CollaGenex Research Highlighted at International Dental Research Meeting.Business Editors/Health & Medical Writers
NEWTOWN, Pa.--(BUSINESS WIRE)--April 5, 2000
CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan)
CGPI Capital Goods Price Index (New Zealand) ), today announced that nine scientific papers highlighting research sponsored by the Company will be presented at the upcoming International Association for Dental Research The International Association for Dental Research(IADR) is a professional association that focuses on research in the field of dentistry. The aim of this association by constitution is to promote research in all fields of oral and related sciences, to encourage improvements in methods for Meeting in Washington DC, April 5-8.
These papers include new data on the safety and efficacy of Periostat(R), the company's flagship product for the adjunctive treatment of adult periodontitis periodontitis
Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. , as well as exciting pre-clinical data on the properties of the Company's novel IMPACS IMPACS Institute for Media, Policy and Civil Society
IMPACS Integrated Manufacturing Planning and Control System
IMPACS International Message and Packet Switching Service (TM) (Inhibitors of Multiple Proteases And CytokineS Cytokines
Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. ) technology.
Among the papers discussing clinical studies with Periostat is a key safety study, which will be presented by Dr. C. Walker (University of Florida University of Florida is the third-largest university in the United States, with 50,912 students (as of Fall 2006) and has the eighth-largest budget (nearly $1.9 billion per year). UF is home to 16 colleges and more than 150 research centers and institutes. , Gainesville), directly addressing the impact of the drug on the colonic and vaginal microflora microflora /mi·cro·flo·ra/ (-flor´ah) the microscopic vegetable organisms of a special region.
The bacterial population in the intestine. . The abstract concludes that "there is no evidence that Periostat exerted an effect on the composition or resistance level of either the fecal or the vaginal microflora," supporting the findings from previous studies reporting no direct effects of the drug on the composition or microbial microbial
pertaining to or emanating from a microbe.
the breakdown of organic material, especially feedstuffs, by microbial organisms. resistance of the oral microflora.
These data are important because they provide further support to the concept that the clinical benefits of Periostat result from the unique ability of the drug to inhibit the proteolytic enzymes proteolytic enzymes (prōˑ·tē·ō·li·tik enˑ·zīmz),
n. involved in connective tissue destruction, without inducing bacterial resistance to commonly used antimicrobial agents.
In a second presentation, Dr. M. Ryan (SUNY SUNY - State University of New York at Stony Brook) will provide further evidence for the unique properties of Periostat in a preliminary study of a group of patients testing positive for a gene thought to be prognostic for the development of severe periodontitis. Genotype positive patients were monitored for expression of proteolytic enzymes and other substances known to cause tissue breakdown in gingival gingival (jin´jv crevicular fluid, the fluid which bathes the tooth surface.
Patients taking Periostat exhibited significantly lower amounts of these substances, whereas traditional periodontal therapy (scaling and root planning) was ineffective in reducing these markers of connective tissue destruction. She concludes that Periostat "may provide genotype positive patients with a therapeutic strategy which specifically addresses their exaggerated host response."
Other papers with potential clinical significance include a study by Dr. Y. Liu et al (SUNY at Stony Brook) which shows that doxycycline doxycycline /doxy·cy·cline/ (dok?se-si´klen) a semisynthetic broad-spectrum tetracycline antibiotic, active against a wide range of gram-positive and gram-negative organisms; used also as d. calcium and d. hyclate. , the active ingredient in Periostat(R) can directly affect the reaction of glucose with biological membranes. This is important because this process, known as "glycation", is thought to be responsible for many of the side effects encountered by diabetic patients if their blood glucose levels are poorly controlled.
A second paper from Dr. L. Xu (SUNY at Stony Brook) characterized the enzymes responsible for the breakdown of connective tissue around failing dental implants, a condition known as peri-implantitis. The authors conclude that "these enzymes are even more elevated in peri-implantitis than in adult periodontitis", suggesting a potential role for Periostat in the adjunctive treatment of peri-implantitis.
A third paper from Dr. D.M. Cohen cohen
(Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male. (U. Nebraska) reports a preliminary clinical study using a combination of Periostat and a non-steroidal anti-inflammatory drug Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. in the treatment of a serious blistering disease of the mouth called Cicatrical Pemphigold. The authors report total remission or significant improvement in disease symptoms within two weeks in 9/9 patients treated with this novel combination therapy, suggesting a potential role for Periostat in the treatment of this severely debilitating de·bil·i·tat·ing
Causing a loss of strength or energy.
Weakening, or reducing the strength of.
Mentioned in: Stress Reduction disorder.
The same combination therapy also significantly reduced the excess enzyme activity in gingival biopsies from a group of patients with adult periodontitis.
Other papers presented at the meeting describe the unique properties of the novel, proprietary CollaGenex core technology, known as "IMPACS(TM)"(Inhibitors of Multiple Proteases And CytokineS). A paper from Dr. J. Thomas (West Virginia U.) confirms that the IMPACS compounds are not antimicrobial agents, despite structural similarities to known antimicrobials. This is important as it supports the application of a wide range of doses of these compounds in clinical trials without concern about development of microbial resistance.
A second paper from Dr. K. Kirkwood (SUNY at Buffalo) describes the ability of the IMPACS technology to down-regulate production by bone forming cells (osteoblasts Osteoblasts
Cells in the body that build new bone tissue.
Mentioned in: Bone Grafting, Osteoporosis ) of a specific substance responsible for the up-regulation of bone resorption (IL-6).
This finding is encouraging as it helps explain the previously reported data suggesting that IMPACS could be useful in the treatment of bone-destruction disorders, such as osteoporosis and periodontitis. A third paper, from Dr. N. Ramamurthy (SUNY at Stony Brook) describes results from a well-characterized rat model of periodontitis in which the IMPACS were able to prevent the progression of the disease.
Finally, a paper from Dr. H.M. Lee (SUNY at Stony Brook) suggests that the IMPACS have effects not only on host derived protease protease /pro·te·ase/ (pro´te-as) endopeptidase.
Any of various enzymes, including the proteinases and peptidases, that catalyze the hydrolytic breakdown of proteins. activity but also on proteases derived from certain bacteria thought to be involved in periodontal breakdown.
"It is encouraging that our ongoing research collaborations conducted under CollaGenex sponsorship continues to contribute to our knowledge about the mechanism of action of Periostat and the IMPACS technology," noted Brian M. Gallagher, PhD, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of CollaGenex. "These studies will help direct our clinical research effort focused on the expanding potential for Periostat(R) and the IMPACS as unique therapeutics for the treatment of diseases of acute and chronic inflammation and connective tissue destruction."
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental market. The company's lead product, Periostat, was approved by the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. in September 1998 and is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues.
Periostat is marketed to the dental community in the United States by CollaGenex through a professional pharmaceutical sales force composed of approximately 135 sales representatives and managers. Currently, the company's dental sales force is also marketing Vioxx(R), a Merck & Co. drug that the Company promotes for the treatment of acute dental pain, and Denavir(R), a SmithKline Beecham Consumer Healthcare prescription drug for the treatment of cold sores.
Research has shown that the enzyme-suppression technology underlying Periostat may also be applicable to other diseases involving destruction of the body's connective tissues including cancer metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases
1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to and a broad range of inflammatory diseases. CollaGenex is developing a series of novel, proprietary compounds known as IMPACS(TM) (Inhibitors of Multiple Proteases And CytokineS) to address these applications. The Company intends to pursue further research and development of this technology primarily through partnerships with third parties.
For additional information on CollaGenex, please visit the Company's web site at www.collagenex.com, which is not a part of this press release.
This news release contains forward-looking statements within the meaning of section 21E of the Securities and Exchange Act of 1934, as amended. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the Company's business and prospects. The Company's business of selling, marketing and developing pharmaceutical products is subject to a number of significant risks, including risks relating to the implementation of the Company's sales and marketing plans, risks inherent in research and development activities, risks associated with conducting business in a highly regulated environment and uncertainty relating to clinical trials of products under development, all as discussed in the Company's periodic filings with the U.S. Securities and Exchange Commission.
Periostat(R), Metastat(R) and IMPACS(TM) are trademarks of CollaGenex Pharmaceuticals, Inc.