Don't want to lose this... I'm leaving the stock reaction below as well:
CGPI
9 5/8
-1 1/4
Company trying to leaverage their product and the market treats them like sh#&t. Biotech 'magic' wearing thin.
Monday May 1, 11:46 am Eastern Time
Company Press Release
SOURCE: Eastman Dental Center - University of Rochester
Study Shows Adjunctive Enzyme Suppression Therapy Improves on Standard Care, Slows Progression of advanced gum disease
Trial Results Published in Journal of Periodontology Validate Role of Unique Therapy:
'...a new approach in the long-term management of adult periodontitis.'
ROCHESTER, N.Y., May 1 /PRNewswire/ -- A multi-center, double-blind, placebo-controlled clinical trial examining the safety and efficacy of subantimicrobial dose doxycycline (SDD) in conjunction with scaling and root planing (SRP) in the treatment of adult periodontitis (AP), found that SDD significantly improved the results of SRP, the non-surgical standard of care for AP, a condition that affects an estimated 67 million US adults and may be linked to heart attack, stroke and diabetes.
The results of the study are published in the current issue of the Journal of Periodontology, the official journal of the American Academy of Periodontology, and one of the most prestigious peer-reviewed journals addressing new developments in periodontics.
``Data from this study suggest that SDD may have an important role in the successful long-term management of adult periodontitis,'' said lead investigator Jack G. Caton, DDS, MS, professor of periodontology at the University of Rochester's Eastman Dental Center. ``These results demonstrate that effective non-surgical treatment may require a two-pronged approach aimed at both reducing bacterial load through the use of SRP and suppressing the destructive enzymes that are produced in response to bacteria, utilizing SDD.''
Dr. Caton and colleagues reported that twice-daily adjunctive treatment with 20-mg capsules of SDD (doxycycline hyclate), yielded a substantial clinical improvement in clinical attachment levels and probing depths compared with SRP and a placebo capsule. According to the authors, the changes were seen within three months, ``indicating a relatively rapid benefit with adjunctive SDD.''
Furthermore, the SDD group experienced significantly more tooth sites with improvements of 2mm or more (considered clinically significant) in attachment level and probing pocket depth, as well as fewer sites experiencing rapid disease progression, as measured by attachment losses of 2mm or more. The improvements were maintained throughout the course of the nine-month study.
``Assessment of attachment loss (AL) is considered the 'gold standard' for diagnosing the severity and progression of periodontitis,'' said Dr. Caton. ``I was particularly impressed by the ability of SDD to prevent rapid disease progression, as measured by the number of tooth sites exhibiting 2mm or more attachment loss. The prevalence of clinically significant attachment loss in severely diseased sites was 90 percent lower in the group receiving SDD than in the placebo group, a finding of considerable clinical significance.'' Investigators found that adjunctive SDD was well tolerated, with a side effect profile similar to placebo.
The study enrolled 190 patients, aged 35 to 75 years, with evidence of periodontitis. All patients underwent SRP and then were randomly assigned to receive either SDD 20 mg twice daily or placebo twice daily for a nine-month period. Efficacy measurements included per-patient mean changes in clinical attachment level and probing depth from baseline, per-patient percentages of tooth sites with attachment loss > 2mm and > 3mm from baseline, and the per- patient percentage of tooth sites with bleeding on probing.
Probing depth and clinical attachment level are measurements used to evaluate the progress of the destructive chain of events that characterizes advanced gum disease, including the deterioration of the periodontal support structures (gums, ligament, bone), as well as gum inflammation and recession.
No Evidence of Microbial Resistance
Dr. Caton and colleagues found also that treatment with SDD did not result in any change in the susceptibility of the oral microflora to doxycycline, or to other antibiotics which are frequently used in the treatment of adult periodontitis. This finding further supports the proposed mechanism of action of SDD, which has been shown to be effective in inhibiting the activity of tissue-degrading enzymes produced by the host tissues in response to the bacterial infection. When produced in excessive quantities or over a long period of time, these enzymes attack and destroy collagen in the connective tissues, breaking down the gums, ligaments and bone. If left untreated, this process can eventually lead to increasing disease severity heralded by bleeding, swollen and inflamed gums, persistent bad breath, loose or shifting teeth, and in some cases, tooth loss.
SDD is available commercially as Periostat© (doxycycline hyclate), manufactured by CollaGenex Pharmaceuticals (Nasdaq: CGPI - news) of Newtown, PA. Periostat was approved by the US Food and Drug Administration in September 1998. Periostat is the first and only orally administered, systemically delivered pharmaceutical specifically indicated for the adjunctive treatment of adult periodontitis.
The trial was conducted at five US dental schools, including State University of New York at Buffalo, West Virginia University Medical Center, University of Florida at Gainesville, University of Pennsylvania and Eastman Dental Center at the University of Rochester.
Eastman Dental Center (EDC) was founded by George Eastman in 1915. More than 85 years later, the Center continues to serve the needs of the greater Rochester community, providing oral health care for more than 35,000 people each year. The Center merged with the University of Rochester (UR) in 1997 and is the Medical Center's oral health clinical service component. The oral health clinical and translational research and education components are within the Eastman Department of Dentistry in the University's School of Medicine and Dentistry. Eastman Dental Center and the UR's School of Medicine and Dentistry are recognized worldwide as leaders in advanced training for dentists and for dental research.
SOURCE: Eastman Dental Center - University of Rochester
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