Author: Coyle, P.K. ; Goodkin, D.E. ; Mocci, S. ; Fischbein, N. ; Winkelhake, J. ; Nelson, S. ; Andersson, P.-B. ; Frohman, E. ; Lee, M. ; Holcenberg, J. ; Stewart, T. ; Jacobs, L. ; Waubant, E. ; Shulman, M.

OBJECTIVETo assess the safety, tolerability, and biologic and clinical activity of a solubilized complex comprised of human leukocyte antigen-DR2 with myelin basic protein84-102 (AG284)in patients with secondary progressive MS.BACKGROUNDSoluble species-specific major histocompatibility complex myelin basic protein91-103 complexes ameliorate disease in a dose-dependent manner when administered to SJL/J mice with chronic relapsing experimental allergic encephalomyelitis. Preincubation with AG284 reduces the proliferative response of a DR2-restricted, myelin basic protein84-102-reactive T cell clone, derived from a MS patient, to myelin basic protein84-102 in the presence of autologous antigen-presenting cells.METHODSThirty-three patients with secondary progressive MS were randomly assigned to receive three alternate day IV doses of AG284 or placebo in a double-masked dose escalation study. The primary outcome was safety and tolerability. Secondary outcomes included a comparison of pre- and post-treatment gadolinium-enhanced brain MRI activity, Kurtzke Expanded Disability Status Scale, and Nine Hole Peg Test scores.RESULTSThe frequency of adverse events was similar in the AG284 and placebo recipients. No significant treatment effect was detected by Expanded Disability Status Scale, Nine Hole Peg Test, or number of new gadolinium-enhancing MRI lesions.CONCLUSIONSAG284 as administered during this study was safe and well tolerated. Further studies are warranted to determine the biologic activity and clinical efficacy of this potential treatment for MS.

01 Nov 1997·Expert Opinion on Investigational DrugsQ2 · MEDICINE

Antigen-specific therapies for the treatment of multiple sclerosis: a clinical trial update

Q2 · MEDICINE

Article

Author: Spack, E G

Within the past year a host of antigen-specific therapies for multiple sclerosis (MS) progressed along the path from IND submission to FDA approval. The Immune Response Corporation vaccinated patients with a Vbeta6 peptide, demonstrating that the vaccine was immunogenic, well tolerated, and reduced the number of Vbeta6+ T-cells in the cerebrospinal fluid (CSF). Connetics Corp. conducted a Phase I/II trial on chronic progressive MS patients vaccinated with CDR2 peptides from TCR Vbeta55.2 and found that patients with a measurable response to the vaccine remained clinically stable for a year. A study at the University of Alberta MS Patient Care and Research Clinic demonstrated that intrathecal injection of a B cell/T cell epitope of myelin basic protein (MBP) decreased the level of antiMBP antibody, but iv. administration did not decrease the relapse rate. AutoImmune Inc. completed a Phase III trial of oral myelin in the spring of 1997 which failed to show a statistical difference between those patients fed placebo and those fed daily capsules of myelin protein (Myoral). Three phase I trials of iv. myelin antigen(s) were initiated: MP4 (Alexion Pharmaceuticals, Inc.), a recombinant fusion of myelin basic protein and proteolipid protein; AG284 (Anergen, Inc.), a solubilised HLA-DR2:MBP peptide complex; and NBI-5788 (Neurocrine Biosciences, Inc.), an altered peptide ligand of an immunodominant MBP T-cell epitope. Following the conclusion of a successful Phase III clinical trial, TEVA Pharmaceutical Industries LTD received FDA approval to market Copaxone (glatiramer acetate) for the treatment of relapsing-remitting MS in December of 1996 and launched the product in 1997. The recent preclinical research and clinical trial status of these antigen-specific MS therapeutics are summarized in this review.

100 Deals associated with AnergiX.MS

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis	Phase 2	-	GSK Plc	-
Multiple Sclerosis	Phase 2	US	Corixa Corp.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

AnergiX.MS

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation