Olaregen — now controlled by Generex — is seeking orphan drug status from the U.S. Food and Drug Administration for Excellagen to also treat people with Ehlers-Danlos syndrome (EDS), a disease characterized by skin hyperextensibility, joint hypermobility, tissue fragility, and wound-healing problems.
What is EDS?
EDS is a rare, genetic disease that affects the connective tissues. People with EDS typically have soft, fragile skin that can bruise easily, and their wounds heal poorly.
Difficulties with healing can affect surgery in EDS patients. Potential complications include wound dehiscence — the separation of the edges of a surgical wound — excessive bleeding because of fragile blood vessels, and delayed wound healing.
How does Excellagen work?
Excellagen contains highly purified bovine type 1 collagen. Once covering a wound, it works by activating platelets, the wound-sealing components of blood. Activated platelets trigger the release of essential growth factors, including platelet-derived growth factor, a key wound-healing molecule. These promote the migration and proliferation of cells required for wound healing, including immune cells and fibroblasts (connective tissue cells that produce collagen).
Excellagen also provides a structural scaffold for wound healing.
Excellagen in clinical trials
The efficacy of Excellagen has been demonstrated in several clinical case studies, which were the basis for its FDA approval. Excellagen is used to treat 17 different types of wounds, including partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds such as abrasions, lacerations, second-degree burns, skin tears, and draining wounds.
Excellagen may benefit EDS patients with wound-healing problems. However, its effectiveness for EDS patients remains to be explored.
Excellagen is generally applied once a week. A topical gel, it comes in easy-to-use, pre-filled and single-use sterile syringes.
Last updated: Jan. 15, 2020
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