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news.Nanotherapeutics, a privately held specialty biopharmaceutical company, has submitted its first investigational new drug application to the FDA for a Phase IIa clinical study of its product NanoDOX hydrogel, a topical doxycycline hydrogel for chronic wounds.
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The Phase IIa study will be conducted at veterans’s administration hospitals in Florida. The company will enroll diabetics, 18 and older, who have diabetic ulcers of the foot and lower limbs at the Gainesville and Lake City Virginia hospitals. The primary endpoint to evaluate the hydrogel’s efficacy will be the rate of complete (100%) wound closure during a 20-week treatment period.
The randomized double-blind study will assess the safety and efficacy of the product on the healing rates of non-infected diabetic ulcers of the lower extremity. Assuming FDA approval, the company expects to complete enrollment in early 2009.
Jim Talton, president of Nanotherapeutics, said: “The company is also exploring the use of NanoDOX hydrogel for treating traumatic open wounds incurred in combat. In collaboration with Walter Reed Army Medical Center, we plan a clinical trial to evaluate safety and efficacy in treatment of deep trauma wounds. A separate investigational new drug (IND) will be filed for this indication.”