Clinical Research Organization, Huntington Study Group “Firsts” Continue
Rochester, NY, December 05, 2022 --(PR.com)-- The Huntington Study Group (HSG), a world leader in conducting clinical trials for Huntington’s Disease (HD) through its Clinical Research Organization (CRO), HSG Clinical Research, Inc. (HSGCR) continues making groundbreaking progress in the HD world. At their Annual Meeting in November, the HSG team presented exciting updates about their Clinical Research Organization’s achievements.
There were many notable highlights, including information about two current HSG clinical trials. The KINECT-HD/KINECT-HD2 trials, sponsored by Neurocrine Biosciences, Inc. (NBI), met enrollment goals and continued study activities during COVID-19. It was announced during the meeting that the KINECT-HD trial met its primary endpoint of change in chorea severity using the Total Maximal Chorea (TMC) score of the UHDRS® from screening period baseline to maintenance period. Improvement in the TMC score was significantly greater with Valbenazine versus placebo. KINECT-HD2 is an open-label trial that is currently enrolling subjects.
Erin Furr-Stimming, MD, the Principal Investigator of the KINECT studies said, “The strong partnership between HSG and NBI was instrumental in facilitating a successful symptomatic trial in HD, an important milestone advancing HD care and awareness. We are incredibly grateful to the study participants and their care partners who participated in KINECT-HD and continue to participate in KINECT-HD2.”
The Phase 3 global PROOF-HD trial, sponsored by Prilenia Therapeutics, is assessing the effect of pridopidine on function in early-stage HD subjects. The trial launched early during COVID-19 and enrolled 499 subjects over 1 year during the height of the pandemic. Andrew Feigin, MD, the North American Principal Investigator (PI) of the study and HSG’s Chief Medical Officer said, “The HSG is proud to be working with an amazing team to conduct this international multicenter clinical trial. The rapid rate of recruitment in this study during the most challenging of times speaks to the inspiring dedication, commitment, and enthusiasm of the HD community.”
The SIGNAL trial, sponsored by Vaccinex, Inc., is the first IV Infusion trial in HD and detailed results were recently published in Nature Medicine1. This 301-subject study met enrollment goals and completed closeout ahead of schedule during COVID-19.
Elise Kayson, MS, ANP, the VP of Clinical Operations said, “HSGCR is committed to designing and conducting innovative HD clinical trials. Our dedicated and experienced HD centric team works closely with HSG sites to be efficient and trial ready to meet the needs of our sponsors and patients and families. HSGCR’s recent successful accomplishments speak multitudes about our capabilities as a CRO.”
Since the HSG was founded in 1993, the organization has continually proven that they are a leader in HD clinical research. The HSG continues to innovate in clinical trial design, biomarkers, and in the operational side of HD clinical trials. Notably, the HSG conducted the clinical trials for the first and only two FDA approved drugs for HD, the first clinical trial in HD, and the first longitudinal study in HD.
“As the year comes to a close, our team is reflecting on the impact our collective efforts have made, and we’re looking forward to continuing to do everything we can to make a difference in 2023 and beyond. We would also like to extend our gratitude to all of our partners, sponsors, and collaborators who make what we do every day a possibility and a reality,” said Shari Kinel, JD, CEO.
1Feigin, A., Evans, E.E., Fisher, T.L. et al. Pepinemab antibody blockade of SEMA4D in early Huntington’s disease: a randomized, placebo-controlled, phase 2 trial. Nat Med 28, 2183–2193 (2022). https://doi.org/10.1038/s41591-022-01919-8
HSG offers a full suite of CRO services. To learn more, please visit: https://huntingtonstudygroup.org/wp-content/uploads/HSG_Trial_Services_Sheet.pdf
About Huntington’s Disease
Huntington’s Disease (HD) is a hereditary neurodegenerative disease characterized by a movement disorder, psychiatric difficulties, and cognitive changes, usually beginning in middle adult life. About 40,000 people in North America have HD, and another 200,000 are considered “at risk” for inheriting the illness because they have (or had) a parent with HD.
About Huntington Study Group / HSG Clinical Research
Founded in 1993 in Rochester, NY, the Huntington Study Group (HSG) is a not-for-profit organization comprised of the world’s first and largest collaborative network of experts in Huntington’s Disease whose mission is to seek treatments that make a difference for those affected by HD. HSG Clinical Research, Inc., a wholly owned subsidiary of the HSG, is a full-service clinical research organization that specializes on conducting trials in HD. There are over 800 HD experts at more than 130 HSG credentialed research sites worldwide. The HSG also offers educational services like CME4HD™ for healthcare professionals and care providers on treating patients with HD. For more information, visit www.huntingtonstudygroup.org.
There were many notable highlights, including information about two current HSG clinical trials. The KINECT-HD/KINECT-HD2 trials, sponsored by Neurocrine Biosciences, Inc. (NBI), met enrollment goals and continued study activities during COVID-19. It was announced during the meeting that the KINECT-HD trial met its primary endpoint of change in chorea severity using the Total Maximal Chorea (TMC) score of the UHDRS® from screening period baseline to maintenance period. Improvement in the TMC score was significantly greater with Valbenazine versus placebo. KINECT-HD2 is an open-label trial that is currently enrolling subjects.
Erin Furr-Stimming, MD, the Principal Investigator of the KINECT studies said, “The strong partnership between HSG and NBI was instrumental in facilitating a successful symptomatic trial in HD, an important milestone advancing HD care and awareness. We are incredibly grateful to the study participants and their care partners who participated in KINECT-HD and continue to participate in KINECT-HD2.”
The Phase 3 global PROOF-HD trial, sponsored by Prilenia Therapeutics, is assessing the effect of pridopidine on function in early-stage HD subjects. The trial launched early during COVID-19 and enrolled 499 subjects over 1 year during the height of the pandemic. Andrew Feigin, MD, the North American Principal Investigator (PI) of the study and HSG’s Chief Medical Officer said, “The HSG is proud to be working with an amazing team to conduct this international multicenter clinical trial. The rapid rate of recruitment in this study during the most challenging of times speaks to the inspiring dedication, commitment, and enthusiasm of the HD community.”
The SIGNAL trial, sponsored by Vaccinex, Inc., is the first IV Infusion trial in HD and detailed results were recently published in Nature Medicine1. This 301-subject study met enrollment goals and completed closeout ahead of schedule during COVID-19.
Elise Kayson, MS, ANP, the VP of Clinical Operations said, “HSGCR is committed to designing and conducting innovative HD clinical trials. Our dedicated and experienced HD centric team works closely with HSG sites to be efficient and trial ready to meet the needs of our sponsors and patients and families. HSGCR’s recent successful accomplishments speak multitudes about our capabilities as a CRO.”
Since the HSG was founded in 1993, the organization has continually proven that they are a leader in HD clinical research. The HSG continues to innovate in clinical trial design, biomarkers, and in the operational side of HD clinical trials. Notably, the HSG conducted the clinical trials for the first and only two FDA approved drugs for HD, the first clinical trial in HD, and the first longitudinal study in HD.
“As the year comes to a close, our team is reflecting on the impact our collective efforts have made, and we’re looking forward to continuing to do everything we can to make a difference in 2023 and beyond. We would also like to extend our gratitude to all of our partners, sponsors, and collaborators who make what we do every day a possibility and a reality,” said Shari Kinel, JD, CEO.
1Feigin, A., Evans, E.E., Fisher, T.L. et al. Pepinemab antibody blockade of SEMA4D in early Huntington’s disease: a randomized, placebo-controlled, phase 2 trial. Nat Med 28, 2183–2193 (2022). https://doi.org/10.1038/s41591-022-01919-8
HSG offers a full suite of CRO services. To learn more, please visit: https://huntingtonstudygroup.org/wp-content/uploads/HSG_Trial_Services_Sheet.pdf
About Huntington’s Disease
Huntington’s Disease (HD) is a hereditary neurodegenerative disease characterized by a movement disorder, psychiatric difficulties, and cognitive changes, usually beginning in middle adult life. About 40,000 people in North America have HD, and another 200,000 are considered “at risk” for inheriting the illness because they have (or had) a parent with HD.
About Huntington Study Group / HSG Clinical Research
Founded in 1993 in Rochester, NY, the Huntington Study Group (HSG) is a not-for-profit organization comprised of the world’s first and largest collaborative network of experts in Huntington’s Disease whose mission is to seek treatments that make a difference for those affected by HD. HSG Clinical Research, Inc., a wholly owned subsidiary of the HSG, is a full-service clinical research organization that specializes on conducting trials in HD. There are over 800 HD experts at more than 130 HSG credentialed research sites worldwide. The HSG also offers educational services like CME4HD™ for healthcare professionals and care providers on treating patients with HD. For more information, visit www.huntingtonstudygroup.org.
Contact
Huntington Study Group
Emma Grushkin
800-487-7671
https://huntingtonstudygroup.org
Emma Grushkin
800-487-7671
https://huntingtonstudygroup.org
Contact
Categories