Report. Phase I trial of recombinant human nerve growth factor for neurotrophic keratitis
Report. Phase I trial of recombinant human nerve growth factor for neurotrophic keratitis
Neurotrophic keratitis/keratopathy (NK), a rare degenerative corneal disease, lacks effective pharmacologic therapies.1 Because NK pathology involves trigeminal nerve damage and loss of corneal innervation, nerve growth factor (NGF) is surmised to promote healing of NK.2 Preliminary studies with murine NGF demonstrated efficacy for treating corneal neurotrophic ulcers;3 however, the complex tertiary structure of NGF has complicated the production of recombinant human NGF (rhNGF) suitable for clinical development. To this end, we developed an Escherichia coli–derived rhNGF formulation that demonstrated to be well tolerated and safe for topical ophthalmic use in a phase I study in healthy volunteers.4 We report phase I results of topical rhNGF for patients with moderate-to-severe NK.
1468-1471
Bonini, Stefano
f18a7448-3007-4bb0-87bf-7cf7698da98a
Lambiasi, Alessandro
df1dcf3e-ef6f-4dfa-8aaf-a50a35f0481b
Rama, Paolo
4758a5b6-577b-41ad-b9e2-b815d1922f97
Filatori, Isabella
c55cd9d6-9e55-450d-b185-3f4a742b4368
Allegretti, Marcello
b9394baa-3b6b-4d58-a8d0-7cf5e5052198
Chao, Wendy
417c6201-e4fa-461c-b625-90b1a4864a1a
Mantelli, Flavio
37f8dcff-4f05-4951-8f68-51dbee6df99c
Hossain, Parwez
563de5fc-84ad-4539-9228-bde0237eaf51
September 2018
Bonini, Stefano
f18a7448-3007-4bb0-87bf-7cf7698da98a
Lambiasi, Alessandro
df1dcf3e-ef6f-4dfa-8aaf-a50a35f0481b
Rama, Paolo
4758a5b6-577b-41ad-b9e2-b815d1922f97
Filatori, Isabella
c55cd9d6-9e55-450d-b185-3f4a742b4368
Allegretti, Marcello
b9394baa-3b6b-4d58-a8d0-7cf5e5052198
Chao, Wendy
417c6201-e4fa-461c-b625-90b1a4864a1a
Mantelli, Flavio
37f8dcff-4f05-4951-8f68-51dbee6df99c
Hossain, Parwez
563de5fc-84ad-4539-9228-bde0237eaf51
Bonini, Stefano, Lambiasi, Alessandro, Rama, Paolo, Filatori, Isabella, Allegretti, Marcello, Chao, Wendy and Mantelli, Flavio
,
REPARO Study Group
(2018)
Report. Phase I trial of recombinant human nerve growth factor for neurotrophic keratitis.
Ophthalmology, 125 (9), .
(doi:10.1016/j.ophtha.2018.03.004).
Abstract
Neurotrophic keratitis/keratopathy (NK), a rare degenerative corneal disease, lacks effective pharmacologic therapies.1 Because NK pathology involves trigeminal nerve damage and loss of corneal innervation, nerve growth factor (NGF) is surmised to promote healing of NK.2 Preliminary studies with murine NGF demonstrated efficacy for treating corneal neurotrophic ulcers;3 however, the complex tertiary structure of NGF has complicated the production of recombinant human NGF (rhNGF) suitable for clinical development. To this end, we developed an Escherichia coli–derived rhNGF formulation that demonstrated to be well tolerated and safe for topical ophthalmic use in a phase I study in healthy volunteers.4 We report phase I results of topical rhNGF for patients with moderate-to-severe NK.
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REPARO phase 1 MS OPHTHA 2017 2894 R1
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Accepted/In Press date: 1 April 2018
e-pub ahead of print date: 10 April 2018
Published date: September 2018
Additional Information:
Case report
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Local EPrints ID: 419682
URI: http://eprints.soton.ac.uk/id/eprint/419682
PURE UUID: 0333eb36-92b3-44cf-876a-010350d2f9df
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Date deposited: 19 Apr 2018 16:30
Last modified: 16 Mar 2024 03:48
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Contributors
Author:
Stefano Bonini
Author:
Alessandro Lambiasi
Author:
Paolo Rama
Author:
Isabella Filatori
Author:
Marcello Allegretti
Author:
Wendy Chao
Author:
Flavio Mantelli
Corporate Author: REPARO Study Group
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