Pediatrix/Obstetrix Medical Groups, Inc. and McGuff Pharmaceuticals, Inc. announce initiation of a clinical trial evaluating the use of 17-Alpha-Hydroxyprogesterone Caproate (17OHP) for the Reduction of Neonatal Morbidity due to Pre-term Birth in Twin and Triplet Pregnancies. (17OHP Study)

Pediatrix/Obstetrix Medical Groups, Inc. and McGuff Pharmaceuticals, Inc., today announced that they have entered into an agreement to support and conduct a clinical trial to test the weekly injection of 17-Alpha-Hydroxyprogesterone Caproate (17OHP) (250mg) as a potential treatment regimen for reduction of neonatal morbidity due to pre-term birth in twin and triplet pregnancies.

Premature delivery is a leading cause of neonatal morbidity and mortality in the United States. The past three decades have seen the introduction of a variety of strategies intended to reduce the rate of pre-term birth. Despite these efforts, the rate of pre-term delivery has been steadily rising and now approximately 12% of all pregnancies in the United States end in pre-term birth. Pre-maturity is the primary reason the United States ranks 28th among industrial nations in infant mortality rates. With the renewed enthusiasm following recent studies using Progesterone in pregnancies at risk for pre-term delivery, there is hope for a more efficacious and safer therapeutic intervention to arrest pre-term birth.

(IND # 69536). The study is designed to incorporate two, concurrent, double-blinded, randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for pre-term birth. The two risk factors to be studied include twin pregnancy and triplet pregnancy. The trials will include 321-patients and have two groups: two thirds of the patients enrolled will receive a drug regimen consisting of weekly injections of Hydroxyprogesterone Caproate. The other one-third of patients will receive weekly injections of a placebo.

The study will be carried out at approximately 24 enrolling sites across the United States. Its purpose is to investigate whether patients who receive the study drug have better outcomes than those who do not. The primary outcome measure will be freedom from major neonatal morbidity, defined as one or more of the following: