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Archive for September, 2010

No increased risk for any autism subtypes
No increased risk associated with prenatal exposure

A new study published today in the journal “Pediatrics” indicated that there was no increased risk of Autism Spectrum Disorder associated with receipt of thimerosal-containing vaccines. The study also found no increased risk for any of the subtypes of Autism Spectrum Disorder, including ASD with regression.  In addition, it found no increased risk of Autism Spectrum Disorder associated with prenatal exposure to thimerosal.

A case-control study was conducted in 3 managed care organizations of 256 children with ASD and 752 controls, matched by age and gender. Exposure to thimerosal was determined by electronic immunization registries, medical charts and parent interviews.

This study confirms previous research, which has not revealed an increased risk of autism associated with receipt of thimerosal containing vaccines. It adds to the body of knowledge by reporting that prenatal exposure to thimerosal is not associated with autism. It also looked specifically at subtypes of autism, including autism with regression, again finding no association with thimerosal exposure.

No significant differences in exposure effects were found between boys and girls for any of the ASD outcomes; there was no evidence that higher prenatal exposure exacerbated the effects of post-natal exposure; and there was no evidence that concurrent ethylmercury exposure was associated with ASD. In addition, there was no substantive difference in the association between thimerosal exposure and risk for ASD among children with an older sibling with autism and those without an older sibling with autism.

“In a way, it’d be great if thimerosal in infant vaccines was the culprit because the U.S. has already removed thimerosal from them” said Dr. Sharon Humiston, a pediatrician and FAAP, former member of the National Vaccine Advisory Committee (NVAC) and member of the Autism Science Foundation Science Advisory Board.  “Because we have not found the root causes of autism, we need to keep funding the research that will help us find them.  Because the resources to find what really does cause autism are scarce – money, scientists, and time – we urgently need to focus these resources on avenues that appear to be fruitful.  The vaccine hypothesis just has not yielded answers that help my autistic son or my typically developing daughter who may want to have children of her own one day.”

Pediatrics, September 13, 2010: Prenatal and Infant Exposure toThimerosal From Vaccines and Immunoglobulins and Risk of Autism

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Several people have written to us asking why Hannah Poling was compensated.

Hannah Poling received 5 shots to protect against 9 diseases on a single day. She developed fever following that series of vaccines. Because she had an existing encephalopathy (presumably on the basis of a mitochondrial enzyme defect) and because worsening of an existing encephalopathy following measles-containing vaccine is a compensible injury, Hannah Poling was compensated.

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Letter Urges Autism Speaks to Correct Website Statement Regarding Autism and Vaccines

(September 10, 2010—New York, NY) —The Autism Science Foundation, a not-for-profit organization dedicated to supporting and funding autism research, today announced that it has signed on to an open letter written by the Association for Science in Autism Treatment (ASAT) to Autism Speaks, calling for Autism Speaks to revise statements posted on its website regarding autism and vaccines to bring them more in line with current science.

On its website, Autism Speaks writes, “Several epidemiological studies have explored whether either the MMR vaccine or thimerosal, a preservative previously used in vaccines, are linked to autism, and these studies have not supported a link. But these studies were not designed to identify effects in a small population of potentially vulnerable children due to rare genetic and/or medical conditions.”

The letter from ASAT asks Autism Speaks to correct its website, specifically where Autism Speaks suggests there is a credible scientific rationale for a “vulnerable population” hypothesis, the implication being that there is a group of children for whom vaccines may cause autism. No data yet exist that support a “vulnerable population” hypothesis; it is entirely theoretical. Moreover, because no criteria are offered by which a parent can determine whether his/her child is in this supposed “vulnerable population”, some parents may assume his/her child is in the risk group, and may then choose to withhold potentially life-saving vaccinations.

“Of course we signed onto this letter,” said Alison Singer, President of the Autism Science Foundation. “The mission of our organization is to ensure that parents and other stakeholders have accurate, evidence-based, scientifically-relevant information about autism. The data are very clear regarding autism and vaccines. There are no studies indicating autism is caused by vaccines and no data to support a “vulnerable population” hypothesis.”

 The full text of ASAT’s open letter to Autism Speaks can be viewed here:  http://www.asatonline.org/media_watches/40

The Autism Science Foundation is a 501(c)(3) public charity. Its mission is to support autism research by providing funding and other assistance to scientists and organizations conducting, facilitating, publicizing and disseminating autism research. The organization also provides information about autism to the general public and serves to increase awareness of autism spectrum disorders and the needs of individuals and families affected by autism.

ASF’s Science Advisory Board (SAB) is comprised of Dr. Emanuel DiCicco-Bloom (UMDNJ-Robert Wood Johnson Medical School, past program chair of the International Society for Autism Research); Dr. Ami Klin (Yale Child Study Center); Dr. Sharon Humiston (University of Rochester); Dr. Harold Koplewicz (The Child Mind Institute); Dr. Eric London (New York Institute for Basic Research); Dr. Catherine Lord (University of Michigan); Dr. David Mandell (Univ. of Pennsylvania/CHOP; past program chair of the International Society for Autism Research); and Dr. Matthew State (Yale Medical School).

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Note from ASF: These data are neither peer reviewed nor published, but we know many of our readers are following Seaside’s work.

CAMBRIDGE, MASS., September 9, 2010—Seaside Therapeutics, Inc. announced today positive data from an open-label Phase 2 study of STX209 conducted in patients with autism spectrum disorders (ASD). The primary endpoint of the study, an improvement on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I), achieved statistical significance (p<0.001). In addition, STX209 demonstrated statistically significant improvements across a number of other global and specific neurobehavioral outcomes, including improvements on the Social Withdrawal subscale of the Aberrant Behavior Checklist (ABC-SW, p<0.001), which assesses a core symptom of ASD. A significant number of patients enrolled in the study are participating in an open-label extension study. STX209 is a selective gamma-amino butyric acid type B (GABA-B) receptor agonist being studied for the treatment of ASD and fragile X syndrome (FXS). In July 2010, Seaside reported clinically meaningful data from a randomized, placebo-controlled study of STX209 in individuals with FXS. The Company intends to present the full results from both studies at future medical meetings.

“We observed marked improvement in the majority of patients treated in the STX209 autism spectrum disorders study, including reductions in agitation and tantrums,” said Craig A. Erickson, M.D., Assistant Professor of Psychiatry, Chief of the Christian Sarkine Autism Treatment Center, Chief of the Fragile X Research Treatment Center at the Indiana University School of Medicine and an investigator in the study. “STX209 was well tolerated and most study participants continue to receive treatment in an open-label extension study. The importance of novel therapeutic development in neurodevelopmental disorders such as autism spectrum disorders and fragile X syndrome cannot be underestimated. This work will potentially open up a door to treating disorders that has, until recently, been firmly shut.”

“These study results add to a growing body of evidence supporting the potential of STX209 to play an important role in treating neurodevelopment disorders such as fragile X syndrome and autism spectrum disorders,” said Randall L. Carpenter, M.D., President and Chief Executive Officer of Seaside Therapeutics. “In addition, we have now observed significant improvement in social interaction across two studies. We believe the reduction in social withdrawal is important as it suggests that STX209 is demonstrating efficacy for a core symptom of both fragile X syndrome and autism. We look forward to initiating later stage clinical studies of STX209 in both fragile X syndrome and autism spectrum disorders.” 

Study Results:

Per Protocol Population:

In the per protocol population of 25 patients, the primary endpoint of the study, improvement on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I), was met (p<0.001). STX209 also demonstrated statistically significant improvements across a broad range of measures, including the ABC-SW subscale (p<0.001), reflecting improvement on a core symptom of both fragile X syndrome and ASD, and the ABC-Total scale (p<0.001), which evaluates a number of neurobehavioral outcomes, including hyperactivity, inappropriate speech and repetitive behavior. In addition, STX209 demonstrated statistical significance across key global measures, including investigators’ assessments of Clinical Global Impressions of Improvement (CGI-I) (p=0.001) and Severity (CGI-S) (p=0.002) and other focused measures of social responsiveness, anxiety, hyperactivity and adaptive function.

Safety Overview:

STX209 was well-tolerated and there were no metabolic side effects observed. One serious adverse event was reported, worsening of aggression, which occurred during taper of STX209 in a subject who had shown significant improvement while taking the drug. Two subjects withdrew due to adverse events, one during initial up-titration of drug and one during the treatment period, due to worsening of their baseline symptoms. The most common adverse events were agitation (22%), irritability (22%), fatigue (16%), hyperactivity (16%), diarrhea (13%) and insomnia (13%). Most events resolved spontaneously or with adjustment of drug dose.

 

Study Design:

The STX209 trial was a Phase 2 open-label study designed to explore safety and efficacy of STX209 in patients with ASD. Thirty-two patients with autism spectrum disorders were enrolled, with 28 patients completing the study. The patients ranged in age from 6-17 years. A broad range of behavioral and cognitive outcomes were included in the study design to add to the Company’s knowledge of potential efficacy measures in patients with ASD.

Key inclusion/exclusion criteria included a diagnosis of autism or a diagnosis of Pervasive Developmental Disorder – Not Otherwise Specified (PDD-NOS). PDD-NOS is a condition on the autism spectrum in which individuals demonstrate multiple symptoms classically associated with autism but of a scope or severity lower than in patients who meet full criteria for autism. In addition, patients in the study had to demonstrate a minimum severity on the ABC-I scale and were not allowed antipsychotic medications. Stable dosing of other medications was required for four weeks prior to entering the study.

Dosing was conducted as a flexible titration over two weeks to the optimal titrated dose (OTD). The starting dose was 1 mg twice a day and was gradually increased up to 10 mg three times a day for subjects greater than 11 years of age. OTD was continued for the remainder of the eight-week treatment period.

About STX209:

STX209 is a selective gamma-amino butyric acid type B (GABA-B) receptor agonist. Many aspects of certain neurodevelopmental disorders, including fragile X syndrome (FXS) and autism spectrum disorders (ASD), are believed to be caused by excessive activation of glutamate receptors and abnormally high ratios of excitatory to inhibitory neurotransmission in the brain. GABA-B receptors play an important role in modulating the release of glutamate and maintaining the optimal excitatory-inhibitory balance. STX209 has demonstrated efficacy in animal models, suggesting that altered excitatory and inhibitory neurotransmission can be corrected by activation of GABA-B receptors, thus ameliorating functional deficits in individuals with FXS and ASD.  

About Autism:

Autism is characterized by three hallmark behaviors that can range from mild to disabling, including difficulties with social interaction, problems with verbal and nonverbal communication and repetitive behaviors or narrow, obsessive interests. Experts estimate that as many as 1 in 100 children have an autism spectrum disorder, with boys being four times more likely than girls to be diagnosed with the disorder. There is no cure for autism. A variety of medications and behavioral interventions are used in an attempt to address individual symptoms of the disease.

About Seaside Therapeutics:

Seaside Therapeutics, Inc. is creating novel drug treatments to correct or improve the course of fragile X syndrome, autism and other neurodevelopmental disorders. The Company is dedicated to translating breakthrough discoveries in neurobiology into therapeutics that improve the lives of patients and their families. For more information please visit www.seasidetherapeutics.com.

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AUTISM SCIENCE FOUNDATION ISSUES
NEW REQUEST FOR SCIENTIFIC GRANT PROPOSALS

Grants will fund pre and post doctoral autism research fellowships

(September 7, 2010—New York, NY)–The Autism Science Foundation, a not-for-profit organization dedicated to supporting and funding autism research, today announced that it had issued a new request for scientific proposals. ASF is inviting applications for Pre and Post Doctoral Training Awards from graduate students, medical students and post-doctoral fellows interested in pursuing careers in basic and clinical research relevant to autism spectrum disorders. 

The proposed training must be scientifically linked to autism. Autism Science Foundation will consider for training purposes all areas of related basic and clinical research including but not limited to: human behavior across the lifespan (language, learning, communication, social function, epilepsy, sleep, repetitive disorders), neurobiology (anatomy, development, neuro-imaging), pharmacology, neuropathology, human genetics/genomics, immunology, molecular and cellular mechanisms, studies employing model organisms and systems, and studies of treatment and service delivery.

Additional information about the RFA can be found at www.autismsciencefoundation.org/ApplyForaGrant.html

The Autism Science Foundation is a 501(c)(3) public charity. Its mission is to support autism research by providing funding and other assistance to scientists and organizations conducting, facilitating, publicizing and disseminating autism research. The organization also provides information about autism to the general public and serves to increase awareness of autism spectrum disorders and the needs of individuals and families affected by autism.

Grant applications will be reviewed by members of ASF’s Science Advisory Board (SAB) and other highly qualified reviewers. Current SAB members include Dr. Emanuel DiCicco-Bloom (UMDNJ-Robert Wood Johnson Medical School; past program chair of the International Society for Autism Research); Dr. Ami Klin (Yale Child Study Center); Dr. Sharon Humiston (University of Rochester); Dr. Harold Koplewicz (The Child Mind Institute); Dr. Eric London (New York Institute for Basic Research); Dr. Catherine Lord (University of Michigan); Dr. David Mandell (Univ. of Pennsylvania/CHOP; past program chair of the International Society for Autism Research) and Dr. Matthew State (Yale Medical School).

To learn more about the Autism Science Foundation’s grant programs, and to read about projects funded through this mechanism in 2009, visit www.autismsciencefoundation.org/ApplyForaGrant.html

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Contact Info:    

Beth Feldman
Beyond PR
beyondpr@gmail.com
914-576-0447

Julie Martin
Autism Science Foundation
jmartin@autismsciencefoundation.org

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