SAN DIEGO, September 5, 2012 - Histogen, Inc., a regenerative medicine company developing innovative therapies for conditions including hair loss and cancer, today announced that the United States Patent & Trademark Office has issued patent 8,257,947, entitled “Extracellular Matrix Compositions Produced Under Hypoxic Culture Conditions” to the Company.
The patent, which is the Company’s first patent issued in the United States, covers Histogen’s method of growing cells under low oxygen and suspension conditions, and the process through which the naturally-secreted protein compositions are produced . The issuance of the `947 patent is an important milestone for Histogen, as all of its products, each with a range of therapeutic applications, are derived from this core manufacturing process.
“Acceptance of this core patent gives tremendous strength to Histogen’s technology and products, and establishes them as unique from any other cell-derived therapies in development today,” said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. “By altering the conditions under which cells are grown, we can actually trigger the cells to revert back to an earlier, multipotent state. This creates products with virtually limitless applications for unmet medical needs.”
By growing cells under proprietary conditions that simulate the embryonic environment, particularly hypoxia, it has been shown that normal human fibroblast cells become multipotent, and express key stem cell markers including Oct4, Sox2 and Nanog. The multipotent cells secrete a variety of soluble and insoluble molecules associated with stem cell niches in the body, as well as rapid tissue regeneration and scarless healing.
It is the soluble and insoluble compositions of multipotent proteins and growth factors which make up Histogen’s products. Applications for these compositions are numerous. Histogen’s lead product, Hair Stimulating Complex (HSC) has shown success in early clinical trials, and is currently in a Phase I/II stage trial as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen’s technology process can be found in the ReGenica line of skincare products by Suneva Medical. Histogen is also evaluating a subfraction of its material as an oncology therapy with the first application in clinical trials expected to be pancreatic cancer.