NeuroTherapia, Inc.

NeuroTherpia, Inc., founded in 2015 by Cleveland Clinic Innovations based on research by Drs. Mohamed Naguib and Joseph Foss, on new therapies for diseases with an underlying component of neuroinflammation. Initial research has led to the development of our lead compound NTRX-07. NTRX-07 (previously known as MDA7) has been shown to decrease activation of microglial cells in the brain. Decreasing activation of these cells leads to decreased inflammation and decreased injury to surrounding nerve cells. Decreasing this inflammation can treat and even prevent the development of neuropathic pain in settings of nerve injury or chemotherapy. Recent work has shown that blocking this inflammation is also important in reversing the effects seen in Alzheimer's disease. We have completed preclinical safety studies and plan on studying NTRX-07 in humans in 2019.

The NeuroTherapia Team:

Mohamed Naguib Attala, MB, BCh, MSc, FCARCSI, MD

Dr. Naguib is currently a professor of Anesthesiology at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio and a staff anesthesiologist, Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio. Naguib is certified from both the American Board of Anesthesiology and the College of Anaesthetists of Ireland. Dr. Naguib held several positions as a tenured professor at both the University of Iowa and University of Texas MD Anderson Cancer Center. He has served on several Editorial boards and is currently an Associate Editor at Anesthesia & Analgesia. He is currently the President elect of the International Society of Anaesthetic Pharmacology (ISAP). Dr. Naguib's major research focus has centered on cannabinoid receptor modulators and drug development. His research on epigenetic regulation of genes involved in cognition, and his recent data (including findings recently published in Nature Neuroscience), have contributed to an understanding of epigenetic and molecular mechanisms involved in the modulation of learning and memory process in Alzheimer's disease. Dr. Naguib is currently involved with a development program for NTRX-07, a small novel neuroprotective molecule which acts on the cannabinoid type 2 receptors on microglia in the CNS.

Joseph F. Foss, M.D.

Dr. Foss is a graduate of Brown University where he did both his undergraduate studies and received his medical degree. He subsequently received his training in clinical pharmacology at the University of Chicago and led the development of methylnaltrexone, a peripherally active opioid antagonist. This involved the proof of principle trials in pre-clinical models, the first-in-man studies, and subsequent proof-of-concept trials and studies of the pharmacokinetics and pharmacodynamics in man. He was responsible for the regulatory submissions during this period and had several meetings with the FDA. Methylnaltrexone was licensed out and approved for clinical use (as Relistor®) in the management of opioid side effects in patients with advanced medical illness, such as cancer patients receiving opioids for palliative care. He subsequently worked for Adolor, a small biotech company developing alvimopan, another peripherally acting opioid antagonist, which also has been approved for clinical use. At Adolor he was also responsible for the translational program developing novel analgesics. He designed and managed two first-in-man trials for these new molecular entities as well as the proof-of-concept trials for the treatment of pain. He was subsequently recruited to Cleveland Clinic to assist in developing the research program in anesthesiology. His extensive experience in research, development of clinical programs and his management of the regulatory aspects of bringing a drug from the lab into clinical use puts him in a strong position to ensure the success of the development of CB2-agonists for the management of AD and neuropathic pain.

Tom Steele, Ph.D.

Dr. Steele is President/CEO of Nonclinical Safety Solutions, LLC, an advisory consulting firm to the pharmaceutical industry. Dr. Steele earned his MS and PhD in Pharmacology and Toxicology from Purdue University, and received postdoctoral training at the University of Maryland and Johns Hopkins Schools of Medicine, mainly focusing on mechanisms of neurotoxicity of amphetamine analogs. Dr. Steele has over 20 years of experience with the pharmaceutical industry, including work at the US FDA as Pharmacology/Toxicology reviewer for Neuropharmacological Drug Products. At Hoffmann-LaRoche, Dr. Steele lead an integrated team of toxicologists and pharmacokineticists to shepherd numerous Discovery and Development Projects from the Early Research to Post-Marketing phases across a wide range of therapeutic areas, including oncology, diabetes, neuroscience, inflammation and virology. At ImClone, a wholly-owned subsidiary of Eli Lilly, and Ariad Pharmaceuticals, Dr Steele headed the Nonclinical Safety assessment groups for biological and small molecular weight therapeutics for oncology. Dr Steele has authored or co-authored the nonclinical sections of numerous successful regulatory applications, and peer-reviewed publications.