FCX-013 / Precigen, Paragon Biosci - LARVOL DELTA

A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) (clinicaltrials.gov) - P1/2 | N=1 | Terminated | Sponsor: Castle Creek Biosciences, LLC. | N=10 ➔ 1 | Trial completion date: Jan 2036 ➔ Apr 2022 | Recruiting ➔ Terminated; Sponsor decision

Enrollment change • Trial completion date • Trial termination • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Castle Creek Biosciences, LLC. | Trial primary completion date: Mar 2022 ➔ Jun 2022

Trial primary completion date • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) (clinicaltrials.gov) - P1/2; N=10; Recruiting; Sponsor: Castle Creek Biosciences, LLC.; Trial completion date: Mar 2021 ➔ Jan 2036; Trial primary completion date: Dec 2020 ➔ Mar 2022

Trial completion date • Trial primary completion date • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Castle Creek Biosciences Announces First Patient Dosed in Phase 1/2 Clinical Trial of FCX-013 Gene Therapy for Treatment of Moderate to Severe Localized Scleroderma (PRNewswire) - "Castle Creek Biosciences...announced that the first adult patient has been dosed in a Phase 1/2 clinical trial evaluating FCX-013, the company's investigational gene therapy, for the treatment of moderate to severe localized scleroderma....The trial will enroll up to 10 patients with moderate to severe localized scleroderma."

Trial status • Immunology • Scleroderma • Systemic Sclerosis

Fibrocell announces submission of Investigational New Drug application for FCX-013 for the treatment of moderate to severe localized scleroderma (GlobeNewswire) - “Fibrocell Science, Inc…announced the submission of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for FCX-013...for the treatment of moderate to severe localized scleroderma.”

IND • Immunology • Systemic Sclerosis

Fibrocell Announces Collaboration with Castle Creek Pharmaceuticals to Develop and Commercialize FCX-007 Gene Therapy (GlobeNewswire, Fibrocell Science Inc.) - “With Castle Creek Pharmaceuticals providing funding for the development of FCX-007, Fibrocell can allocate additional resources to advance clinical development of FCX-013 for the treatment of moderate to severe localized scleroderma.”

Financing

Fibrocell announces positive feedback from type B end-of-phase 2 meeting with FDA on phase 3 clinical trial design for FCX-007 (GlobeNewswire) - "Fibrocell is also developing FCX-013 for the treatment of moderate to severe localized scleroderma....Fibrocell is currently enrolling the Phase 1 portion of a Phase 1/2 clinical trial for FCX-013, and expects to complete enrollment of Phase 1 adult patients in the third quarter of 2019."

Enrollment status

A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (clinicaltrials.gov) - P1/2; N=10; Recruiting; Sponsor: Fibrocell Technologies, Inc.; Initiation date: Dec 2018 ➔ Mar 2019

Trial initiation date

Fibrocell to Present at 21st Annual BIO CEO & Investor Conference (GlobeNewswire, Fibrocell Science Inc.) - “Fibrocell Science, Inc….today announced that John Maslowski…will present at the 21st Annual BIO CEO & Investor Conference on Monday, February 11 at 9:45 am EST in New York City. Mr. Maslowski will discuss…FCX-013 for the treatment of moderate to severe localized scleroderma…”

Clinical data