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Traditional stem cell therapies like bone marrow transplants can require complicated processes prior to administration, like tissue matching or immune suppression, and lack the inherent qualities necessary for manufacturing at scale for commercial use. MultiStem cells, on the other hand, have shown widespread treatment ability and favorable commercialization properties throughout trials which could alleviate the major drawbacks of traditional stem cell therapies.
MultiStem cells are primarily manufactured by obtaining bone marrow from healthy adult donors and expanding the biological material into a master cell bank from which to produce clinical-grade stem cell therapies. Material obtained from just one donor could potentially be used to generate millions of individual doses, a yield substantially greater than other stem cell therapies have been able to achieve. Furthermore, these cells don’t require genetic matching between donor and recipient prior to administration, so MultiStem is produced as a cryogenically preserved “ready-to-use” product that can be widely accessible to clinicians to rapidly treat many patients with a variety of therapeutic needs.
MultiStem is being developed and tested to treat a variety of unmet human and even animal clinical needs. However, Athersys is prioritizing the two main areas of neurological injury and disease, and inflammatory and immunological disorders.
According to CDC data, over 795,000 people in the US suffer from a stroke each year. Of those, approximately 87% are ischemic strokes, which occur when blood flow to the brain is blocked and therefore the supply of oxygen and nutrients is cut off. This often causes permanent neurological damage and even death. Despite this, there is currently only one FDA-approved therapy, called tPA, that is used to treat ischemic strokes. However, tPA is just an anti-clotting therapy that must be administered within a few hours of the stroke in order for it to be effective, leaving most stroke patients that cannot receive treatment within that limited time frame with permanent damage.
Thus far, clinical trials of MultiStem in ischemic stroke patients have garnered favorable results, with subjects showing continual improvement throughout year-long treatment like reduced mortality rates, post-stroke inflammation, infections, and hospitalization occurrences. Beyond ischemic stroke, there are many other neurological conditions that are lacking in treatment options like Multiple Sclerosis (MS), spinal cord injury (SCI), or traumatic brain injury (TBI), that MultiStem has shown potential to effectively treat.
There are more than 80 autoimmune disorders that can cause inflammation, tissue deterioration, and loss of functionality. While currently available therapies have shown effectiveness for treating these conditions in some patients, many who suffer from inflammatory and immune disorders are left without proper treatment. MultiStem cells have shown the ability to restore immune system balance, reduce active inflammation and stimulate tissue repair.
MultiStem has shown promising indications as a treatment for Acute Respiratory Distress (ARDS), which is characterized by widespread inflammation in the lungs and can be triggered by various diseases like Covid-19, pneumonia, or sepsis. ARDS requires hospitalization and rehabilitation, with no effective drug therapies currently available. A long-term study of MultiStem treatment of ARDS found that this stem cell therapy afforded a lower mortality rate and less time spent in the ICU.
Athersys is also focused on using MultiStem as a superior alternative to stem cell and bone marrow transplants in cancer patients. Treatment for many blood-borne cancers like leukemia involves radiation or chemotherapy, which can significantly deplete bone marrow and reduce the functionality of the immune system. The result of this can lead to serious consequences for the patient, like severe anemia, immunodeficiency, disability, and even death. The common approach to resolve this is a peripheral blood stem cell or bone marrow transplant, but these involve high risk, and finding a suitable donor match can be difficult. MultiStem showed promising results in clinical trials of cancer patients receiving bone marrow transplants, including improved relapse-free survival.
Athersys does not have any commercially approved product candidates and therefore has generated no commercial product revenue. Athersys, however, has generated revenue from contracts, licensing fees, royalties and milestone payments from collaborators, and grant proceeds. The company’s principal source of revenue comes from collaboration agreements with Healios, who also holds a substantial stock interest in Athersys.
The company has incurred consecutive net losses for nearly 30 years since its inception and will need to obtain significant capital in the near term to continue its efforts toward the commercialization of its MultiStem product. Due to financial circumstances, Athersys was forced to restructure and reduce its workforce by an overwhelming 70% in June 2022, confirming its precarious financial situation. The company is also partaking in other cost-cutting initiatives like scaling back MultiStem commercialization strategies, suspending internal research for MultiStem applications outside of current trials, and pausing research for the animal health segment at its Belgian subsidiary.
Athersys’s MultiStem product platform certainly has the potential to positively influence human longevity and overall life circumstances by improving therapeutic treatment across various diseases. However, the company’s current financial situation and extended history of negative cash flow do put the goal of achieving commercialization for MultiStem at risk.