WEBSTER, Texas, Sept. 26, 2013 /PRNewswire/ -- The Center of Reproductive Medicine 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 Vicki L. Schnell MD, FACOG, Thrive-IVF study investigator, and founder and medical director, Center of Reproductive Medicine.
More than seven million couples in the U.S. 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 the Center of Reproductive Medicine 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 U.S. Visit http://www.thriveivf.com or www.clinicaltrials.gov for more information.
About Center of Reproductive Medicine
Established in 1993, Center of Reproductive Medicine (CORM) is a privately-owned company located in Webster and Beaumont, TX. Their state-of-the-art facility includes a surgery suite and IVF lab that allows treatment of all fertility related diagnoses. With three fertility specialists, they have more than twenty-five years combined experience and consistently rank high in fertility success rates in the area. Their donor egg program has been named number one in Texas for the past several years.
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.