Coronado Biosciences Announces IND Submission for CNDO-109 for the Treatment of Relapsed Acute Myeloid Leukemia; $CNDO

Coronado Biosciences Announces IND Submission for CNDO-109 for the Treatment of Relapsed Acute Myeloid Leukemia; $CNDO

Coronado Biosciences (NASDAQ: CNDO) 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 autoimmune diseases, such as Crohn’s disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML) and solid tumors. 

The Company announced that “it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CNDO-109, a novel biologic that primes natural killer (NK) cells without the need for cytokines (IL-2), and is being studied for the treatment of patients with high risk acute myeloid leukemia (AML) in first complete remission.”

Coronado President and CEO Dr. Bobby W. Sandage, Jr. commented,

"The submission of the IND marks an important milestone in the development of our NK cell program. We are extremely encouraged by the data generated to date on CNDO-109.  Pending FDA review of our IND, we anticipate initiating a Phase I/II allogeneic clinical trial for the treatment of patients with high risk AML in first complete remission in the second quarter of this year."

The Company presented results from a Phase I investigator-initiated clinical trial of CNDO-109 at the 53rd American Society of Hematology (ASH) Annual Meeting and Exposition on December 13, 2011. Although "the primary endpoint of the Phase I clinical trial was safety, the results demonstrated that the majority of AML patients experienced a longer complete remission (CR) after receiving CNDO-109 activated NK cells than their previous complete remission."

For more information please see www.CoronadoBiosciences.com.

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