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 received daily supplements of calcium (500 mg), vitamin D (400 IU) and vitamin A (5,000 IU).
At the end of the trial, researchers measured BMD and BMC in the lumbar spine, at the hip and throughout the body. The scientists also evaluated serum and urine markers of bone formation and resorption.
The results showed a dose-related increase in BMD in the women's lumbar spines after 12 months of treatment, with increases of 2.6, 4.6 and 6.9 percent, at the 50, 75 and 100 mcg/day doses of ALX1-11 respectively. All of the women receiving the drug had significantly greater increases in BMD than those who took the placebo. The women had even greater changes in BMC, with average increases of nearly 10 percent seen at the highest dose. The results also indicated a trend toward a positive effect of treatment in the hip after 12 months.
Researchers reported a more striking increase in lumbar spine BMD among women who, subsequent to the primary study, received 10 mg/day of a currently marketed bisphosphonate for an additional year. This drug, an oral antiresorptive agent, slows down the process of bone loss. It appears to extend and strengthen the bone growth stimulatory properties of ALX1-11. The increase in these patients averaged 12.5 percent after 24 months.
In the primary study, total body BMD slightly decreased by approximately 0.3 and 0.9 percent at the mid and high doses after 12 months. "Our preclinical and clinical data suggest that the observed decrease in total body BMD is related to increased bone turnover. This decrease would likely be transient during the initial 6 to 18 months of treatment and will probably not interfere with the drug therapy benefits," said Lindsay, who was the primary US investigator for the multi-center study.
Overall, the patients tolerated ALX1-11 well during the study and only 8 percent discontinued treatment, with the majority of these not related to the therapy. The compliance rate was 98 percent.
Allelix's ALX1-11 is a proprietary recombinant version of human PTH and is identical to the naturally occurring protein produced by the parathyroid gland. Studies conducted during the last 20 years have suggested that PTH, when administered daily at low doses, can rebuild bone faster than presently available treatments for osteoporosis. Unlike agents such as bisphosphonates and hormone replacement therapy, which act by preventing further bone loss, ALX1-11 acts on bone generating cells called osteoblasts to stimulate new bone formation. Additional preclinical studies have demonstrated this new bone is of normal architecture and strength.
Postmenopausal osteoporosis affects one in four women older than 50 in the United States -- some 8 million - according to the National Osteoporosis Foundation. An additional 18 million more women are at risk for the disease. Osteoporosis patients are very susceptible to fractures, especially at the spine, hip and forearm, with consequent significant rates of associated illness and death. In addition to postmenopausal osteoporosis, bone loss also affects one in eight men older than 50 as well as patients on long-term corticosteroid use. Currently, no approved osteoporosis treatments rebuild the skeleton in the manner that ALX1-11 does.
ALX1-11 was tested as part of the age related experiments conducted by NASA during the Space Shuttle Discovery mission that launched Oct. 29. The experiments examined the effects of microgravity on animal bone cells and the ability of these cells to grow new bone in response to ALX1-11. Allelix recently reacquired all development and commercialization rights to ALX1-11 from Astra AB and is seeking a new corporate partner to develop and market the drug.
Allelix Biopharmaceuticals Inc. is a Canadian based company with R&D facilities in Canada and the United States. The company discovers and develops biopharmaceuticals in partnership with both international pharmaceutical companies and other members of the biopharmaceutical sector. Products in clinical development include ALX1-11 for osteoporosis, ALX-0646 for migraine and ALX-0600 for gastrointestinal disorders. The product pipeline includes ALE-26015 for dementia, a family of GRI-1 antagonists for schizophrenia plus additional neuroscience compounds for other indications.
This release is also available at http://www.allelix.com and http://www.noonanrusso.com/www/allelix/
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