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Nanotherapeutics, a privately held specialty biopharmaceutical
company, announced today that it has submitted its first
Investigational New Drug (IND) application to the FDA for a phase IIa
clinical study for its product NanoDOX(TM) Hydrogel, a topical
doxycycline hydrogel for chronic wounds. 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.

The phase IIa study will be conducted at Veterans’ 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 VA 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.

“Diabetic ulcers are the primary cause of amputations of the leg,
foot, or toe. Two-thirds of all lower extremity amputations in the
United States are directly linked to diabetes. We believe that
NanoDOX(TM) is a unique formulation that holds significant promise for
the millions of people suffering from diabetic ulcers,” said Weaver H.
Gaines, Chairman of the Board. “Filing the IND for the phase II study
is a major step forward in our clinical program and demonstrates the
strength of our technology and our capability to generate unique new
product opportunities.”

NanoDOX(TM) Hydrogel, the company’s leading pharmaceutical product
in development, is an alternative topical formulation of doxycycline.
Nanotherapeutics developed the product with its proprietary particle
stabilization technology and formulated it to improve the topical
delivery of doxycycline to increase local efficacy of the drug.

Jim Talton, Ph.D., President of Nanotherapeutics, said, “The
Company is also exploring the use of NanoDOX(TM) 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 IND will
be filed for this indication.”

NanoDOX(TM) 1% Doxycycline Monohydrate Hydrogel

NanoDOX(TM) Hydrogel is a topical hydrogel applied directly to the
entire surface of the wound. A gauze dressing or a non-adhering
dressing is applied to cover the hydrogel and wound. This allows the
hydrogel to provide a moist healing environment. NanoDOX(TM) Hydrogel
is composed of doxycycline monohydrate, a currently marketed
antibiotic available in tablet and injectable forms.

Lower Extremity Diabetic Ulcers

There are more than 18 million people diagnosed with diabetes in
the United States and about 5% of them will develop foot and lower
limb ulcers. There are, however, about another 7 million diabetics who
are undiagnosed. Foot and lower leg ulcers are the primary cause of
the approximately 80,000 amputations of toes, feet, and lower legs
each year. It is estimated that up to 30% of diabetics with foot
ulcers will eventually require amputation. (National Institutes of
Health and CDC data)

About Nanotherapeutics

Nanotherapeutics is a privately held specialty biopharmaceutical
company with full product development and cGMP manufacturing
capabilities and a proprietary pipeline. The Company’s technologies
can be used with all drug types ranging from small molecules to
proteins and peptides. Nanotherapeutics is focused on drug
development, not early-stage discovery. Its first FDA approved
product, Origen(TM) DBM with Bioactive Glass, is an injectable bone
graft for orthopedic applications. For more information, visit
www.nanotherapeutics.com.