FIBROCELL SCIENCE, INC. The combined organization is committed to advancing late-stage development programs in important rare genetic diseases such as epidermolysis bullosa (EB) and plans to target additional rare conditions with the gene therapy platform.
Both Castle Creek and Fibrocell have advanced investigational therapies for the treatment of EB into late-stage clinical research. EB is a rare genetic condition that leads to extremely fragile skin resulting in mild to severe blistering, skin erosion and peeling of the epidermis layers in response to minor injury. There are currently no treatment options approved by the
'Our organizations have a shared commitment to delivering new treatment options to underserved communities such as EB patients and their families who have no approved therapies,' said
Prior to the acquisition, Fibrocell initiated a pivotal Phase 3 clinical trial evaluating a gene therapy candidate, FCX-007, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The FDA has granted Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, Rare Pediatric Disease and Fast Track designations to FCX-007. Castle Creek has also continued Phase 2b clinical research evaluating a diacerein topical ointment, CCP-020, for epidermolysis bullosa simplex (EBS) and other forms of EB. The FDA has designated the CCP-020 program for Fast Track development in the treatment of EBS.
Castle Creek is a portfolio company of Paragon Biosciences, which founded Castle Creek with the vision to deliver transformative therapies to patients with rare genetic dermatologic diseases.
About
About
About Fibrocell
Fibrocell is a cell and gene therapy company focused on improving the lives of people with rare diseases of the skin and connective tissue. Fibrocell is utilizing its proprietary autologous fibroblast technology to develop personalized biologics that target the underlying cause of disease. Fibrocell's pipeline of localized gene therapy candidates include FCX-007 for the treatment of RDEB, a life-threatening genetic disorder diagnosed in infancy with no cure or treatment approved by the FDA. A pivotal Phase 3 clinical trial for FCX-007 was initiated in late
About Paragon Biosciences
Paragon is a life science innovator that invests in, builds, and advises bioscience companies. Our mission is to serve patients living with severe medical conditions which do not yet have adequate treatments. Paragon's portfolio of independently-run bioscience companies focus on: biopharmaceuticals, AI-enabled life science products, and advanced treatments such as cell and gene therapies. We help people live longer, healthier lives.
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