K-V Pharmaceutical Company ( KVa; KVb) (the "Company") announced today it has been informed by Hologic, Inc. (Nasdaq: HOLX) that site initiation and patient enrollment has begun at international clinical trial sites in Europe in the ongoing trial of Gestiva™ (hydroxyprogesterone caproate injection, 250 mg/1 mL), commonly referred to as "17P," for the prevention of preterm birth in women pregnant with a single baby with a history of singleton spontaneous preterm birth. The study was initiated in late 2009 and currently has 36 clinical trial sites worldwide open to enrollment, many of which have recently opened, with expectations to open additional sites.
"We are pleased by the progress being made toward the enrollment of the Gestiva (17P) study. If approved, Gestiva will provide physicians with the first FDA approved product to prevent recurrent preterm birth in eligible patients," said David Van Vliet, Interim President & CEO K-V Pharmaceutical. "This trial will be an important step in further understanding the impact of Gestiva in preventing preterm birth."
According to the March of Dimes, preterm birth, or the birth of a baby prior to 37 completed weeks of pregnancy, affects one in eight babies born in the United States. Additionally, the rate of preterm birth has increased more than 35 percent in the last 25 years, and late preterm births – babies born at 34 to 36 weeks of pregnancy – account for nearly three quarters of all preterm births in the U.S. Preterm birth has been estimated to cost the nation more than $26 billion a year.
The initiation of the multi-year trial is one of the requirements stipulated by the U.S. Food and Drug Administration (FDA) prior to considering approval to market Gestiva. In addition, the FDA has requested the following milestones to be achieved in the clinical study:
- Fifteen clinical trial sites must receive Institutional Review Board (IRB) approval for study initiation.
- Eighty-five study subjects must be entered or "randomized" into the study (5% of the total study patient enrollment).
- At least fifteen of the first eighty-five subjects randomized must enroll from U.S. sites.
- Demonstrate a total of one hundred seventy study subjects (10% of the total patient enrollment) will be enrolled from U.S. and Canadian sites prior to final study completion.
To date, the trial has received 36 different IRB or Ethics Committee approvals covering 78 sites globally with randomization of 44 subjects from U.S. sites. In total, the multinational study is expected to take place at more than 90 trial sites, including already approved sites in the U.S., Canada, and Europe and is expected to enroll approximately 1,700 patients.
The trial is a phase 3b, multi-center, randomized, double-blind study of Gestiva for the prevention of preterm birth in women who are pregnant with a single baby and have spontaneously delivered a single baby preterm in the past. The trial is designed as a follow on study to confirm the data submitted in the Gestiva new drug application (NDA). The data submitted in the Gestiva NDA were published in 2003 in The New England Journal of Medicine and examined the safety and efficacy of Gestiva, also known as "17P," for the prevention of preterm birth in women pregnant with a single baby with a history of spontaneous singleton preterm birth.
As previously announced, K-V Pharmaceutical has an agreement with Hologic, Inc. to acquire the rights of Gestiva upon FDA approval.
K-V Pharmaceutical Company