Glycomed Inc.'s product for treating infected corneal ulcers showedstatistical significance in reducing the incidence of cornealperforations in a Phase II/III trial, the Alameda, Calif., company saidThursday.
Company officials added that perforation reduction is an endpointsufficient for the filing of a new drug application (NDA). Glycomed,which is not releasing specific results of the 556-patient study, plansto use the data to secure a marketing partner for the drug, GalardinMPI, rather than filling for regulatory approval on its own.
Galardin, a synthetic small molecule designed as a metalloproteinaseinhibitor, was tested as an adjunct to antibiotics in a randomized,double-masked, vehicle-controlled trial. The drug was administeredtwice every hour for 12 hours as an eye-drop formulation, for anaverage of two weeks. The control group got only vehicle andantibiotics.
Glycomed is waiting to release specific findings of the study untilthey are published in a scientific journal, according to Mark Moran,Glycomed's vice president of operations and medical affairs. Andthe company wants to present the data at one of the two majorophthalmic meetings in the U.S., which occur in May and the fall.
"My mandate from the board is to use these data to find a partner,"Moran told BioWorld. "The regulatory strategy for the U.S. andEurope will be dependent on the choice of the marketing partner."
Moran said Glycomed earlier refused overtures from potentialpartners who wanted an option to get first rights to the drug, pendingtrial results. But Glycomed refused, believing that its position wouldbe stronger after the trial, if it was positive.
The company decided last summer to "develop a robust data packageso we could spin that program off," said Julie Wood, the company'ssenior director of corporate communications and human resources.She added that the belief is that the data are compelling enough toachieve that goal.
Moran said, "The Phase II/III are legitimately Phase II and III. Theywere designed to be large enough to support registration, dependingon the results. We believe we have acquired Phase III data." Moransaid there are additional studies of Galardin he would like to seeundertaken by the eventual partner.
While making clear that the FDA has in no way approved the data orthe interpretation of it, Moran said, "We have communicated thepreliminary results to the FDA. We have a confirmation that thereduction in corneal perforations is the kind of clinical endpoint thatwould of sufficient importance to sustain a registration. That's whatour data have shown."
He said a number of clinical endpoints would have been sufficientfor a successful NDA: ulcer size and depth, stromal injury, reductionin the need for emergency surgery and pacification and visual acuity.
"The most important finding of the studies suggesting activity of thedrug was the reduction in perforations," he said. "There also wasevidence of reduction in progression to deep ulcers. We have amedication that will reduce the incidence of perforation and the needfor emergency surgery."
Glycomed owns worldwide rights to the product everywhere exceptAsia, where rights are held by Tokyo-based Sankyo Co. Ltd. Sankyoand Glycomed also have an agreement related to the latter's cell-adhesion inhibitor program.
In July Glycomed, in a cost-cutting move, cut staff by 30 percent, to71 employees, and narrowed its development focus to include mostlyprograms based on cell-adhesion inhibitors and other biologicallyactive carbohydrates. In September, Genentech Inc., of South SanFrancisco, discontinued its research collaboration with Glycomed incell-adhesion inhibitors.
Glycomed stock (NASDAQ:GLYC) was $2.69 a share, down 13cents. n
-- Jim Shrine
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