Offers Potential for More Precise Measurement of Therapeutic Benefit, Enabling Clinical Trials to Reach Statistical Significance with Fewer Patients
Part of New York's $620 Million Life Science Initiative
Governor Andrew M. Cuomo today announced a $5 million grant that will allow NeuroCuresNY, Inc. to conduct a two-year demonstration of its unique clinical trial network and process for testing drugs to treat disability due to neurological impairment. NCNY, a not-for-profit initiative formed by Burke Neurological Institute, the University of Rochester and the Wadsworth Center to conduct clinical trials of drugs for chronic neurological impairment and disability, aims to reduce the time and cost of drug development for patients disabled from stroke who have exhausted everything that the health care system currently offers. The grant is part of New York State's $620 million Life Science Initiative to spur the growth of a world-class life science research cluster in New York, as well as expand the state's ability to commercialize this research and grow the economy.
"Building a healthier future for New York means leading the way on critical scientific research and development projects today," Governor Cuomo said. "NeuroCuresNY's demonstration trial will test innovative new drugs and therapies that have the potential to make a world of difference for patients suffering from the effects of stroke and continue New York's unprecedented growth in the life sciences industry."
"The life sciences industry continues to grow across the state thanks to investments in cutting edge research and development," said Lieutenant Governor Kathy Hochul. "This funding will provide the resources needed to help find a cure for neurological impairments that result from a stroke. The grant for NeuroCuresNY builds on our commitment to support innovative studies and treatments to ensure the health and well-being of all New Yorkers."
The demonstration trial will combine the use of medication to repair the brain in combination with robotic training technology, which can re-educate the individual's nervous system. The two-year trial will require over 150 patients with chronic disability due to stroke and will run for approximately 24 months. Over time, NCNY plans to evaluate treatments for disability due to other neurological conditions such as brain injury, Alzheimer's disease and spinal cord injury.
NCNY's unique approach is designed to reduce infrastructure costs for trials, enabling them to be run more efficiently. This approach includes:
- A stable network of physicians who refer patients to participate in trials and also serve as trial investigators, ensuring an ongoing source of trial participants and overcoming the challenge of patient recruitment,
- Treatment strategies that use drugs to repair the brain in combination with robotic technology that "retrains" the nervous system and yields more precise measurement of therapeutic benefit, and
- Use of a standardized, rigorous study protocol to serve as the basis for all trials, so that protocols do not have to be reinvented for each trial, creating a more efficient testing environment.
The trial will also enable NeuroCuresNY to refine its path toward self-sufficiency, expand its physician network and solidify its position as an anchor entity for neurologic clinical development. With this success, NeuroCuresNY will offer the potential for such long-term economic development benefits as:
- Attracting commercial companies to run clinical trials and create revenue in New York State
- Generating jobs in trial management, product development, rehabilitation and data analysis
- Encouraging greater individual and venture investment
- Creating new intellectual property and spin-off companies
- Attracting medical tourists to New York to participate in neurological trials
- Showcasing New York's premier neurological treatment facilities
Empire State Development President, CEO and Commissioner Howard Zemsky said, "New York State is committed to supporting innovations like NeuroCuresNY that further build our vibrant life science industry while also enabling the development of treatments that will improve lives."
"Millions of Americans and their families struggle on a daily basis with the challenges from being disabled from neurological diseases such as stroke, Alzheimer's disease and spinal cord injury," said Dr. Rajiv Ratan, Director of the Burke Neurological Institute, an affiliate of Weill Cornell Medicine, and the Interim Director of NeuroCuresNY, Inc. "The enduring lack of treatment options to significantly address the challenges that people with these neurological conditions face highlight the need for a novel, game-changing approach. With the organizational and financial support of the Empire State Development Corporation and the Governor's office, an unprecedented collaboration among the Burke Neurological Institute; the Neurorestoration Institute at the University of Rochester (led by Brad Berk MD, PhD); and the Center for Adaptive Neurotechology at the Wadworth Laboratories of the NYSDOH (led by Jon Wolpaw MD); has brought forth a unique, innovative clinical trials model with potential to change this trajectory not only in New York, but nationally and globally."
Neurological impairment and disability research are often overlooked because of the challenges and high costs of conducting clinical trials, despite the great need for treatments to address disability. NCNY was created specifically to overcome these challenges. Neurological conditions such as traumatic brain and spinal cord injury and stroke permanently disable more than 1 million individuals each year in the United States, costing approximately $387 billion per year to manage. Clinical development of therapeutics to treat or cure neurological impairment has been challenging and costly. The lack of effective treatments for the chronic disability and impairment resulting from neurological disorders can create considerable personal and financial burden.
The potential for reduction in clinical trial duration and cost of neurological drug development has already generated interest among companies with products ready for clinical evaluation.
New York State's $620 Million Life Science Initiative
In the FY 2018 budget, New York State enacted a $620 million initiative to spur the growth of a world-class life science research cluster in New York, as well as expand the state's ability to commercialize this research and grow the economy.
This multi-faceted initiative includes $100 million to expand the Excelsior Jobs Program Tax Credit across the life sciences industry, $100 million for a life sciences research and development refundable tax credit program, and $320 million in other forms of investment. This includes state capital grants to support the development of wet-lab and innovation space, and operating support and investment capital for early stage life science companies that leverages an additional match of at least $100 million from the private sector.
The Life Science sector encompasses the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, and includes organizations and institutions that devote the majority of their efforts to the various stages of research, development, technology transfer and commercialization. Every day, firms in this sector are developing new medical and pharmaceutical breakthroughs that have the potential to save lives, whether through new therapies or the early detection of diseases like autism and cancer. These firms are also making significant advancements in the realms of agriculture and environmental biotechnologies, helping create a cleaner and more sustainable future.
By strengthening incentives, investing in the facilities, and improving access to talent and expertise, New York will significantly increase its share of industry-funded research and development, support the commercialization of existing academic research, and usher in the next generation of advanced technologies. Beyond the advancements in science, this initiative will position New York as a magnet for emerging manufacturing- based enterprises, bolstering regional economies and creating thousands of jobs.