Garnet BioTherapeutics commences treatment in GBT009 trial for incisional wounds following breast reconstruction surgery

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.

The GBT009 clinical trial targets female patients scheduled for a mastectomy with breast reconstruction surgery using an abdominal flap technique.  The goal of this study is to assess whether intradermal injections of GBT009 along full thickness abdominal incisions following surgery leads to an improvement in scar appearance.  Efficacy measures include assessments of scar appearance that will be periodically evaluated by the Investigator and patient using the Patient Observer Scar Assessment Scale (POSAS), the Manchester Scar Scale (MSS) and a Visual Analog Scale (VAS).  In addition, photographs will be taken throughout the study and an independent scar assessment panel will evaluate and rate the standardized, calibrated digital photographs.

"We are very pleased to report the first patient being enrolled in this study of GBT009.  The event marks a key milestone for women, notably breast cancer survivors, because this therapy addresses one of the least-desired attributes of our patients – the visible scars which linger as a reminder of their ordeal," explained Dr. Stephen Vega, study investigator and plastic surgeon working in Rochester, New York.

More information about the trial can be found at www.clinicaltrials.gov and the identifier is NCT01053897.

Garnet is initially developing its cell-based therapy for cosmetic and dermatologic applications where accelerated healing and reduced scarring are desirable.  The company believes that the cell-based therapy may also be applicable for treatment of burns, auto-immune disorders such as psoriasis, and in other conditions where inflammation or scar formation plays an important role in disease pathology.  In addition, Garnet has developed proprietary scalable cell manufacturing technology that has largely solved the challenge of commercial manufacturing scale-up of patient doses from a single donor source.

SOURCE Garnet BioTherapeutics, Inc.