Gameto Announces First U.S. Clinical Site Open for Enrollment in Fertilo Study
AUSTIN, Texas--(BUSINESS WIRE)-- Gameto, a clinical-stage biotech company developing iPSC-based therapies to transform fertility care, today announced that the Reproductive Fertility Center in Corona, CA, led by , is now open for patient enrollment in Gameto's first clinical study of Fertilo in the United States.
Fertilo is an investigational platform designed to reduce the burden of ovarian stimulation for women undergoing fertility treatment. By using engineered ovarian support cells to promote egg maturation outside of the body, Fertilo aims to shorten or eliminate the need for weeks of hormone injections typically required in conventional in vitro fertilization (IVF) cycles.
The trial at Reproductive Fertility Center represents a significant milestone as Gameto expands Fertilo's clinical development across leading fertility centers in the U.S. In addition to this center in California, Gameto expects to open over a dozen additional clinical sites in the coming weeks as part of its U.S. Fertilo study rollout. New sites are anticipated across key states including Florida, Texas, New York, and Connecticut, with more locations to follow.
'Opening our first U.S. clinical site for our pivotal study, is an exciting step forward for Gameto and for the future of fertility care,' said Dr. Dina Radenkovic, CEO & Co-Founder, Gameto. 'We are proud to partner with Dr. Williams and his outstanding team at Reproductive Fertility Center to offer women a new investigational option aimed at making fertility treatment faster, easier, and less invasive.'
The Fertilo study will evaluate the ability of engineered ovarian support cells to mature patient eggs ex vivo, with the goal of achieving fertilization and embryo development after a much shorter period of ovarian stimulation. Patients participating in the study will receive personalized monitoring and care at Reproductive Fertility Center, one of Southern California's leading fertility clinics.
'We are excited to be the first clinical site in the U.S. enrolling patients in this innovative study,' said Dr. Daniel Williams, Medical Director of Reproductive Fertility Center. 'Our mission has always been to provide patients with access to the latest advances in reproductive medicine. Fertilo has the potential to offer a safer, simpler alternative for women who want to preserve their fertility or start a family. And with the expertise of our clinical team, including Dr. James P. Lin and Dr. Susan Nasab, we are proud to contribute to advancing this important research.'
Gameto recently published a preprint on medRxiv demonstrating that Fertilo can effectively promote egg maturation, leading to a higher number of viable embryos and significantly improved pregnancy success rates. In mini-stimulation (mini-stim) cycles supplemented with Fertilo, patients achieved a 44% pregnancy rate per cycle after the first embryo transfer, more than double the success rate typically observed with conventional in vitro maturation (IVM), which stands at 20%. Patients treated with Fertilo also had more viable embryos available for transfer, further enhancing their chances of conception.
The company plans to open additional clinical sites in its pivotal U.S. Phase 3 clinical trial (NCT06858111) of Fertilo, a first-in-class iPSC-derived therapy. Individuals interested in joining the study can learn more at clinicaltrials.gov.
About Fertilo
Fertilo is Gameto's ovarian support cell (OSC) product that matures eggs outside the body using iPSC-derived cells. By mimicking the natural ovarian environment in vitro, Fertilo enables replacement of ~80% of hormone injections and shortens IVF or egg freezing cycles from 10-14 days to just 2-3 days. This approach offers a potentially safer, less invasive alternative to traditional IVF, significantly reducing patient burden and the risk of ovarian hyperstimulation.
About Gameto
Gameto is a biotechnology company developing novel solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of one of North America's largest fertility networks Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
23 minutes ago
- Business Wire
Epiminder Announces Publication of Landmark Clinical Trial Confirming Safety and Efficacy of the Minder® System
MELBOURNE, Australia & DALLAS--(BUSINESS WIRE)-- Epiminder, a pioneer in implantable continuous EEG monitoring (iCEM™), today announced the publication of results from its landmark UMPIRE (sUb-scalp Monitoring ePileptic seIzuREs) clinical trial in Epilepsia validating the safety and efficacy of its iCEM. The study, conducted across leading Australian hospitals, demonstrated Minder's ability to capture high-quality EEG data for extended periods that are comparable to current standard of care scalp-based EEG monitors. The Minder system is a designated Breakthrough Device and has recently been granted clearance for marketing in the United States by the FDA. A world record five-year continuous EEG recording has recently been reported by Epiminder using the system. 'The UMPIRE results exceeded our expectations, proving that continuous EEG monitoring over years—not just days—is not only possible but transformative for epilepsy management,' said Professor Mark Cook, Epiminder's Founder and Chief Medical Officer. Key Highlights of UMPIRE Clinical Trial: The Minder system was found to be safe, with no device or procedure related Serious Adverse Events EEG signal clarity was comparable to standard of care 10-20 scalp-based recordings Clinically relevant findings were identified in 88% of drug-resistant epilepsy patients, including patients with frequent unreported seizures Minder's unique bilateral recording capability revealed clinically relevant findings not possible with unilateral recordings in 23% of patients Commercial Outlook: Rohan Hoare, Epiminder's CEO, said, 'We are very pleased with the positive impact that Minder can have on the lives of people with epilepsy. Following the FDA authorization in April 2025, Epiminder will initiate a phased U.S. launch in Q3 2025, targeting major epilepsy centers.' Please visit Epilepsia for open access to the UMPIRE publication. Follow Epiminder on LinkedIn and explore for more information. About Minder Minder is a minimally invasive device for continuous monitoring of electrographic activity of the brain, providing epilepsy patients and their doctors with detailed data on brain activity over an extended period. Patients can wear the device as they go about their normal daily activities. Minder's long-term monitoring of patients outside of a controlled clinical environment provides data needed for better understanding and more effective treatment of underlying conditions, including determining the effectiveness of drug therapies and other potential interventions. About Epiminder Founded in 2017 by Professor Mark Cook together with the Bionics Institute, St Vincent's Hospital, the University of Melbourne and Cochlear Limited, Epiminder is a medical device and information solutions company focused on developing diagnostic and treatment tools for epilepsy and other seizure disorders where continuous monitoring is required. Epiminder is headquartered in Melbourne, Australia and has offices in the United States.
Business Wire
42 minutes ago
- Business Wire
Merck Initiates Phase 3 Study Evaluating Dengue Vaccine Candidate
BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the MOBILIZE-1 Phase 3 clinical trial evaluating the safety, immunogenicity and efficacy of a single dose of V181, an investigational quadrivalent vaccine, for the prevention of dengue disease caused by any of the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4), regardless of prior dengue exposure. Recruitment for the trial has begun, and the first participants are now enrolling in Singapore. 'Approximately half of the world's population live in areas with a risk for dengue, making it a serious public health threat,' said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories. 'The initiation of the MOBILIZE-1 study, the first Phase 3 trial in our clinical development program, marks a key milestone in our work to help address this widespread mosquito-borne disease. If successful, V181 could provide an important single-dose option for at risk populations, regardless of previous exposure to dengue, to help reduce the significant burden around the globe.' Merck is committed to research and innovation that aims to help protect the millions of people at risk for dengue virus infection and is establishing a program of clinical trials for V181, including conducting trials globally, in places where dengue is a significant health threat. About MOBILIZE-1 (NCT07013487) MOBILIZE-1, also known as V181-005, is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety, immunogenicity and efficacy of V181, an investigational vaccine for the prevention of dengue disease. The study aims to enroll approximately 12,000 healthy individuals 2 to 17 years of age who will be randomized to receive either a single dose of V181 or placebo. The study is planned to include more than 30 trial sites in dengue endemic areas in the Asia-Pacific region, including Indonesia, Malaysia, Philippines, Singapore, Thailand and Vietnam. The primary endpoints of the study are safety and efficacy of a single dose of V181 in preventing symptomatic virologically confirmed dengue (VCD) of any severity, due to any of the four dengue serotypes, regardless of prior dengue exposure. The key secondary efficacy endpoint is evaluating a single dose of V181 in preventing symptomatic VCD of any severity due to each of the four dengue serotypes, regardless of prior dengue exposure. Additional secondary endpoints include evaluating a single dose of V181 in preventing symptomatic VCD with warning signs, severe VCD and hospitalization. For more information on the trial, visit About V181 V181 is a live attenuated quadrivalent vaccine currently being investigated for the prevention of dengue disease caused by any of the four dengue virus types (DENV-1, DENV-2, DENV-3, and DENV-4). V181 is designed to be a single-dose vaccination and is being studied in individuals to provide protection against dengue, including severe forms, whether the individuals have been previously infected with the dengue virus or had no prior infections. About Dengue disease Dengue disease is one of the fastest growing mosquito-borne diseases that affects not just the health but often the economic stability of communities across the globe. It is a rapidly emerging cause of serious and sometimes debilitating illness in tropical and subtropical countries. With approximately half of the world's population, or four billion people, at risk for dengue disease, it represents a critical public health challenge. Globally, around 105 million dengue viral infections occur annually, with approximately 50-60 million being symptomatic on average per year. While the majority of infections are uncomplicated, serious illness caused by dengue can be severe and lead to death (on average, ~4-11 million cases result in hospitalizations per year and there is an average annual incidence of ~29,000 dengue-related deaths worldwide). Symptoms of mild dengue fever may include a high fever, a rash and muscle and joint pain. Dengue fever might evolve to severe dengue, formerly known as dengue hemorrhagic fever, which can cause severe bleeding, a sudden drop in blood pressure, and in rare cases, death. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (
Business Wire
an hour ago
- Business Wire
Galderma's Nemluvio ® (nemolizumab) Receives National Institute for Health and Care Excellence (NICE) Recommendation for Moderate-to-severe Atopic Dermatitis in England and Wales
LONDON--(BUSINESS WIRE)--Galderma today announced that nemolizumab has been recommended for routine funding on the National Health Service in England and Wales for moderate-to-severe atopic dermatitis in final draft guidance from the National Institute for Health and Care Excellence. 1 This follows its recent marketing authorisation by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years and older with a body weight of at least 30 kg, who are candidates for systemic therapy. 2 'Additional advances are needed in the treatment of atopic dermatitis due to the heterogeneity of the disease. Nemolizumab addresses this need for treatments with a favourable safety profile that effectively target both itch and skin lesions – two of the most burdensome symptoms of this disease – and we are delighted that patients in England and Wales will now have access to it.' GALDERMA Expand Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signalling of IL-31. 2 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis. 5,9,10 It is also the first and only biologic approved for atopic dermatitis with four-week dosing intervals from the start of treatment. 2 After 16 weeks of treatment, for patients who achieve clinical response, the recommended maintenance dose of nemolizumab is 30 mg every eight weeks. 2 The approval was based on results from the phase III ARCADIA clinical trial program. The phase III ARCADIA 1 and ARCADIA 2 trials met their co-primary endpoints and all key secondary endpoints, demonstrating that nemolizumab, administered subcutaneously every four weeks in combination with background topical corticosteroids, with or without topical calcineurin inhibitors (+TCS/TCI), clinically improved skin lesions, and rapidly and significantly improved itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis, when compared to placebo +TCS/TCI. 3 Significant itch relief was observed as early as Week 1. 3 Nemolizumab was generally well tolerated in all trials. 3,10 It does not require preliminary laboratory evaluations or monitoring during treatment. 2 'It is hugely positive to have a new treatment option available for atopic dermatitis patients that can help to ease the relentless and unforgiving burden this disease can have on their lives. Nemolizumab will be an important addition to the current treatment landscape with its novel mode of action and infrequent dosing regime.' DR ANDREW PINK CONSULTANT DERMATOLOGIST GUY'S AND ST THOMAS' NHS FOUNDATION TRUST LONDON, UNITED KINGDOM Expand Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease which affects approximately 1.6 million people in the UK. 4-8 Often reported as one of patients' most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians. Atopic dermatitis can also be associated with several comorbid conditions, namely mental health disorders and other autoimmune- or immune-mediated diseases. 11-14 Given the significant burden of these symptoms and the heterogeneity of the disease, there is a need for additional treatment options with a favourable safety profile that effectively target both itch and skin lesions. 5,11,15 'Relentless itch makes life so difficult for the many people living with moderate-to-severe atopic eczema (atopic dermatitis) in the UK. It disrupts sleep and impacts people's ability to concentrate throughout the day. This is in addition to the painful physical symptoms of inflamed, sore, cracked and bleeding skin. National Eczema Society welcomes the NICE decision to recommend nemolizumab for treating moderate-to-severe atopic dermatitis. It's really important we have a range of treatment options, so patients have the chance of accessing a treatment that works effectively for them.' ANDREW PROCTOR Expand About nemolizumab Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga ® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in paediatric, adolescent, and adult patients. 16,17 About the ARCADIA clinical trial program 18,19 The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2. These global, randomized, multicentre, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroids with or without topical calcineurin inhibitors). The trials were conducted in adolescent (12 years and over) and adult patients with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator's global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks. About atopic dermatitis Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions. 4-6 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis. 5,20 About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References NICE. Nemolizumab for treating atopic dermatitis - technology appraisal guidance. Available online. Accessed June 2025 Nemolizumab. UK summary of product characteristics 2025. Available online. Accessed June 2025 Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi:10.1016/S0140-6736(24)01203-0 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1 Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi: 10.1056/NEJMra2023911 Kleyn E, et al. Prevalence and treatment patterns of adult atopic dermatitis in the UK Clinical Practice Research Datalink. Skin Health and Disease. 2023;3(4):e232. doi:10.1002/ski2.232 UK Office for National Statistics - national population projections: 2021-based interim. Available online. Accessed June 2025 Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi:10.1002/cti2.1390 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi:10.1016/ Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/ Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932 Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966 Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3 Lobefaro F, et al. Atopic Dermatitis: Clinical Aspects and Unmet Needs. Biomedicines. 2022;10:2927. doi: 10.3390/biomedicines10112927 Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed June 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed June 2025 Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed June 2025 Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03989349). Available online. Accessed June 2025 Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257
