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Soligenix Announces Issuance of Hong Kong Patent for its LPM(TM) Oral Drug Delivery Technology
Date:2/17/2010

his results in a drug-delivery system that is a thermodynamically stable clear dispersion of the water-soluble drug in the lipid phase. But unlike water-in-oil systems, stabilized reverse micelles do not depend on the presence of other surfactants and are thermodynamically stable. In the LPM™ system, water-soluble drugs are contained in the water space in the core of the micelles and are protected against degradation.

Soligenix anticipates proceeding towards clinical development of an oral form of the peptide hormone drug leuprolide using the LPM™ technology. Leuprolide is a synthetic peptide agonist of gonadotropin releasing hormone (GnRh) that is used in treatment of endometriosis in women and prostate cancer in men. In preclinical studies in rats and dogs, Soligenix has demonstrated that the LPM™ technology results in high systemic bioavailability of intestinally absorbed leuprolide. In both animal models, the bioavailability of leuprolide ranged from 20 to 40 percent, compared to less than 5 percent for the control oral solution. Leuprolide is one of the most widely used anti-cancer agents for advanced prostate cancer in men. Injectable forms of leuprolide marketed under trade names such as Lupron® and Eligard® had worldwide sales of approximately $1.7 billion in 2006. Injectable leuprolide is also widely used in non-cancer indications, such as endometriosis in women (a common condition in which cells normally found in the uterus become implanted in other areas of the body), uterine fibroids in women (noncancerous growths in the uterus) and central precocious puberty in children (a condition causing children to enter puberty too soon). Leuprolide is currently available only in injectable, injectable depot and subcutaneous implant routes of delivery.

LPM™ is thought to promote intestinal absorption through the action of the micelles to open up small channels that allow only
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SOURCE Soligenix, Inc.
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