|Coronado Bio Presents Interim Data from Autism Study; FDA Advisory Committee Unanimously Recommends GRASTEK|
|By Staff and Wire Reports|
|Thursday, 12 December 2013 19:50|
Coronado Biosciences, Inc. (Nasdaq: CNDO), a biopharmaceutical company developing novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that Dr. Eric Hollander, Clinical Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine of Yeshiva University and Director of the Autism and Obsessive Compulsive Spectrum Program at Montefiore Medical Center and Einstein, presented interim data from his pilot study of oral TSO (Trichuris suis ova or CNDO-201) to treat autism at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, Florida.
The study is a double-blind, randomized, placebo-controlled, cross-over study and enrolled 10 high-functioning adult autism spectrum disorder patients who were able to give informed consent to participate in the study and who had a history of allergies and/or a family history of immune-inflammatory illness. They were treated for 12 weeks with either TSO or placebo, followed by a 4-week washout phase and then 12 weeks of placebo or TSO. The TSO dosage used in the study was 2,500 ova once every two weeks.
In the first 5 patients that completed the study, there was a statistically significant separation from placebo in favor of TSO on three measures of disease: the Montefiore-Einstein Rigidity Scale (MERS), the Repetitive Behavior Scale-Revised (RBS-R) Sameness Scale, and the Social Responsiveness Scale (SRS)-Repetitive Behaviors Scale. The treatment was well tolerated.
The study is still ongoing and final results are expected in the middle of 2014.
"There is increasing evidence that immune dysregulation plays an important role in this developmental disorder and we are encouraged by the interim data from this pilot study with TSO," said Dr. Harlan F. Weisman, Coronado's Chairman and CEO. "We believe autism is an area of unmet medical need where a natural immune system regulator like TSO may help a part of the autism population."
ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the Allergenic Products Advisory Committee of the US Food and Drug Administration has voted unanimously that the available data support the efficacy and safety of Merck's GRASTEKTM in patients aged five to 65 years. The committee further recommended that adrenaline auto-injectors should be made available for patients at home.
GRASTEKTM is the proposed US trade name of the grass sublingual allergy immunotherapy tablet, licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK, and marketed in Europe under the brand name GRAZAX(R).
The FDA is currently reviewing Merck's Biologic License Application (BLA) for GRASTEKTM for the treatment of grass pollen induced allergic rhinitis, with or without conjunctivitis, in adults and children of five years and older.
Jens Bager, ALK's President and CEO, said: "ALK welcomes the FDA Advisory Committee's conclusion, which represents another important step towards bringing this innovative new treatment to US patients."
Although not binding, the FDA will consider the committee's recommendation as it completes its review of the BLA for GRASTEKTM, a process that is expected to be concluded during the first half of 2014.
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Coronado Biosciences, Inc. (Nasdaq:CNDO), a biopharmaceutical company developing novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that Dr. Eric Hollander, Clinical Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine of Yeshiva University and Director of the Autism and Obsessive Compulsive Spectrum Program at Montefiore Medical Center and Einstein, presented interim data from his pilot study of oral TSO (Trichuris suis ova or CNDO-201) to treat autism at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, Florida.
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