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Hope Biosciences Receives FDA Approval to Commence Groundbreaking Stem Cell Clinical Trial for Alzheimer's Disease
[November 20, 2019]

Hope Biosciences Receives FDA Approval to Commence Groundbreaking Stem Cell Clinical Trial for Alzheimer's Disease


Hope Biosciences, a clinical stage biotechnology company focused on developing cell-based therapeutics for acute and chronic disease, today announced that FDA has approved a Phase I/II clinical trial evaluating safety and efficacy of Hope Biosciences' autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) for Alzheimer's Disease, in partnership with Altoida, Inc., a predictive digital biomarker company.

"This study will utilize our proprietary core technology to deliver high quality, pure mesenchymal stem cells with standardized doses and multiple treatments. Our novel technology allows us to overcome the burdens of traditional cell therapy, such as inability to make enough cells to make a significant impact. We can produce, on-demand, over 1,000 highly concentrated HB-adMSC treatments from a single tablespoon of the patient's own fat tissue. This technology eliminates potential donor rejection and donor-to-donor variability. We expect HB-adMSCs to safely and effectively diminish the effects of Alzheimer's Disease and provide patients more time with better cognitive function. As a high-tech cell therapy manufacturer, Hope Biosciences seeks out innovative, novel tools to assemble comprehensive clinical protocols that deliver superior cell products with state-of-the-art assessment technology. Hope Biosciences is establishing itself as an innovator in cell therapy clinical protocols by forging these kinds of relationships, extracting significantly more information than standard assessment tools and using that data to deliver the most effective therapies to patients. We are enthusiastic about this revolutionary partnership with Altoida, Inc," said Donna Chang, President and CEO of Hope Biosciences.

Currently, there are no therapies clinically proven to slow the progression of Alzheimer's Disease or restore cognitive functions and Hope Biosciences is confident this can be accomplished. Chronic neurodegenerative diseases like Alzheimer's Disease have underlying neuroinflammation which contributes to deposition of amyloid plaques and tau tangles. Advanced imaging techniques reveal localization of amyloid in the brain, which can be monitored in serial imaging over time. Behavioral assessments are often used to detect disease progression by focusing on a variety of memory tasks. Traditional memory assessments are generally helpful; however, they lack the sensitivity to detect subtle changes in different types of memory and cognitive function. Altoida, Inc. has created a powerful application that utilizes augmented reality (AR), machine learning (ML) and active Digital Biomarkers to classify patient's risk for Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD). Altoida's novel technology, the Altoida Neuro Motor Index (NMI), is a Medical Device which detects MCI due to AD 6-10 years prior to the onset of symptoms and with a 94% accuracy. The gamified collection of functional and cognitive data by utilizing tablet or smartphone sensors takes 10min only and is the world's first cognitive measurement of micro errors with active digital biomarkers. Altoida NMI is commercially available in all major global healthcare markets and is both, FDA and CE approved.

"Altoida is at the forefront of a new era to leverage Artificial Intelligence and Machine Learning to assess brain health," said Dr. Richard Fischer, CEO & President of Altoida Inc. "We are convinced, that digital biomarkers are the future and will lead to earlier diagnosis, prevention and better treatments for a wide range of brain diseases. Altoida stands for deepening our understanding of brain health and will have a transformative impact on medicine and society," said CSO & Founder Dr. oannis Tarnanas.



This Phase I/II study is a single arm, non-randomized study that is expected to enroll 24 participants. The study's primary objective is to determine the safety and treatment effect of HB-adMSCs for treatment of Alzheimer's Disease. HB-adMSCs are administered via four intravenous infusions over an eight-week period and follow-up evaluations every 6 weeks after the last infusion for one year. Assements with Altoida NMI will be performed prior to each infusion and at each follow-up visit thereafter. HB-adMSCs are autologous and have an established safety profile.

Hope Biosciences is actively offering clinical grade, stem cell banking for adults and newborns. For more information please visit https://www.hope.bio/banking


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About Hope Biosciences

Hope Biosciences is a clinical stage biotechnology company focused on developing novel cell-based therapeutics for acute and chronic injury and disease. Hope Bio's core technology lies in stem cell culture and banking. Mesenchymal stem cells are isolated from approximately one tablespoon of a patient's own fat tissue, purified, and cultured with Hope Bio's proprietary culture media, HB-101. HB-adMSCs are expanded to multiple passages and released at Passage 4 for therapeutic use. Samples of each passage are banked in order to create a master cell bank for each patient, which will be used to make additional therapies in the future. HB-adMSCs have already been used as a safe and effective treatment in a Phase I/IIa clinical trial for Rheumatoid Arthritis and Individual Expanded Access IND for Parkinson's disease, Cerebral Palsy, Spinal Cord Injury, Pancreatic Cancer, and Thrombotic Thrombocytopenic Purpura.

About Altoida Inc.

Altoida Inc. is a predictive Digital Biomarker company and is the leading Digital Health innovator utilizing active Digital Biomarkers and cutting-edge technology in Artificial Intelligence (AI) & Augmented Reality (AR) to collect functional and cognitive data to classify a patients' risk of Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD). Altoida Inc. has developed a disruptive technology - the Altoida Neuro Motor Index (NMI) - a Medical Device offering the world's first cognitive measurement of micro errors with active digital biomarkers for the early detection of MCI due to AD. Validated by 12 peer-reviewed publications and in clinical studies with more than 4,000 patients, this FDA & CE cleared Medical Device detects patterns of cognitive decline with 94% diagnostic accuracy between 6 to 10 years prior to the onset of symptoms.

For more information please visit www.Altoida.com.

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Forward Looking Statements

This press release includes forward-looking statements including, but not limited to, statements related to our current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending December 31, 2019. The Company disclaims any intent or obligation to update these forward-looking statements.


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