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Acuity Pharmaceuticals Completes Patient Enrollment In Phase II Trial In Wet AMD And Initiates New Trial In Diabetic Macular Edema



2/2/2006 10:39:19 AM

PHILADELPHIA, Feb. 2 /PRNewswire/ -- Acuity Pharmaceuticals, a product- focused ophthalmic pharmaceutical company, today announced that it has completed the patient dosing component of its Phase II clinical program for Cand5, Acuity's lead product candidate for the treatment of wet age-related macular degeneration (wet AMD), a leading cause of adult blindness. Acuity also announced that it has begun dosing patients in a pilot Phase II trial of Cand5 in its second indication of diabetic macular edema (DME).

The Cand5 Anti-VEGF RNAi Evaluation, or C.A.R.E.(TM) trial, is the first- ever Phase II efficacy trial for a small interfering RNA (siRNA) therapy, an innovative approach based on the powerful gene silencing technology of RNA interference (RNAi). The C.A.R.E. study is a randomized, double-masked trial that includes three dose levels of Cand5. The study enrolled 129 patients at 28 sites nationwide in just four months time. Patient data and study results are expected by mid-year.

The RNAi Assessment of Cand5 in Diabetic Macular Edema, or R.A.C.E.(TM) trial, is a pilot phase II investigation of the safety and preliminary efficacy of Cand5 in patients with diabetic macular edema. This 48 patient multi-center, double-masked and randomized trial will study three dose levels of Cand5. The R.A.C.E. study is expected to be completed by the end of 2006.

"Investigator recognition of the therapeutic potential of Acuity's novel gene silencing drug facilitated achievement of our enrollment targets for this pioneering Phase II study in wet AMD," said Lawrence Singerman, M.D. of Retina Associates of Cleveland, an investigator for Acuity's C.A.R.E. and R.A.C.E. studies. "Cand5 may also help preserve and enhance vision for the millions of individuals whose vision is threatened by the related condition of diabetic macular edema, which is a growing problem worldwide and currently has few effective treatment options."

Cand5's RNAi mechanism silences the genes that promote the overgrowth of blood vessels that lead to vision loss in wet AMD and DME. By shutting down the production at the source of vascular endothelial growth factor (VEGF), the central stimulus in the development of wet AMD and DME, Cand5 is expected to have efficacy advantages over other therapies, which inhibit VEGF only after it has already been produced in the eye. Acuity's RNAi mechanism also has the potential for safety and administration advantages compared to other approaches.

"Our rapid progress in completing this stage of the C.A.R.E. study reflects the focus of Acuity and our investigators on clinical development excellence," said Dale Pfost, Ph.D., president and CEO of Acuity. "The value of the outstanding scientific and clinical team we have assembled is already evident in our ability to execute our programs quickly and cost effectively, while achieving quality results. This capability will facilitate our clinical studies of Cand5 in wet AMD, diabetic macular edema and other indications, as well as the clinical development of our pipeline products."

Diabetes is a growing global problem. The World Health Organization estimates that 15 million Americans have diabetes and more than 150 million people worldwide have the disease. After 20 years, nearly all patients with type I and 60% of patients with type II diabetes will have some degree of retinopathy, which includes damage to the blood vessels in the retina. These blood vessels begin to leak fluid, which can lead to diabetic macular edema, a condition in which fluid accumulates in the macula of the eye and erodes vision.

About Wet AMD

Wet age-related macular degeneration (wet AMD) is the number one cause of irreversible vision loss in the developed world, and its incidence is growing rapidly. Advanced age is the main risk factor for wet AMD, and it is expected to become increasingly common as the population ages. An estimated 1.65 million Americans have wet AMD today and an estimated 11 million people worldwide will have AMD by 2013. Existing treatments for wet AMD are of limited efficacy and fail to halt disease progression in many patients. In the search for more effective treatments, researchers are targeting vascular endothelial growth factor (VEGF), which has been shown to be a key cause of the excess growth of blood vessels that results in loss of vision.

About DME

DME affects up to 10% of all diabetes patients - an estimated 75,000 new cases occur in the U.S. alone every year. Patients with DME often experience blurred vision, which may progress to blindness. There are few treatments available for DME - control of blood glucose levels and other risk factors can help to some degree, as can laser treatments to reduce leakage into the eye. Cand5 silences the genes that produce VEGF, the primary cause of the blood vessel overgrowth and leakage. In animal models, Cand5 has demonstrated the ability to reduce the type of blood vessel leakage associated with DME.

About Acuity

Founded in 2002, Acuity Pharmaceuticals is a product-focused ophthalmic pharmaceutical company applying its proprietary technology to the treatment and prevention of ophthalmic diseases, focusing initially on leveraging its strong technology and intellectual property portfolio in the field of RNA interference (RNAi). Acuity is developing treatments for age-related macular degeneration (AMD) and diabetic macular edema (DME), two of the leading causes of adult vision loss. Its lead clinical compound Cand5, a small-interfering RNA (siRNA) therapeutic currently in Phase II trials, shuts down vascular endothelial growth factor (VEGF), which has been shown to be the central stimulus in the development of AMD and DME. In late 2004, Cand5 became the first-ever RNAi therapy to enter human trials. Its novel siRNA mechanism of action is expected to give Cand5 efficacy, safety and administration advantages over other therapies. For more information, see the company's website at http://www.acuitypharma.com.

Contacts: Media: Acuity Pharmaceuticals GendeLLindheim BioCom Partners Todd Wallach Stephen Gendel 215 966-6181 212 918-4650

Acuity Pharmaceuticals

CONTACT: Todd Wallach of Acuity Pharmaceuticals, +1-215-966-6181; orMedia, Stephen Gendel of GendeLLindheim BioCom Partners, +1-212-918-4650


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