Latest news with #Tiziana
Business Upturn
06-05-2025
- Health
- Business Upturn
Tiziana Life Sciences Announces Comprehensive Positive Results from Study of Nasal Foralumab in Patients with Multiple Sclerosis
Meaningful Fatigue score reduction seen in study is a critically important quality of life (QoL) measure for Multiple Sclerosis patients. All patients experienced stabilization of Expanded Disability Status Scale (EDSS) scores. TSPO-PET imaging showed significant reductions in microglial activation at six months (p<0.05). NEW YORK, May 06, 2025 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ('Tiziana' or the 'Company'), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced promising results from an open-label clinical study evaluating nasal foralumab, the world's only fully human anti-CD3 monoclonal antibody administered intranasally, for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS). This comprehensive study demonstrated that nasal foralumab was safe, induced potent regulatory immune responses, reduced microglial activation, and stabilized clinical progression in patients suffering from progression independent of relapse activity (PIRA)—a major unmet need in the treatment of MS, and a key disease endpoint for intranasal foralumab development. The article is titled 'Nasal foralumab treatment of PIRA induces regulatory immunity, dampens microglial activation and stabilizes clinical progression in non-active secondary progressive MS.' This study is the first to integrate, F18TSPO PET, Proteomics, and Clinical assessments in na-SPMS. These findings in MFIS score reduction are a critically important Quality of Life (QoL) measure for patients with MS. Study Highlights: Ten patients with na-SPMS, who continued to progress despite B-cell therapy, were treated with nasal foralumab for a minimum of six months. No serious or severe treatment-related adverse events were reported. All patients experienced stabilization of their Expanded Disability Status Scale (EDSS) scores; three of four patients that were treated continuously for 12 months showed improvement. Fatigue, a major symptom burden in MS, improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale (MFIS). Total MFIS scores correlated strongly with mGALP scores in the hippocampus (r=0.89, p=0.007) at baseline. No new T2 lesions were observed on MRI. TSPO-PET imaging showed significant reductions in microglial activation at six months (p<0.05). Single-cell RNA sequencing revealed early and sustained changes in peripheral immune cells, including increased regulatory T cells (Tregs) and expression of TGFβ across multiple cell types. 'Our findings mark a significant advancement for patients living with non-active Secondary Progressive MS, who currently have very limited treatment options,' said Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School and senior neurologist at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare System. 'Nasal administration of foralumab represents a novel, non-invasive approach that not only induces regulatory immunity but also reduces harmful CNS inflammation.' PIRA and progressive forms of MS are characterized by central nervous system-centric inflammation driven by microglial activation, processes not adequately addressed by existing therapies. Traditional MS treatments targeting B-cells and cell trafficking have limited efficacy in managing progression behind the blood-brain barrier. Nasal foralumab leverages the mucosal immune system to induce regulatory immune responses, offering a novel mechanism to suppress CNS inflammation without the systemic immunosuppression seen with intravenous therapies. Previous studies showed that nasal anti-CD3 could treat progressive MS in animal models by expanding LAP+ and IL-10+ Tregs, providing the scientific rationale for this human study. In parallel with these encouraging results, Tiziana Life Sciences has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial to further assess the efficacy and safety of nasal foralumab in a larger cohort of patients with na-SPMS. This trial is expected to reach top line data read out at the end of 2025. 'We are incredibly excited by these results, which validate the potential of nasal foralumab to fundamentally shift the treatment paradigm for progressive MS,' said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. 'We are also committed to advancing this promising therapy into other larger clinical studies, such as Alzheimer's Disease and ALS as quickly as possible.' This article has been submitted for peer review, and the full preprint is available here: About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana's innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana's lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana's technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit Forward-Looking Statements Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Tiziana's Annual Report on Form 20-F for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development, and Investor Relations+44 (0) 207 495 2379 email: [email protected]
Forbes
05-05-2025
- Entertainment
- Forbes
Orogami To Present Diverse Luxury Jewelry Collections At Couture Show
The 18-karat gold Orogami Seed of Capri collection is set with gemstones that embody colors of the ... More island's vibrant flowers and blue-green waters. 'Fortune favors the bold,' and this rings especially true for jewelers, who invest finances, time and energies into creating luxuries that often take months or years to yield returns. Nevertheless, the Italian goldsmiths Tiziana and Massimo Aloisio, co-founders of Orogami fine jewelry, embody proof of the ancient saying's truth, as by any objective standard, they are boldly prolific and artistically successful. Orogami encompasses 18 distinct and stylistically varied fine jewelry ranges, all of them are classic, and many of them are gender-fluid in style and appeal. With a unique narrative animating each collection, there is thus a story inside of each Orogami design. As the Orvieto-based Aloisios explained during a Zoom interview, 'Our jewels are designed and made in Italy, and they are talismans with meaning besides being beautiful adornments.' Orogami's widely resonant designs distinguish the brand as a creator of heirlooms, and it will be exhibiting at the Couture Show, held at the Wynn Las Vegas, from the 4th till the 8th of June, in Cristal Ballroom, booth #630. From Orgami's Seed collection, this 18-karat yellow gold bracelet is a sculptural jewel and a ... More meditation on the essential life force of seeds. Sparkling in its 35th year, Orogami derives its name from "Oro," the Italian word for gold, and "Gamos," the ancient Greek word for wedding. 'Our company name means union in gold,' Tiziana explained, 'it also holds a deeper significance, embodying the Japanese word 'Imagoro,' meaning 'about this time.' This underlying philosophy infuses each collection with a timeless essence, capturing the spirit of the present moment. Moreover, our logo," she continued, "is an Etruscan rose, which is the Western version of the Far East's lotus flower, a symbol of life.' The Aloisios both studied classical art, architecture, and jewelry history, and have restored ancient Etruscan jewelry for various museums. Their Orogami collections retail worldwide through their e-commerce platform and they are initiating retail partnerships within the USA and other countries. Orogami's Labyrinth collection is based on the belief that each one of us must boldly walk our own ... More path through life. While space limitations prohibit discussion of all Orogami collections, one of the most intriguing ones is the Labyrinth, which is available in 18-karat white, 18-karat yellow gold, and 18-karat rose gold. This collection elevates the age-old symbolism of the labyrinth through a dynamic and meaningful element: a moving stone. This precious gem, delicately set within the design, becomes the tangible representation of our self-walking along the winding path of life. Its free movement within the confines of the labyrinth constantly reminds us of the necessity to persevere, not to get lost in uncertainties, but to always maintain direction towards the intended goal, towards the full realization of our potential. (Cuff links, necklaces, rings, earrings, and pendants comprise this range.) For example, 'Labyrinth pendants come with a silk cord, and there are six silk cord colors to choose from,' Massimo explained. 'Inspired by the moving stone's representation of our life's journey and the need to stay true to ourselves, some clients will, over time, add a new stone to their personal labyrinth as a tangible reminder of a significant moment or a cherished goal.' As with any labyrinth, Massimo summarized, 'The goal is to stay on path to reach the center. These jewels remind us to stay centered.' FEATURED | Frase ByForbes™ Unscramble The Anagram To Reveal The Phrase Pinpoint By Linkedin Guess The Category Queens By Linkedin Crown Each Region Crossclimb By Linkedin Unlock A Trivia Ladder Handmade in Italy, the Bubbles collection by Orogami makes a festive yet classic statement with ... More graceful design, richly hued gemstones and master artisanship. Orogami's Seed of Life collection poignantly reminds us of Nature's regenerative power. 'We designed Seed of Life after September 11, 2001.' Tiziana said. 'We lost friends during that tragedy, and we honor them with this collection, which encapsulates the consciousness of our creative acts, emphasizing the profound impact of every thought, word, and deed. Encouraging kindness, compassion, and positivity, the Seed Collection urges us to nurture these seeds within ourselves and others, fostering a world where love and understanding flourish abundantly.' The circular motif, also present in the Seed of Life bracelet, stands as Orogami's signature, a visual echo of the designers' deepest wish. Inspired by the circle's ancient representation of life across diverse cultures, this motif conveys a heartfelt wish for a long and prosperous life. Then there is the Seed of Capri collection, an outgrowth of the Seed of Life, which is the Aloisios way of celebrating the beautiful island that hosted the Orogami store for years, a heartfelt tribute to a place they deeply admire. Crafted from 18k gold and adorned with composite stones, each piece radiates the island's kaleidoscope of colors and textures. 'The gems in Seed of Capri are cut by one of Italy's most renowned stonecutters, a father and son lapidary duo, who also have worked for Bulgari and Cartier,' the Aloisios related. 'The island of Capri is a natural wonder, and the blue mother-of-pearl and rock crystal jewels in this collection were inspired by the unforgettable color of the water in Capri's Blue Grotto, which is a magical, azure sea cave that can be visited by boat.' Alive with buoyant shapes, precious gemstones and negative space, the Bubbles collection by Orogami ... More is a timeless and intricate range. Created after their daughter Angelica graduated high school, the best-selling Bubbles collection references how bubbles give champagne its festive fizz; how bubbles remain on the beach after the tide has receded, and how the floating iridescence of soap bubbles look magically colorful, bright and light. 'Bubbles also grew out of what we told Angelica as she left for university,' Massimo recalled. 'Quoting the Eleanor Roosevelt saying - the future belongs to those who believe in the beauty of their dreams, we told her to keep her dreams alive.' Made in 18K rose gold, yellow gold, and white gold, the Bubble collection looks and feels full of lightness and purity. This writer found the two-sided Bubble pendant with enhancer a versatile, as well as beautiful, design which can be worn on either side for two looks. The fact that it can easily detach for wear on various chains or cords is another plus. As Tiziana and Massimo's daughter Angelica works alongside them, Orogami is now a heritage brand, one committed to a more sustainable future. As she explained during the Zoom interview, 'I studied economics in Milano and have a Master of Science degree in global business management. My dissertation documented how sustainable practices can factor into textile production to make the industry friendlier to our planet and our society.' The Orogami "We Wear Art" sustainable silk scarf collection embodies imagery from frescos that adorn ... More the interior of Orvieto's cathedral. Her university studies in sustainable business continue to pay dividends for Orogami operations and for Orvieto's famed cathedral (the Duomo). Recently, Angelica spearheaded an initiative that bridges the worlds of fine art and applied art called 'We Wear Art.' As she explained, 'We Wear Art is an OROGAMI sustainable silk scarf project that celebrates and communicates the beauty, power, and cultural importance of fine art. In the We Wear Art Orvieto Collection,' she detailed, 'historically renowned artworks from the cathedral of Orvieto are reproduced on sustainable Italian silk scarves that come in five different sizes: Twilly (13x43 inches), Man Pocket Square (18x18inches), Smaller Carré 27.5x27.5 inches, Classical Carré (35.5x35.5 inches) and Shawl (18x71 inches).' Orogami is donating a percentage of each scarf purchase to the Opera of the Duomo of Orvieto to support the preservation of its artistic heritage. For example, Luca Signorelli's fresco series in the San Brizio Chapel of the cathedral. The Orvieto collection's Trumpeter Angel scarf faithfully reproduces part of a fresco from the chapel of San Brizio, located in the right transept of the cathedral, which was built between 1408 and 1444. (This chapel is famous for its frescoes depicting the Last Judgment, begun by the painter Beato Angelico in 1447 and completed by Luca Signorelli in 1499-1502.) As Signorelli was the first artist to paint bodies in perspective, his work made a deep and haunting impact on his contemporaries—and on art history. Churchgoers had literally never seen any images like that before. 'In his day, this was considered Signorelli's greatest work,' Angelica explained, 'due to the grandeur of its size and its graphic imagery. We took great care during the photographic process,' she added, 'to ensure that the colors faithfully reproduced the hues in these precious, world-renowned artworks.' Other scarves from Orogami depict details from various Orvieto cathedral areas. For example, Orogami's scarf of the Musician Angel is reproduced from mosaics that adorn the cathedral's façade: these were based on a 13th century drawing and completed in the 19th century. 18-karat white gold, diamond and colored gemstone Bubble earrings embody a painterly color sense and ... More sculpturally strong structure that's reminiscent of Italian mosaics Each of the scarves in the We Wear Art collection is made of 100% Italian organic silk, and is finished by hand and certified GOTS. (This appellation is an abbreviation of the Global Organic Textile Standard, the world's pre-eminent certification system for organic textiles.) 'GOTS certification,' Angelica said, 'ensures that a given textile is made from organic fibers and was processed sustainably throughout the entire textile process, from fiber production to the finished product. GOTS certification also ensures that materials are organic, all manufacturing processes are environmentally and socially responsible, and that the products are safe for consumers.' As Angelica ventured, 'Thanks largely to the Opera of the Duomo of Orvieto, the We Wear Art initiative is succeeding.' This autonomous body, she related, 'is responsible for the maintenance and conservation of the cathedral, and administration of its assets. It's extremely satisfying to be working with the cathedral on preserving its masterpieces, while uniting Orogami with Orvieto's artistic heritage.' This Orogami scarf design reproduces bejeweled mosacis that adorn the facade of the Duomo of ... More Orvieto, Italy. Speaking of artistic heritage, the Aloisios gave birth to their very own through serendipitous circumstances. 'We found ourselves seated next to each other in 1990 on a flight from Rome to Milan,' Massimo recalled. 'Neither of us intended to take it due to scheduling problems.' When Massimo gave Tiziana his business card on that flight, Tiziana recalled with a laugh, 'I could never have imagined we'd start a family in addition to a prolific fine jewelry collection that's going strong after 35 years. What good fortune! We are all looking forward to showing Orogami in Las Vegas this June.'
Yahoo
11-02-2025
- Health
- Yahoo
Tiziana Life Sciences Announces TV Interview with First Patient Dosed with Moderate Alzheimer's Disease
NEW YORK, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ('Tiziana' or the 'Company'), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that its investigational drug, intranasal foralumab, was featured on a prominent News Channel. The segment highlighted the experiences of the first patient dosed in the company's expanded access program for moderate Alzheimer's disease. In the segment, Joe and his Wife, Karen, shared their journey and shed light on the hope that innovative therapies like Foralumab offer for individuals battling moderate Alzheimer's, a condition that currently has no cure and limited treatment options. Watch the full interview here: Dr. Howard Weiner, Co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham healthcare system commented 'Foralumab, administered via a novel intranasal delivery method, aims to target immune system dysregulation associated with Alzheimer's disease, potentially slowing disease progression and improving cognitive function. The recent coverage in the News underscores the growing recognition of Foralumab's promise in the field of neurodegenerative diseases.' Foralumab's mechanism of action involves modulating the immune system to reduce inflammation, which has been linked to neurodegeneration in Alzheimer's. The expanded access program enables patients who do not have access to clinical trials to receive this promising treatment as part of a compassionate use initiative. Microglial activation is increasingly recognized as a critical component of neurodegenerative diseases, including Alzheimer's, secondary progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and Parkinson's disease. In Alzheimer's, this activation contributes to the pathogenesis alongside increased beta-amyloid and tau protein levels. Cognitive dysfunction in AD has been linked to both tau accumulation and microglial activation, highlighting the need for treatments beyond amyloid-targeting therapies. Nasal foralumab, a fully human anti-CD3 monoclonal antibody, has shown efficacy in dampening microglial activation through the induction of Tregs, which travel to the brain and modulate neuroinflammation. This therapeutic effect has been validated in animal models and observed in subjects with secondary progressive MS. Nasal foralumab also holds promise as a potential adjunctive therapy that addresses a major component of AD pathogenesis not targeted by anti-amyloid therapies. About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana's innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana's lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana's technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit Forward-Looking Statements Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Tiziana's Annual Report on Form 20-F for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development, and Investor Relations+44 (0) 207 495 2379email: info@ A video accompanying this announcement is available at: ____________________[1] in to access your portfolio
