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Debiopharm Announces First Patient Enrolled in Phase III Study for the Rare Disease Central Precocious Puberty
Date:8/27/2012

LAUSANNE, Switzerland, August 27, 2012 /PRNewswire/ --

Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced that the first patient has been enrolled in an open-label phase III study to investigate the efficacy, safety, and pharmacokinetics of the sustained release triptorelin pamoate 22.5 mg 6-month-formulation in children with central precocious puberty (CPP), a rare disease.

The multicentre, open-label, non-randomised study will involve 44 children from the United States, Chile and Mexico. Its primary objective is to evaluate the efficacy and safety of triptorelin pamoate (embonate) 22.5 mg 6-month formulation in decreasing luteinizing hormone (LH) to prepubertal levels at Month 6 (Day 169) in children with CPP.

"We are excited to be part of this study, which is the first Debiopharm-sponsored clinical trial using triptorelin for the treatment of CPP," said Rolland-Yves Mauvernay, President and founder of Debiopharm Group. "Our aim is to show that a gonadotropin-releasing hormone (GnRH) agonist therapy prevents the social and psychological difficulties associated with premature sexual development, and has a positive impact on compromised adult height. The 6-month-formulation would entail an improved compliance in a paediatric indication for which no other 6-month GnRH agonist formulation is currently approved, whilst reducing the frequency of injections in children."

About Central Precocious Puberty (CPP)

GnRH-dependent CPP is defined by pubertal development occurring before the age of 8 years in girls and 9 years in boys. It is characterised by early pubertal changes such as breast development and start of menses in girls and increased testicular and penile growth in boys, appearance of pubic hair, as well as acceleration of growth velocity and bone maturati
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SOURCE The Debiopharm Group
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