Coronado Biosciences,
Inc. 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."
About Coronado Biosciences
Coronado Biosciences is engaged in the development of novel immunotherapy
biologic agents. The company's two principal pharmaceutical product candidates
in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic
for the treatment of immune-mediated diseases such as psoriasis, ulcerative
colitis and multiple sclerosis, and other diseases such as autism; and
CNDO-109, a biologic that activates natural killer (NK) cells, for the
treatment of acute myeloid leukemia (AML), multiple myeloma and solid tumors.
For more information, please visit www.coronadobiosciences.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Such statements include, but are not limited to, any
statements relating to product development programs and any other statements
that are not historical facts. Forward-looking statements are based on
management's current expectations and are subject to risks and uncertainties
that could negatively affect our business, operating results, financial
condition and stock price. Factors that could cause actual results to differ
materially from those currently anticipated are: risks relating to the results
of research and development activities; uncertainties relating to preclinical
and clinical testing; the early stage of products under development; our
ability to attract, integrate and retain key personnel; our ability to obtain,
perform under and maintain financing and strategic agreements and
relationships; our need for substantial additional funds; government
regulation; patent and intellectual property matters; our dependence on third
party suppliers; competition; as well as other risks described in our SEC
filings. We expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements contained
herein to reflect any change in our expectations or any changes in events,
conditions or circumstances on which any such statement is based, except as
required by law.
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