Positive results reported from first clinical trial of recombinant human gelatin.

2003 AUG 20 - (NewsRx.com & NewsRx.net) -- FibroGen, Inc., announced positive results from the first clinical safety study of recombinant human gelatin, finding the study material safe and well tolerated at all doses tested.

The data support the use of FibroGen's proprietary 8.5 kD gelatin fragment as a safe and fully characterized alternative to animal- and plasma-derived proteins currently used as stabilizing components in formulations of vaccines and biological therapeutics.

Products containing animal- or plasma-derived proteins, such as gelatin and albumin, respectively, have the potential to induce harmful inflammatory or immune responses in humans and pose risk of contamination with potentially life-threatening pathogens, such as viruses or prions. In addition, the current process of making gelatin by denaturing collagen (a protein extracted from the skin, bones, and tissues of animal carcasses) yields a highly variable material that is not easily traced to its source once incorporated into consumer products.

"FibroGen's recombinant gelatin stabilizer is expected to provide safer delivery and improved performance of vaccines and biologics," said James W. Polarek, PhD, vice president, collagen and gelatin development. "Our recombinant gelatin is produced in a yeast system, eliminating the risk of contamination with transmissible pathogens that is associated with proteins derived from animal tissues or human plasma. FibroGen's proprietary technology also enables the consistent production of highly purified and fully characterized recombinant gelatin fragments that can be tailored for specific customer applications."

The safety of FibroGen's 8.5 kD recombinant gelatin fragment was ...