Alzheimer’s disease has no cure and all drug efforts to date have only delayed or slowed the progression of the disease. Most drug studies have ended before even making it to the formal U.S. Food and Drug Administration (FDA) application process because the efficacy has been so limited. The Alzheimer’s Association indicates that roughly 5.4 million Americans have the disease, and the situation will worsen as our population continues to age. The annual cost is projected to be from $150 billion to $200 billion per year in the United States alone to treat the patients with Alzheimer’s disease.
Why today’s study launch matters is that its stated goal is to file an Investigational New Drug (IND) application with the FDA within four years. It will evaluate StemCells’ proprietary HuCNS-SC product candidate as a potential therapeutic in the treatment of Alzheimer’s.
As a part of the arrangement, the California Institute for Regenerative Medicine is providing close to $19.3 million to StemCells via a forgivable loan. This will help to fund preclinical development and IND-enabling activities. StemCells already has received an initial $3.8 million disbursement from the institute to begin the study.
Again, there are currently no cures and no approved drugs that effectively or universally prevent or rapidly alter the progression of Alzheimer’s disease. StemCells is signaling that cell-based therapies have a better potential than the biologic efforts of pharmaceutical R&D to date by acting on several relevant biological targets.
StemCells is targeting the healthy and self-renewing cells that can halt or slow disease progression rather than targeting a single mechanism in an effort to preserve or restore cognitive function. StemCells will evaluate its HuCNS-SC cells in collaboration with researchers at the University of California, Irvine.
Whether StemCells will get a true financial boost from this effort remains up in the air. Investors who have chased stem cell projects have made and lost fortunes on this sector over the past 15 years or so. StemCells closed at $1.59 on Monday, against a 52-week range of $1.40 to $2.67, and its market capitalization was roughly $62 million.
The California Institute for Regenerative Medicine was established in November 2004 with the passage of Proposition 71, as approved by state voters under the California Stem Cell Research and Cures Act. The statewide ballot provided for up to $3 billion to fund stem cell research at California universities and research institutions.