Endometriosis

LONDON, March 15, 2024 /PRNewswire/ -- Serac Healthcare Limited ("Serac Healthcare" or "the Company"), a clinical radiopharmaceutical company developing an innovative molecular imaging agent, and the Nuffield Department of Women's and Reproductive Health at the University of Oxford announce that preliminary data has been presented from the "Detecting Endometriosis expressed integrins using technetium-99m" (DETECT) imaging study, indicating that 99mTc-maraciclatide is capable of imaging superficial peritoneal endometriosis, the earliest stage of the disease. The data was presented today by Dr Tatjana Gibbons, an investigator on the study from the University of Oxford, in an oral presentation at the Society for Reproductive Investigation (SRI) annual meeting taking place from 12-16 March 2024 in Vancouver, Canada. Serac Healthcare Logo Nuffield Department of Women's & Reproductive Health at the University of Oxford Logo

Phase 1 Study Led by World-Renowned Expert Prof. Felice Petraglia to Evaluate Gynica's Non-Hormonal, Intra-Vaginal Drug Candidates In perfect timing with Endometriosis Awareness Month, the announcement of the study is one step forward for the well-being and quality of life of over 200 million women in the world FLORENCE, Italy, March 14, 2024 /PRNewswire/ -- Gynica, a clinical-stage women's health biotech startup developing a novel Endometriosis treatment, announces today the submission of a first-in-human Phase 1 trial. The global first-of-its-kind clinical study will take place at Careggi University Hospital in Florence, Italy. It will evaluate the safety, tolerability, and pharmacokinetics of the IntraVag© intra-vaginal drug delivery platform and two proprietary drug candidates, S-301 and S-302. Gynica, which was founded in 2019, set a goal to develop a solution for one of the most common but untreated diseases in the world - Endometriosis; a debilitating disease characterised by abnormal growth of uterine-like tissue outside the uterus, has a devastating impact on the lives of over 200 million women globally - around 1 in 10 of reproductive age. The physical and emotional tolls are immense, disrupting careers, relationships, and overall quality of life for these women. Despite its widespread prevalence representing an estimated $180 billion annual market according to the World Economic Forum and Mckinsey's Health Institute, Endometriosis continues to be an underserved and underfunded area lacking truly effective treatment solutions. As awareness of this condition continues rising, there is an urgent need to develop innovative therapies that can finally provide relief and restore quality of life for the hundreds of millions profoundly impacted by endometriosis worldwide. This global-first clinical study will evaluate Gynica's proprietary pharmaceutical-standard cannabinoids-based formulations intravaginally. Through these first-of-their-kind studies, the company is leveraging the promising potential of cannabinoids as therapeutic agents in women's health. The trial will be led by world-renowned Endometriosis expert Prof. Felice Petraglia, Past President and founding member of the Society for Endometriosis and Uterine Disorders (SEUD). It will evaluate the safety, tolerability, and pharmacokinetics of the IntraVag platform and drug candidates. During the study, the team will examine the promising potential of cannabinoids as they engage with the endocannabinoid system (ECS), which is extensively distributed in women's reproductive organs, such as the uterus and ovaries. This positioning makes the ECS a crucial target for addressing conditions like Endometriosis. In this context, cannabinoids may possess the capability to alleviate various types of Endometriosis-associated pain. Further, it can mitigate the inflammatory microenvironment associated with Endometriosis. Gynica's proprietary IntraVag technology enables controlled release and direct delivery of APIs to target organs. Gynica aims to pursue registration of its novel solutions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Pending positive Phase 1 results, the company plans to advance into Phase 2 efficacy trials rapidly. "After four years of rigorous pre-clinical research and development efforts, we are thrilled to announce this upcoming milestone during Endometriosis Awareness Month. This trial represents a significant step forward in our mission to revolutionise care and provide a better quality of life for the millions of women worldwide suffering from endometriosis. In this enormous unmet need, patients urgently seek efficient solutions," stated Yotam Hod, CEO of Gynica. "Endometriosis is now recognized as a chronic disease, and to have a non-hormonal treatment for Endometriosis-associated pain has an absolute priority for many patients who require long-term management and for the gynecologist in order to have new therapeutic options with multiple mechanisms of action, says Prof. Petraglia. SOURCE Gynica

At the State of the Union on Thursday evening, First Lady Jill Biden hosted Maria Shriver, who brought the issue of lapses in women's health research to the White House last year. President Joe Biden urged Congress to adopt a $12 billion plan to fund women’s health research, including conditions like rheumatoid arthritis, menopause, Alzheimer’s disease and endometriosis. “Women are more than half of our population but research on women’s health has always been underfunded,” Biden said in his prepared State of the Union remarks Thursday evening. The initiative, originally launched in November 2023, is being led by First Lady Jill Biden. The president called on lawmakers to pass a plan to fund it with $12 billion to “transform women’s health research and benefit millions of lives across America.” If the plan were adopted, the White House plans to use the cash to start a new fund at the National Institutes of Health to create an interdisciplinary research agenda and a new nationwide network of research centers of excellence and innovation in women’s health. The goal is also to bring together private and philanthropic commitments to boost funding for women’s health research. “These new resources will make investments that maximize our ability to prevent, diagnose, and treat health conditions in women and ensure women get the answers they need when it comes to their health,” the White House explained in a fact sheet that accompanied the announcement. At the State of the Union, the First Lady hosted Maria Shriver, who was on hand in November when the White House Initiative on Women’s Health Research was launched. Shriver brought the idea to the White House, urging the administration to close research gaps in women’s health. In February, Jill Biden announced $100 million for Advanced Research Projects Agency for Health (ARPA-H) to launch the “Sprint for Women’s Health,” which will fund discoveries for diseases that affect women. “We are going to invest in your discoveries early, when private companies may not be willing to take the risk. We are going to give women’s health researchers and startups the funding they need to grow and help them bring ideas to market—and to the women who need them most,” the First Lady said at the time. Jill Biden specifically singled out migraines, heart attacks and menopause as key women’s health issues that have long been underfunded. After receiving the first $100 million jolt of funding, ARPA-H is now working on issuing requests for solutions funding opportunities, which will seek ideas for research and development in women’s health. The ideas will also encompass accelerating tools, products and platforms that could be commercialized to improve women’s health outcomes.  Besides women's health, Biden's much-anticipated speech touched on healthcare issues such as abortion, IVF, prescription drug costs and insurance coverage.