I can’t think of a single family in my neighborhood that hasn’t been touched by Alzheimer’s. For those in the biotech family that are also affected, the announcement by Pfizer and Johnson & Johnson that a second Phase III trial of their anti-amyloid antibody, bapineuzumab, for the treatment of Alzheimer’s disease was a failure, was probably pretty depressing. Despite the emerging importance of Alzheimer’s, which affects 5.1 million Americans and 35 million worldwide, there are currently no licensed drugs that can slow the progression of disease. But there were some naysayers from the get go on “bapi” (short for bapineuzumab). For starters, it’s not clear whether amyloid plaque is a cause or a symptom of the disease. For a great blog on the reason why “bapi” should never have succeeded in the first place, read Nathan Sadeghi-Nejad’s blog, here.
And so, you wonder, why are we blogging about Bapi too? Well, because there is hope on the horizon, and of course, that hope might just turn out to be related to Tregitope. It turns out that IVIG (intravenous immunoglobulin), a pluripotent remedy, made from natural antibodies of healthy blood donors, and used for everything from anemia to transplantation, may also be useful for arresting Alzheimer’s disease. And you knowwe’re interested in what makes IVIG tick, because we believe the Tregitope mechanism of action parallels that of IVIG (and that’s the name of a new Tregitope paper that we just published, see here. The NIH is also interested, because we were just awarded a new SBIR to test whether Tregitopes will induce tolerance to enzyme replacement therapy in Pompe’s disease. Interesting that IVIG is used as part of the ERT tolerance induction therapy already!
What has been known for a few years is that IVIG has both T cell-mediated and antibody-mediated effects on the immune system. For a great review of IVIG, see here. Baxter International recently reported a small study that appears to suggest that IVIG may offer long-term benefits to patients suffering from Alzheimer’s.
The study showed that four patients with a mild to moderate form of the disease saw their cognitive and functional abilities stabilize while receiving an IVIG treatment over the course of three years—a striking discovery considering Alzheimer’s patients typically experience a dramatic decline within 18 months. Considering the small size of the study, more research will have to be done to prove the treatment’s efficacy. Clinical studies have been encouraging enough to prompt Baxter to move their IVIG product, Gammagard, into Alzheimer’s. More results are expected next year.
If the IVIg does prove effective, a new problem arises concerning its cost and availability. Off-label IVIG demand for Alzheimer’s could siphon the supply available for patients with immunodeficiency disorders.That’s a big problem. Baxter is one of several companies that make IVIg, but it takes more than 100 plasma donations to make a year’s worth of treatment for one immune-deficient patient. The treatment is usually administered twice monthly, and it can cost between $1,500 and $3,000 per year, depending on a person’s weight. Competition for the drug by patients affected by Alzheimer’s will reduce the available supply, making the drug more expensive for those that depend on it for life-saving antibody replacement.
EpiVax is working on a potential solution to the IVIG shortage, using peptides derived from immunoglobulin (also known as antibody or IgG) that appear to have many parallels in terms of their mechanism of action. Yes, those pesky Tregitopes. Interested in hearing about the next big deal in Alzheimer’s disease treatment? Read more about this exciting solution to our nation’s biggest emerging health care problem right here, in our new article, published just this week.