Human Studies of Recombinant Human Nerve Growth Factor and Diabetic Peripheral Neuropathy

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Abstract

Recombinant human nerve growth factor (rhNGF) is the first neurotrophin to be investigated in clinical trials of diabetic peripheral neuropathy (DPN). To date, the drug has been administered to 60 healthy volunteers and 209 patients with DPN in phase I and II studies. Results from phase I have demonstrated rhNGF to be safe and generally well tolerated in doses up to 1.0 µg/kg given intravenously or subcutaneously for up to 12 doses. Doses investigated in phase II were 0.1 or 0.3 µg/kg s.c. 3 days a week for 6 months. Preliminary results from this trial suggest that rhNGF specifically improves the function of small-fibre sensory peripheral neurons, which is consistent with its postulated mode of action. Two pivotal 12-month phase III trials are underway in diabetic patients with symptomatic peripheral neuropathy to confirm the therapeutic effects of rhNGF. Results from these trials are expected in 2000.

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Journal ID (publisher-id): ENE

Journal ID (nlm-ta): Eur Neurol

Journal ID (doi): 10.1159/issn.0014-3022

Title: European Neurology

Publisher: S. Karger AG

ISBN: 978-3-8055-6843-2

ISBN: 978-3-318-00410-6

ISSN (Print): 0014-3022

ISSN (Electronic): 1421-9913

Publication date Subscription-year: 1999

Publication date (Print): February 1999

Publication date (Electronic): 25 February 1999

Volume: 41

Issue: Suppl 1

Pages: 20-26

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Harvard Medical School, Boston, Mass., USA

Article

Publisher ID: 52076 Other ID: Eur Neurol 1999;41(suppl 1):20–26

DOI: 10.1159/000052076

PubMed ID: 10023125

SO-VID: 7bed79c0-e354-455c-a29b-c076e516e9e2

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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

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Human Studies of Recombinant Human Nerve Growth Factor and Diabetic Peripheral Neuropathy

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Karger: Neurology and Neuroscience

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