For proper wound healing, host defenses and repair mechanisms must be activated and then at least partially suppressed to maintain homeostasis. The right balance must be established to aid healing while preventing cellular, tissue, and organ damage that can occur from prolonged or over-reactive inflammatory responses.
Several cell types must collaborate in order to complete wound healing processes. These wide-ranging cell types located throughout the body in different tissue types require multiple redox-sensitive signaling pathways to collaborate in a timely manner. Controlling these highly reactive redox signals has historically been biologically and therapeutically difficult. This makes proper wound healing, especially in major wounds caused by trauma and surgery, highly variable with frequent complications which may impede the healing process.
The therapeutic goal for GVT® is to augment standard treatment regimens and reduce the effect of wound related complications, such as inflammation, scarring, adhesions, infections, and edema.
Target indications for GVT® include wound healing related to:
Coronary artery bypass surgery (CABG)
Joint replacement
Tonsillectomies
Adjunct therapy for faster healing of soft tissue damage resulting from trauma
Non-clinical / Clinical Results.
Bach is currently pursuing an IND for GVT and has completed proof of concept non-clinical trials to demonstrate activity related to wound healing.
Study Name
Name of Research Institution and Principal Investigator (s)
Completion Date
Wound care and inflammation of GVT® in C57BL/6 mice
The University of Texas M. D. Anderson Cancer Center
Dr. Nomeli Nuñez
Completed 2008
Wound care and inflammation of GVT® in obese mice
The University of Texas M. D. Anderson Cancer Center
Dr. Nomeli Nuñez
Completed 2008
Commercial Potential for GVT®
A high unmet medical need exists for wound healing treatments that prevent or minimize further cell damage resulting from surgery, trauma, and burns. Complications in wound healing are currently addressed by a number of means. Steroids are used to suppress the body’s general inflammatory responses. Anti-coagulants are administered for prophylactic care. Anti-infectives are used to suppress opportunistic invasions by bacteria and viruses. Medical devices are coated to reduce contact of blood and tissue with oxygen and other stress-inducing agents.
These approaches reduce intracellular stresses if administered correctly and in a timely way. However, if administered too slowly or inadequately, persistent chronic imbalance in the redox potential leads to poor healing at the site of injury, and then to cell death, tissue loss and generalized hyper-inflammation in otherwise-healthy patients. Several current therapeutic approaches have been linked to adverse events.
Case Study Example
In on-pump coronary artery bypass surgery (CABG), there is strong documented evidence to support the relationship between inflammation and the occurrence of cardiovascular events. Furthermore, intracellular oxidative stress and inflammation have been linked to the development of postoperative atrial fibrillation (PAF) in 20% to 40% of patients receiving on-pump CABG.
The risk of PAF has been reported to increase the length of hospital stay up to 5 days, which increases costs by approximately $11,000 per stay. It has also been associated with a 2- to 3-fold increase in postoperative stroke, adding additional medical costs and complications. Current treatments for PAF include anti-arrhythmic devices and anticoagulation drugs.
A new therapeutic agent that reduces or prevents oxidative stress and
the associated inflammatory responses before, during, and after CABG would
help reduce the incidence of post CABG complications, and produce significant
economic and medical benefits to patients, insurers and hospitals
