Garnet BioTherapeutics, Inc. ("Garnet"), a regenerative medicine company focused on developing cell based therapies, today announced that the first patient has been treated in a Phase 2 multicenter, double-blind, placebo-controlled study of its lead product candidate GBT009 at Unity Hospital in Rochester, New York. GBT009 gives off a variety of pro-regenerative growth factors and cytokines which help repair damaged tissue and reduce inflammation, ultimately augmenting the body's ability to heal itself. The trial will assess the safety and efficacy of GBT009 for the treatment of incisional wounds following breast reconstruction surgery.
"Recent advances in reconstructive surgery mean that women who have breast cancer today have greater choices that were not widely available 10 years ago," according to Joseph M. Serletti, MD, Chief of the Division of Plastic Surgery at the University of Pennsylvania School of Medicine, who specializes in breast reconstruction in cancer patients. "There are definite advantages to this surgery which uses the patient's own tissue to create a natural breast reconstruction. However, the limitation of this surgery is scarring in the area of the body where the tissue was taken. We are excited about the potential of this novel cell therapy which meets an unmet need for patients and surgeons looking for more options to improve scar formation and repair damaged tissue," he added. Dr. Serletti is a Principal Investigator for the study and serves as a consultant to Garnet BioTherapeutics, Inc.
There were over 79,000 breast reconstruction procedures performed by plastic surgeons in the U.S. in 2008. The transverse rectus abdominis myocutaneous (TRAM) flap is a common type of breast reconstruction that uses skin, muscle tissue and fat tissue from the lower abdomen to create a very natural looking breast. Breast reconstruction with TRAM flap surgery is a major, invasive procedure and carries with it the possibility of significant complications, including poor wound healing.