NEW YORK, May 17 /PRNewswire/ -- Danube Pharmaceuticals, Inc., a privately held drug development company, announced the initiation of a multi-center, randomized, double-blind, placebo controlled Phase II study with DNB-001 in 60 patients with ocular hypertension (elevated intraocular pressure).
The primary objective of this Phase II study is to evaluate the efficacy of DNB-001, a novel oral therapy with a dual mechanism of action, in lowering the intraocular pressure (“IOP”) in patients with ocular hypertension. The secondary objective is to evaluate the safety of DNB-001 administered over a 4-week period. The trial is being conducted at 6 ophthalmic research centers in the United Kingdom. Results from the trial are expected to be available by the end of the year. Based on the results of the study, Danube plans to pursue global development of DNB-001 as a treatment for glaucoma, a disease where untreated pressure elevation can lead to progressive blindness.
“Initiation of this Phase II trial is a significant step in the development of DNB-001 as a potential first-in-class treatment for glaucoma,” noted David R. Guyer, M.D., Chairman of Danube. “There are currently no marketed therapies that both lower the intraocular pressure, and directly address the damage to the optic nerve. We are thrilled to have the top research centers for ophthalmology in the United Kingdom partnering with us in this trial.”
“Today more than 65 million people worldwide suffer from glaucoma, and it is one of the world’s leading causes of irreversible blindness,” stated Clive Migdal, M.D. and Principal Investigator for this trial. “Evaluation of DNB-001 in glaucoma is potentially an important step forward in the treatment of this disease.”
DNB-001, a potential first-in-class oral therapy with dual potent IOP- reducing and tissue protective effects, is initially being developed for the treatment of glaucoma. In-vivo studies of DNB-001 have shown the ability to achieve a reduction in IOP by increasing trabecular outflow, as well as the ability to protect several tissue types including the retina and optic nerve from ischemic or toxic injury. Moreover, in a 79-patient Phase I study in the United Kingdom, DNB-001 was well tolerated at all dose levels, with side effects being generally mild and comparable to those observed in the placebo group.
Additionally, Danube is in the process of initiating a second Phase II study of DNB-001 to evaluate the agent’s cardiac and renal protective effects in patients with coronary artery and kidney disease undergoing coronary artery angioplasty. This study will be conducted in the EU and Australia, and is expected to commence in Q3 2007.
About Glaucoma
Glaucoma is a degenerative eye disease characterized by progressive damage to the optic nerve and frequently associated with elevated IOP. A leading cause of blindness worldwide, glaucoma affects over 3 million people in the United States alone. While marketed therapies lower IOP and reduce risk of disease progression, none have been clinically demonstrated to possess a mechanism for direct neuroprotection. Additionally, all currently marketed oral therapies for glaucoma possess considerable side-effects which limit their clinical use.
About Danube Pharmaceuticals, Inc.
Danube Pharmaceuticals is an entrepreneurial, science-driven biopharmaceutical company involved in early-stage clinical research. We are dedicated to serving the medical community with integrity while assisting patients fight serious illness through the development of novel therapies. Our goal is to bring these new therapies to market efficiently by relying on the experience and expertise of our multidisciplinary team.
Danube Pharmaceuticals is currently in clinical phase II development of a compound for the treatment of glaucoma, and beginning phase II development of a treatment for ischemic cardiac and kidney damage.
Contact:
David R. Guyer
Chairman
Danube Pharmaceuticals, Inc.
(212) 994-3931
info@danubepharma.com
This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our pharmaceutical collaborator’s ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, and product pricing and third party reimbursement. We undertake no obligation to update any forward-looking statement contained in this press release, except as required by law.
Danube Pharmaceuticals, Inc.
CONTACT: David R. Guyer, Chairman, of Danube Pharmaceuticals, Inc.,+1-212-994-3931, info@danubepharma.com
