Topical treatment with TGFbeta3 to facilitate skin and corneal wound healing in diabetic patients

Case ID:
14-1207

 Topical Treatment with TGFb3 to Facilitate Skin and Corneal Wound Healing in Diabetic Patients  

WSU Tech#: 14-1207

Technology Summary:

TGFb3 has been implicated in the reduction of scar formation in wound healing.  Renovo Group PLC, is a European based biopharmaceutical company developing drugs to reduce scaring, improve wound healing and enhance tissue regeneration.  The company tried to use a formulation of TGFb3, called Juvista, to reduce scar formation.  Juvista passed phase I and II clinical trials but failed phase III trials (350 normal postsurgical patients); as it failed to meet primary (assessment of scars by physicians) and secondary (assessment of scars by patients) endpoints.

 

The advantage of this disappointment is that a formulation of TGFb3 has successfully made it through toxicology testing, NDA and phase I and II trials; though the endpoints for efficacy were not successful.

Work in Dr Fu-Shin Yu's laboratory has shown, however, that topical TGFb3 can accelerate wound healing in diabetic patients (versus normal patients like those in Renovo's trial).  Their research discovered that TGFb3 that is dramatically increased in wound healing in normal patients is baseline in diabetic patients.

Cornea injury wound healing gene array data from normal patients and those with diabetes were compared and examined for fold changes in gene expression between individuals.  This array data implicated TGFb3 as being dramatically different as well as 36 other genes.

 

Formulations of TGFb3 that was applied to a wound on diabetic animals dramatically increased wound healing.  This formulation could increase wound healing and decrease wound complications experienced by diabetic patients.  An example of this is neuropathy and tissue damage to the feet that is common among older diabetics.  This could also be used to heal pressure wounds and bed sores that are common to elderly patients in nursing or assisted living homes.

Benefit Analysis:

 

Diabetes affects approximately 170 million people worldwide, including 20.8 million in the USA, and by 2030 these numbers are projected to double.  The American Diabetes Association (Association) released new research on March 6, 2013 estimating the total costs of diagnosed diabetes have risen to $245 billion in 2012 from $174 billion in 2007, when the cost was last examined.  The total estimated cost of diagnosed diabetes in 2012 is $245 billion, including $176 billion in direct medical costs and $69 billion in reduced productivity.

 

One area where wound healing in diabetics is an acute problem is in nursing homes where diabetics are at higher risk of getting bed sores and pressure ulcers.   In 2004, nearly 25% of all residents in nursing homes had diabetes as a primary admission and/or current diagnosis.   Although specifics on pressure ulcers were not found specifically for diabetics at healthcare facilities, the overall incidence and costs are remarkable.

 

Another large area for wound healing in diabetic patients is foot ulcers.  Diabetic ulcers are the most common foot injuries leading to leg amputation, according to American Family Physician, while foot complications are the most frequent reason for hospitalization in patients with diabetes.  The size of the U.S. diabetic foot-ulcer market is estimated at about $2 billion, with about 80% in the outpatient segment and about 20% in the inpatient and Veteran's Administration space.

 

Diabetic neuropathy is a type of nerve damage that can occur in people with diabetes. High blood sugar can injure nerve fibers throughout the body, but diabetic neuropathy most often damages nerves in the legs and feet.  According to a research report by GlobalData, they estimate that the global diabetic nephropathy (DN) therapeutics market was valued $1.65 billion in 2010, after increasing at a Compound Annual Growth Rate (CAGR) of 7.6% during 2005-2010. However, during 2010-2017, the market is expected to record a CAGR of 5.2%, to reach $2.35 billion by 2017.

 

Stage of Development: Pre-Clinical

 

Currently running in vivo studies.

 

Patent Status:

 

Through the Office of Technology Commercialization at Wayne State University, we have filed an extensive and detailed patent application to the USPTO office. This is a detailed methods based application with both specific and fairly broad claims.

 

Licensing Opportunity:

WSU is looking for a commercial partners interested in furthering the validation of this technology and bringing the technology to market.  The inventors would be open to assist in the generation of SBIR/STTR  grants to fund the further development of this technology.

Contact for Further Information:  

 Frank Urban, MS, CBA, BA.   email: frank.urban@wayne.edu   Phone (mobile): (734) 355-0730

Patent Information:
For Information, Contact:
Nicole Grynaviski
Commercialization Principal
Wayne State University
nicole.grynaviski@wayne.edu
Inventors:
Fu-Shin Yu
Keywords: