Cocrystal Lithium-Based Therapy, “LiProSal™” Targets the Reduction of Agitation in Patients with AD
Salt Lake City, UT – (Globe Newswire – October 29, 2018) – Alzamend Neuro™, Inc. (Alzamend™ or the “Company”) announced today that it secured two new licenses from the University of South Florida (“USF”) that, together, comprise the basis for a therapy targeted to treat agitation in those who are diagnosed with Alzheimer’s disease (AD). The therapy, named LiProSal™, combines lithium, proline and salicylate leveraging cocrystal technology to deliver relief to patients with AD and possibly other forms of dementia. The cocrystal technology enables a greater bioavailability from the therapeutic lithium while potentially reducing side effects to patients. Lithium has long been a popular treatment for neuropsychiatric disorders, yet has been plagued by poor bioavailability and adverse effects. LiProSal™ was created by a dedicated team
of researchers led by Dr. Doug Shytle in the Center of Excellence for Aging and Brain Repair in the Department of Neurosurgery and Brain Repair and Dr. Jun Tan, PhD, M.D., Robert A. Silver Endowed Chair, in the Department of Psychiatry and Behavioral Neurosciences, USF Morsani College of Medicine. In the U.S., Alzheimer’s disease is the most prevalent form of dementia estimated at over 5.7 million adults today.
“We are very excited about executing the two license agreements with the University of South Florida for LiProSal™. We look forward to bringing this ionic cocrystal based oral therapy to patients that have long suffered with the effects of AD. There are no profound treatments today for Alzheimer’s. With LiProSal™, we are very hopeful that we can change that,” said Milton “Todd” Ault, III, the Founder and Chairman of Alzamend Neuro, Inc. Mr. Ault continued, “Our consulting firm, TAMM Net, Inc. led by Art Spalding, will be providing the Company with a detailed timeline and development plan for completing and filing both the Pre-IND and IND with the FDA and launching clinical trials. Our underlying goal is to get a treatment or cure for Alzheimer’s to market at a reasonable cost as quickly as possible. Far too many suffer daily, patients
and caretakers alike, from the burden created by the nation’s 6 th leading cause of death and ‘most feared disease’.”
Despite the advent of newer medications, Lithium is still currently approved by the FDA as a mood stabilizer and is considered the gold standard for treatment of bipolar disorder. Lithium is also commonly prescribed off-label for other neuropsychiatric symptoms, including suicidality and impulsive aggression as well as neurodegenerative diseases such as AD.
Pharmacokinetics is the way the body absorbs, distributes and eliminates a drug. The findings from the preclinical studies by the creators of LiProSal™ support the notion that an ideal lithium preparation would be one that would both “flatten” high blood level peaks and “slow” declining blood concentrations.
“Remarkably, LiProSal™ produced elevated levels of lithium in the mouse blood and brain 48 hours after an oral dose, but without the sharp peaks that contribute to the toxicity problems of lithium in the current FDA-approved lithium product,”
said Dr. Shytle. “Additionally, oral administration of LiProSal™ to Alzheimer’s-like mice exhibited improved pharmacokinetics and significantly reduced β-amyloid plaques and abnormal tau phosphorylation, two pathological features for clinical AD,” added Dr. Tan. If these preclinical results hold true in humans, this would allow for a lower lithium dosing regimen and possibly fewer troublesome adverse events that plague conventional lithium therapy. Thus, LiProSal™ stands to be a major improvement over current lithium-based treatments and may also represent a means of
treating Alzheimer’s disease.
“Our company is committed to supporting the full product development life cycle of treatment and cures for Alzheimer’s disease,” said Philip Mansour, President and CEO of Alzamend Neuro™. “We are now at the doorstep of the next very important step, FDA registration and application to conduct human clinical trials. All too often great research never moves out of the lab and the initial testing phase. We are seeking every person who is aware of the devastation that AD causes, inform them of our projects, and call them to arms to support our mission to ‘make Alzheimer’s just a memory’. We are
excited to be working with Dr. Shytle and Dr. Tan to advance LiProSal™ and other technologies that we believe can help prevent, slow down or cure Alzheimer’s disease.”
In 2017, USF was granted a patent related to this technology (USPTO # 9,603,869), and the patent has been exclusively licensed to Alzamend Neuro™, a Utah-based biotechnology company dedicated to finding a prevention, treatment and cure for Alzheimer’s disease. The company’s goal is to move the technology out of the research and preclinical testing stages into clinical trials as it works toward commercialization of LiProSal™. It is estimated by the Alzheimer’s Association that every 65 seconds, someone in the U.S. develops Alzheimer’s and as many as one in ten adults over 65 have
Alzheimer’s. It is also projected that by the year 2050, one in three seniors will have AD or another form of dementia and the disease may affect as many as 88 million adults if a cure is not found. Alzheimer’s disease is one of the costliest chronic diseases to society and estimates are that the total care for Alzheimer’s and other dementias in 2017 cost the nation more than $277 billion.
The Company recommends its shareholders and any interested parties read its public reports and financial statements filed with the Securities and Exchange Commission for further information. All public filings, financial statements, management profiles and other Company information are available on the Company’s web site, www.Alzamend.com™.
About Alzamend Neuro™, Inc.
Alzamend Neuro™, Inc. is a Delaware corporation doing business in the State of Utah. The mission of Alzamend Neuro™ is to support the full product development life cycle of treatment and cures for Alzheimer’s driven by the belief that strong support of research is the foundation for true innovation. The Company is providing current hope through the commercialization of existing patented intellectual property and know-how while simultaneously funding future hope through advanced research and development.
The vision of Alzamend Neuro™ has been to license CAO22W, the patented mutant peptide for use in immunotherapy as well as other AD technology from the University of South Florida. It is one of the Company’s strategic goals to support the continuing research by the teams at the USF Health Byrd Alzheimer’s Institute and other USF Health Colleges to develop and commercialize their results into meaningful solutions.
From his family’s personal experience with relatives having been afflicted with AD, Mr. Milton “Todd” Ault, III, the Company’s Founder and Chairman, diligently studied the status of treatments and the landscape of medical technology. Mr. Ault selected USF and its formative intellectual property and formed the Company. With over twenty-seven years of experience on Wall Street as an activist driven by his relentless passion for business and technology, Mr. Ault’s efforts have culminated in a commitment to depart from the traditional while forging ahead with an innovative, yet disruptive path
to financing the commercialization and the discovery of future solutions.
Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and those statements are subject to the
safe harbor created by those rules. All statements, other than statements of fact, included in this release, including, without limitation, statements regarding potential plans and objectives of the Company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The Company cautions that these forward-looking statements are further qualified by other factors. The Company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events or otherwise.