Alzamend Neuro Launches Pursuit to Secure FDA IND and First Stage Clinicals
SALT LAKE CITY, Oct. 24, 2017 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc.™, Inc. (Alzamend™ or the “Company”) announced today that it has selected TAMM Net of Marietta, GA to lead its FDA regulatory application and oversight efforts including the successful filing of a FDA IND application and resulting in FDA approval to conduct a First Stage Clinical Trial for CAO22W. The Company stated that TAMM Net will be immediately providing services starting with conducting a gap analysis and other assessment and planning processes. TAMM Net is a nationally recognized firm specializing in providing biomedical companies integrated solutions and expertise in obtaining reimbursement, conducting research with government resources, regulatory issues and applications, and distribution to closed systems. CAO22W is an innovative immunotherapeutic biologic developed to be used for the prevention, treatment and cure of Alzheimer’s disease as well as other neurological disorders the Company has exclusively licensed from the University of South Florida Research Foundation. TAMM Net will be working closely with Dr. Chuanhai Cao and his research team of clinicians and other medical professionals who are located at the USF Health Byrd Alzheimer’s Institute in Tampa Florida. Dr. Cao is the developer of CAO22W and is a USF associate professor of pharmaceutical sciences, a neuroscientist and researcher at the USF Health Byrd Alzheimer’s Institute.
TAMM Net is led by Arthur Spalding, an industry expert that has over 25 years’ experience in pharmaceuticals and medical device consulting directing various functions including clinical trial design and facility recruitment, distribution, business development, managed markets, market research, hospital sales, forecasting, and sales operations. The TAMM Net team will include regulatory experts who led the last Alzheimer compound reviewed by the FDA and have successfully guided BLA submissions. Additionally, the team has extensive experience with Biologics and is encouraged by the recent FDA approval of two Chimeric Antigen Receptor therapies.
“We are quite excited about being able to achieve this milestone and being able to start on the path towards one day conducting clinical trials that will actually test our immunotherapy in humans,” said Milton “Todd” Ault, III, the Founder and Chairman of Alzamend Neuro™, Inc. Mr. Ault added, “Our underlying goal is to get to market a treatment or cure of Alzheimer’s at a reasonable cost as quickly as possible. Far too many suffer daily, patient and caretaker alike, from the burden created by the nation’s 6th leading cause of death and ‘most feared disease’.”
Dr. Cao has focused his research on peptides for use as a vaccine for Alzheimer’s disease and other neurological diseases. Dr. Cao has developed an antigen activated immune cell-based vaccine that shows promise in helping combat nervous system dysfunctions in Alzheimer’s disease. Research has shown that the therapeutic vaccine can target the toxic protein in the brain and fix the impaired immune system in several Alzheimer’s mouse models. “Our research team has developed a therapeutic vaccine that can both combat the disease and improve the immune system,” Cao said. “The most recent results have proved that such therapy can improve memory and avoid an unwanted vaccine associated reaction in a mouse model, so it could be a very promising therapeutic for Alzheimer’s disease patients.” Dr. Cao will assist Alzamend Neuro and TAMM Net to complete the process and to consult on the goals and the details of the First Stage Clinical Trials.
“Our company is committed to supporting the full product development life cycle of treatments 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, to submit an IND application to the FDA and to conduct clinical trials needed for FDA registration. All too often great research never moves out of the lab and to the initial testing phase. We are excited to be working with Art Spalding and the team at TAMM Net to advance CAO22W that we believe can help prevent, slow down or cure Alzheimer’s disease.”
An estimated 5.5 million Americans have Alzheimer’s disease, and one in three seniors die with Alzheimer’s or another form of dementia. Alzheimer's disease is one of the costliest chronic diseases to society, and the Alzheimer’s Association estimates that the total care for Alzheimer’s and other dementias in 2017 cost the nation more than $259 billion.
The Company recommends any investors to read its Form 1-A Offering Statement and other public reports and financial statements that may be 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™. Some of the content of this press release was reprinted by permission of the USF Technology Transfer Office and the Director of Strategic Communications for the University of South Florida Research & Innovation Department.
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 an existing patented intellectual property and know-how while simultaneously funding future hope through advance research and development.
As its first step in its vision, Alzamend Neuro™, has licensed a patented mutant peptide for use in immunotherapy from the University of South Florida. It is one of the Company’s strategic goals to support the continuing research by the team at the USF Health Byrd Alzheimer’s Institute and to develop and commercialize their results into meaningful solutions.
From his family’s personal experience with 6 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 the Byrd Institute and its formative intellectual property and formed the Company. With over twenty-seven years of experience on Wall Street buying and selling companies 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.