BURLINGTON, Mass., Feb. 14, 2012 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc. (Nasdaq:CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today 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.
"The submission of the IND marks an important milestone in the development of our NK cell program," said Dr. Bobby W. Sandage, Jr., Coronado's President and CEO. "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."
Results from a Phase I investigator-initiated clinical trial of CNDO-109 were presented 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.
AML is one of the most deadly and most common types of acute leukemia in adults. There are over 30,000 cases worldwide, primarily afflicting elderly and relapsed and refractory populations. Once diagnosed with AML, patients typically receive induction and consolidation chemotherapy, with the majority achieving complete remission. However, about 70-80% of patients who achieve first complete remission will relapse, and the overall five year survival rate is less than 25%.
About CNDO-109
CNDO-109 is a novel biologic that primes natural killer (NK) cells without the need for cytokine (IL-2) treatment that is being evaluated for the treatment of hematological cancers, including AML, and solid tumors. CNDO-109 activated NK cells have shown early efficacy in an investigator-initiated Phase I clinical trial in patients with AML and demonstrated preclinical activity in multiple myeloma, breast cancer, prostate cancer and ovarian cancer.
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 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. For more information, please visit www.coronadobiosciences.com.
Forward-Looking Statements
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