Phase 2B, Partially Blinded, Randomized Study in Treatment Naive HCV G1 to Compare the Efficacy, Safety, and Tolerability of Three Doses of Locteron Plus Ribavirin Given Bi-weekly in Comparison With PEG-Intron Plus Ribavirin Given Weekly

The purpose of the study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the virologic response to 3 dose levels of Locteron™, dosed every 2 weeks, in comparison with PEG-Intron™ dosed weekly.

开始日期2009-03-01

申办/合作机构

Biolex Therapeutics, Inc.

NCT00593151 / Completed临床1/2期

An Open-Label, 3-Panel, Dose-Escalation Study to Assess the Safety and Tolerability, Pharmacokinetics, and Viral Kinetics of Two Doses of LocteronTM (Poly ActiveTM - Interferon Alpha 2b) Given Every 2 Weeks for 4-12 Weeks in Comparison With PEG-Intron Given Weekly for 4-12 Weeks in Patients With Chronic Hepatitis C

The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability, and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All subjects were also to receive oral daily weight-based ribavirin.

开始日期2008-01-01

申办/合作机构

Biolex Therapeutics, Inc.

100 项与 Interferon alpha-2b controlled release(Biolex Therapeutics, Inc.) 相关的临床结果

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100 项与 Interferon alpha-2b controlled release(Biolex Therapeutics, Inc.) 相关的转化医学

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100 项与 Interferon alpha-2b controlled release(Biolex Therapeutics, Inc.) 相关的专利（医药）

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项与 Interferon alpha-2b controlled release(Biolex Therapeutics, Inc.) 相关的文献（医药）

2012-01-01·Expert Opinion on Investigational Drugs

Controlled-release interferon alpha 2b, a new member of the interferon family for the treatment of chronic hepatitis C

Review

作者: Peter L M Jansen ; Joep De Bruijne

INTRODUCTIONCombination therapy with pegylated interferon alpha (Peg-interferon) and ribavirin is currently the cornerstone of antiviral therapy for chronic hepatitis C. Monotherapy with Peg-interferon still is important for the treatment of chronic hepatitis B. With the advent of new therapies, protease inhibitors for chronic hepatitis C and nucleotide inhibitors for chronic hepatitis B, there remains a need for interferon-based therapies. The side effects of Peg-interferon are a main disadvantage and represent a stumbling block for many patients to enter and continue therapy.AREAS COVEREDIn this review, the authors will discuss controlled-release interferon alpha 2b (CR2b) (Locteron®, Biolex Therapeutics, Pittsboro, NC, USA), a new slow-release interferon alpha 2b preparation for the treatment of chronic viral hepatitis. Other alternative interferons will also be discussed.EXPERT OPINIONCR2b is a slow-release microsphere preparation for the administration of plant-derived recombinant human interferon alpha 2b. Compared with Peg-interferon, treatment with CR2b shows less flu-like reactions and less depression, and is at least as effective as conventional Peg-interferon-based therapy in patients with chronic hepatitis C. CR2b has the added advantage of biweekly instead of once weekly administration. CR2b appears to cause more neutropenia than Peg-interferon alpha 2b. This may be due to higher trough serum levels of CR2b at the end of a dosing interval. The bone marrow effects of CR2b closely resemble those published for the registered Peg-interferon alpha 2a. CR2b appears to have at least comparable efficacy with fewer side effects than current registered Peg-interferons.

2008-02-01·Journal of Interferon & Cytokine Research4区 · 医学

Novel Controlled-ReleaseLemna-Derived IFN-α2b (Locteron): Pharmacokinetics, Pharmacodynamics, and Tolerability in a Phase I Clinical Trial

4区 · 医学

Article

作者: De Leede, Leo G.J. ; Humphries, John E. ; Spencer, David G. ; Van Hoogdalem, Ewoud J. ; Verrijk, Ruud ; Bechet, Anne C.

Locteron, a newly developed controlled-release formulation of Lemna-derived free (unpegylated) recombinant interferon-alpha2b (IFN-alpha2b, Biolex Therapeutics, Pittsboro, NC) in poly(ether-ester) microspheres (PolyActive, OctoPlus N.V., Leiden, the Netherlands), was evaluated in 27 volunteers injected with either 20, 80, or 320 microg Locteron (equivalent to 6.25, 25, or 100 x 10(6) IU, respectively), 80 microg pegylated IFN-alpha2b (PEG-IFN-alpha2b), microspheres not containing IFN-alpha2b, or placebo. Serum free or PEG-IFN-alpha2b and two biomarkers of IFN activity, neopterin and 2',5'-oligoadenylate synthetase (2',5'-OAS), were measured. After injection of 320 microg Locteron, serum IFN-alpha2b remained elevated through 14 days. The elimination half-life of Locteron was more than 2-fold that of PEG-IFN-alpha2b. The effects of 80 microg Locteron and 80 microg PEG-IFN-alpha2b on both neopterin and 2',5'-OAS were in a comparable range. Serum persistence of both these biomarkers was similar at 14 days after 320 microg Locteron compared with 7 days after 80 microg PEG-IFN-alpha2b. Mild, moderate, or severe influenza-like symptoms developed in all 6 subjects receiving 80 microg PEG-IFN-alpha2b. No such symptoms occurred after 20 or 80 microg Locteron doses. Among the 4 recipients of 320 microg Locteron, 1 experienced mild and 2 experienced moderate influenza-like symptoms. Locteron merits further clinical investigation as a hepatitis C therapy suitable for dosing once per 2 weeks.

100 项与 Interferon alpha-2b controlled release(Biolex Therapeutics, Inc.) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性丙型肝炎	临床2期	罗马尼亚	Biolex Therapeutics, Inc.	2009-03-01
慢性丙型肝炎	临床2期	美国	Biolex Therapeutics, Inc.	2009-03-01
慢性丙型肝炎	临床2期	保加利亚	Biolex Therapeutics, Inc.	2009-03-01
慢性丙型肝炎	临床2期	波多黎各	Biolex Therapeutics, Inc.	2009-03-01