This Is MS Multiple Sclerosis Community: Knowledge & Support

Not sure if this is new or not...but, thought I would post it

TOL



Bayhill Therapeutics to Present Positive Data From a Phase IIb Trial of BHT-3009 in Multiple Sclerosis

Preparations for a Phase III Trial Underway
BIO Investor Forum 2007

PALO ALTO, Calif.--(BUSINESS WIRE)--Bayhill Therapeutics Inc., announced today top line data from a phase IIb study of its lead investigational drug candidate, BHT-3009, for the treatment of multiple sclerosis (MS). Patients in a prospectively defined group with high anti-myelin basic protein (MBP) antibodies in their cerebral spinal fluid (CSF) showed statistically significantly fewer gadolinium-enhancing lesions in their brain after treatment with 0.5 mg of BHT-3009 compared with placebo. Reductions in T2 volumes and T1 black holes were also observed in this same population. In addition, there were strong trends in these same measures when applied to the trial’s intent-to-treat patient population. BHT-3009 was found to be well tolerated in this study. Furthermore, using the company’s proprietary protein microarray technology, statistically significant reductions in several CSF myelin-specific autoantibodies were achieved in all patients treated with 0.5 mg of BHT-3009, compared with placebo. These findings thus demonstrate strong evidence of antigen-specific tolerance produced by BHT-3009.

The Company announced that it intends to schedule an end of Phase II meeting with the FDA to discuss designs for registration trials.

Hideki Garren, M.D., Ph.D., Bayhill’s co-founder and Vice President of Research will present data from this trial at the American Neurological Association meeting in Washington D.C. on October 9 and at a podium presentation at the annual conference of the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic on October 12. Mark Schwartz, Ph.D., Bayhill’s CEO and President will also present data from this trial at the BIO Investor Forum 2007 in San Francisco on October 10.

The phase IIb trial is a multi-center, randomized, double-blind placebo-controlled trial of 289 relapsing remitting MS patients. Patients were dosed monthly for one year with intramuscular injections of the investigational product BHT-3009. The trial’s endpoints are brain magnetic resonance imaging (MRI) measures of disease activity including gadolinium-enhancing lesions, T2 lesions and T1 black holes. These endpoints are uniformly used in Phase II trials for multiple sclerosis.

Commenting on the data from the Phase IIb trial, Dr. Lawrence Steinman, Professor of Neurology and Neurological Sciences at Stanford Medical School and co-founder of Bayhill said, "A long sought after goal in immunology has been to obtain tissue specific tolerance, without globally suppressing the immune system. We are delighted with the demonstration of tolerization of the immune system to myelin proteins in individuals with multiple sclerosis.”

“We are pleased with the top line results of our Phase IIb trial. BHT-3009 is the first of several programs arising from our BHT-DNA technology platform,” said Dr. Schwartz. “This platform is capable of rapidly producing new molecular entities targeting major unmet medical needs in large autoimmune disease markets. Our second program from this platform is BHT-3021, currently in the clinic for autoimmune Type 1 diabetes. We are very excited about expanding our efforts in these programs.”

About BHT-3009

The investigational product BHT-3009 is an autoimmune DNA vaccine that encodes MBP. It is designed to reprogram the immune system to tolerate rather than attack the brain’s myelin sheath. After administration of BHT-3009, immunological studies indicated that MS patients demonstrated decreased MBP-specific T cells in their blood and decreased anti-MBP antibodies in their spinal fluid. Normal T cells were not affected.


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Thank you, thinkingoutloud.

Here (http://www.thisisms.com/ftopict-4313.html) I tried to summarize what BHT-3009 is.

I think it is promising. I'm a bit surprised: the early-phase trial results were in the web in august 2007 and now they are going to publish the phase IIb results - pretty fast.

With best wishes from germany,
Sandrine

The very careful wording of the press release makes me wonder what the results look like. I guess we'll find out in the next couple of weeks, but they don't seem too enthusiastic.

Dignan, I agree that the careful wording seem suspicious but I ask myself wy would someone go into Phase-III trial when the results will likly be humbling compared to Campath, Tysabri, Tovaxin etc.

Regarding the immense cost (does anyone have data about the cost of a - lets say - two years 700 patients - MS trial?) of huge MS trials no company would sponsor them without the hope of placing the durg successfully on the market.

--Frank

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Treatment: CCSVI both IJV ballooned 09/2010, No DMDs, Tysabri on hold after 24 Infusions, after LDN, ABX Wheldon Regime for 1 year.