner’s Hospital that can be used to treat severe burns, as well as several other catastrophic and cosmetic dermatological indications. Another subsidiary, MANF Therapeutics Inc., owns key intellectual property rights and licenses related to the development of the therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor (MANF). MANF Therapeutics is developing MANF-based products as treatments for ophthalmological disorders such as Wolfram syndrome, retinitis pigmentosa and glaucoma, as well as neurodegenerative diseases such as Parkinson’s disease.
