SAN FRANCISCO, Dec. 3, 1998 -- Allelix Biopharmaceuticals (TSE/ME: AXB) announced today results of a Phase II clinical trial demonstrating that its compound ALX1-11, recombinant human parathyroid hormone significantly increases bone mineral density (BMD) and bone mineral content (BMC) in the spine of women with postmenopausal osteoporosis.
Dr. Robert Lindsay, president of the National Osteoporosis Foundation today reported the results from the double blind, placebo controlled, clinical trial of the drug at the American Society for Bone and Mineral Research (ASBMR) meeting.
"ALX1-11 appears to be a promising novel approach to treat the millions of people with osteoporosis especially that which affects the spine," said Dr. Lindsay, one of the study's principal investigators, who holds the position of professor of clinical medicine at Columbia University School of Medicine. "These data are particularly encouraging because patients at the higher dose had greater increases in bone mass than have been observed with currently available therapies. For the many patients with more advanced osteoporosis, this rapid increase in bone mass and density could be an important clinical benefit."
"These results confirm that ALX1-11 can rapidly increase bone mass and produce new bone," said Dr. John Dietrich, senior vice president of research and development at Allelix. "We believe that ALX1-11 will offer osteoporosis patients an important new option to decrease their risk of experiencing incapacitating fractures."
The Phase II trial was conducted in 18 centers in the United States and Canada
and involved 217 women with postmenopausal osteoporosis. The women, who ranged
in age from 50-75, gave themselves daily subcutaneous injections of ALX1-11 for
one year. The women received one of three doses of the drug or a placebo, for
comparison. In addition, to the Allelix drug, all of the women rece
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