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ALS Community Updates

MGH Expanded Access Protocol (EAP) Program

Posted on by MOFF
24
Sep

The Martha Olson-Fernandez Foundation will donate $30,000 from their upcoming 9th Annual Golf Tournament (02-Oct) to the Expanded Access Protocol (EAP) Program at the Healey Center for ALS at Massachusetts General Hospital. Here’s why:

Amyotrophic lateral sclerosis (ALS) is a fatal, neurodegenerative disease that affects roughly 9 out of a 100,000 people in the United States at any given time1. Put in more relatable terms, the average person has a 1 out of 300 chance to develop ALS in their lifetime 2.

There are currently only 3 FDA approved therapies indicated in the treatment of amyotrophic lateral sclerosis (ALS). These drugs, RADICAVA®, NEUDEXTA®, and Rilutek fall short of providing significant, disease modifying effects for those living with the disease. Those individuals that seek a more significant therapeutic benefit and a better chance at survival enroll in clinical trials. There are currently 86 global clinical trials that are currently recruiting patients3. The caveat is that nearly 60% of ALS patients fail to qualify for clinical trial enrollment due to the rigid inclusion/exclusion criteria written into each trial protocol.4  Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials.5

2020 statistics provided by the Golden West Chapter of the ALS Association revealed that there were just over 90 patients living with ALS on the Central Coast. These patients, right in our backyard, are dying. Their only chance is experimental therapies. The MGH Expanded Access Protocol (EAP) provides just that. Since the second quarter of 2018, The MGH EAP has supervised 133 ALS patients receiving access to therapies not yet approved by the FDA. These patients have seen therapeutic benefits and their stories of function recovery are inspiring.

Some of the drugs the EAP at MGH allows access to are currently being tested in the Healey Platform Trial: Verdiperstat, CNMAu8, and Pridopidine. All of these drugs are administered under the supervision of an interdisciplinary team of doctors and longitudinal data is collected for research purposes to assist with therapy validation and categorization.

This fundraising effort is a partnership between the Ken Brenner Family and the Martha Olson-Fernandez Foundation. To date, they have raised $6,900.00 and they need your help to reach their $30,000 goal. Since it costs $10,000 to provide 1 patient access to therapy for 1 year, this total will fund 3 patients.

NEVER GIVE UP

Donate to the MGH EAP Program today.

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6567553/
  2. https://www.neurologylive.com/view/an-overview-of-causes-and-risk-factors-for-als
  3. https://clinicaltrials.gov/ct2/results?cond=ALS&Search=Apply&recrs=a&age_v=&gndr=&type=Intr&rslt=
  4. https://alsnewstoday.com/news-posts/2019/01/21/new-eligibility-criteria-needed-to-improve-als-trial-outcome/
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443564/

Natalie Fernandez
Program Director, CFO
Natalie is the associate project manager of clinical development at Viracta Therapeutics in San Diego, CA. In her spare time, she works as the program director and CFO of MOFF. Well connected within the ALS community, Natalie runs the ALS Research Paper Review Initiative (ALS RPR) and is a member of the ALS Association National Chapter Patient and Caregiver Advisory Committee (PCAC). Natalie completed her MBA degree in Pharmaceutical and Healthcare Business at The University of the Sciences in Philadelphia in June 2019. She holds an undergraduate degree from NYU in Communicative Sciences and Disorders and Spanish.

Andrea Fernandez
Director, Secretary
Andrea is currently working for Plaid in San Francisco, California. She earned her B.S. at California Polytechnic State University at San Luis Obispo. Andrea chose to live abroad and teach in Spain for a year prior to moving to San Francisco. She is currently enjoying the NorCal city lifestyle and looking forward to all that is to come.

John Ronca
Board Member
John joined the MOFF board of directors in April 2020. Bio coming soon.

Cheri Humphrey
Board Member
Cheri Humphrey joined the MOFF board of directors in August of 2019. Cheri grew up in Dixon, CA and moved to San Luis Obispo to attend Cal Poly. It was there that she met her husband Jim. They now reside in SLO and have a daughter, Victoria and a son, Riley. Cheri is instrumental in the operations of the iconic Madonna Inn, which she has been the manager of since 1989. Cheri and her family have been ALS advocates since the inception of MOFF. We are honored to have Cheri as part of the board to guide community outreach and continue raising awareness of ALS prevalence on the Central Coast.

Ian Parkinson
Board Member
We are very excited to welcome San Luis Obispo County Sheriff, Ian Parkinson, into his second two-year term as a member of the Martha Olson-Fernandez Foundation Board. Ian has served as Sheriff since 2011 and is well known in the community for this tireless efforts to improve the law enforcement processes of SLO County. Ian knew Martha Olson-Fernandez and has been a supporter of MOFF since 2012. We are very grateful for his commitment to help us carry out our mission to fight ALS through patient care and research. We look forward to utilizing his strategic insights and community outreach to further the MOFF mission.

Larry Fernandez
Director, CEO
Larry is currently an executive for a private vegetable seed company. He has been an entrepreneur in the seed industry for 35 years. He is the proud father of Andrea and Natalie and enjoys watching them pursue their education and practical learning through their job experiences. When time allows, Larry enjoys hunting and fishing. His desire is to find a cure for ALS.