Nanotherapeutics receives contract from DOD to support clinical trial for treating dehisced surgical wounds

Nanotherapeutics, Inc.Nov 4 2010

Nanotherapeutics, Inc. announced that it has been awarded a contract by the U.S. Department of Defense (DOD) to support a clinical trial for treating dehisced surgical wounds with the Company's NanoDOX^® Hydrogel, a topical doxycycline hydrogel for chronic wounds. Nanotherapeutics is collaborating with Walter Reed Army Medical Center, the Henry Jackson Foundation, and the Armed Forces Institute of Pathology to conduct the trial. Funds were made available from the DOD 2009 Congressional appropriation for the Accelerating Treatment for Trauma Wounds.

“Our service members in combat deserve the best medical care available and I commend Nanotherapeutics for their work in developing improved treatments for chronic wounds.”

Congressman Cliff Stearns (R-FL) sponsor of the appropriation commented, "Our service members in combat deserve the best medical care available and I commend Nanotherapeutics for their work in developing improved treatments for chronic wounds."

The wounds sustained by combat military personnel are often traumatic and have a higher incidence of dehiscence. A dehisced wound is one that has reopened or come apart after it has been closed surgically. An infection, injury, poor healing, or failure of the material used to close the wound may cause wound dehiscence; the associated mortality can range from 14% to 50%. Estimates are that up to 3% of civilian patients experience wound dehiscence. The Company estimates the market at up to $3 billion annually. While NanoDOX has a military or biodefense application, like many of Nanotherapeutics' products developed with federal grants and contracts, it also has a civilian application.

NanoDOX^® Hydrogel is a topical formulation of doxycycline developed by the Company using its proprietary particle stabilization technology. This fine particle dispersion is designed to improve the delivery of doxycycline and increase the local efficacy of the drug.

Nanotherapeutics has also completed a Phase lla clinical trial to evaluate the safety and efficacy of NanoDOX^® Hydrogel in diabetic adults with lower extremity ulcers. The results of the Phase lla trial are being used to establish benchmarks for an expanded clinical trial using NanoDOX^® Hydrogel in the treatment of diabetic foot ulcers. Foot complications are the most frequent reason for hospitalization in patients with diabetes, accounting for up to 25 percent of all diabetic admissions in the United States.

NanoDOX^® 1% Doxycycline Monohydrate Hydrogel

NanoDOX^® Hydrogel is composed of doxycycline monohydrate, a currently marketed antibiotic available only in tablet and injectable forms. The NanoDOX^® Hydrogel topical fine particle dispersion is applied directly to the entire surface of the wound. Gauze or a non-adhering dressing is used to cover the hydrogel and wound, providing a moist healing environment.