Delving into the Latest Updates on Plovamer acetate with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Plovamer, Plovamer acetate (USAN)

+ [1]

Target

HLA class II antigen

Mechanism

HLA class II antigen modulators

Therapeutic Areas

Immune System DiseasesNervous System DiseasesOther Diseases

Active Indication

Multiple Sclerosis, Relapsing-Remitting

Inactive Indication

Crohn DiseaseRheumatoid ArthritisUveitis

Originator Organization

Peptimmune, Inc.

Active Organization

Peptimmune, Inc.

Inactive Organization

EMD Serono, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure

Molecular FormulaC27H43N5O9

InChIKeyBBFYAJHFKUFNCR-GPOOOTPOSA-N

CAS Registry507277-44-3

Gene Sequence

Sequence Code 1058236825

Source: *****

This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.

Start Date01 Oct 2013

Sponsor / Collaborator

EMD Serono, Inc.

EUCTR2009-012716-40-SK / Not yet recruitingPhase 2

The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial

Start Date03 Feb 2010

Sponsor / Collaborator

Peptimmune, Inc.

EUCTR2007-007759-15-HU / Not yet recruitingNot Applicable

The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple SclerosisA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial

Start Date10 Nov 2008

Sponsor / Collaborator

Peptimmune, Inc.

100 Clinical Results associated with Plovamer acetate

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100 Translational Medicine associated with Plovamer acetate

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100 Patents (Medical) associated with Plovamer acetate

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2

Literatures (Medical) associated with Plovamer acetate

01 May 2011·The Journal of Clinical PharmacologyQ3 · MEDICINE

Safety, Pharmacokinetic, and Pharmacodynamic Evaluations of PI-2301, a Potent Immunomodulator, in a First-in-Human, Single-Ascending-Dose Study in Healthy Volunteers

Q3 · MEDICINE

Article

Author: Allyson Masci ; Claire Toutin ; Eric Lacoste ; Tony Avril ; Joseph Kovalchin ; Jeffrey Krieger ; Edward Mascioli ; Uday Patel ; Michelle Genova ; Gwenola Gandon ; Alain Patat ; Michael Augustyniak ; Eric Zanelli ; Kathy Collins ; Nicolas Fauchoux

PI-2301 is an amino acid copolymer acting as an immunomodulator for the treatment of autoimmune diseases. The present study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics of PI-2301 in a single ascending dose, first-in-human study involving healthy, male adult volunteers. A total of 56 subjects were given a subcutaneous injection of PI-2301 ranging from 0.035 to 60 mg. The only consistent side effect was transient injection site reactions. We describe, for the first time, a pharmacokinetic assay to monitor amino acid copolymer concentration in human serum. PI-2301 was detected in the serum of subjects in the 10-, 30-, and 60-mg cohorts. Maximum serum concentration was achieved between 10 and 30 minutes postdosing with some compound detected 4 hours after dosing. PI-2301's lasting immunological properties were evident by an ex vivo recall assay showing T-cell proliferation and IL-13 production in subjects dosed with 1, 3, or 10 mg of PI-2301, up to 6 months after dosing. A transient increase in chemokine CXCL9 and CXCL10 plasma levels was seen in subjects dosed with 30 or 60 mg of PI-2301. These results are highly consistent with our preclinical findings and suggest that PI-2301 could facilitate the expansion of a favorable immune posture in patients with autoimmune disorders.

25 Aug 2010·Journal of NeuroimmunologyQ3 · MEDICINE

Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response☆

Q3 · MEDICINE

Article

Author: C. Braudeau ; E. Zanelli ; M. Genova ; M. Augustyniak ; G. Edan ; J. Krieger ; U. Patel ; T. Hittinger ; J. Kovalchin ; E. Mascioli ; B. Kuca ; K. Collins ; M. Rimbert ; A. Masci

PI-2301 is an immunomodulator that could be an alternative therapy for MS. A placebo-controlled, multiple-ascending dose, double-blind study was performed in patients with secondary-progressive MS. Treatment was given subcutaneously once weekly for 8 weeks, followed by a 4-week open-label treatment period with active drug. The most common adverse event was transient injection site reactions. Non-significant trend for increases in serum levels of IL-3, IL-13, and CCL22 over time were suggestive of a beneficial T(H)2 immune response in subjects dosed with PI-2301 at 3 and 10 mg. MRI data indicated a non-significant trend for a reduction of lesion numbers in subjects treated with 1 and 3 mg PI-2301.

1

News (Medical) associated with Plovamer acetate

25 Aug 2009

·www.biospace.com

Peptimmune, Inc. Completes Phase Ib Study of PI-2301 in Multiple Sclerosis Patients, and Presentation at ECTRIMS 2009

CAMBRIDGE, Mass., Aug. 25 /PRNewswire/ -- Peptimmune, Inc., a privately held biotechnology company, announced the completion of a clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with Secondary Progressive Multiple Sclerosis (SP-MS). PI-2301 is a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

100 Deals associated with Plovamer acetate

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External Link

KEGG	Wiki	ATC	Drug Bank
D09657	-	-	-

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	FR	Peptimmune, Inc.	03 Feb 2010
Uveitis	Phase 1	US	Peptimmune, Inc.	-
Crohn Disease	Preclinical	US	Peptimmune, Inc.	-
Rheumatoid Arthritis	Preclinical	US	Peptimmune, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01963611 (CTgov)	Phase 2	Multiple Sclerosis, Relapsing-Remitting	255	Plovamer acetate 0.5 milligram (mg) (Plovamer Acetate 0.5 Milligram (mg))	loecdmnbpa(khtguaoxis) = znlvletgnu gwrliiggjv (kigcasezcw, alewkmslqe - vmoxfvehmt) View more	-	11 May 2016
				Plovamer acetate 3 mg (Plovamer Acetate 3 mg)	loecdmnbpa(khtguaoxis) = neffisxxmu gwrliiggjv (kigcasezcw, qxduvqgpym - szxcoqzawq) View more