1. New Blood Test Predicts Efficacy of Multiple Sclerosis Drug Beta Interferon
A scientific breakthrough recently published in Nature Medicine may help patients with Multiple Sclerosis find out, with a simple blood test, whether they will respond to one of the leading drugs on the market today (beta interferon) or not. Dr. Larry Steinman, one of the co-authors of the paper, tells BioBusiness.TV how he and his team came to this discovery. When asked by analyst Michael King, about the EAE model used for the test, Dr. Steinman explains the difference between the IL1 and IL17 pathways that caused paralysis. When beta interferon was administered, paralysis was reversed in animals with IL1, and was made worse in animals with IL17. An independant study from the University of Amsterdam showed a correlation between the occurrence of relapses in MS and the presence of IL17 in the blood, which is fully congruent with the data found here in animal models.
2. 1-in-4 MS Patients Could Be IL17 Non-Responders to the $4Bn Revenue Beta Interferon Drug
Dr. Larry Steinman and Mike King discuss some of the supporting research that shows Beta Interferon worsens the condition of Multiple Sclerosis (MS) patients with high levels of IL17 (in Neuromyelitis Optica a prevalent form of MS in Asia). Dr. Larry Steinman outlines the potential benefits of a screening test for the “IL17″ non-responder group (25% of patients), and for the “IL1″ responder group. Taking these different pathways in consideration, Beta Interferon may prove to work as well as the more powerful second line MS drugs such as Tysabri. Having said that, Dr. Steinman insists that other groups will have to repeat this observation in order to validate it, and the FDA will have to approve this finding before any test being available for patients.
3. IL17 to Multiple Sclerosis as KRAS to Colon Cancer?
Analyst Mike King compares the discovery of Dr. Steinman’s team to that of the KRAS gene mutation and anti-EGFR monoclonal antibody drugs like Erbitux for the treatment of metastatic colon cancer. The implication are two-fold, explains Dr. Larry Steinman. First, Multiple Sclerosis may not be a single disease, but a collection of diseases. Second, knowing whom a drug will benefit and whom it won’t is one of the most efficient ways to deliver medicine. Mike asks if insurance companies will demand this test to be performed prior to treat MS patients, and if many more tests are to be expected in the future in many other disease treatments, to which Larry responds that there are too many scientific, economic and common sense arguments in favor of this type of gating tests to be developed for all major drugs in the future.
4. When Will the 300,000+ Patients on Beta Interferon Benefit From Dr Steinman’s Breakthrough Study?
An expedited FDA study on IL17 would be welcome, says Dr. Steinman, given the potential impact of the IL17 pathway discovery on current treatments. The Multiple Sclerosis society will, hopefully, try to expedite the process. Mike King compares it again to KRAS, which took off like wildfire after it’s discovery with a very proactive FDA. Dr. Steinman insists we should not take shortcuts and make sure it’s “absolutely solid!” Dr. Steinman’s has also begun working on Teva’s Copaxone, and other experimental drugs in the pipeline.
5. Impact of IL17 on MS Drugs in the Pipeline, and Potential Applicability in Progressive Multifocal Leukoencephalopathy (PML)
Looking at some of the drugs in the Multiple Sclerosis pipeline (e.g. Ocrelizumab, Daclizumab), we could expect them to subdivide within the patient population, as with Beta Interferon. Dr. Steinman also tells us that a number of people are working to create a predictive test that can tell who is at risk of getting PML if they take Tsyabri, and that this test could bring great hope if announced and validated. “It’s going to be a wonderful frontier to watch as genetic medicine really comes to the forefront in neurology, as it has in so many other diseases” comments analyst Mike King.
This interview was conducted at the NASDAQ Marketsite, and is being broadcasted in conjunction with the release of Dr. Laurence Steinman’s paper, published in Nature Medicine on March 28th, 2010
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