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Posted: Thu Apr 17, 2008 7:54 am Post subject: BHT-3009
An update from AAN on the BHT-3009 phase 2a trial...not bad, not great...
Bayhill Therapeutics Presents Data From a Phase II Trial of BHT-3009 in Multiple Sclerosis at American Academy of Neurology 60th Annual Meeting
www.bayhilltherapeutics.com - Bayhill Therapeutics, Inc. today announced that the Company's co-founder and Vice President of Research, Hideki Garren, M.D., Ph.D., gave a podium presentation at the American Academy of Neurology 60th Annual Meeting (AAN) in Chicago. Dr. Garren's presentation, "Results from a Phase II Trial of a Myelin Basic Protein Encoding DNA Vaccine for Relapsing Multiple Sclerosis,"
provides further analysis of data from a Phase II study evaluating BHT-3009, a tolerizing DNA vaccine for multiple sclerosis (MS).
Dr. Garren's presentation focused on findings from all patients enrolled in two of the study's sites, a total of 80 patients from whom cerebral spinal fluid (CSF) was collected at week 0 to define a responder population based on baseline CSF levels of total immunoglobulin (IgG).
Patients whose baseline CSF IgG levels were greater than or equal to 2.5 mg/dl, representing 73% of the 80 patients in the cohort who provided CSF, demonstrated a statistically significant response to 0.5 mg BHT-3009. In this population, the number of new gadolinium (Gd)-enhancing lesions shown on brain magnetic resonance imaging studies (MRIs) from weeks 28 to 48 was reduced by 44% (p=.04) versus placebo. Annualized relapse rates for this group were reduced by 36%.
The authors, Drs Olaf Stüve, Petra Cravens and Todd Eager, draw attention to recent clinical studies involving BHT-3009, a DNA vaccine encoding full-length human myelin basic protein. MS is a demyelinating disease i.e. it involves degeneration of the myelin sheath surrounding axons - components of the neurons that make up nerve tissue. The authors highlight a recent safety trial with BHT-2009 - the first trial with a DNA vaccine for an autoimmune disease in human patients - which showed it to be safe and well tolerated, although clinical efficacy is, as yet, difficult to assess. However, a forthcoming Phase IIb clinical trial comparing two doses of BHT-3009 with placebo in 289 patients with relapsing-remitting multiple sclerosis (RRMS) promises to reveal more about the potential clinical benefits of this approach.
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