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Ondine Biopharma Announces Results from Clinical Trial |
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05 Oct 2006 |
Today announced results from a prospective, randomized, controlled, blinded clinical trial of its PeriowaveTM Photodynamic Disinfection (PDD) System for the treatment of periodontal diseases.
VANCOUVER, Canada | Oct 04, 2006 | Ondine Biopharma Corporation (TSX: OBP; AIM: OBP) today announced results from a prospective, randomized, controlled, blinded clinical trial of its PeriowaveTM Photodynamic Disinfection (PDD) System for the treatment of periodontal diseases. Results showed significant improvement in pocket depth, clinical attachment level and bleeding on probing when compared to the gold standard of scaling and root planing (SRP).
This study focused on a maintenance protocol, in which patients received PeriowaveTM during initial therapy and then again at recall 6 weeks later. Statistically significant improvements were found on all endpoints. The primary goal of periodontal therapy is to return a pocket from a diseased state (greater than 5 millimeters) to recovery (less than or equal to 3 millimeters). The Periowave™ arm had 56% of the 698 diseased sites recover (≤ 3 millimeters) at 12 weeks as compared to 37% of the 588 diseased sites in the SRP arm. Over 50% more sites treated under this Periowave™ arm fully recovered at 12 weeks compared to those treated with SRP alone (p<0.0001).
“We are truly excited about the benefits that multiple-dose PeriowaveTM therapy can bring to dental patients,” said Carolyn Cross, President and CEO of Ondine Biopharma Corporation.
About Periowave™ and Photodynamic Disinfection
Periowave™ is a Photodynamic Disinfection system developed by Ondine that utilizes low-intensity lasers and wavelength-specific, light-activated compounds to specifically target and destroy microbial pathogens and reduce the symptoms of disease. The compounds are generally topically applied and one or more lasers are used to activate the compounds and complete the disinfection. The Photodynamic Disinfection technologies were developed by Professor Michael Wilson and colleagues at the Eastman Dental Institute, University College London, and licensed to Ondine by UCL Biomedica PLC, University College London. Additional information about Periowave™ is available at www.periowave.com.
About Periodontal Disease
Periodontitis (gum disease) is a common human affliction, affecting one third of all adults, and over half of the population over the age of 50. Periodontitis results in gum tissue detachment, bleeding gums, oral malodour, bone and tooth loss as well as other complications. Currently, the standard of care for treating periodontal disease is Scaling and Root Planing ("SRP"), or gum surgery, or both. SRP is the sub-gingival removal of plaque biofilm adhering to the root surfaces. Periodontitis is associated with a host of other serious conditions including heart disease, stroke, premature births and diabetes.
About Ondine Biopharma Corporation
Ondine is developing non-antibiotic therapies for the treatment of a broad spectrum of bacterial, fungal and viral infections. The Company is focused on creating and commercializing leading-edge products based on its patented light-activated technology.
Photodynamic Disinfection (PDD) provides broad-spectrum antimicrobial efficacy without encouraging the formation and spread of antibiotic resistance. While Ondine’s first commercialized product is intended for the treatment of chronic adult periodontitis, the company is developing its platform technology for other applications both within and outside the oral cavity. The Company is headquartered in Vancouver, British Columbia, Canada, with a research laboratory in Redmond, Washington, USA and an international office in St Michael, Barbados. For additional information, please visit the company's website at www.ondinebiopharma.com.
SOURCE: Ondine Biopharma Corporation |
