Collagenex Inc. said data from Phase III trials of its lead drug,Periostat, showed statistical significance in preventing theprogression of periodontal disease.
"We're really encouraged by the data," said Brian Gallagher,president and CEO of the privately held company in Newtown, Pa."We're on track to file a new drug application by the end of theyear."
Periostat is an orally delivered drug derived from Collagenex'stechnology using compounds to inhibit collagenase, an enzyme thatbreaks down connective tissues. In periodontal disease, bacteriaaround teeth cause inflammation, triggering the release of collagenaseand separation of gums from teeth. Severe forms of the diseaseeventually result in loss of teeth.
Collagenex's Phase III studies involved 400 patients, all of whomexhibited various stages of periodontal disease, from mild to severe.Patients took either a Periostat capsule or a placebo once or twice aday for one year in addition to receiving traditional treatments, whichinvolve removal of bacterial build-up.
Periostat, Gallagher said, is designed to prevent gums from recedingas opposed to current treatments that focus on killing or scrapingaway bacteria.
At the end of the one-year treatment period, patients' gum attachmentloss was compared with measurements taken prior to the start of thetrials.
Patients receiving the placebo experienced a two millimeter orgreater attachment loss at up to 7 percent to 8 percent of all sitesaround teeth where periodontal disease was present. That rate of gumdetachment, Gallagher said, is typical of the disease's progression.
With Periostat, he said, the two millimeter or greater attachment losswas reduced to less than 2 percent of sites affected by the disease.
"That's statistically significant," Gallagher said, adding that the drugachieved its primary end point.
He also said the data shows Periostat worked even better at siteswhere the disease was more severe. Patients taking placeboexperienced a three millimeter attachment loss at up to 3 percent to 4percent of infected sites, Gallagher said, while those taking Periostatshowed a reduction in that amount of disease progression at less thanhalf of one percent of infected sites.
Another key difference between current forms of therapy andPeriostat, Gallagher said, is that the Collagenex drug provides asystemic approach to fighting a disease that varies in intensity in eachpatient and traditionally has been treated locally.
"We see the drug being used as an adjunct therapy," Gallagher said."It will add significant value to current treatments."
Gallagher is scheduled to release data from the Phase III trialsWednesday in Boston at Cowen & Co.'s 15th Annual Health CareConference.
"One-third of the U.S. population is affected by some form ofperiodontal disease," Gallagher said, "and 10 percent of them havesevere forms. This drug will be significant for our company and asignificant help in treating an extremely common disease."
Collagenex was formed in 1992. In addition to Periostat, thecompany has two other drugs based on the same technology ready forclinical development. Metastat, designed to inhibit angiogenesis inbattling cancer tumors, is expected to enter Phase I trials by the endof this year. And Nephrostat, which could enter clinical studies inearly 1996, is aimed at preventing diabetic nephropathy. n
-- Charles Craig
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