SOURCE:
PregLem SA Reproductive Medicine
2008-08-19 01:00:00
GENEVA, SWITZERLAND–(EMWNews – August 19, 2008) –
Geneva, Switzerland, 19 August 2008 – PregLem SA, a Swiss
biopharmaceutical company specialized in reproductive medicine, today
announced the start of an international Phase III clinical trial
program for PGL4001 (ulipristal) in symptomatic uterine myoma, a
common benign solid tumor of the genital tract in women of
reproductive age. PGL4001, an orally active, selective progesterone
receptor modulator, was shown in a previous Phase II study to be well
tolerated and effective both in immediately stopping uterine
bleeding, a major symptom associated with the condition, and in
reducing myoma volume. Results of the Phase III trials are expected
in 2010.
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. The trials are being coordinated by
Professor Jacques Donnez of the Université Catholique de Louvain in
Brussels.
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 3-month period for the pre-operative
treatment of pre-menopausal women suffering from excessive uterine
bleeding due to uterine myoma. PGL4001 at dosages of 5 and 10 mg 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 GnRH (gonadotropin-releasing hormone) agonist, over a
3-month period for the pre-operative treatment of pre-menopausal
women suffering from excessive uterine bleeding due to uterine myoma.
PGL4001 at dosages of 5 and 10 mg will be compared with leuprorelin
3.75 mg. Parameters to be evaluated will be similar to those in the
first trial.
Dr. Ernest Loumaye, CEO of PregLem, commented, “Uterine myoma is a
highly common condition that often negatively affects women’s quality
of life and can, in its severest form, lead to surgery. 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. This is our second clinical trial
authorization in just five months, proof that our young company is
now fully operational and on track to develop therapeutic innovations
for female reproductive health.”
About Uterine Myoma
Uterine myoma is the most common benign solid tumor of the genital
tract in women of reproductive age. It affects approximately 40% of
women between 35 and 55 years of age, including 24 million women in
Europe and 14 million in the US. The cardinal symptoms of uterine
myoma are heavy menstrual bleeding, abdominal pressure and pain,
increased urinary frequency and infertility. Beyond its physical
morbidity, the condition frequently causes a significant impairment
of quality of life and is a leading reason for the performance of
hysterectomies. The main therapy for uterine myoma is surgery,
including hysterectomy as the most invasive option, myomectomy and
uterine artery embolisation, and in some cases endometrial ablation.
As a medical approach to treating symptomatic uterine myoma, GnRH
(gonadotropin-releasing hormone) agonists have been shown to be
effective, but their use is restricted due to side effects that
include bone mineral density loss and a range of symptoms associated
with castration. PregLem is addressing symptomatic uterine myoma with
PGL4001, an orally active new chemical entity with the potential for
faster efficacy than GnRH agonists without their associated side
effects.
About PregLem
PregLem SA is a Swiss specialty biopharmaceutical company focused on
the development and commercialization of innovative compounds for the
treatment of major benign gynecological conditions as well as
infertility. PregLem currently has four products in clinical and
pre-clinical development. Its most advanced product, PGL4001,
in-licensed from French pharmaceutical company HRA Pharma, is in
Phase III clinical trials for the treatment of uterine myoma. PregLem
raised CHF 68 million from leading life science investors in Series A
and B funding rounds in 2007. The company obtained SME status from
the European Medicines Agency (EMEA) in November 2007. PregLem was
founded in Geneva in 2006 by Ernest Loumaye and Eric Rolin.
More information is available at www.preglem.com.
For further information, please contact: Solveig Hole, PregLem CEO office, Tel: +41 22 884 03 40, Email: [email protected] Dr. Jonathan Leighton, Leighton Communications, Tel: +41 76 559 67 88, Email: [email protected]
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