San Francisco, California – August 25, 2010 – FibroGen, Inc., today announced results of a 2-year clinical study demonstrating that surgical implantation of biosynthetic corneas formulated with the company's proprietary recombinant human type III collagen (rhCIII) restored vision and promoted nerve regeneration (restoring sensitivity) in patients who had corneal damage and significant vision loss. The results of this phase 1, investigator-sponsored study were published today in Science Translational Medicine .1
Corneal damage and disease are major causes of blindness worldwide. In countries where tissue banking is available, such as the US, treatment is by implantation of human donor corneas. However, there is a severe shortage of human donor tissue worldwide. Patients who do receive donor human corneas, however, can still suffer complications, such as tissue rejection. Corneal prostheses, made from synthetic plastics are used in limited cases, but only where human donor grafts are contraindicated or have been repeatedly unsuccessful. These synthetic alternatives are not designed to replace donor tissues or promote tissue regeneration.
FibroGen pioneered the development of recombinant collagen production technology and is the only producer of rhCIII. Since 2005, FibroGen has collaborated with Dr. May Griffith of Linköping University, senior author of today's publication, to develop biosynthetic corneas molded from chemically cross-linked rhCIII. The biosynthetic implants are designed to mimic the human cornea, which is composed mainly of the protein collagen.
"Recombinant human collagen is a viable replacement for naturally occurring human collagen that does not have the limitations of human donor tissue or animal-sourced collagens, such as risk of disease transmission and availability of donor supply," said Dr. Griffith. "Our study provides proof-of-concept that corneal implants composed of recombinant human collagen can promote tissue regrowth and restore vision."
"These clinical results suggest that our collagen could potentially provide an important option for patients by reducing risk of disease transmission and increasing supply of corneal implant material in the face of the worldwide shortage of human donor corneas," said Thomas B. Neff, Chief Executive Officer of FibroGen. "This product concept continues to be improved and additional studies are planned."
About the Phase 1 Study
Unmet medical need for a biosynthetic corneal implant
Loss of vision due to corneal disease or trauma affects over 10 million individuals worldwide, but lack of access to good quality donor tissue severely limits the number of transplant procedures that can be done, particularly in the developing world. In the US, an estimated 42,000 corneal grafts are performed annually using optical tissue from cadavers; however, graft rejection can occur, and failure rates are significant. In addition, the mandatory use of steroids with cadaver-sourced corneal material limits their successful use to certain patient populations. Fully synthetic prostheses (without biological activity) have been developed, but their use has been limited to cases where human donor tissue fails repeatedly or cannot be used. Moreover, apart from the US, in most countries, tissue donation and banking systems do not exist.
About FibroGen's recombinant human collagens
About FibroGen
FibroGen, Inc. is a biotechnology-based drug discovery and development company using its expertise in the fields of tissue fibrosis, connective tissue growth factor (CTGF), and hypoxia-inducible factor (HIF) biology to discover, develop, and commercialize novel therapeutics for fibrotic disorders, diabetic complications, anemia, conditions associated with tissue damage or injury, cancer, and other areas of unmet medical need. FibroGen also develops and produces recombinant human collagens and gelatins using unique production technology that provides the basis for FibroGen's proprietary cosmetic dermal filler and biomaterials supply business.
For more information about FibroGen, Inc., please visit www.fibrogen.com .
Reference
1Fagerholm P, et al., A Biosynthetic Alternative to Human Donor Tissue for Inducing Corneal Regeneration: 24-Month Follow-up of a Phase 1 Clinical Study. Science Translational Medicine Volume 2 (25 August 2010).
Science Translational Medicine