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Amy Chesire, L-CSW-R, MSG was recently recognized by the Huntington Study Group as Coordinator of the Year!

Tuesday, December 10, 2019

Amy Chesire

The Huntington Study Group, which was founded in 1993, is a research organization that is devoted to finding new treatments for Huntington's disease. The group includes more than 400 investigators and coordinators from over 100 research sites. Amy has been Instrumentally involved with our Huntington's disease program for more than twenty years. Her commitment to the Huntington's disease community is unparalleled. She is compassionate, knowledgeable, reliable and engaged at all levels of care for patients and families: local, regional, national and international. It is an honor to continue to work with and learn from her. Congratulations, Amy!

CMSU Tapped for ALS Clinical Trial Initiative

Thursday, November 14, 2019

The Clinical Materials Services Unit (CMSU) has been awarded the contract to provide drug supply and distribution services to the for a new clinical research initiative that seeks to rapidly evaluate new drug candidates for Amyotrophic Lateral Sclerosis (ALS).

The HEALEY ALS Platform Trial -- which will be conducted by the Sean M. Healey & AMG Center at Massachusetts General Hospital -- is a new clinical trial initiative in which studies of investigational ALS treatments are tested and evaluated simultaneously. New treatments can be added to the study as they become available. This approach has already proven successful in the cancer field and will greatly accelerate therapy development by allowing investigators to test more drugs, increase patient access to trials, and reduce the cost by quickly and efficiently evaluating the effectiveness of multiple therapies.

Three drugs developed by Biohaven Pharmaceuticals, RA Pharma, and Clene Nanomedicine will be the first to participate in the platform trial. CMSU will be responsible for providing clinical supply chain management, packaging, labeling, distribution, and return services for all the drugs used in the platform study.

CMSU is led by senior research associate Cornelia Kamp, M.B.A., and director of Clinical and Business Affairs Patrick Bolger, R.Ph., M.B.A., and is a core research unit of the Center for Health + Technology (CHeT). Over the past 11 years CMSU has provided clinical supply services to 60 multi-center clinical trials conducted in the US, Canada, New Zealand and Australia supported with funding from the NINDS, NCCAMS, NICHD, NEI, Michael J. Fox Foundation, DOD, FDA, and numerous pharmaceutical and biotech companies. At any given time, CMSU supports between 15-20 clinical trials. CMSU recently moved to its new location at 150 Metro Park in Rochester.

URMC-099 Combats Surgery-Induced Delirium, Cognitive Dysfunction in Preclinical Model of Orthopedic Surgery

Wednesday, November 6, 2019

URMC-099

Living microglia, genetically marked to glow green, in the cerebral cortex with magenta colored blood vessels from a mouse treated with URMC-099.

A new study published in the Journal of Neuroinflammation found that prophylactic treatment with URMC-099 -- a "broad spectrum" mixed-lineage kinase 3 inhibitor -- prevents neuroinflammation-associated cognitive impairment in a mouse model of orthopedic surgery-induced perioperative neurocognitive disorders (PND).

PND, a new term that encompasses postoperative delirium, delayed neurocognitive recovery, and postoperative neurocognitive disorder, is the most common complication after routine surgical procedures, particularly in the elderly. Following surgery, such as hip replacement or fracture repair, up to 50 percent of patients experience cognitive disturbances like anxiety, irritability, hallucinations, or panic attacks, which can lead to more serious complications down the line. Currently, there are no FDA-approved therapies to treat it.

Developed in the laboratory of Harris A. "Handy" Gelbard, M.D., Ph.D., director of the Center for Neurotherapeutics Discovery at the University of Rochester Medical Center, URMC-099 inhibits damaging innate immune responses that lead to inflammation in the brain and accompanying cognitive problems. Using animal models of diseases like HIV-1-associated neurocognitive disorders, Alzheimer's disease and multiple sclerosis, Gelbard has shown that the compound blocks enzymes called kinases (such as mixed lineage kinase type 3, or MLK3) that respond to inflammatory stressors inside and outside cells.

Gelbard and Niccolò Terrando, Ph.D., director of the Neuroinflammation and Cognitive Outcomes laboratory in the Department of Anesthesiology at Duke University Medical Center, used an orthopedic surgery mouse model that recapitulates features of clinical procedures such as a fracture repair or hip replacement, which are often associated with PND in frail subjects. In a pilot experiment, they treated one group of these mice with URMC-099 before and after surgery, and another group prior to surgery only. Gelbard and Terrando's teams, including first author Patrick Miller-Rhodes, a senior pre-doctoral student in the Neuroscience Graduate Program working in the Gelbard lab at URMC, measured the following:

  • How the surgery affected the central nervous system and the immune cells (microglia) that reside there was evaluated using stereology and microscopy.
  • Surgery-induced memory impairment was assessed using the "What-Where-When" and Memory Load Object Discrimination tasks.
  • The acute peripheral immune response to surgery was assessed by cytokine/chemokine profiling and flow cytometry.
  • Long-term fracture healing was assessed in fracture callouses using micro-computerized tomography and histomorphometry analyses.
  • For additional details see the "Materials and Methods" section of the study

The team found that the surgery disrupted the blood brain barrier and activated microglia (a first line immune responder present in the inflamed brain), which led to impaired object place and identity discrimination when the mice were subject to the "What-Where-When" and Memory Load Object Discrimination tasks. Both URMC-099 dosing methods prevented the surgery-induced microgliosis (increase in the number of activated microglia) and cognitive impairment without affecting fracture healing.

"A major concern regarding the use of anti-inflammatory drugs for PND is whether they will affect fracture healing. We found that our preventive, time-limited treatment with URMC-099 didn't influence bone healing or long-term bone repair," said Gelbard and Terrando, professor of Neurology, Neuroscience, Microbiology and Immunology, and Pediatrics at URMC and associate professor of Anesthesiology at Duke University Medical Center, respectively. "These findings of improvement in cognition and normal fracture healing provide compelling evidence for the advancement of URMC-099 as a therapeutic option for PND."

"Right now we have nothing to treat this condition," said Mark A. Oldham, M.D., assistant professor in the department of Psychiatry at URMC who treats patients with PND. "We work hard to provide good medical care, including helping people sleep at night and making sure they are walking, eating and drinking, but it isn't clear that these efforts have any meaningful long-term impact."

According to Oldham, recent studies that track patients following an episode of PND show that many of them don't resolve completely, and that they have a new cognitive baseline after delirium.

"It is increasingly an accepted fact that after delirium, people have suffered some kind of neurological insult, which leaves them cognitively or functionally worse off than before the incident," he noted.

Next steps for the research include identifying definitive mechanisms for pain modulation, immune cell trafficking and neuro-immune characterization in PND. Gelbard and Terrando are tackling some of these questions with funds from the National Institutes of Health (RO1 AG057525). The current study was also funded by multiple grants from the NIH (P01MH64570, RO1 MH104147, RO1 AG057525 and F31 MH113504). The University of Rochester has four issued U.S. patents and multiple issued patents in foreign countries covering URMC-099.

New Location for Clinical Trial Support Services

Wednesday, September 4, 2019

The URMC Clinical Materials Services Unit (CMSU) has relocated to a newly renovated space at 150 Metro Park in Rochester. CMSU is a unique academic-based organization that provides consulting and supply chain logistics to small and large multi-center clinical trials.

The CMSU will hold an open house at the new facility on Tuesday, September 10 from 3:00 to 6:00pm.

CMSU was founded in 2008 when clinical researchers at URMC determined the need for a dedicated, on-site facility to manage entire supply chains in support of clinical trials. The CMSU is a core research unit of the Center for Health + Technology (CHeT) which is directed by Ray Dorsey, M.D.

CHeT faculty have been involved in the conduct of clinical research for more than 30 years and have conducted 133 clinical trials, involving 48 different sponsors, 43,000 study participants, and have played a leading role in bringing seven new drugs to market -- five for Parkinson's disease and two in Huntington's disease.

CMSU provides a full array of investigational drug and device packaging, labeling, distribution, and accountability services that support academic medical centers, pharmaceutical and biotech companies, and contract research organizations. CMSU, which is led by executive director Cornelia Kamp, M.B.A, is staffed by 8 dedicated full time employees with more than 150 years of collective pharmaceutical industry experience.

Over the past 11 years CMSU has provided clinical supply services to 60 multi-center clinical trials conducted in the US, Canada, New Zealand and Australia supported with funding from the NINDS, NCCAMS, NICHD, NEI, Michael J. Fox Foundation, DOD, FDA, and numerous pharmaceutical and biotech companies. At any given time, CMSU supports between 15-20 clinical trials.

CMSU also manages the logistical drug supply operations of NeuroNEXT, a NINDS-funded national network of academic medical centers dedicated to accelerating clinical research for neurological disorders. To date, CMSU has been involved in determining the drug supply requirements for 36 of the 67 proposals approved for clinical trials.

The CMSU was previously located in the BioVenture Center in Henrietta. The new 8,800+ square foot facility operates under current Good Manufacturing Practices (cGMP) and is licensed by the New York State Board of Pharmacy. The new location consolidates warehouse, office, and processing space and allows for the more efficient coordination and distribution of research materials.

Mobile Stroke Unit Expands Operations to Monroe County

Wednesday, August 21, 2019