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CEO Letter July 13, 2009 I am happy to report that over the last few months, Seaside has made considerable progress advancing our clinical development programs. We are now actively enrolling subjects as young as 12 years old in two Phase 2 studies of STX209—the first in individuals with Fragile X Syndrome and the second in individuals with autism spectrum disorders. Assuming an acceptable safety and efficacy profile, we plan to expand these studies to include younger children betweens the ages of 6 and 11. To date there are 8 sites across the country recruiting patients for the Fragile X study and 4 sites for the autism study. In an ongoing effort to make it easier for patients and families to participate in our trials, we are currently adding sites to broaden our geographic coverage. For a complete listing of clinical trial sites, please visit the STX209 autism study listing and the STX209 Fragile X study listing on clinicaltrials.gov. In addition to our lead clinical programs, we continue to make progress advancing our second candidate, STX107. STX107 is a highly potent, selective mGluR5 antagonist. Our scientific founder, Dr. Mark Bear, discovered a connection between mGluR5 signaling and Fragile X Syndrome that suggests that exaggerated signaling through mGluR5 receptors is responsible for many of the neurological and psychiatric consequences of fragile X. Seaside has been awarded translational research grants to support the development of STX107 by the National Institutes of Health, Autism Speaks and FRAXA. Working in close collaboration with these organizations, we plan to initiate exploratory safety and efficacy trials of this novel product candidate in patients with Fragile X in 2010. Our collaborative approach for the development of STX107 is a reflection of our belief that significant strides to treat brain development disorders will not be made unless those leading the scientific research work together. As such, we routinely partner with pharmaceutical and biotechnology companies, universities, government agencies, foundations and advocacy groups to bring together the best minds, the most advanced science and the necessary resources to drive the development of new therapeutics and new hope. As part of these efforts, Seaside also participates in a number of scientific meetings and events to help support and advance research in the field. In April, I presented a talk entitled "Translating Research Discoveries into Novel Therapeutics" at the second annual Florida Fragile X Young Investigators Research Conference "From Mechanism to Medicine" cosponsored by the National Fragile X Foundation and Scripps Florida. This meeting provides a unique opportunity for young scientific investigators new to Fragile X research to present their work to their peers and scientific thought-leaders. Seeing first-hand the impressive research and the excitement that these new investigators bring to the Fragile X field supports my belief that, as a community, we are making significant strides in understanding and developing new drug treatments for this devastating disease. Also in April, Dr. Mark Bear, cofounder of Seaside, presented a talk entitled "Fragile X: Translation in Action" at the Roche-Nature Medicine Translational Neuroscience Symposium 2009," a meeting to discuss the recent advances made in understanding the pathophysiology of autism and to explore how insights from other developmental brain disorders can add to this knowledge-base. The three day meeting brought thought-leaders together from around the world to share their insights and research as we all work together to find more effective therapeutics to help individuals with autism or autism spectrum disorders. In May, Dr. Bear also delivered a keynote address on "Fulfilling the Promise of Molecular Medicine in Autism" at The International Meeting for Autism Research, an annual meeting held for autism spectrum disorder (ASD) clinicians and scientists to promote exchange and dissemination of the latest scientific findings and to stimulate research progress in understanding the nature, causes and treatments for ASD. As we move to the second half of the year, we will continue to build on this progress and I look forward to updating you on our successes throughout the coming months. Until then, I hope you enjoy your summer. Sincerely, |
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