National Institute of Child Health & Human Development

CHARLOTTESVILLE, VA, UNITED STATES, July 30, 2025 / EINPresswire.com / -- Contraline, Inc. , a clinical-stage biotechnology company developing novel male contraceptives, today announced that it has exercised its option to exclusively license the Nestorone ® /Testosterone (NES/T) gel from the Population Council . NES/T is poised to become the first FDA-approved hormonal contraceptive for men. Developed by the Population Council’s Center for Biomedical Research and the 𝘌𝘶𝘯𝘪𝘤𝘦 𝘒𝘦𝘯𝘯𝘦𝘥𝘺 𝘚𝘩𝘳𝘪𝘷𝘦𝘳 National Institute of Child Health and Human Development (NICHD), NES/T is a once-daily topical gel that delivers Nestorone and testosterone, suppressing sperm production while maintaining normal hormone levels. The first-in-class male contraceptive recently completed a global Phase 2b clinical trial involving 462 couples. NES/T is the most advanced investigational male contraceptive studied to date, with promising potential for high efficacy, safety, reversibility, and patient acceptability. Contraline’s decision to exercise its exclusive option agreement for NES/T marks a major milestone in its mission to transform the landscape of contraception and advance reproductive equality. Contraline is uniquely positioned to advance NES/T through a Phase 3 trial and into commercialization. “This marks a pivotal moment not just for Contraline, but for the future of contraception. With NES/T and ADAM, we will be advancing two male contraceptive programs towards late-stage trials and approvals, positioning us at the forefront of a category that will reshape global reproductive health,” said Kevin Eisenfrats, Co-Founder & CEO of Contraline. “The enthusiasm and demand we have seen from the patients and investigators involved in the NES/T trials have been unmistakable: the world is ready for male birth control. We’re proud to build on the decades of groundbreaking work by the Population Council and NICHD and carry this momentum into Phase 3 and beyond.” “We are delighted that Contraline, a leader in male contraceptive development, has exercised their option to license the NES/T contraceptive gel,” said Anita Garg, Senior Director of Strategy and Commercial Relations at the Population Council’s Center for Biomedical Research. “Contraline has demonstrated their vision and commitment to pioneer contraceptive options for men, and we look forward to them leading the product through the final stages of development and into the hands of users.” Contraline will transition the NES/T program in-house upon execution of the license agreement. With expanded choice for men, Contraline is one step closer to making family planning a shared responsibility. Disclaimer NES/T The NES/T gel is a U.S. FDA-Regulated Investigational Drug Product not yet authorized by the US FDA or any other regulatory authority worldwide. It is available only for investigational use in approved clinical trials. About Contraline, Inc. Contraline, Inc. is a clinical-stage, biotechnology company focused on innovation in reproductive health. The company’s mission is to develop novel male contraceptives that are safe, effective, and reversible. Visit www.contraline.com . About the Population Council The Population Council is a leading research organization dedicated to building an equitable and sustainable world that enhances the health and well-being of current and future generations. We generate ideas, produce evidence, and design solutions to improve the lives of people around the world. Learn more at www.popcouncil.org . Media Contact Martin Sandgren Klover Communications press@klovercommunications.com (949) 438-0425 Kevin Eisenfrats Contraline, Inc. email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Lowering the body temperature of preterm infants (born at 33 to 35 weeks of pregnancy) with hypoxic ischemic encephalopathy (HIE -- a type of brain damage caused by oxygen loss -- offers no benefits over standard care, according to a new study. Previous studies of near-term and term infants (born after 36 weeks) with HIE found that this cooling treatment, which lowers body temperature to about 92 degrees Fahrenheit, significantly reduced the risk of death or disability by age 18 months (corrected for prematurity). However, the current findings show that such benefits are not observed for preterm infants with HIE. The authors noted that use of the cooling treatment in preterm infants has increased, despite little research on its effectiveness in this age group. Lowering the body temperature of preterm infants (born at 33 to 35 weeks of pregnancy) with hypoxic ischemic encephalopathy (HIE) -- a type of brain damage caused by oxygen loss -- offers no benefits over standard care, according to a study funded by the National Institutes of Health (NIH). Previous studies of near-term and term infants (born after 36 weeks) with HIE found that this cooling treatment, which lowers body temperature to about 92 degrees Fahrenheit, significantly reduced the risk of death or disability by age 18 months (corrected for prematurity). However, the current findings show that such benefits are not observed for preterm infants with HIE. The authors noted that use of the cooling treatment in preterm infants has increased, despite little research on its effectiveness in this age group. The study was conducted by Roger G. Faix, M.D., of the University of Utah, and colleagues at 19 newborn research centers. It appears in JAMA Pediatrics. Funding was provided by NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). HIE-associated oxygen loss can result from compression of the umbilical cord, a tear in the uterus, or other complications at birth. Of 188 preterm infants with HIE born from 2015 to 2020, 88 infants were assigned at random to the cooling treatment and 80 were maintained at normal temperature. Researchers evaluated occurrences such as death and moderate to severe disability when the infants were 18 to 22 months old. They found that 35% of those receiving the cooling treatment and 29% kept at normal temperature had died or had a disability. More specifically, deaths occurred in 20% of those receiving cooling treatment and 12% of those receiving standard care. Overall, preterm infants who received the cooling therapy had a 74% higher risk of death or disability and an 87% higher risk of death.

FRIDAY, Dec. 6, 2024 -- Could a prenatal blood test designed to find abnormalities in a fetus also detect hidden cancer in the mom-to-be? A new study says yes: Scientists report they discovered cancer in nearly half (48%) of expecting mothers with abnormal results on the blood test, known as a prenatal cell-free DNA test. The cancers included colon, breast, lung, kidney, lymph gland, bile duct and pancreatic cancer, according to research published Dec. 4 in the New England Journal of Medicine . "They looked like healthy, young women and they reported themselves as being healthy,” said senior researcher Dr. Diana Bianchi , director of the National Institute of Child Health and Human Development, told the Associated Press . Blood tests are used to check pregnancies for any health problems of either the mom or the fetus. The prenatal cell-free DNA test analyzes DNA fragments released into the bloodstream by the placenta. It can be used to determine the baby’s sex, or to identify an extra chromosome that will contribute to disorders like Down syndrome. But this test also can detect DNA fragments leaking from an undetected cancer in mom, researchers noted. For this study, researchers performed cancer screening on 107 pregnant women using whole-body MRI scans, standard diagnostic testing and cell-free DNA tests. Of the group, 52 women were diagnosed with cancer. The most common cancers were lymphomas -- 31 of the women had cancer of the lymph glands. More than half (56%) of the women with cancer had no symptoms of their disease, researchers added. Another quarter had symptoms that had been ascribed to their pregnancy. For example, stomach pain caused by pancreatic cancer had been diagnosed as acid reflux. Whole-body MRI scans were most effective at detecting cancers, followed by cell-free DNA tests. Standard diagnostic techniques like taking a medical history and performing a physical exam were least useful. About 1 in every 10,000 women who get a cell-free DNA test each year will get an abnormal result that’s tough for doctors to interpret, researchers told the AP . These women -- maybe as few as 250 a year in the United States -- could be at risk for cancer. “They and their care providers need to take the results seriously and have additional testing because in that population there is a 48% risk of cancer,” Bianchi said. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.