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Clinical Trial: Vanishing White Matter - Calico
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id="content" class="site-content"> <div id="primary" class="content-area"> <main id="main" class="site-main"> <article id="post-2985" class="post-2985 page type-page status-publish hentry"> <div class="entry-content"> <div class="hero mt-default mb-default pt-default pb-default mobile-mt-default mobile-mb-default mobile-pt-default mobile-pb-default hero-background block_background background_type_color short" id="hero_block_4de6f891e7edfce680aa64a35dc0f004" style=" --background-color:#28a059;"> <div class="hero__container"> <figure class="hero__background block_background background_type_image block_background__media " style="--bg-position-x-dt:center;--bg-position-y-dt:top;--bg-position-x-mb:center;--bg-position-y-mb:center;--fill-mode:cover;"> <img decoding="async" data-src="/wp-content/themes/calico/assets/images/hero/calico-hero-background-short.webp" alt="" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" class="lazyload"><noscript><img decoding="async" src="/wp-content/themes/calico/assets/images/hero/calico-hero-background-short.webp" alt=""></noscript> </figure> <div class="hero__heading "> <div class="hero__heading__container"> <div class="hero__heading__title"> <h1 class="h1"> Clinical Trial: Vanishing White Matter </h1 > </div> </div> </div> <div class="hero__scroll__container"> <div class="hero__scroll"> <a href=""> <svg height="39" viewBox="0 0 39 39" width="39" class=""> <g> <g id="scroll-icon-arrow"> <rect y="-40" fill="none" stroke="none" width="40" height="80"></rect> <path d="M27.5,19.5c-0.3-0.3-0.8-0.3-1.1,0l-5.7,5.7V13c0-0.4-0.3-0.8-0.8-0.8s-0.8,0.3-0.8,0.8v12.2l-5.7-5.7 c-0.3-0.3-0.8-0.3-1.1,0s-0.3,0.8,0,1.1l7,7c0.1,0.1,0.2,0.1,0.2,0.2c0.1,0,0.2,0.1,0.3,0.1s0.2,0,0.3-0.1c0.1,0,0.2-0.1,0.2-0.2 l7-7C27.8,20.2,27.8,19.8,27.5,19.5z"> </path> <path d="M27.5-20.5c-0.3-0.3-0.8-0.3-1.1,0l-5.7,5.7V-27c0-0.4-0.3-0.8-0.8-0.8s-0.8,0.3-0.8,0.8v12.2l-5.7-5.7 c-0.3-0.3-0.8-0.3-1.1,0s-0.3,0.8,0,1.1l7,7c0.1,0.1,0.2,0.1,0.2,0.2c0.1,0,0.2,0.1,0.3,0.1s0.2,0,0.3-0.1c0.1,0,0.2-0.1,0.2-0.2 l7-7C27.8-19.8,27.8-20.2,27.5-20.5z"> </path> </g> <!-- <circle fill="none" cx="20" cy="20" r="18.5"></circle> --> </g> </svg> </a> <div class="hero__scroll__line"></div> </div> </div> </div> </div> <section id="page_section_block_d698c17865d220cf9dee2e00f2b22ff2" class="page-section mt-default mb-default pt-default pb-default mobile-mt-default mobile-mb-default mobile-pt-default mobile-pb-default block_background background_type_color " style=""> <div class="acf-innerblocks-container"> <div id="sizing_container_block_c2afd015c233afd2ab9db579c571add0" class="sizing-container section__margin_auto container__small mt-default mb-default pt-default pb-default mobile-mt-default mobile-mb-default mobile-pt-default mobile-pb-default" style=""> <div class="sizing-container_wrapper"> <h2 class="wp-block-heading">Understanding Vanishing White Matter</h2> <p>Vanishing White Matter (VWM) is an ultra-rare genetic condition that causes the deterioration of white matter in the brain and permanently affects the transmission of nerve signals to the rest of the body.</p> <p>Individuals with VWM commonly have symptoms such as:<br>· Impaired muscle movement<br>· Cognitive decline<br>· Behavioral changes<br>· Seizures<br></p> <p>While symptoms often begin to appear between ages 2 and 6, the disease can present at any age. VWM is chronic and progressive, and stressors such as fever, infection, and mild head trauma may cause periods of faster deterioration.<br></p> <p>VWM is an autosomal recessive disorder, meaning that both copies of the affected gene must be altered for the disease to manifest. There is currently no cure and no treatment approved for VWM.</p> <figure class="wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio"><div class="wp-block-embed__wrapper"> <iframe title="Vanishing White Matter" width="500" height="281" data-src="https://www.youtube.com/embed/9UvCpAHV23w?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" class="lazyload" data-load-mode="1"></iframe> </div></figure> <h2 class="wp-block-heading">Developing a new approach to the management of Vanishing White Matter</h2> <p>VWM is caused by genetic variations in any of the five genes responsible for producing a protein complex called the eukaryotic translation initiation factor 2B (eIF2B). The activity of eIF2B is required for the production of new proteins in all our cells and is a key factor in the regulation of the integrated stress response (ISR). When the activity of eIF2B is reduced, protein production is also reduced and the ISR is turned on. When activated in the brain, a chronic ISR can cause the destruction of white matter. </p> <p>Pursuant to their 2014 collaboration, Calico and AbbVie are investigating fosigotifator (ABBV- CLS-7262) as a potential regulator of the ISR. Fosigotifator directly targets eIF2B and increases the activity of elF2B complexes carrying VWM variations. In preclinical studies, fosigotifator has demonstrated the ability to decrease the ISR in the brain and spinal cord in disease models that carry VWM variations and has been shown to improve coordination and movement problems. It is hypothesized that if proper function of the elF2B protein complex can be restored, brain white matter damage and loss may be prevented in people with VWM. </p> <p>Calico has also partnered with the Vanishing White Matter Consortium to investigate the use of fosigotifator in treating VWM. For more information about this global consortium visit: <a href="https://www.vwmconsortium.org/">www.vwmconsortium.org</a>.</p> <h2 class="wp-block-heading">Our Vanishing White Matter clinical trial</h2> <p>Calico and AbbVie are currently conducting a Phase 1b/2 trial of fosigotifator to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of fosigotifator in participants diagnosed with VWM disease. This study is the first time an eIF2B activator has been administered to people with VWM disease (<a href="https://www.clinicaltrials.gov/study/NCT05757141">NCT05757141</a>). Fosigotifator is currently used only under clinical investigation and is not approved for any use in any markets at this time. </p> <p>The most up-to-date information about this investigational study can be found by visiting <a href="https://www.clinicaltrials.gov/">www.clinicaltrials.gov</a> and entering “NCT05757141” in the “Other terms” field. </p> <p>For questions about potential trial participation and available travel support, please call: 1-833- 250-9660 or send an email to: vwminfo@mylocalstudy.com.</p> <h2 class="wp-block-heading">About our clinical trials</h2> <p>Calico and our collaborative partners are committed to designing and conducting clinical studies with the highest integrity and ethical standards and we are devoted to the safety and well-being of the people who participate. All interventional clinical trials sponsored by Calico are designed in accordance with, and authorized by, the appropriate regulatory agencies. If you have additional questions, please contact us at: <a href="mailto:clinicaltrialcommunication@calicolabs.co"><strong>clinicaltrialcommunication@calicolabs.com</strong></a>.</p> <p><strong>References</strong></p> <p>Yao Liang Wong, et al. <strong>The small molecule ISRIB rescues the stability and activity of Vanishing White Matter Disease eIF2B mutant complexes.</strong> <em>eLife</em> 7:e32733 (2018). <a href="https://doi.org/10.7554/eLife.32733" target="_blank" rel="noreferrer noopener"><strong>https://doi.org/10.7554/eLife.32733</strong></a></p> <p>Yao Liang Wong, et al. <strong>eIF2B activator prevents neurological defects caused by a chronic integrated stress response</strong>. <em>eLife</em> 8:e42940 (2019)<em>.</em> <a href="https://doi.org/10.7554/eLife.42940" target="_blank" rel="noreferrer noopener"><strong>https://doi.org/10.7554/eLife.42940</strong></a></p> <p>James J. Lee, et al. <strong>eIF2B Activator Rescues Neonatal Lethality of an eIF2Bα Sugar Phosphate Binding Mutation Associated with Vanishing White Matter Disease. </strong><em>bioRxiv </em>2023.05.06.539602 (2023). <a href="https://doi.org/10.1101/2023.05.06.539602" target="_blank" rel="noreferrer noopener"><strong>https://doi.org/10.1101/2023.05.06.539602</strong></a></p> </div> </div> </div> </section> </div><!-- .entry-content --> </article><!-- #post-2985 --> </main><!-- #main --> </div><!-- #primary --> </div><!-- #content --> <footer id="colophon" class="site-footer"> <div class="site-footer__container container"> <div class="site-footer__logo from-bottom__0"> <svg height="95" viewBox="0 0 95 95" width="95"><g fill="none" fill-rule="evenodd"><path fill="#25BD56" d="M53.646 55.464c-4.063 3.286-9.981 2.608-13.22-1.514-3.237-4.122-2.57-10.127 1.492-13.414a9.3 9.3 0 0 1 11.73.002L57 36.275c-6.382-5.167-15.682-4.105-20.773 2.371-5.09 6.476-4.045 15.914 2.337 21.08a14.613 14.613 0 0 0 18.432.003l-3.35-4.265z"></path><path fill="#25BD56" d="M56.852 65.326c-9.845 5.165-22.014 1.371-27.18-8.474-5.164-9.846-1.37-22.014 8.476-27.18 9.845-5.164 22.014-1.37 27.18 8.475a20.131 20.131 0 0 1-4.48 24.423l3.558 4.019c10.543-9.337 11.52-25.453 2.183-35.996-9.337-10.542-25.452-11.52-35.995-2.183-10.543 9.337-11.52 25.453-2.184 35.995a25.5 25.5 0 0 0 30.936 5.675l-2.494-4.754z"></path><path fill="#25BD56" d="M77.47 36.48c6.165 16.058-2.033 34.005-18.31 40.086-16.271 6.08-34.458-1.999-40.63-18.047-6.169-16.055 2.024-34.004 18.3-40.09 13.559-5.07 28.875-.36 37.11 11.415l4.511-3.071C66.847 10.183 43.807 6.013 26.99 17.46c-16.818 11.448-21.044 34.177-9.44 50.767 11.604 16.59 34.644 20.76 51.462 9.313 14.011-9.537 19.617-27.274 13.584-42.976l-5.125 1.917z"></path><g><path fill="#25BD56" d="M27.92 10.348C48.47-.432 73.87 7.488 84.65 28.04c10.78 20.55 2.861 45.948-17.687 56.73-20.551 10.78-45.951 2.86-56.732-17.69C1.249 49.96 5.108 28.92 19.582 16.1l-3.595-4.059c-19.614 17.372-21.432 47.356-4.06 66.97C29.3 98.627 59.28 100.446 78.896 83.076c19.615-17.371 21.434-47.355 4.063-66.97C68.486-.236 44.73-4.595 25.4 5.547l2.519 4.801z" mask="url(#b)"></path></g></g></svg> </div> <div class="site-footer__content"> <div class="site-footer__menus"> <div class="site-footer__menu from-bottom__1 from-bottom-mb__0 hide_on_mobile"> <h5 class="h5_small">About Us</h5> <ul> <li> <a class="animated_underline_link small" href="/research-technology/" target="">Research & Technology</a> </li> <li> <a class="animated_underline_link small" href="/drug-development/" target="">Drug Development</a> </li> <li> <a class="animated_underline_link small" href="/people/" target="">Leadership</a> </li> <li> <a class="animated_underline_link small" href="/partnering/" target="">Partnering</a> </li> <li> <a class="animated_underline_link small" href="/life-at-calico/" target="">Life at Calico</a> </li> </ul> </div> <div class="site-footer__menu from-bottom__2 from-bottom-mb__0 hide_on_mobile"> <h5 class="h5_small">Resources</h5> <ul> <li> <a class="animated_underline_link small" href="/publications/" target="">Publications</a> </li> <li> <a class="animated_underline_link small" href="/calico-stories/" target="">Calico Stories</a> </li> <li> <a class="animated_underline_link small" href="/news-and-media/" target="">News & Media</a> </li> <li> <a class="animated_underline_link small" href="/patients/" target="">Patients</a> </li> </ul> </div> <div class="site-footer__menu from-bottom__3 from-bottom-mb__0 hide_on_mobile"> <h5 class="h5_small">Contact Us</h5> <ul> <li> <a class="animated_underline_link small" href="/contact-us/" target="">Contact Us</a> </li> <li> <a class="animated_underline_link small" href="/careers/" target="">Join Us</a> </li> </ul> </div> <div class="site-footer__menu from-bottom__4 from-bottom-mb__1 show_on_mobile"> <h5 class="h5_small">Follow Us</h5> <ul> <li> <a class="animated_underline_link small" href="https://twitter.com/calico" target="_blank">X</a> </li> <li> <a class="animated_underline_link small" href="https://www.linkedin.com/company/calico-life-sciences-llc" target="_blank">LinkedIn</a> </li> </ul> </div> <div class="site-footer__menu from-bottom__0 from-bottom-mb__2 show_on_mobile"> <ul> <li> <a class="animated_underline_link small" href="/privacy-policy/" target="">Privacy Policy</a> </li> <li> <a class="animated_underline_link small" href="/privacy-policy/#collection-notice" target="">Notice at Collection</a> </li> <li> <a class="animated_underline_link small" href="/terms-of-use/" target="">Terms of Use</a> </li> <li> <a class="animated_underline_link small" href="/code-of-conduct/" target="">Code of Conduct</a> </li> </ul> </div> </div> <div class="site-footer__copyright from-bottom__0 from-bottom-mb__3"> <span>2024 Calico Life Sciences LLC. 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