Matrix Pharmaceutical Inc.'s stock gained $2.38 Monday uponrelease of interim Phase II data showing its AccuSite gel achievedcomplete clearance of squamous cell carcinoma lesions in all 15patients evaluated to date.
All 25 patients in the study have been enrolled in the trial andcomplete results are expected by the end of the year, said BeverlyHolley, director of corporate communications and investor relationsfor the Fremont, Calif., company. Matrix, with a number of ongoingand planned late-stage trials, is not planning to take AccuSite intoPhase III at this time in this indication, she said.
In the squamous cell carcinoma study, AccuSite injectable gel wasadministered into the lesion weekly for six weeks. Patients werefollowed for 16 weeks, then had the area surgically removed tohistologically evaluate the tissue.
"You can call it a cure," Holley said. "If there are any cancer cells wewouldn't consider it a complete response."
The data were presented at the American Academy of Dermatologyconference in Washington. Matrix stock (NASDAQ:MATX) gained11 percent to close at $23.63 after reaching a high of $25.25.
AccuSite gel is a sustained-release chemotherapy package consistingof a biodegradable protein matrix, 5-fluorouracil and thevasoconstrictor epinephrine. Regulatory filings have been made inEurope and the U.S. seeking clearance to market AccuSite for genitalwarts.
AccuSite currently is being tested in two Phase III studies in basalcell carcinoma and has completed Phase II studies in psoriasis.IntraDose, a similar product using cisplatin instead of 5-fluorouracil,is in Phase III studies in head and neck cancers and is expected to betaken into pivotal studies this year in liver tumors. Phase II IntraDosestudies in prostate cancer are ongoing.
Holley said Matrix, assuming things go positively, would file asupplement in 1997 seeking approval of AccuSite in basal cellcarcinoma and would seek approval of IntraDose for head and neckcancers.
Matrix is establishing a direct sales force in the U.S., Holley said, andis seeking distribution arrangements in Europe. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.