Ilex Oncology Inc has initiated a randomized, double-blind, placebo-controlled Phase I/II proof of principle trial to evaluate the effects of Apomine in postmenopausal women with osteoporosis, or low bone mass.
Apomine belongs to a novel class of non-hormonal therapeutic agents known as bisphosphonate esters. In pre-clinical studies, the orally available compound Apomine not only prevented breakdown of existing bone (anti-resorption effect), but it also demonstrated the ability to stimulate new bone growth (anabolic effect). Current treatment standards are limited to bisphosphonate acids, which prevent bone resorption. In addition, injectable anabolic agents, which build new bone, are currently under FDA review.
"This approach is very exciting because it potentially represents the next generation of osteoporosis treatments," said Jeffrey Buchalter, President and CEO of Ilex. "While our main focus remains in oncology, we recognize the important potential for Apomine in the large osteoporosis market. Based on the results of this trial, we'll be seeking to outlicense Apomine in osteoporosis, in line with our business strategy."
Ilex acquired Apomine as a result of its acquisition of Symphar S.A. of Geneva, Switzerland in February 2001.