University of Minnesota, Essentia Health Dose First Participants in Sean M. Healey & AMG Center for ALS, Never Surrender Inc. Led Expanded Access Protocol Programs

BOSTON- The Healey & AMG Center for ALS at Massachusetts General Hospital (MGH) and Never Surrender, Inc. have announced the successful first dosing of participants in the Expanded Access Protocol (EAP) programs at the University of Minnesota (UMN) and Essentia Health.  

Expanded Access, also referred to as Compassionate Use, is a pathway for patients with a serious and life-threatening disease to access an investigational product (IP) that is not yet approved by the FDA. To read more about EAPs, visit the FDA's website. 

“We are thrilled to have reached this first milestone at both UMN and Essentia,” said Sabrina Paganoni, MD, PhD, Co-Director of the Neurological Clinical Research Institute at the Healey & AMG Center. “We are committed to expanding research and participation. Support from Never Surrender is making it possible for more people living in different communities to be a part of innovative ALS research programs.” 

The two new EAP sites were announced in the Spring of 2024 to bring access to experimental treatments for people living with ALS who are not eligible for clinical trials in the Midwest region. The site at the University of Minnesota is led by David Walk, MD, FAAN, and the site at Essentia Health is led by Amber Erickson, MD. Both sites are supported by the Healey & AMG Center at MGH.  

“Development of an EAP at Essentia Health in Duluth, MN has allowed members of our community with ALS, who do not qualify for traditional research trials, access to treatments that are being investigated as potential treatments for ALS,” said Dr. Erickson. “This has provided hope for many living with ALS, while at the same time, supporting on-going research of these treatments by collecting further safety data in a more diverse ALS population.  In a smaller city, it can be more difficult to have access to programs like this; the EAP is allowing us to provide the best care right here in our own community.” 

The data collected from EAP programs, including the safety and biomarker data, can help inform the next clinical trial or help support market approval for a broader group of ALS patients than those typically included in double-blind clinical trials.  

“We are very pleased to have the opportunity to develop our ALS EAP program at the University of Minnesota,” said Dr. Walk. “EAPs are a critical component of clinical research, providing opportunities for research participation and to expand our understanding of the safety and utility of drugs for all people living with ALS.”  

Never Surrender Inc., based in Hermantown, MN, raises money through charitable activities to raise money to fight and help people with ALS. 

“We remain steadfast in ensuring all those who require access to investigational products can,” said David Kolquist, president of Never Surrender. “As both sites move forward with enrolling participants, we will continue to provide support to those affected by ALS and their families.” 

For more information on EAP opportunities, visit our EAP web pages

About the Sean M. Healey & AMG Center for ALS at Mass General 
At the Sean M. Healey & AMG Center for ALS at Mass General, we are committed to bringing together a global network of scientists, physicians, nurses, foundations, federal agencies, and people living with ALS, their loved ones, and caregivers to accelerate the pace of ALS therapy discovery and development. 

Launched in November 2018, the Healey & AMG Center, under the leadership of Merit Cudkowicz, MD and a Science Advisory Council of international experts, is reimagining how to develop and test the most promising therapies to treat the disease, identify cures and ultimately prevent it. 

With many clinical trials and lab-based research studies in progress right now, we are ushering in a new phase of ALS treatment and care. Together, we will find the cures. 

About Never Surrender Inc. 
Never Surrender Inc. is a 501(c)(3) organization, made up of the same dedicated volunteers and long-time participants that have grown the Black Woods Blizzard Tour into the world-class fundraising event it is today and the Kolar Toyota ALS Fishing Tournament into a first-class tournament where anglers are treated like royalty. A third event, the Tomassoni Tour – Cycle for ALS, on the Mesabi Trail on the Iron Range was created in 2023 and shows great promise for a large following in years to come. The structure within Never Surrender Inc allows for expanded flexibility and effectiveness in maximizing every dollar raised to support those living with ALS, as well as their caregivers. The intent of all events is entirely unchanged from the previous two decades – to raise as much money as possible to fund the fight against ALS.