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    You are here : Home » MS Research News » Drugs » PI-2301

    PI-2301

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    Merck Serono aquires phase II-ready MS drug candidate

    PI-2301Merck Serono acquired worldwide exclusive rights to a Phase II-ready multiple sclerosis candidate, PI-2301, originally developed by Peptimmune, the Cambridge, MA-based peptide therapeutics firm that reportedly filed for Chapter 7 bankruptcy earlier this year after it failed to complete a $35 million fundraising round.

    PI-2301 is a second-generation peptide copolymer derived from a similar compound class as Teva Pharmaceuticals’ Copaxone®. PI-2301 is believed to work by enhancing the regulatory response of the immune system, and dampening immune responses that drive autoimmune diseases such as multiple sclerosis. Merck will evaluate the product for autoimmune diseases including multiple sclerosis.

    Merck Serono’s marketed MS drug, Rebif® (interferon beta-1a) is a disease-modifying therapeutic used to treat relapsing forms of multiple sclerosis. The drug was approved in Europe in 1998 and in the U.S. in 2002, and is now registered in more than 90 countries worldwide. Studies are in progress to evaluate Rebif in related indications such as clinically isolated syndrome (CIS), which manifests as intermittent neurological attacks that resemble those of multiple sclerosis. An extended release formulation of interferon beta-1a is separately undergoing Phase I clinical development.

    The firm’s Phase I stage pipeline includes two additional MS candidates: ARX 424 is a long-acting interferon, and ATX-MS-1467 is an immune-tolerizing agent. Merck Serono is also collaborating with Bionomics on the development of MS therapeutics that target the potassium ion channel Kv1.3, a key modulator of the immune system and a target found on human immune cells associated with nerve cell damage in patients with multiple sclerosis.

    Source: GEN © 2011 Genetic Engineering & Biotechnology News (19/09/11)

    Peptimmune announces second grant of a United States patent for PI-2301 peptide copolymer for Multiple Sclerosis

    Peptimmune LogoPeptimmune, Inc. a privately held biotechnology company, announced the grant of US Patent Number 7,655,221 (the '221 patent) which protects the target product profile for its PI-2301 peptide copolymer for the treatment of multiple sclerosis, and other autoimmune diseases.

    The '221 patent claims important treatment modalities for PI-2301 and related compounds. "The '221 patent enhances the exclusivity for what we believe may become a very important therapy for the treatment of multiple sclerosis and other autoimmune diseases," stated Thomas P. Mathers, President & CEO of Peptimmune.

    Peptimmune recently completed a Phase Ib multiple-ascending dose, double-blind, placebo-controlled randomized study in subjects with SP-MS. The Company plans to continue developing PI-2301 by initiating a Phase II study in multiple sclerosis patients later this year.

    PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone® (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in some diseases.

    PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry. In preclinical studies, PI-2301 has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in preclinical models of autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis, and autoimmune uveitis. Peptimmune has put in place high-quality synthesis and analytical methods that provide a superior level of batch-to-batch reproducibility in the manufacturing of PI-2301.

    Over 400,000 Americans have multiple sclerosis (MS), and MS may affect over 2.5 million individuals worldwide. MS is an autoimmune disease in which the individual's immune system responds against multiple components of nerve-insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.

    Peptimmune Presentation at the upcoming meeting of the American Society for Experimental NeuroTherapeutics

    Dr. Eric Zanelli, Vice President Research, will make a presentation entitled "Induction of an anti-inflammatory immune response toward toxic species of alpha-synuclein; Immunomodulatory therapy for Parkinson's Disease" in the Oral Pipeline Session on March 5, 2010 from 2:00 pm - 6:00 pm in the Haverford Suite of the Crystal Ballroom of the Hyatt Regency Bethesda, Bethesda Maryland.

    Dr. Zanelli will discuss the application of Peptimmune's DEEP technology to the development of a first-line disease modifying treatment for Parkinson's Disease.

    About DEEP

    DEEP is a peptide copolymer technology that anticipates antigenic diversity while preserving specificity for the epitope of interest. DEEP takes advantage of Peptimmune's know-how in the solid-phase manufacturing of complex peptide mixtures. The technology combines the epitope specificity of a fixed-sequence peptide with the randomness of a broadly immune-interactive copolymer.

    Source: Medical News Today © 2010 MediLexicon International Ltd (10/03/10)

    Peptimmune completes Phase Ib study of PI-2301 in Multiple Sclerosis patients

    Peptimmune LogoPeptimmune, Inc.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.

    The Phase Ib multiple-ascending dose, double-blind, placebo-controlled, randomized study enrolled 50 subjects with SP-MS. A total of 36 subjects received PI-2301 once weekly for 8 weeks followed by an open label extension of an additional 4 weeks. The doses ranged from 1 to 60 mg. Safety at all doses, including potentially therapeutic doses, was established. The most frequent adverse events (AEs) were dose-dependent site reactions which were mild to moderate, transient, and resolved without specific therapy. Dose-dependent increases in serum levels of anti-inflammatory markers were consistent with PI-2301 exposure as measured using the Company's proprietary pharmacokinetic assay. The Company plans to continue developing this promising compound by initiating a Phase II study in multiple sclerosis patients later this year.

    "PI-2301 has now shown safety and pharmacologic activity in two clinical studies, the first in healthy volunteers, and this second in patients with multiple sclerosis. As we look forward to the Phase II, we are excited about the observed pharmacologic effects of PI-2301 in patients suffering from secondary progressive MS," stated Thomas P. Mathers, President and CEO of Peptimmune.

    Data from this Phase Ib study will be presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Eric Zanelli will make a poster presentation titled "Clinical and biological results of a 12-week, double-blind, multiple ascending dose study evaluating the safety and tolerability of peptide copolymer PI-2301 in patients with the secondary progressive form of multiple sclerosis." The poster (P-422) will be presented within Topic 15 - Immunomodulation - 1 during the Poster Session I taking place on Thursday, September 10, 2009, between 2:30 and 5:00 p.m.

    About PI-2301

    PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in autoimmune diseases such as multiple sclerosis. PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and, in preclinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis and other autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis, and autoimmune uveitis. Peptimmune has high-quality synthesis and analytical methods that provide a superior level of batch-to-batch reproducibility in the manufacturing of PI-2301.

    In January 2009 Peptimmune granted Novartis an exclusive option to obtain exclusive worldwide rights to develop and commercialize PI-2301.

    Source: Peptimmune, Inc.(26/08/09)

    Peptimmune grants Novartis exclusive option to license PI-2301 for Multiple Sclerosis

    Peptimmune Logo

    Peptimmune, Inc. announced that it has granted Novartis an exclusive option to obtain exclusive worldwide rights to develop and commercialize PI-2301, Peptimmune's multiple sclerosis drug candidate.

    In the event that Novartis exercises the option to PI-2301, Novartis would assume the global clinical development, manufacturing, and marketing of PI-2301 and all associated costs. Peptimmune would receive payments upon the option exercise and upon successful completion of certain development, regulatory, and commercial milestones. These payments together could total more than $500 million. In addition, Peptimmune shall be eligible to receive royalties on product sales. Additional terms were not disclosed.

    "We believe that Novartis represents an outstanding future partner for Peptimmune and the global development of PI-2301. This option agreement provides Peptimmune with access to both Novartis' world class development expertise and the necessary capital to invest in this proprietary product," said Thomas P. Mathers, President and CEO of Peptimmune.

    Todd Foley, Managing Director at MPM Capital commented, "Peptimmune and its world-leading expertise in peptide copolymers represent an attractive investment opportunity."

    About PI-2301

    PI-2301 is a peptide copolymer developed using Peptimmune's novel platform peptide chemistry. PI-2301 is designed to enhance the regulatory response of the immune system, thereby controlling the pathogenic autoimmune response in certain diseases. PI-2301 is currently in Phase 1b development by Peptimmune.

    Source: Peptimmune, Inc.(19/01/09)

    United States patent for PI-2301 peptide copolymer for Multiple Sclerosis granted

    Peptimmune Logo

    Peptimmune, Inc. announced today the grant of US Patent Number 7,381,790 (the '790 patent) which protects the composition of matter for its PI-2301 peptide copolymer for the treatment of autoimmune diseases.

    PI-2301 is currently in a Phase Ib multiple-ascending dose, double-blind, placebo-controlled randomized study in subjects with multiple sclerosis. Following establishment of safety at potentially therapeutic doses and proof of pharmacologic mechanism, the Company plans to initiate its Phase II study in relapsing remitting multiple sclerosis patients in early 2009.

    "This patent represents an important component in the development of our intellectual property in peptide copolymers, including PI-2301," stated Thomas P. Mathers, President and CEO of Peptimmune. "The '790 patent protects what we believe may become a very important therapy for the treatment of multiple sclerosis and other autoimmune diseases."

    PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 has been designed to be more efficacious and more convenient (weekly versus daily dosing) than Copaxone for the treatment of multiple sclerosis. PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in some diseases. In a Phase I single ascending dose, double blind placebo controlled randomized study, all doses of PI-2301 were safe and well tolerated, and no serious adverse events were observed. Pharmacodynamic assays demonstrated evidence of immune exposure consistent with the pharmacologic mechanism of action for PI-2301, and dose-dependent pharmacokinetics was observed.

    PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and, in preclinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in preclinical models of autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis, and autoimmune uveitis. Peptimmune has put in place high-quality synthesis and analytical methods that provide a superior level of batch-to-batch reproducibility in the manufacturing of PI-2301.

    Over 400,000 Americans have multiple sclerosis (MS), and MS may affect over 2.5 million individuals worldwide. MS is an autoimmune disease in which the individuals' immune system responds against multiple components of nerve-insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.

    The '790 patent claims "A linear random copolymer YFAK comprising amino acids tyrosine (Y), phenylalanine (F), alanine (A), and lysine (K)," )." which was licensed from Harvard University. The copolymer technology was developed in conjunction with Professor Jack L. Strominger M.D., Higgins Professor of Biochemistry, Department of Molecular and Cellular Biology, at Harvard University. Peptimmune is the exclusive worldwide licensee of the '790 patent.

    Source: PR Newswire (C) 2008 PR Newswire. (31/07/08)

    Phase Ib Study of PI-2301 in Multiple Sclerosis Patients Initiated

    Peptimmune, Inc. announced that physicians have treated the first participant in 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.

    The Phase Ib multiple-ascending dose, double-blind, placebo-controlled randomized study will involve up to fifty-three subjects with SP-MS who will receive the drug once weekly in four escalating-dose cohorts. Following establishment of safety at potentially therapeutic doses and proof of pharmacologic mechanism, the Company plans to initiate its Phase II study in multiple sclerosis patients in early 2009.

    "While the primary goal of this study is to demonstrate safety of PI-2301 in multiple sclerosis patients, we believe that this clinical trial is one of the most comprehensive looks at the pharmacologic effects of any immunomodulator in patients suffering from autoimmune diseases," stated Thomas P. Mathers, President and CEO of Peptimmune.

    PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone® (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in some diseases.

    In a Phase I single ascending dose, double blind placebo controlled randomized study, all doses of PI-2301 were safe and well tolerated, and no serious adverse events were observed. Pharmacodynamic assays demonstrated evidence of immune exposure consistent with the pharmacologic mechanism of action for PI-2301, and dose-dependent pharmacokinetics was observed.

    PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and, in preclinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in preclinical models of autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis, and autoimmune uveitis. Peptimmune has put in place high-quality synthesis and analytical methods that provide a superior level of batch-to- batch reproducibility in the manufacturing of PI-2301.

    Source: Peptimmune, Inc (17/06/08)

    Peptimmune presents early clinical data for PI-2301 for Multiple Sclerosis
    Peptimmune, Inc., presented early clinical results from its PI-2301 peptide copolymer program at both the 17th Annual ENS meeting in Nice, France and at FOCIS 2008 in Boston, MA. The Company presented data from its Phase Ia Single-Ascending-Dose, first-in-man study involving healthy, male adult volunteers following SC administration of the second-generation peptide copolymer PI-2301. This study demonstrated that all doses were safe and well tolerated, and demonstrated early immunological effects of PI-2301 consistent with its pharmacologic mechanism of action.

    The Phase I single-ascending dose, double-blind placebo, controlled-randomized study involved fifty-six healthy volunteers who received the drug in eight escalating dose cohorts. All doses were safe and well tolerated (0.035 - 60mg), and there were no serious adverse events. Pharmacodynamic assays demonstrated evidence of immune exposure (tritium uptake, IL-13 in recall responses) consistent with the pharmacologic mechanism of action for PI-2301, and dose-related pharmacokinetics were observed (proprietary antibody-based assay). The Company plans to initiate its first repeat-dose study in multiple sclerosis patients in Q2/2008.

    Peptimmune also presented data that details significant differences in the bioavailability, mechanism of action, and pharmacodynamic effects between PI-2301 and Copaxone(R) (Teva Pharmaceuticals). The Company demonstrated four-fold greater bioavailabilty of PI-2301 than Copaxone, and a significantly greater regulatory immune response than Copaxone.

    "We are pleased to see that PI-2301 was well tolerated and that this trial has provided evidence of PI-2301's immunomodulatory effects. These data, along with the significant improvements on bioavailability and pharmacodynamic effects with PI-2301, provide further evidence that PI-2301 may replace Copaxone as first-line therapy in  relapsing remitting multiple sclerosis," stated Thomas P. Mathers, President and CEO of Peptimmune. "We have designed PI-2301 to maximize the therapeutic benefit of a proven, safe compound class in multiple sclerosis as well as increasing patients' convenience."

    PI-2301 is a second generation peptide copolymer from a similar compound class as Copaxone. PI-2301 works through immune modulation by enhancing the regulatory response of the immune system to control the pathogenic autoimmune response in certain diseases. PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and in pre-clinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in pre-clinical models of autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has also introduced highly reproducible manufacturing methods that allow very strict control and characterization of PI-2301 and should provide a superior level of batch to batch consistency.

    Source: Peptimmune, Inc.

    Peptimmune Completes Phase I Study with a Novel Peptide Copolymer for the Treatment of Multiple Sclerosis
    Peptimmune, Inc. a privately held biotechnology company, announced that it has completed its first clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PI-2301, a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

    The Phase I single ascending dose, double blind placebo controlled randomized study involved 56 healthy volunteers who received the drug in eight escalating dose cohorts. All doses were safe and well tolerated, and there were no serious adverse events. Pharmacodynamic assays demonstrated evidence of immune exposure consistent with the pharmacologic mechanism of action for PI-2301, and dose related pharmacokinetics were observed. The Company plans to initiate its first repeat dose study in multiple sclerosis patients in Q2/2008.

    "We are pleased to see that PI-2301 was well tolerated and that this trial has provided evidence of single dose priming of healthy subjects. This effect is important as repeated doses in multiple sclerosis patients should lead to therapeutic immune modulation," stated Thomas P. Mathers, President and CEO of Peptimmune. "We have designed PI-2301 to maximize the therapeutic benefit of a proven, safe compound class in multiple sclerosis as well as increasing patients' convenience."

    PI-2301 is a second generation peptide copolymer from a similar compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system to control the pathogenic autoimmune response in certain diseases. PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and in pre-clinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in pre-clinical models of autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has also introduced highly reproducible manufacturing methods that allow very strict control and characterization of PI-2301 and should provide a superior level of batch to batch consistency.

    Source: Peptimmune, Inc (19/03/08)

    Peptimmune Initiates Phase I Study With a Novel Peptide Copolymer for the Treatment of Multiple Sclerosis

    Peptimmune, Inc. a privately held biotechnology company, announced that physicians have treated the first participant in a clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PI-2301, a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

    The Phase I single ascending dose, double blind placebo controlled randomised study will involve 56 healthy male volunteers who will receive the drug in eight escalating dose cohorts. Following establishment of safety at potentially therapeutic doses, the Company will initiate its first repeat dose study in multiple sclerosis patients in early 2008.

    PI-2301 is a second generation peptide copolymer from a similar compound class as Copaxone® (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system to control the pathogenic autoimmune response in certain diseases. PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and in pre-clinical studies, has shown to be more potent and effective than Copaxone® in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in pre-clinical models of autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has also introduced highly reproducible manufacturing methods that allow very strict control and characterisation of PI-2301 and should provide a superior level of batch to batch consistency.

    "The commencement of this clinical trial is an important milestone for the development of PI-2301 and for the Company," stated Thomas Mathers, President and CEO of Peptimmune. "The goal for PI-2301 is to enhance the therapeutic benefit of a proven compound class in multiple sclerosis and give neurologists a new weapon as a primary treatment for patients with this debilitating disease."

    Over 400,000 Americans have multiple sclerosis (MS), and worldwide MS may affect over 2.5 million individuals. MS is an autoimmune disease in which the individuals' immune system responds against multiple components of nerve-insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.

    Source: Peptimmune, Inc.(03/10/07)

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