CLEARWATER, Fla., Aug. 20, 2013 /PRNewswire/ -- Florida Fertility Institute today announced its participation in the Thrive-IVF Research Study, a Phase 2 clinical trial sponsored by Nora Therapeutics, Inc., to evaluate the efficacy, safety and tolerability of NT100 in women who have had repeated in vitro fertilization (IVF) failures despite having good quality embryos. A novel biologic agent similar to a naturally occurring protein in the female reproductive tract, NT100 is being specifically designed and developed for use following in vitro fertilization (IVF) procedures to improve pregnancy success rates and outcomes.
"We are delighted to be part of the Thrive-IVF Research Study to help evaluate a unique treatment option that could help improve pregnancy success rates and outcomes for women who have undergone multiple unsuccessful IVF procedures," said Edward A. Zbella MD, FACOG, CPI, Thrive-IVF study investigator, and owner and medical director, Florida Fertility Institute.
More than seven million couples in the US suffer from infertility and 10 percent of women of childbearing age in the developed world experience infertility in any given 12-month period. While significant research efforts in IVF have been focused on the embryo, it is estimated that three-fourths of all embryos that are transferred still fail to implant in the uterus.
A critical part of the equation for the establishment and maintenance of a successful pregnancy is the presence not only of a good embryo, but also a favorable maternal environment for the embryo to implant and thrive. NT100's novel mechanism of action may better enable embryo implantation and pregnancy maintenance by optimizing maternal-fetal immune tolerance. There are currently no FDA-approved therapies focused on this critical dimension of endometrial receptivity.
"Nora believes that Florida Fertility Institute is an ideal partner for this important infertility study," said Jeffrey K Tong, Ph.D., President and CEO, Nora Therapeutics. "We are excited to advance our NT100 clinical program with the goal of generating the evidence needed to earn FDA approval as the first and only treatment indicated to improve pregnancy success rates and outcomes for women with a history of repeated IVF failures."
About the Thrive-IVF Research Study
The Thrive-IVF Research Study (NT-03) is a randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy, safety and tolerability of NT100 in approximately 150 women 21-38 years of age who have had repeated (three or more) IVF failures despite having good-quality embryos. Study participants will be randomized to receive NT100 (low or high dose) or placebo. The study will be conducted at approximately 15-20 clinical sites in major metropolitan areas across the US. Visit http://www.thriveivf.com or www.clinicaltrials.gov for more information.
About the Florida Fertility Institute
The Florida Fertility Institute is nationally recognized for its state-of-the-art diagnosis and treatment of the full range of infertility problems. The Institute is equipped to perform comprehensive testing, including hormonal assays, transvaginal ultrasound scanning, andrology testing and computer assisted hysterosalpingography. The practice is accredited by the prestigious Joint Commission on Accreditation of Healthcare Organizations.
About Nora Therapeutics, Inc.
Nora Therapeutics, Inc.,is a specialty biopharmaceutical company focused on developing therapeutics to address unmet clinical needs in reproductive medicine. Nora's lead compound, NT100, is being specifically designed and developed for use following in vitro fertilization (IVF) procedures to improve pregnancy success rates and outcomes. NT100 is a novel biologic agent similar to a naturally occurring protein in the female reproductive tract. NT100's mechanism of action may better enable embryo implantation and pregnancy maintenance by optimizing maternal-fetal immune tolerance. For more information about Nora Therapeutics, visit www.noratherapeutics.com.
SOURCE Nora Therapeutics, Inc.