Latest news with #PRIZM
Yahoo
14-05-2025
- Business
- Yahoo
Tisento Highlights Two Venues Advancing Patient-Focused Therapeutic Development for Mitochondrial Diseases
Tisento to Present at the 'Primary Mitochondrial Diseases' Therapeutic Development Workshop Hosted by the Reagan-Udall Foundation for the FDA on May 22, 2025 Tisento to Sponsor the First Externally Led Patient-Focused Drug Development Meeting Dedicated to MELAS on February 10, 2026; MitoAction to Lead CAMBRIDGE, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Tisento Therapeutics today announced upcoming opportunities to collaborate with patient advocates, leading clinicians, and regulators to optimize therapeutic development for mitochondrial diseases, including the rare mitochondrial disease MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes). 'Incorporating the insights gleaned from listening to patients and integrating the perspectives of all critical stakeholders are foundational to our drug development approach,' said Peter Hecht, Ph.D., chief executive officer of Tisento. 'We look forward to advancing patient-focused therapeutic development for mitochondrial diseases at two important events. We will share key learnings related to the design of our Phase 2b PRIZM study in MELAS at the primary mitochondrial diseases public workshop, hosted by the Reagan-Udall Foundation for the FDA. We also appreciate the opportunity to hear more from patients and advocates at the first externally led patient-focused drug development meeting dedicated to MELAS and are proud to support MitoAction's efforts to shed light on the unmet needs in this rare condition.'Chad Glasser, Pharm.D., senior director of clinical research at Tisento, is presenting Tisento's approach to developing zagociguat for the treatment of MELAS, a primary mitochondrial disease, at a public workshop. Dr. Glasser will share key insights on overcoming challenges associated with developing medicines for rare, heterogeneous diseases, including how learnings from Tisento's MELAS patient interview study informed selection of assessments and endpoints in the company's ongoing Phase 2b PRIZM study in adults with MELAS. Hosted by the Reagan-Udall Foundation for the FDA in collaboration with the U.S. Food and Drug Administration, the workshop brings together patient advocates, academics, healthcare practitioners, and drug developers to explore opportunities to optimize the development of therapies to treat primary mitochondrial diseases and best practices in designing and interpreting clinical studies to accelerate drug development. The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) organization created by Congress to modernize product development, accelerate innovation, and enhance product safety. The Foundation serves as a crucial conduit between the FDA and the public, providing a means for the FDA to interact directly with stakeholders, including industry and consumers. Virtual Event DetailsDate: Thursday, May 22, 2025 Time: 10am-4pm ETRegistration: Free; register hereTisento is sponsoring the first externally led patient-focused drug development (EL-PFDD) meeting dedicated to systematically obtaining patient perspectives on living with MELAS and on the most important symptoms to address when developing drug candidates. Led by MitoAction, the EL-PFDD is intended to provide an opportunity for the FDA, pharmaceutical industry, and other key stakeholders to hear directly from patients, their families, caregivers, and patient advocates about the symptoms that matter most to them, the impact MELAS has on patients' daily lives, and patients' experiences with currently available disease management approaches. There are no FDA-approved treatments specifically for MELAS. MitoAction is planning and hosting the meeting; Tisento is providing financial support and is not involved in planning or content development. Virtual Event DetailsDate: Tuesday, February 10, 2026 Registration: Free (registration details to be announced); reach out to MitoAction at info@ for updates About the PRIZM Study PRIZM – a Phase 2b Randomized, Placebo-Controlled Trial Investigating Zagociguat in MELAS – is evaluating the efficacy and safety of oral zagociguat 15 mg or 30 mg compared to placebo when administered once-daily for 12 weeks in participants with genetically and phenotypically defined MELAS. The PRIZM study has a crossover design, with two 12-week treatment periods separated by a 4-week washout period. All participants will receive zagociguat during one of the 12-week periods and placebo during the other. Participants who complete the study may be eligible for an open-label extension study. PRIZM is a global study that will enroll approximately 44 participants at mitochondrial disease centers of excellence in the U.S., Italy, Germany, United Kingdom, Australia, and Canada. For more information, please visit or (NCT06402123). Interested individuals can also reach out to their physicians for participation details. About Zagociguat Zagociguat is a once-daily, oral, clinical-stage investigational medicine with potential to positively impact both peripheral and central nervous system manifestations of mitochondrial diseases. Zagociguat stimulates soluble guanylate cyclase (sGC), an enzyme that is found in virtually every cell in every tissue of the body and is part of a system of cellular mechanisms that control critical physiological functions including neuronal function and blood flow. A first-in-class, brain-penetrant sGC stimulator, zagociguat is hypothesized to rebalance dysregulated cellular pathways in MELAS. By restoring cellular functions that support mitochondria, zagociguat may help restore mitochondrial energy production and physiological function. In a Phase 2a study in patients with MELAS, zagociguat exhibited a favorable safety profile, exposure throughout the body including in the central nervous system, and improvements in neuronal function, mitochondrial function, and blood flow in the brain. Zagociguat is currently being evaluated as a treatment for MELAS in the Phase 2b PRIZM study. For more information, visit About Tisento Therapeutics Tisento Therapeutics, a privately held biotech company, is developing novel medicines to treat diseases with significant unmet need, beginning with MELAS and other genetic mitochondrial diseases. Ti sento means 'I hear you' in Italian; our approach to innovation begins with listening to patients and then channeling what we learn into decisive actions that shape our research and clinical programs. Tisento is guided by a high-caliber internal team of biopharma veterans and an extensive external network of expert physicians, patient advocacy groups, researchers, industry-leading vendors, and other close collaborators who are partners in our mission to develop meaningful treatments for mitochondrial diseases. Learn more at our website, or connect with us on LinkedIn, Facebook, X (@tisentotx), or Bluesky. Contact Tisento Media RelationsJessi Rennekamp, Astrior CommunicationsEmail: jessi@
Yahoo
12-04-2025
- Lifestyle
- Yahoo
Get ready for warmer weather with these sunglasses
Fox News and its syndication partners may earn a commission if you buy through our referral links. This content was created by a team that works independently from the Fox newsroom. Sunglasses are more than just a stylish tool to shield your eyes from the sun; they are an impactful accessory that can define your style and elevate your outfit. As the days grow longer (and sunnier), now is a great time to refresh your look with a new pair of shades. It doesn't matter if you are heading to the beach, driving to work, hiking a trail or simply strolling in the park, the right pair of sunglasses can provide UV protection plus make a bold fashion statement. This spring and summer, sunglasses trends for men and women are all about blending functionality with style and it's easier than ever to find a pair that matches your personal aesthetic. From sporty designs to retro-inspired classics, there's something for everyone. Here are 10 options to consider. Ray-Ban continues to dominate with its classic aviator style, which remains a perennial favorite for both men and women. This spring, the brand has introduced modern twists on these icons, such as gradient lenses and bold color frames and more than a dozen different options. With its teardrop-shaped lenses, the aviator is perfect for those looking for a sleek and versatile look. If you like the idea of classic Ray-Ban but prefer plastic frames, consider the wayfarer style. Its thicker frames offer a retro vibe. Both styles provide 100% UV protection and are available in prescription versions, ensuring comfort and clarity. From Watches To Sunglasses: Here Are 15 Accessories To Elevate Your Next Run Oakley's performance-driven Holbrook sunglasses are a must-have for outdoor enthusiasts and athletes. Their PRIZM lens technology enhances color and contrast, making them ideal for cycling, running and water sports. Oakley has expanded its range with vibrant lens colors and lightweight materials this spring, ensuring you stay stylish and functional on every adventure. Be sure to check out Oakley's selection on Amazon, where the pricing is a little more competitive and you can take advantage of free Prime shipping. If you're already an Amazon Prime member, you can get these sunglasses to your door ASAP. You can join or start a 30-day free trial to start your shopping today. Read On The Fox News App Warby Parker combines style with affordability, and this unisex Percey style is no different. They feature rounded frames in tortoiseshell, perfect for a fresh spring look. With Warby Parker's virtual try-on feature, finding your perfect pair is easier than ever. Plus, the scratch-resistant lens coating is a game-changer if you're the type who tosses your shades in a purse without a case. If you're looking to spend a little less, consider this pair on Amazon is under $15. Known for their high-quality polarized lenses, Costa Del Mar is a leading brand for those who love the water. All their sunglasses are designed to reduce glare and enhance clarity, making them perfect for fishing, boating or beach outings. The Fantail offers a sleek design that blends performance with style. Costa Del Mar is an excellent pick for environmentally conscious shoppers with several eco-friendly frame options and a focus on sustainability. Plus, you can even personalize your frames with up to six characters! And if you're planning to wear them for outdoor activities, pick up one of their adjustable retainers to ensure you don't lose them. These oversized plastic frames from SOJOS at Amazon are a budget-friendly option for those seeking trendy sunglasses without breaking the bank. They provide an affordable option for polarized lenses in a style that echoes high-end designs. They're also a comfortable choice if you don't like a pair that presses into the bridge of your nose. Amazon has some great plastic polarized frame options for men too, for around the same price point. 16 Beauty Products To Get Your Skin Ready For Summer Gucci GG0061S round sunglasses: $249 at Amazon Gucci sunglasses are excellent for label lovers looking to make a high-end fashion statement this spring. Known for their bold and glamorous designs, Gucci's round gradient metal pair features oversized frames, logo embellishments and gradient lenses. If you don't want to break the bank, there's a similar style that is more budget friendly at Amazon. Maui Jim sunglasses are all about comfort and clarity, inspired by the beauty of island life. Their polarized lens technology in this Red Sands style ensures exceptional glare reduction, vivid colors and UV protection. With lightweight materials and a focus on durability, Maui Jim's a practical purchase. The brand also offers a chic choice for women, with this ombre plastic cat-eye style. Persol offers a blend of vintage elegance and modern craftsmanship, making their sunglasses a timeless choice for spring. Known for their high-quality acetate frames, Persol's Steve McQueen style makes a true statement. While this pair is a bit of a splurge, Amazon offers a similar style from WearMe for under $40. Blenders Eyewear is a rising star in sunglasses, known for its vibrant designs and affordable prices with an array of styles under $50. Their spring collection features this North Park style, with its colorful mirrored lenses and a trendy oversized cat-eye shape. You might also consider this SciFi style for a fun take on a futuristic look. For more deals, visit Prada's sunglasses combine modern minimalism with high-end fashion, offering this sleek cat-eye design at Macy's that is both trendy and timeless with a vintage nod. While the dramatic cat-eye is ideal for balancing out the features in a rounder face, square or heart-shaped face shapes might opt for a less angular pair with softer edges, like this Ray-Ban article source: Get ready for warmer weather with these sunglasses
Fox News
12-04-2025
- Lifestyle
- Fox News
Get ready for warmer weather with these sunglasses
Sunglasses are more than just a stylish tool to shield your eyes from the sun; they are an impactful accessory that can define your style and elevate your outfit. As the days grow longer (and sunnier), now is a great time to refresh your look with a new pair of shades. It doesn't matter if you are heading to the beach, driving to work, hiking a trail or simply strolling in the park, the right pair of sunglasses can provide UV protection plus make a bold fashion statement. This spring and summer, sunglasses trends for men and women are all about blending functionality with style and it's easier than ever to find a pair that matches your personal aesthetic. From sporty designs to retro-inspired classics, there's something for everyone. Here are 10 options to consider. Ray-Ban continues to dominate with its classic aviator style, which remains a perennial favorite for both men and women. This spring, the brand has introduced modern twists on these icons, such as gradient lenses and bold color frames and more than a dozen different options. With its teardrop-shaped lenses, the aviator is perfect for those looking for a sleek and versatile look. If you like the idea of classic Ray-Ban but prefer plastic frames, consider the wayfarer style. Its thicker frames offer a retro vibe. Both styles provide 100% UV protection and are available in prescription versions, ensuring comfort and clarity. Oakley's performance-driven Holbrook sunglasses are a must-have for outdoor enthusiasts and athletes. Their PRIZM lens technology enhances color and contrast, making them ideal for cycling, running and water sports. Oakley has expanded its range with vibrant lens colors and lightweight materials this spring, ensuring you stay stylish and functional on every adventure. Be sure to check out Oakley's selection on Amazon, where the pricing is a little more competitive and you can take advantage of free Prime shipping. If you're already an Amazon Prime member, you can get these sunglasses to your door ASAP. You can join or start a 30-day free trial to start your shopping today. Warby Parker combines style with affordability, and this unisex Percey style is no different. They feature rounded frames in tortoiseshell, perfect for a fresh spring look. With Warby Parker's virtual try-on feature, finding your perfect pair is easier than ever. Plus, the scratch-resistant lens coating is a game-changer if you're the type who tosses your shades in a purse without a case. If you're looking to spend a little less, consider this pair on Amazon is under $15. Known for their high-quality polarized lenses, Costa Del Mar is a leading brand for those who love the water. All their sunglasses are designed to reduce glare and enhance clarity, making them perfect for fishing, boating or beach outings. The Fantail offers a sleek design that blends performance with style. Costa Del Mar is an excellent pick for environmentally conscious shoppers with several eco-friendly frame options and a focus on sustainability. Plus, you can even personalize your frames with up to six characters! And if you're planning to wear them for outdoor activities, pick up one of their adjustable retainers to ensure you don't lose them. These oversized plastic frames from SOJOS at Amazon are a budget-friendly option for those seeking trendy sunglasses without breaking the bank. They provide an affordable option for polarized lenses in a style that echoes high-end designs. They're also a comfortable choice if you don't like a pair that presses into the bridge of your nose. Amazon has some great plastic polarized frame options for men too, for around the same price point. Gucci GG0061S round sunglasses: $249 at Amazon Gucci sunglasses are excellent for label lovers looking to make a high-end fashion statement this spring. Known for their bold and glamorous designs, Gucci's round gradient metal pair features oversized frames, logo embellishments and gradient lenses. If you don't want to break the bank, there's a similar style that is more budget friendly at Amazon. Maui Jim sunglasses are all about comfort and clarity, inspired by the beauty of island life. Their polarized lens technology in this Red Sands style ensures exceptional glare reduction, vivid colors and UV protection. With lightweight materials and a focus on durability, Maui Jim's a practical purchase. The brand also offers a chic choice for women, with this ombre plastic cat-eye style. Persol offers a blend of vintage elegance and modern craftsmanship, making their sunglasses a timeless choice for spring. Known for their high-quality acetate frames, Persol's Steve McQueen style makes a true statement. While this pair is a bit of a splurge, Amazon offers a similar style from WearMe for under $40. Blenders Eyewear is a rising star in sunglasses, known for its vibrant designs and affordable prices with an array of styles under $50. Their spring collection features this North Park style, with its colorful mirrored lenses and a trendy oversized cat-eye shape. You might also consider this SciFi style for a fun take on a futuristic look. For more deals, visit Prada's sunglasses combine modern minimalism with high-end fashion, offering this sleek cat-eye design at Macy's that is both trendy and timeless with a vintage nod. While the dramatic cat-eye is ideal for balancing out the features in a rounder face, square or heart-shaped face shapes might opt for a less angular pair with softer edges, like this Ray-Ban pair.
Yahoo
27-01-2025
- Health
- Yahoo
First Participant Dosed in Tisento Therapeutics' Global Phase 2b PRIZM Study Evaluating Zagociguat for the Treatment of MELAS
Patient-Centered PRIZM Study Measures Impact of Once-Daily Oral Zagociguat on Fatigue and Cognitive Impairment, Hallmark Features of this Rare Mitochondrial Disease CAMBRIDGE, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Tisento Therapeutics today announced that the first patient has been dosed in its global Phase 2b PRIZM study. The study is investigating the impact of once-daily oral zagociguat treatment on fatigue, cognitive impairment, and other key aspects of the rare mitochondrial disease MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes). The PRIZM study is centered in multiple ways on what matters to people living with MELAS. The study incorporates features that maximize convenience for participants, including at-home assessments, the potential for at-home study visits, and door-to-door travel support. In addition, all participants will receive zagociguat during one period of this crossover study, and participants who complete the study may be eligible for continued access via an open-label extension study. Importantly, the clinical outcome assessments and endpoint strategy for the PRIZM study were informed by Tisento's interview study in which individuals living with MELAS described the symptoms and impacts of the disease that are most important to them. PRIZM is a global study now enrolling in North America, Europe, and Australia. Patients and families interested in learning more can visit Tisento's PRIZM page, (NCT06402123), or discuss with their physician. 'Since Tisento's founding, we have been focused on initiating a thoughtful, well-designed clinical study to evaluate zagociguat for the treatment of MELAS, and we are humbled by the enthusiastic response we have received from physicians and the mitochondrial disease community,' said Peter Hecht, PhD, chief executive officer of Tisento. 'We are pleased that the first participants are enrolling in the global PRIZM study, which was designed with patient perspectives at the forefront. We will continue to put patients first every step of the way as we work to develop creative solutions to address what matters most for people with serious diseases.' 'MELAS is the most common condition we see in our mitochondrial clinic, with profound effects on patients' daily lives and wellbeing. Right now, we have no approved treatments, making the search for effective therapies absolutely critical,' said Dr. Austin Larson, associate professor of pediatric clinical genetics and metabolism at the University of Colorado School of Medicine and PRIZM study investigator. 'I am excited about zagociguat's potential to address both the severe fatigue and cognitive challenges that so significantly impact our MELAS patients.' About the PRIZM Study PRIZM – a Phase 2b Randomized, Placebo-Controlled Trial Investigating Zagociguat in MELAS – is evaluating the efficacy and safety of oral zagociguat 15 mg or 30 mg compared to placebo when administered once-daily for 12 weeks in participants with genetically and phenotypically defined MELAS. The PRIZM study has a crossover design, with two 12-week treatment periods separated by a 4-week washout period. All participants will receive zagociguat during one of the 12-week periods and placebo during the other. Participants who complete the study may be eligible for an open-label extension study. PRIZM is a global study that will enroll approximately 44 participants at mitochondrial disease centers of excellence in the U.S., Italy, Germany, United Kingdom, Australia, and Canada. For more information, please visit or (NCT06402123) for more information. Interested individuals can also reach out to their physicians for participation details. About Zagociguat Zagociguat is a once-daily, oral, clinical-stage investigational medicine with potential to positively impact both peripheral and central nervous system manifestations of mitochondrial diseases. Zagociguat stimulates soluble guanylate cyclase (sGC), an enzyme that is found in virtually every cell in every tissue of the body and is part of a system of cellular mechanisms that control critical physiological functions including neuronal function and blood flow. A first-in-class, brain-penetrant sGC stimulator, zagociguat is hypothesized to rebalance dysregulated cellular pathways in MELAS. By restoring cellular functions that support mitochondria, zagociguat may help restore mitochondrial energy production and physiological function. In a Phase 2a study in patients with MELAS, zagociguat exhibited a favorable safety profile, exposure throughout the body including in the central nervous system, and improvements in neuronal function, mitochondrial function, and blood flow in the brain. Zagociguat is currently being evaluated as a treatment for MELAS in the Phase 2b PRIZM study. For more information, visit About Tisento Therapeutics Tisento Therapeutics, a privately held biotech company, is developing novel medicines to treat diseases with significant unmet need, beginning with MELAS and other genetic mitochondrial diseases. Ti sento means 'I hear you' in Italian; our approach to innovation begins with listening to patients and then channeling what we learn into decisive actions that shape our research and clinical programs. Tisento is guided by a high-caliber internal team of biopharma veterans and an extensive external network of expert physicians, patient advocacy groups, researchers, industry-leading vendors, and other close collaborators who are partners in our mission to develop meaningful treatments for mitochondrial diseases. Learn more at our website, or connect with us on LinkedIn (Tisento Therapeutics) or X (@tisentotx). Contact Tisento Media RelationsJessi Rennekamp, Astrior CommunicationsEmail: jessi@ in to access your portfolio
