The Phil Smith Neuroscience Institute at Holy Cross Health in Fort Lauderdale has been selected as one of three sites nationally and the only one in Florida for a clinical trial in the treatment of patients living with Amyotrophic Lateral Sclerosis (ALS).
Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., has launched this, the second U.S. Food and Drug Administration expanded access program (CNMAu8.EAP02) with CNM-Au8 for people living with ALS. This expanded access program is implemented in conjunction with the Healey ALS Platform trial, by the Sean M. Healey & AMG Center at Massachusetts General Hospital, which Holy Cross Health was selected to participate in two years ago. At that time, the Sean M. Healey & AMG Center at Massachusetts General Hospital launched the first platform trial for ALS patients affected by this disease. The expanded access program is designed to provide patients with ALS who are not eligible to enroll in the Healey ALS Platform trial access to CNM-Au8, which is an investigational cellular energetic catalyst that supports energy production.
“We are committed to continuously working with our partners in researching and developing lifesaving therapies for treating patients with ALS,” said Dr. Eduardo Locatelli, Director of the Holy Cross Neuroscience Institute and Interim Chief Medical Officer at Holy Cross Health. “It is through trials like this that we can have the greatest impact on the quality of life for our patients.”
ALS is a progressive neurological disease that results in the death of nerve cells called motor neurons in the brain and spinal cord which control voluntary muscles. ALS affects more than 16,000 patients in the U.S. According to the ALS Association, every 90 minutes someone is diagnosed with ALS and someone passes away from it.
“While CNM-Au8 advances through the registration platform trial with an aim to become available to all patients with ALS, expanded access programs enable more people with ALS to benefit today from the potential neuroreparative properties of our groundbreaking nanocatalytic drug candidate. Clene is
committed to supporting communities living with devastating neurodegenerative diseases, and we are doing our utmost each day to reach and treat more patients,” said Clene’s President and CEO Rob Etherington.
Holy Cross Health opened the Phil Smith Neuroscience Institute and Phil Smith ALS and Movement Disorders Clinic in 2018. More than 15 neurologists and rehabilitation specialists at the Phil Smith Neuroscience Institute provide comprehensive neurological and neurosurgical care for a variety of conditions. It is the only specialized care for ALS patients in Broward and Palm Beach counties and one of only five Certified Treatment Centers of ExcellenceSM in Florida as named by the ALS Association.
ABOUT HOLY CROSS HEALTH
A member of Trinity Health, Fort Lauderdale-based Holy Cross Hospital, dba Holy Cross Health, is a full-service, non-profit, Catholic, teaching hospital operating in the spirit of the Sisters of Mercy. Holy Cross has been named one of the top 10 hospitals in the Miami metro area and among the top 30 in the state in U.S. News and World Report’s 2020-2021 Best Hospital rankings. Through strategic collaborations and a commitment to being a person-centered, transforming, healing presence, the 557-bed hospital offers progressive inpatient, outpatient and community outreach services and clinical research trials to serve as our community’s trusted health partner for life. Holy Cross Health also encompasses Holy Cross HealthPlex outpatient facility, urgent care centers and more than 50 Holy Cross Medical Group physician practices. To learn more about Holy Cross Health, visit holy-cross.com. Connect @holycrossfl.
