PARSIPPANY, N.J. and REDWOOD CITY, Calif., Feb. 25 /PRNewswire/ -- Ferring Pharmaceuticals and Gene Security Network (GSN) announced that they have signed an agreement to conduct a clinical trial of GSN's advanced preimplantation genetic diagnosis (PGD) technology, Parental Support™. The 11-center U.S. trial is designed to evaluate if GSN's PGD technology helps increase in vitro fertilization (IVF) success rates when using single cell embryo testing for an abnormal number of chromosomes, a condition called aneuploidy. GSN's Parental Support technology is designed to help improve embryo selection during IVF procedures in order to increase the pregnancy rate following embryo transfer compared with IVF procedures without embryo PGD testing.
"As the market leader in innovative infertility products, we are delighted to partner with GSN to help evaluate this unique product for the fertility medical community and patients," said Olivier Delannoy, Vice President, Infertility Business Unit at Ferring. "GSN's technology is supported by impressive data, and may enable reproductive endocrinologists to achieve more accurate embryo selection, and hopefully lead to higher live birth rates. We are hopeful that this upcoming clinical trial will support the positive early data generated for the PGD technology."
"Our agreement with Ferring provides the framework for our testing technology to become state of the art treatment for infertility patients. By using Parental Support to select embryos that have the best chance of developing into a healthy pregnancy, we hope to augment Ferring's drug therapy regimen and boost pregnancy rates," said Matthew Rabinowitz, PhD, Chief Executive Officer of Gene Security Network. "Our early data from 24-chromosome aneuploidy screening with Parental Support resulted in a 50 percent ongoing pregnancy rate for patients undergoing PGD, most of whom have had problems with previous IVF cycles. We are looking forward to initiating the prospective randomized trial in May."
Under the terms of the agreement, every trial patient will exclusively use Ferring fertility products for their IVF cycle, receiving the medications at a discounted rate. Ferring will also provide financial support and assistance in finalizing the trial protocol and monitoring the trial's progress, with the option to partner with GSN in distribution of Parental Support upon conclusion of the study.
About Preimplantation Genetic Diagnosis
Preimplantation genetic diagnosis (PGD) is a technique used to identify genetic defects before pregnancy in embryos created through IVF. PGD represents a means to help prevent genetic disease before implantation, thereby helping reduce the need to address the dilemma of pregnancy termination following an unfavorable prenatal diagnosis. PGD for aneuploidy refers to techniques where embryos from presumed chromosomally normal genetic parents are screened for aneuploidy. Most early pregnancy failures can be attributed to aneuploidy. Primary candidates for PGD can include: women of advanced maternal age, couples with a history of recurrent pregnancy loss, couples with repeated IVF failure, and a male partner with severe male factor infertility. The risk of aneuploidy in embryos increases as women age. The aneuploidy rate for mothers aged 35-39 years is greater than 70 percent, and is over 80 percent in mothers aged 40 years and older.(1)
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of products in the U.S. market. They include: BRAVELLE® (urofollitropin for injection, purified), MENOPUR® (menotropins for injection, USP) and REPRONEX® (menotropins for injection, USP), Novarel® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, 100 mg, FIRMAGON® (degarelix for injection), PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA® (1% sodium hyaluronate).
Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com or www.ferringfertility.com.
About Gene Security Network
GSN's proprietary Parental Support™ technology is the first to leverage data informatics to deliver highly accurate single cell testing for chromosome abnormalities and genetic diseases. Parental Support uses genetic information from the parents, as well as HapMap data from the Human Genome Project, to clarify the typically noisy measurements from a single cell and to generate an in silico reconstruction of the cell's genotype. GSN operates a CLIA-certified laboratory in Redwood City, CA and is supported by multiple grants from the National Institutes of Health and leading venture investors, including Claremont Creek Ventures and Sequoia Capital. For more information, please visit www.genesecurity.net.
(1) Cohen et al. Fertility and Sterility 2007;87;496-503.
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