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PregLem Initiates Phase III Uterine Myoma Program

August 19, 2008

PregLem has started an international Phase III clinical trial program for PGL4001 in symptomatic uterine myoma, a common benign solid tumor of the genital tract in women of reproductive age.

The program is composed of two separate Phase III clinical trials involving a total of 540 patients and being carried out in parallel in a total of 14 countries. Results of the Phase III trials are expected in 2010.

The first trial (Pearl I) is a randomized, parallel group, double-blind, placebo-controlled, multi-center study on a total of 240 patients. This trial will assess the efficacy and safety of PGL4001 versus placebo over a three-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

PGL4001 at dosages of 5mg and 10mg will be compared with placebo, with concomitant iron administration in all groups. Parameters to be evaluated include reduction in uterine bleeding, correction of anemia, change in both myoma and uterine volume, and improvement in pain and other symptoms.

The second trial (Pearl II) is a randomized, parallel group, double-blind, double-dummy, active comparator-controlled, multi-center study on a total of 300 patients. This trial will assess the efficacy and safety of PGL4001 versus the only currently approved medication, a gonadotropin-releasing hormone agonist, over a three-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

PGL4001 at dosages of 5mg and 10mg will be compared with leuprorelin 3.75mg. Parameters to be evaluated will be similar to those in the first trial.

Ernest Loumaye, CEO of PregLem, said: “With this Phase III program, we expect to confirm PGL4001′s demonstrated efficacy and its potential to significantly improve the clinical treatment of this condition.”




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