Coronado Biosciences Announces Presentation of Interim Data From Autism Study at Neuropsychopharmacology Meeting
December 12 2013 - 4:30PM
- Study Investigator Eric Hollander, M.D., Reports
Potential Benefits of TSO Immunotherapy in First 5
Patients
- Study Completion and Final Results Expected
Mid-2014
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."
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.
CONTACT: Lucy Lu, MD, Executive Vice President &
Chief Financial Officer
Coronado Biosciences, Inc.
781-652-4525; ir@coronadobio.com
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