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    You are here : Home » MS Research News » Drugs » PEGylated interferon beta

    PEGylated interferon beta

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    Nuron closing in on new treatment for relapsing MS

    Nuron Biotech Inc. said Tuesday it has completed enrollment of 500 patients for a pivotal phase-III study evaluating the safety and effectiveness of the company’s experimental multiple sclerosis treatment.

    Phase-III studies are typically the last hurdle a drug developer must clear before seeking approval for a new drug candidate.

    Nuron, an Exton, Pa., specialty biologics and vaccines company, is developing NU100 to treat relapsing remitting multiple sclerosis.

    Shankar Musunuri, the company’s founder and CEO, said it expects to complete the study in late 2013.

    The company hopes to use the results of the study to support the filing of a European marketing authorization application.

    Multiple sclerosis is an autoimmune disease in which a person’s own immune system mistakenly attacks normal tissues. An estimated 2.5 million people worldwide and 400,000 people in the United States have the condition.

    Source: Philidelphia Business Journal © 2012 American City Business Journals. (14/11/2012)

    Proprietary recombinant human interferon beta-1b (NU100) in RRMS study launched

    NU100Nuron Biotech Inc., a specialty biologics and vaccines company, today announced the initiation of a randomized, double-blind, placebo-controlled, pivotal Phase 3 study to evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS).

    NU100 is a proprietary recombinant human interferon beta-1b (IFN beta-1b) being developed as a new molecular entity. The product is an essentially aggregate-free liquid formulation produced utilizing an advanced processing technology.

    "Nuron Biotech has assembled a proven management team, established a quality pipeline in multiple disease areas and worked very diligently to advance our lead compound into Phase 3," said Shankar Musunuri, Ph.D., MBA, Chief Executive Officer and Founder of Nuron Biotech. "We are making excellent progress toward our goal of bringing innovative and improved biologics to markets in need."

    The Phase 3 study involves 500 patients from approximately 125 clinical sites across Europe and Asia. Patients will be randomized to receive NU100, a marketed IFN beta-1b or placebo and will be treated over a 12-month period. The study is designed to measure the safety and efficacy of NU100.

    "This pivotal trial is unique in that we have designed it in collaboration with regulatory authorities as a one-year study to assess the safety and efficacy of this product," said Tracy Goeken, M.D., Vice President, Clinical and Medical Affairs of Nuron Biotech. "We expect data from this study in late 2013."

    About NU100

    NU100 is a proprietary recombinant human interferon beta-1b produced utilizing proprietary refolding process technology. It is being developed as a standalone molecule for the treatment of relapsing remitting multiple sclerosis (RRMS) and as a new molecular entity based on positive opinion from the European Medicines Agency and the Food and Drug Administration.

    Patients treated with currently marketed interferon beta-1b products have up to 40 percent neutralizing antibody prevalence after two years of treatment. NU100 is essentially aggregate-free compared to those products; therefore, it should result in lower immune responses, potentially improving overall long-term clinical efficacy and improving the tolerability and safety for RRMS patients presently requiring therapy with interferon beta-1b.

    About Nuron

    Nuron Biotech's vision is to bring innovative and improved biologics to market for the better health of patients. Nuron's management team consists of proven veteran industry executives who have made significant contributions in developing, launching and managing the life cycle of various biologics.

    Nuron is currently working on products in three disease areas: central nervous system (CNS), wound healing and vaccines.

    Source: Nuron Biotech Inc.(01/11/11)

    Nuron secures option, license deal to develop NU400 for R & R MS

    Nuron LogoNuron Biotech Inc., a specialty biologics and vaccines company, today announced that it has secured an exclusive option and license agreement utilizing PolyTherics' site-specific TheraPEG™ PEGylation technology to develop NU400, a long-acting version of Nuron's proprietary recombinant human interferon beta-1b (NU100).

    PEGylating NU100 can also potentially improve other properties including its solubility, stability and safety profile. NU100 is poised to enter Phase 3 clinical studies in 2011 based on recent positive regulatory advice from the European Medicines Agency (EMEA).

    "In the last year Nuron has acquired products or licensed technologies to build our pipeline of four exciting programs to realize our vision of bringing better biologics to market with enhanced product profiles for better health of patients," commented Shankar Musunuri, PhD, MBA, Chief Executive Officer and Founder of Nuron Biotech.

    "This new program, NU400, is especially exciting for us in that it further enhances the product profile of our lead program for Relapse Remitting Multiple Sclerosis (RRMS) and supports long-term life cycle strategy in the MS area."

    Source: News-Medical.Ne (27/05/11)

    Multiple Sclerosis drug, PEGylated interferon beta-1a, gets FDA's fast track status

    Biogen Logo

    Biotechnology firm Biogen Idec Inc. announced that the U.S. Food and Drug Administration, or FDA, has granted its PEGylated interferon beta-1a formulated drug fast track status.

    The drug is indicated for the treatment of relapsing-remitting multiple sclerosis, a disease in which the central nervous system becomes inflamed and remissions occur with varying symptoms.

    The company said it plans to enroll more than 1,200 patients in a global Phase III study to evaluate the efficacy and safety of either bi-weekly or once-monthly injections of the drug.

    The FDA designates drugs with the fast track status in order to shorten the review period for new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

    Source: RTT News © 2009 RTTNews. All rights reserved. (08/07/09)

    Biogen enrolls patients in new Multiple Sclerosis trial

    Biogen Logo

    Biogen Idec has enrolled its first patient in a phase 3 trial for a potential multiple sclerosis treatment that, when compared with existing therapies, would reduce the number of injections patients must receive.

    The trial, called ADVANCE, will determine the efficacy and safety of Biogen’s drug target, called PEGylated interferon beta-1a, in reducing relapse rates in patients with multiple sclerosis (RMS).

    The global study will enroll more than 1,200 patients with RMS between the ages of 18 and 55. The study’s goal is to determine whether the drug reduces the annualized relapse rate in patients with RMS at one year. The study will also examine if, over time, the potential treatment can slow disease progression and lead to a decrease in the number of a certain kind of brain lesions commonly seen in MS patients.

    The treatment is a combination of Interferon beta-1a, which has been used successfully to treat MS for more than 10 years, and PEGylation, which can extend the amount of time a drug remains in a patient’s system. If the trial is successful, the treatment has the potential to reduce the frequency of treatment injections and provide patients with an effective and more convenient dosing option.

    Source: Boston Business Journal © 2009 American City Business Journals, Inc.(23/06/09)

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