Delving into the Latest Updates on BHT-3009 with Synapse

Overview

Basic Info

Drug Type

DNA vaccine, Therapeutic vaccine

Synonyms

Target

MBP

Mechanism

MBP modulators(Myelin basic protein modulators)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesOther Diseases

Active Indication-

Inactive Indication

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting

Originator Organization

Bayhill Therapeutics, Inc.

Active Organization-

Inactive Organization

Bayhill Therapeutics, Inc.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses of Butylated Hydroxytoluene Via Respimat Soft MistTM Inhaler B (Sub-study 1) and Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses of BI 54903 XX Via Respimat Soft MistTM Inhaler B as Randomised, Double-blind, Placebo-controlled Phase I Trial in Healthy Male Volunteers (Main Study) and Comparison of Systemic Exposure Following a Single Dose of BI 54903 XX Via Respimat Soft MistTM Inhaler B and of a Single Dose of Ciclesonide Via MDI (Randomised, Open-label, Two-way Crossover Sub-study 2)

The objective of the study was to investigate safety, tolerability and pharmacokinetics of butylated hydroxytoluene (BHT) (sub-study 1) administered via Respimat® Soft MistTM Inhaler B (SMI B); to assess safety, tolerability and pharmacokinetics of multiple rising doses of BI 54903 XX administered via Respimat® SMI B (main study), and to compare systemic exposure of single dose BI 54903 XX administered via Respimat® SMI B (sub-study 2) with single dose Alvesco® (ciclesonide) administered via HFA-134a propellant metered dose inhaler (MDI).

Start Date01 Jun 2008

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT00382629 / CompletedPhase 2

BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis

The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple sclerosis.

Start Date01 Feb 2006

Sponsor / Collaborator

Bayhill Therapeutics, Inc.

EUCTR2005-001340-22-FI / Not yet recruitingNot Applicable

BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS

Start Date29 Nov 2005

Sponsor / Collaborator

Bayhill Therapeutics, Inc.

100 Clinical Results associated with BHT-3009

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100 Translational Medicine associated with BHT-3009

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100 Patents (Medical) associated with BHT-3009

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9

Literatures (Medical) associated with BHT-3009

01 Jul 2012·Journal of NeurologyQ2 · MEDICINE

Evolution of MS lesions to black holes under DNA vaccine treatment

Q2 · MEDICINE

Article

Author: Stefanie von Felten ; Hideki Garren ; Athina Papadopoulou ; Joanne Quan ; Stefan Traud ; Ludwig Kappos ; Lawrence Steinman ; Ernst Wilhelm Radue ; Amena Rahman ; Gary Cutter ; Robert King

Persistent black holes (PBH) are associated with axonal loss and disability progression in multiple sclerosis (MS). The objective of this work was to determine if BHT-3009, a DNA plasmid-encoding myelin basic protein (MBP), reduces the risk of new lesions becoming PBH, compared to placebo, and to test if pre-treatment serum anti-MBP antibody levels impact on the effect of BHT-3009 treatment. In this retrospective, blinded MRI study, we reviewed MRI scans of 155 MS patients from a double-blind, randomized, phase II trial with three treatment arms (placebo, 0.5 and 1.5 mg BHT-3009). New lesions at weeks 8 and 16 were tracked at week 48 and those appearing as T1-hypointense were classified as PBH. A subset of 46 patients with available pre-treatment serum anti-MBP IgM levels were analyzed separately. Overall, there was no impact of treatment on the risk for PBH. However, there was a significant interaction between anti-MBP antibodies and treatment effect: patients receiving 0.5 mg BHT-3009 showed a reduced risk of PBH with higher antibody levels compared to placebo (p < 0.01). Although we found no overall reduction of the risk for PBH in treated patients, there may be an effect of low-dose BHT-3009, depending on the patients' pre-treatment immune responses.

01 Dec 2010·IDrugs : the investigational drugs journal

Biological Therapeutics Research and Development--GTCbio's Fifth Annual Conference. October 20-22, 2010, San Francisco, CA, USA.

Author: Garren, Hideki

The Biological Therapeutics Research and Development--GTCbio's Fifth Annual Conference, held in San Francisco, included topics covering new therapeutic developments in the field of vaccines and peptide therapies. This conference report highlights selected presentations on the development of vaccines for NSCLC, DNA delivery platforms as vaccines, vaccine combination therapy for cancer, DNA vaccines for autoimmune diseases, and improved peptide therapeutics. Investigational drugs discussed include TG-4010 (Transgene), and a series of vaccines targeting autoimmune diseases, including BHT-3021 (Bayhill/Genentech) for type I diabetes, BHT-3009 (Bayhill) for multiple sclerosis and BHT-3034 (Bayhill) for myasthenia gravis.

01 Jun 2010·Current Opinion in NeurologyQ2 · MEDICINE

New drug therapies for multiple sclerosis

Q2 · MEDICINE

Review

Author: Mangas, Arturo ; Covenas, Rafael ; Geffard, Michel

PURPOSE OF REVIEWMultiple sclerosis (MS) is an autoimmune and inflammatory disease of the central nervous system (CNS) that causes neurological disability in young adults and that to date has no cure. Until now, expensive and only partially efficacious therapies have become available. For this reason, researchers, clinicians and pharmaceutical companies are currently investigating new drugs for the treatment of MS. Here, we review the most recent data on drug candidates for MS.RECENT FINDINGSIn the preclinical phase, such drug candidates have shown a beneficial effect on the onset of experimental autoimmune encephalomyelitis (microtubule-stabilizing drugs, MS14, Lithium, GEMSP...), a decrease in CNS cell infiltrates (recombinant T cell receptor ligand, lovastatin-rolipram, ribavirin, GEMSP...), prevention of demyelination (lovastatin-rolipram, calpain inhibitor, lithium...); and a reduction of axonal loss (phenytoin, lovastatin-rolipram, calpain inhibitor). In clinical trials, drug candidates against MS have shown safety (rituximab, ustekinumab, intravenous immunoglobulin, laquinimod, BHT-3009, fumarate, chaperonin 10, GEMSP...), an improvement of gadolinium-enhanced lesions (protiramer, fingolimod, laquinimod, BHT-3009, fumarate, daclizumab...), and an improvement of the relapse rate (fingolimod, fumarate...).SUMMARYFuture research into MS should focus on a combination of therapies and on the development of drugs directed against the remitting and progressive phases of the disease. In this sense, MS is a very complex multifactorial disease that requires treatment able to cover all the aspects of MS and not only the anti-inflammatory aspect.

100 Deals associated with BHT-3009

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	Phase 2	-	Bayhill Therapeutics, Inc.	01 Feb 2006
Multiple Sclerosis	Preclinical	-	Bayhill Therapeutics, Inc.	-
Multiple Sclerosis	Preclinical	US	Bayhill Therapeutics, Inc.	-