Gentamicin Therapy Induced Functional Type VII Collagen in RDEB Patients Harboring Nonsense Mutations. David T. Woodley and Mei Chen
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1 Gntamicin Thrapy Inuc Functional Typ VII Collagn in RDEB Patints Harboring Nonsns Mutations Davi T. Wooly an Mi Chn Dpartmnt of Drmatology, Univrsity of Southrn California, Los Angls, CA EB2017 Mting, Salzburg, Austria, Spt. 25, 2017
2 Conflicts of Intrsts W hav no Conflict of Intrst.
3 Gntamicin Inuc Functional Full-lngth Typ VII Collagn in RDEB Clls A) RDEB1 RDEB2 B) RDEB3 RDEB4 C7 (µg/ml) IKC NFB CON C) RDEB1+RDEB4 RDEB1/GENT +RDEB4 NHK+NFB RDEB2+RDEB4 RDEB2/ GENT+RDEB4 NHK+NFB RDEB1: R578X/Q906X; RDEB2: Q251X/Q251X; RDEB3:R578X/R578X; RDEB4:R613X/R1683X Cogan t al, Mol. Thr. 2013
4 OBJECTIVES Th primary objctivs for this oubl-blin, placbocontroll stuy wr: 1) Th tction of nw typ VII collagn an anchoring fibrils in th patints rmal-pirmal junction. 2) Safty paramtrs such as gntamicin-inuc ototoxicity or nphrotoxicity an antibois to typ VII collagn. A sconary objctiv was assssmnt of woun closur an nw blistr formation in two qual-siz, rosiv Wouns trat topically.
5 Stuy Protocol Two qual-siz wouns wr trat TID with 0.1% gntamicin sulfat ointmnt or placbo vhicl for 2 wks. Two Tst Sits of intact skin rciv intrarmal injctions of gntamicin (8 mgs) or placbo for two ays. Tst Sit biopsy spcimns wr valuat for C7 an anchoring fibrils at ay 0, months 1 an 3. Safty paramtrs (CBC, CMP, cratinin claranc, auiomtry an anti-c7 antibois) wr valuat at Day 0, months 1 an 3. Wkly tlphon intrviws wr conuct to assss patint safty an th status of th Tst Sits. Wkly patint photographs of th Tst Sits an patints aily iaris wr submitt to USC.
6 Summary of th Mutations, C7 Exprssion an AFs of th Fiv RDEB Patints ID PT1 PT2 PT3 PT4 PT5 NHS Sx Mal Mal Fmal Fmal Mal Ag, y Alll1 / Alll2 C7 at DEJ % R578X / V168GfsX12 R578X / R578X R2814X / IVS17-2lA R236X / IVS85-1G>A R613X / R1683X AFs / -
7 PT4 Topical & Intrarmal Gntamicin Inuc Nw C7 I-PLAC PT1 I-PLAC I-PLAC Wk 4 I-PLAC TOP - GENT I-PLAC NHS PT2 I-GE PT5 PT3 PT5 PT4 NHS Wooly t al, J. Clin. Invst. 2017
8 Topical & Intrarmal Gntamicin Inuc Nw C7 Wooly t al, J. Clin. Invst. 2017
9 Gntamicin Inuc Nw Anchoring Fibrils PT3 PT3! PT4!
10 Topical Gntamicin Improv Woun Closur Day 0 1 Month 3 Month
11 Topical Gntamicin Improv Woun Closur Day 0 1 Month 3 Month
12 Charactristics an Clinical Assssmnt of th Wouns Trat with Topically in th Fiv Stuy Patints ID PT1 PT2 PT3 PT4 PT5 Tratmnt GENT PLAC GENT PLAC GENT PLAC GENT PLAC GENT PLAC Location Lft Shoulr Right Shoulr Lowr Abomn Right Thigh Right Thigh Right Thigh Lft Shoulr Lft Back Uppr Lft Arm Uppr Right Arm Trat Ara Woun History Woun Closur Blistr Evnts > 3 yr > 3 yr 1-3 yr 1-3 yr > 3 yr > 3 yr 1-3 yr < 1 yr < 1 yr < 1 yr Wooly t al, J. Clin. Invst. 2017
13 Assssmnt of Safty Safty Paramtrs: complt bloo counts; bloo ura nitrogn; calculat cratinin claranc; livr function tsts; pur-ton auiomtry. PT1 PT2 PT3 PT4 PT5
14 Conclusions an Implication Gntamicin aministration crat nw full-lngth C7 an AFs in th DEJ of skin of RDEB patints with nonsns mutations. Th rstoration of C7 vari btwn 20% an 165% of th C7 xprssion in normal human skin an was urabl for at last thr months. Topical gntamicin corrct rmal-pirmal sparation, improv woun closur an ruc nw blistr formation. Thr wr no untowar si ffcts. Inuction of nw C7 i not gnrat nw anti-c7 autoantibois. Gntamicin-miat nonsns-supprssion thrapy may provi a novl, low cost, non-invasiv, raily availabl thrapy for RDEB patints harboring nonsns mutations.
15 ACKNOWLEDGMENTS Patints an Thir Familis USC: Jon Cogan, Yingping Hou, Lyu Chao Collaborators: Douglas Kn (Orgon) Ptr Marinkovich (Stanfor) Grant Supports:
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