Diagnosed with multiple sclerosis (MS), Tonja Martin was in trouble. Biologics drugs that are available to help stave off the disease cost $40,000 or more per year. Tonja’s insurance wouldn’t cover her prescription, and she had to start using her retirement savings. She would have nothing left. Fortune came, however, in the form of Oklahoma Medical Research Foundation’s (OMRF) Dr. Gabriel Pardo. He offered her the opportunity to participate in a clinical trial for an experimental MS drug.
Bankruptcy to Benefits
The game changed once Ms. Martin joined the OMRF clinical trial; the research sponsor covered the costs. As it was a double-blinded study so she would not know if she would be receiving the new experimental drug or not. However, she was all in—it didn’t matter at this point. She would rather take the chance for the benefits associated with the clinical trial than opt for the current path, which was potentially bankruptcy. Martin looked at the bigger picture early on. In evaluating whether to join the study or not, she also looked at her condition and the calling to contribute to a bigger goal—advancing new medicines that could help not only her but potentially millions in the future.
The National Multiple Sclerosis Society reports that nearly 1 million people are living with the disease in America alone, and over 2.3 million worldwide. The disease tends to strike in Northern European populations with more frequency.
The Study Produces Results
Martin was treated with an infusion every six months. Although she wasn’t certain she was receiving the actual drug, she started to feel different—her dizziness started to give way to a more energetic and confident demeanor—she noted that she “felt like I used to feel.” As it turns out after the study, she was notified that she was receiving the experimental drug. OMRF continued her administration of the drug even after the study to continue an evaluation of the drug’s benefit and side effects through 2021.
OMRF Clinical Trials in MS
OMRF is a powerful research center few have heard of, outside of perhaps, Oklahoma or clinical research circles. TrialSite News has profiled their success. Located in Oklahoma City, OK, OMRF is an independent, nonprofit biomedical research institute established back in 1946. Their scientists hold more than 700 US and international patents and have spun off 11 biotech companies.
OMRF is currently conducting five clinical trials. A summary:
· A prospective, multi-center, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA®(alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis. Alemtuzumab was produced by Genzyme and became part of Sanofi during the acquisition.
· A Phase 3 study in subjects with relapsing-remitting multiple sclerosis to evaluate the tolerability of ALKS 8700 and Dimethyl Fumarate. The experimental drug is the result of a partnership between Alkermes and Biogen.
· Multi-center, randomized, double-blinded assessment of Tecfidera® in extending the time to the first attack in radiologically isolated syndrome (RIS) (ARISE). Tecidera is based on Dimethyl Fumarate, developed decades ago and commercialized by Biogen. In Europe, a version has been approved for moderate-to-severe psoriasis. In America, Biogen’s version (Tecidera) was approved by the FDA for first-line disease-modifying therapy for patients with relapsing forms of MS. in 2013. At this point, this represented the third oral therapy approved for relapsing MS and the tenth modifying treatment in the country.
· A multi-center, randomized, double-blind, placebo-controlled study in subjects with relapsing multiple sclerosis to evaluate the efficacy and safety of BIB033 as an add-on therapy to anti-inflammatory disease-modifying therapies, the AFFINITY Study. Sponsored by Biogen, this study’s primary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of the study is to evaluate the long-term safety profile of BIIB033 as add-on therapy in participants with MS. BIIB033, or opicinumab is a fully human monoclonal antibody designed for the treatment of multiple sclerosis, acute optic neuritis (AON), and other associated demyelinating diseases. A biologic drug, it is designed to function as a LINGO-1 protein antagonist, known as “Anti-Lingo-1.” Some Phase II clinical trials have been carried out, but preliminary results indicate that primary study endpoints were not met and that opicinumab exhibits unexpected dose-response relationships.
Further studies were planned by the company, as opicinumab still was deemed to show potential for clinical efficacy in the treatment of MS.
· A 12-month, prospective, multi-center, two-cohort, nonrandomized, open-label study in adult patients with relapsing multiple sclerosis (RMS), to investigate changes in immune phenotype biomarkers after treatment with 0.5 fingolimod (FLUENT). This study is sponsored by Novartis. Fingolimod is a sphingosine 1-phosphate receptor modulator indicated and approved for the treatment of relapsing-remitting multiple sclerosis. In December 2019, the first generic forms of Fingolimod were granted FDA approval.
Call to Action: For those diagnosed with MS and that could potentially fit into the inclusion criteria, reach out to OMRF to learn more.