FDA has informed Hyal Pharmaceutical Corp. that Phase IIIclinical trials of HYAL-CT1101, its topical therapeutic for thetreatment of basal cell carcinoma, should be expanded toexamine tumor recurrence rates and to compare the efficacy ofthe agent with surgical recission, the company said Friday.
The new protocol, which the company is calling a Phase III/IVtrial, will supersede the Phase III trial that has been underway in the U.S. since May 1993. David Harper, chief operatingofficer of Hyal of Mississauga, Ontario, told BioWorld that in aninformal meeting with FDA at the end of last year, agencyrepresentatives concluded that Hyal's U.S. Phase III trialswould be likely to produce the same results as the company'sAustralian and Canadian trials. Therefore, Harper said, currentU.S. Phase III trial will be halted at 75 patients. The companysaid it hopes to file an NDA shortly after the results of thisstudy are reported in mid-1994.
While Harper said the new protocol has not been finalized, itwill likely involve the enrollment of more than 200 patients,who will be randomized to either surgery or drug treatment.Hyal (NASDAQ:HYALF) said it hopes to begin enrollment for thenew trial in the second quarter of this year.
In Hyal's previous double-blind, placebo-controlled trial ofHYAL-CT1101 in 68 patients with superficial basal cellcarcinoma, 86 percent exhibited positive response and 40percent showed complete or near complete resolution oflesions. The company's U.S. trials were apparently revealingsimilar efficacy.
"We regard this as an extra study that will really support themarketing of the drug," Harper stated.
The company's stock closed at $4.63 a share on Friday, downsix cents.
-- Karl A. Thiel Associate Editor
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