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Another article of the same drug.


The bit I liked was "All patients are clinically stable, or improved with treatment". Surely this should be the outcome measurement of any MS drugs trial. Too much in the past has focussed on numbers of lesions / enhancing lesions etc. What we want (I assume we all want) is stability i.e. no more deterioration and, if possible, improvement.

Ian


Scientists Demonstrate Investigational MS Drug Down Regulates the Underlying Cause Believed Responsible for Multiple Sclerosis at the 16th Meeting of the European Neurological Society

Bayhill Therapeutics, a Palo Alto, CA-based biotechnology drug development company, will present clinical findings today at the Sixteenth Meeting of the European Neurological Society 27 May - 31 May, 2006, in Lausanne, Switzerland in connection with development of the company's lead drug candidate, BHT-3009, for the treatment of multiple sclerosis.
Co-founder and Vice President of Research, Hideki Garren, MD, PhD, will present clinical data for Bayhill's Phase I/II trial of BHT-3009, and details on the Phase IIb trial of BHT-3009, which is currently being enrolled in Europe.

ENS ABSTRACT AVAILABLE AT: http://bayhilltx.com/bayhill_ens_2006_abstract.pdf

RESEARCH/PROGRAM HIGHLIGHTS:

1. Bayhill's Phase I/II clinical investigation of BHT-3009 is believed to be the first human trial of an antigen-specific DNA plasmid for multiple sclerosis (MS), an autoimmune disease.

2. BHT-3009 is an antigen-specific treatment for MS. The MS therapeutic has been designed to NOT cause broad-based immunosuppression.

3. Bayhill's experimental MS therapeutic, BHT-3009, has been designed to down-regulate rogue T cells specific for MBP. Left unchecked, these rogue T cells shred the myelin sheath that insulates the nerve cells of the brain and spinal cord, resulting in MS. BHT-3009 down regulates, or tolerizes, these MBP specific T cells and only these T cells. The remainder of the immune system remains intact to fight infections and cancer.

4. Researchers and clinicians believe that BHT-3009 is distinguished from other antigen-specific approaches attempted in the clinic in several ways:

(1) the DNA allows low-level persistence of the antigen for 2-4 weeks, thus allowing for less frequent dosing.
(2) BHT-3009 expresses full-length MBP, thereby encompassing all possible target auto-antigens rather than a single auto-antigen, and allowing for a broader possible population of responders to the drug.
5. Bayhill's Phase I/II clinical trial of BHT-3009 is complete. In the Phase I/II trial, clinicians observed that BHT-3009 is safe and reported that "adverse events" were higher in the placebo arm compared to the treated arms.

a. Clinicians observed brain MRI trending toward improvement in Gad + lesion count with BHT-3009 versus placebo.

b. All patients are clinically stable, or improved with treatment.

c. Peripheral T cell assays showing decrease in activity of MBP specific T cells were observed in a number of patients.

d. Thus, safety and proof-of-concept were demonstrated in this phase I/II 30-patient trial.

Phase IIb trial:

Enrollment in this double-blind, placebo-controlled, multi-center trial has begun. A total of 252 patients are being recruited in the following countries: Bulgaria, Czech Republic, Finland, Poland, Romania, Russia, Serbia, Slovakia, Turkey, Ukraine, UK, and in the US.

Over 120 patients have been enrolled and randomize to the study as of 30 May 2006.

Dosing will be for one-year with MRI Gad + lesion formation as the primary endpoint.

For clinical trial enrollment information, please send an email to: BHT3009@bayhilltx.com

Source: Bayhill Therapeutics Inc.