dabocemagene autoficel (FCX-007) / Precigen, Paragon Biosci - LARVOL DELTA

Evaluation of D-Fi for the Treatment of Wounds Due to DEB (clinicaltrials.gov) - P3 | N=32 | Recruiting | Sponsor: Castle Creek Biosciences, LLC.

New P3 trial

Exploring the Financial Burden Associated with the Management of Dystrophic Epidermolysis Bullosa (DEB): A Systematic Literature Review (SLR) with Database Review of Future Disease-Modifying Therapies (DMTs) (ISPOR 2024) - "Nine clinical trials research 7 potential DMTs: advanced/gene therapies (EB-101, B-VEC, ALLO-ASC-SHEET, FCX-007), protein-replacement therapies (PTR-01, PTR-01-002), and a proteinase inhibitor (Polyphenon E). Previously, as there were no DMT options for patients with DEB treatment was symptomatic only. Future innovative DMTs should aim to prevent skin wounds, thereby decreasing the need for hospitalization and outpatient visits."

Review • Dermatology • Gene Therapies

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - P1/2 | N=6 | Terminated | Sponsor: Castle Creek Biosciences, LLC. | Trial completion date: Dec 2033 ➔ Apr 2022 | Active, not recruiting ➔ Terminated; Subjects were all in Long-Term Follow Up and were transferred to the ongoing EB-002 study

Trial completion date • Trial termination

A Randomized Trial to Determine the Efficacy and Safety of FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (EADV 2022) - No abstract available

Clinical

DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - P3 | N=6 | Active, not recruiting | Sponsor: Castle Creek Biosciences, LLC. | Recruiting ➔ Active, not recruiting | N=24 ➔ 6

Enrollment change • Enrollment closed

Castle Creek Biosciences, Inc. (BIO 2022) - "Castle Creek’s most advanced product candidate, dabocemagene autoficel (FCX-007, D-Fi), an ex vivo, autologous gene therapy, is currently being evaluated in a Phase 3 clinical trial for the localized treatment of chronic wounds due to recessive dystrophic epidermolysis bullosa (RDEB)...Castle Creek Biosciences, Inc. is a portfolio company of Paragon Biosciences, LLC."

Gene Therapies • Genetic Disorders

The Treatment of Wounds Associated with Recessive Dystrophic Epidermolysis Bullosa with Local Injections of Gene-Corrected, Collagen VII-Expressing Autologous Human Dermal Fibroblasts (ASGCT 2022) - "Local injection of COL7- expressing autologous human dermal fibroblasts (D-Fi, also known as FCX-007) led to wound healing in patients with RDEB...The local injection of gene-corrected autologous fibroblasts to the wounds of RDEB appears to be generally safe, and complete wound healing is typically exhibited. The durability of wound healing needs to be evaluated over a longer period."

Genetic Disorders • Infectious Disease

A Randomized Trial to Determine the Efficacy and Safety of FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa -DEFI-RDEB (ASGCT 2022) - "Safety assessments include adverse events (including the presence of neoplasms), replication-competent lentivirus (RCL), COL7 antibody and clinical laboratory testing. Subjects who have received at least one treatment injection will continue in the long-term safety follow-up period through 15 years."

Clinical • Genetic Disorders • Mood Disorders • Oncology • Pain

DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - P3; N=24; Recruiting; Sponsor: Castle Creek Biosciences, LLC.; Trial completion date: Jul 2036 ➔ Jul 2037; Trial primary completion date: Apr 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - P1/2; N=6; Active, not recruiting; Sponsor: Castle Creek Biosciences, LLC.; Trial primary completion date: May 2020 ➔ Sep 2020

Trial primary completion date

[VIRTUAL] "A Phase 3 Randomized Trial to Determine the Safety and Efficacy of FCX-007 for the Treatment of Wounds Associated with Recessive Dystrophic Epidermolysis Bullosa (SBS 2021) - "The safety and efficacy of local injection of autologous gene-corrected, COL7-expressing fibroblasts for the treatment of wounds associated with RDEB will be evaluated in this late-phase clinical study. Authors are employees of Castle Creek Biosciences"

Clinical • P3 data • Oncology • Pain

DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - P3; N=24; Recruiting; Sponsor: Fibrocell Technologies, Inc.; Trial completion date: Nov 2035 ➔ Jul 2036

Trial completion date

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - P1/2; N=6; Active, not recruiting; Sponsor: Fibrocell Technologies, Inc.; N=12 ➔ 6

Enrollment change

DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - P3; N=24; Recruiting; Sponsor: Fibrocell Technologies, Inc.; Trial completion date: Mar 2021 ➔ Nov 2035; Trial primary completion date: Dec 2020 ➔ Apr 2022

Trial completion date • Trial primary completion date

DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - P3; N=20; Recruiting; Sponsor: Fibrocell Technologies, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open

DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - P3; N=20; Not yet recruiting; Sponsor: Fibrocell Technologies, Inc.

New P3 trial

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - P1/2; N=12; Active, not recruiting; Sponsor: Fibrocell Technologies, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed

"Pres & CEO @JohnMaslowski5 to discuss @Fibrocell #genetherapy candidate FCX-007 for RDEB at #BIO2019 on June 4 at 1:00 pm ET. Details https://t.co/wlNjCLVTcS" (@fibrocell)

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - P1/2; N=12; Recruiting; Sponsor: Fibrocell Technologies, Inc.; Trial primary completion date: Dec 2018 ➔ Apr 2020

Trial primary completion date

"$FCSC Announces Collaboration with Castle Creek Pharmaceuticals to Develop and Commercialize FCX-007 Gene Therapy. $30M Upfront" (@BioStocks)