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CERESPIR INCORPORATED Assembles World Class Clinical Advisory Board Chaired by Professor Robert A. Hauser to Support CERESPIR’S Parkinson’s Disease Development Program for Itanapraced
NEW YORK, March 26, 2019 (PR Newswire) — CERESPIR INCORPORATED, a pharmaceutical company engaged in the discovery and development of disease-modifying therapeutics for the treatment of neurodegenerative diseases, announced the formation of an expanded Clinical Advisory Board (CAB) to support Phase 2 clinical development of its lead compound itanapraced in Parkinson’s disease (PD).
“We are fortunate to have attracted some of the world’s leading experts in PD to support CERESPIR as we continue to develop our lead compound, itanapraced.” commented Daniel G. Chain, PhD, Founder and Chief Scientific Officer of CERESPIR. “Itanapraced has been shown to block both the expression of LRRK2 and its neurotoxic effects. LRRK2 is a protein kinase that has been implicated in both familial and idiopathic PD.”
“Itanapraced has a novel mechanism of action with the potential to slow or stop progression of PD,” said Professor Robert A. Hauser, M.D., MBA, Chair of CereSpir’s CAB and Professor of Neurology and Director, USF Health Parkinson’s Disease and Movement Disorders Center Parkinson Foundation Center of Excellence. “I look forward to working with my distinguished colleagues on the CAB to advise CERESPIR on the development and execution of phase 2 clinical activities to comprehensively evaluate this new and promising small molecule in PD.”
“The composition of CERESPIR’s CAB speaks to the excitement over itanapraced’s novel mechanism of action, positive prior clinical trial experience and compelling new data in an animal model of PD,” said Adrian N. Hobden, PhD, President and Chief Executive Officer of CERESPIR. “We have the most clinically advanced compound that targets LRRK2-mediated neurotoxicity and with the help of our advisors aim to rapidly progress this promising therapeutic agent as the first disease modifying treatment for patients suffering from Parkinson disease.”
CERESPIR’S PD Clinical Trials Specialists
Professor Stewart Factor: Dr. Factor is Professor of Neurology, Director of the Movement Disorders Program and Vance Lanier Chair of Neurology at Emory University School of Medicine. He received his DO Degree in 1982, completed his Neurology Residency at Albany Medical Center in 1986 and Movement Disorder Fellowship at University of Miami in 1988. He is past Chair of the Movement Disorders Section of the American Academy of Neurology and member of the Committee On Sections Executive Committee. He has edited three textbooks: “Parkinson’s Disease: Diagnosis and Clinical Management” first & second editions and “Drug-induced Movement Disorders” as well as authoring over 250 peer reviewed articles. Areas of research interest include evaluation of biomarkers in PD (Funded by the Michael J Fox Foundation), freezing of gait in PD (private funding), clinical trials previously site PI for the NINDS supported NeuroNext network), participation in a consortium to study gene environment interactions in PD, and tardive dyskinesia. As program director he is also the fellowship program director in movement disorders and has mentored 15 fellows in the last 10 years.
J.Timothy Greenamyre, MD, PhD: Dr. Tim Greenamyre is the Love Family Professor and Vice-chair of neurology, Chief of Movement Disorders, and Director of the Pittsburgh Institute for Neurodegenerative Diseases (PIND) and the American Parkinson Disease Association Advanced Center for Parkinson’s Disease Research at the University of Pittsburgh. He is Co-Chair of the Parkinson’s Foundation SAB and a member of the SAB of the Michael J. Fox Foundation and the American Parkinson Disease Association. He has been listed as one of the ‘Best Doctors in America’ since the mid-1990s. He is editor-in-chief of the scientific journal Neurobiology of Disease and serves on other editorial boards. His laboratory studies mechanisms of neurodegeneration in Parkinson’s disease, with a focus on gene-environment interactions. Translational studies use pharmacological and ‘gene therapy’ approaches. He is Chair of the 2019 Parkinson’s Disease Gordon Research Conference.
Robert A. Hauser, MD, MBA: Dr. Robert Hauser is Professor of Neurology at the University of South Florida College of Medicine, in Tampa, Florida. He serves as Director of the USF Parkinson’s Disease and Movement Disorders Center, a Parkinson Foundation Center of Excellence. Dr. Hauser earned a medical degree from Temple University School of Medicine, in Philadelphia, Pennsylvania, and completed neurology training at the Eastern Virginia Graduate School of Medicine, in Norfolk, Virginia. Dr. Hauser completed a fellowship in Movement Disorders at the University of South Florida and became Center Director in 1994. Dr. Hauser has authored or co-authored more than 300 peer-reviewed publications and is one of the world’s most cited Parkinson’s Disease investigators. He is Past Chairman of the Interventional Neurology Section of the American Academy of Neurology, has served on the executive committee of the Parkinson Study Group, and was a member of the steering committee for the NIH sponsored Neuroprotective Exploratory Trials in Parkinson’s Disease program (NET-PD). Dr. Hauser lectures frequently at scientific meetings and served as Chairman of the 2009 World Federation of Neurology International Congress on Parkinson’s Disease and Related Disorders. He has extensive expertise in clinical trial design and execution. Outcome measures that he developed have become the gold standard for use in clinical trials. He maintains an active patient practice and has been voted a Top Doctor by his peers every year since 1993. His primary research interest is the development of new medical and surgical treatments for Parkinson’s disease and other movement disorders.
Professor Rajesh Pahwa, MD: Dr. Pahwa is a Professor of Neurology at the University of Kansas Medical Center and Director of the Parkinson’s Disease and Movement Disorder Center with The University of Kansas Health System. Together those two entities create the region’s premier academic medical center. He received his M.B.B.S. (M.D.) degree at Seth G.S. Medical College, University of Bombay, India. He completed an internship in medicine at Baylor College of Medicine followed by a residency in Neurology at Baylor College of Medicine, Houston, Texas. Dr. Pahwa’s research interests are centered around the various aspects of Parkinson’s disease and essential tremor. He is currently involved in studies related to medical and surgical forms of therapies for Parkinson’s disease and essential tremor. Dr. Pahwa has published more than 250 peer-reviewed articles, chapters and abstracts in leading neurology and movement disorder journals. He has conducted more than 75 clinical trials related to Parkinson’s disease and other movement disorders. He is the co-editor of “Handbook of Parkinson’s Disease,” 3rd and 4th editions; “Therapy of Parkinson’s Disease,” 3rd edition; and “Handbook of Essential Tremor and other Tremor Disorders.” He is co-author of the book “Parkinson’s Disease: Questions and Answers,” 4th edition. The Movement Disorders Clinic, led by Dr. Rajesh Pahwa, offers diagnostic and treatment services for persons with Parkinson’s disease and related disorders.
Professor Olivier Rascol, MD, PhD: Dr. Rascol has run the Toulouse Clinical Research Centre since 1994 and the Toulouse European Space Clinic since 1998. He has also run a research group on motricity in the Research Unit INSERM U825. Dr Rascol is a neuropharmacologist specializing in Parkinson’s disease and movement disorders, drug development for Parkinson’s disease and functional neuroimaging. Dr Rascol has been actively involved in the development of several marketed antiparkinsonian medications (ropinirole, rasagiline, entacapone, safinamide, pramipexole ER, amantadine ER). He is an external advisor for French and European scientific organizations, patients’ associations, drug agencies and international pharmaceutical companies. Professor Rascol was the Secretary of the international Movement Disorders Society (2006-2009) and the chair of the MDS-ES (2013-2015) and is a member of the WFN Research Committee on Parkinsonism and Related Disorders. Dr Rascol is Associate-Editor for the Journal Fundamental and Clinical Pharmacology and the Movement Disorder Journal and is or been a member of the editorial board of Lancet Neurology, Neurology, the European Journal of Neurology, the Evidence Medicine. He has published more than 450 peer reviewed articles and invited to give more than 400 lectures.
Professor Tan Eng King, MD: Dr. Tan is a senior consultant neurologist and research director at the National Neuroscience Institute. Dr. Tan also serves as a professor at both the Duke-NUS Medical School and the Lee Kong Chian School of Medicine. Dr. Tan is an editor of the European Journal of Neurology, and Parkinson’s disease Journal and has written over 300 peer reviewed research articles focused mainly on Parkinson’s disease. He has received several accolades and awards including the David Marsden Lectureship and Yoshi Mizuno lectureship awards from the International Movement Disorders Society (MDS). He is a founding member of the MDS Asian Oceanic Section. Dr. Tan’s clinical interest is in neurodegenerative disorders including Parkinson’s disease, essential tremor and other related disorders. He also runs a botulinum toxin clinic managing patients with various neurological disorders. Dr. Tan’s research interests include clinical and neuroimaging studies, functional genomics and experimental therapeutics in movement disorders.
Itanapraced is the first of a new class of molecules known as AICD inhibitors that bind to AICD (amyloid precursor protein intracellular domain) and inhibits its transcriptional activity. Under conditions of chronic oxidative stress, AICD induces expression of a pro-apoptotic factor, BIM, PINK1, LRRK2 and other proteins that cause neuroinflammation and neurodegeneration. PD is a common, progressive neurodegenerative disorder associated with loss of midbrain dopaminergic neurons which produce the essential neurotransmitter, dopamine. In a recent press release, CERESPIR and the National Neuroscience Institute Singapore, reported data in an animal model of PD in which itanapraced was shown to block neurotoxicity and expression of LRRK2, an enzyme linked to both familial and idiopathic PD. Treatment with itanapraced resulted in the preservation of healthy dopaminergic neurons. Itanapraced, is a clinical stage, orally available, molecule with a long plasma half-life, substantial penetration into the brain and with significant clinical trial experience involving more than 200 subjects, including in a Phase 2 study in patients with MCI treated up to two years. The compound was found to be well tolerated and showed evidence of clinical activity including positive effects on biomarkers and cognition.
CERESPIR is a privately held, science-driven pharmaceutical company with an innovative approach to treating neurodegenerative disorders. Its clinical stage compound itanapraced is being developed for Parkinson’s disease with the aim of initiating Phase 2 trials this year. CERESPIR has a medicinal chemistry program aimed at identifying next generation AICD inhibitors that could be developed for a broad range of neurodegenerative diseases. For more information about CERESPIR, visit www.cerespir.com.
NOVEMBER 5, 2014 – BioPharm Insight -London,U.K. and New York, N.Y – CereSpir is in active discussions with multiple pharma companies to secure a partnership or financing to run two Phase III trials of its Alzheimer’s disease (AD) drug candidate CSP1103, said CEO Daniel Chain.
The New York-based company is also talking to investment banks for possible assistance in negotiations with a strategic partner or for IPO advisers, he added.
It has targeted either firms that have an imaging agent that may be used in the forthcoming trials, or ex-US companies, said Chain. Eli Lilly [NYSE:LLY] has a betaamyloid positron emission tomography (PET) imaging agent marketed as Amyvid (florbetapir F 18 Injection). Chain noted the company is likely to use PET amyloid imaging in Phase III trials.
Ideally the company is looking to retain US rights for the drug, noted Chain. Codevelopment
is a requirement for any deal, he added. CereSpir is in discussions with a mixture of large and midsized pharmaceutical companies in the US, Asia, Japan, the Middle East and Europe, he noted. A Phase II study for CSP1103 has already been completed and CereSpir believes it has
enough data to secure a partnership, he said. Chain declined to comment on how far along discussions were or when a deal could be announced.
In terms of deal structure the company would be looking for a combination of milestone and upfront payments as well as a substantial contribution to the trials’ cost, said Chain. The company is not interested in a company sale at this stage, although once Phase III data is available the preferred exit is a trade sale, he added.
The company is also raising money in tandem with partnership discussions and may consider conducting the trial alone if needed, said Chain. The company has largely been funded by one undisclosed private investor as well as the license source of CSP1103, Chiesi Farmaceutici, a privately owned, Parma, Italy based pharmaceutical company, he said. Chain declined to
comment on the amount CereSpir was looking to raise or the amount the company had raised to date.
CereSpir is also talking to various crossover funds with a view to a future IPO, he noted. If the company was to undertake a listing in the future it would list on the NASDAQ, he noted, declining to comment on any further details of a future IPO. The company is in discussions with a number of investment banks though has not formally engaged one yet, said Chain.
CereSpir has been in discussions with CROs and is close to making its final selection shortly, noted Chain. Cerespir has a list of less than five companies to choose from and will be narrowing down the selection and making a final decision once the company has agreed a final Phase III protocol with the FDA, he said.
The company is to run two Phase III studies with approximately 1,000 patients in each trial, said Chain. The program will be conducted in patients with mild cognitive impairment (MCI) with evidence to suggest they will develop AD in the future, he said. This will be done using PET amyloid scans and/or cerebrospinal fluid (CSF) amyloid measurements, he added. Chain declined to comment on the likely choice of primary endpoint though ruled out the use of the Alzheimer’s Disease Assessment Scale Cognitive subscale (ADASCog).
CSP1103 is a smallmolecule immunomodulator of the brain’s innate immune system. It is able to stimulate clearance of toxic protein aggregates in the brain by microglial phagocytosis and inhibit production of proinflammatory cytokines thought to be important in the pathogenesis of AD, said Chain.
by Hamish McDougall in London