Coronado Biosciences Announces Phase 1 Results of CNDO-109 in AML Presented at the American Society of Hematology

BURLINGTON, Mass., Dec. 13, 2011 /PRNewswire/ -- Coronado Biosciences, Inc., (OTCBB: CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that an oral presentation on CNDO-109 was given at the 53rd American Society of Hematology (ASH) Annual Meeting and Exposition held at the San Diego Convention Center in California.  CNDO-109 is a biologic that activates natural killer (NK) cells for the treatment of acute myeloid leukemia (AML) and solid tumors.

Dr. Panagiotis Kottaridis of the Department of Haematology, Royal Free Hampstead NHS Trust and University College London Medical School, UK reported the final results of the Phase 1 clinical trial of CNDO-109 in AML (abstract #946).  The results demonstrated that AML patients experienced a longer complete remission (CR) after receiving CNDO-109 activated NK cells than their previous CR.

The analysis was based on eight AML patients of whom five were in a subsequent CR, one was in their first CR, one was in partial relapse (PR) and one was in relapsing disease.  As conditioning, patients received fludarabine 25mg/m2/day for three days plus a single fraction (2Gy) total body irradiation (TBI) on day four.  24 hours after the completion of TBI, patients received 1 million activated haploidentical related donor CNDO-109 tumor primed NK cells as a single i.v. infusion. 

Three of the patients in a subsequent CR demonstrated a longer CR than their previous one, and the patient in PR reverted to CR.  No comparison was available for the patient in their first CR, and the patient in relapsing disease was not evaluable.

No toxicity related to the infusion was observed. Seven patients experienced bone marrow suppression with a median time of 55 days (19-101) for neutrophil recovery. Two patients who previously had an allogeneic transplant were salvaged with a CD34+ top up stem cell transfusion from their original donors. All patients experienced neutropenic fevers requiring antibiotic support.

Dr. Panagiotis Kottaridis commented, "In my experience it is unusual for any patient with AML to have subsequent CRs longer than their previous CRs. In this study, the majority of patients experienced this after treatment with CNDO-109 activated NK cells.  This finding demonstrates that CNDO-109 may have a significant role in treating AML patients and supports further development of the product."

Coronado Biosciences expects to file an IND on CNDO-109 with the US FDA in the first quarter of 2012 and initiate a Phase I/II dose escalation trial in AML patients shortly thereafter. 

CNDO-109 was discovered by Dr. Mark Lowdell, Director of Cellular Therapy & Biobanking at Royal Free Hampstead NHS Trust and Assistant Professor and Senior Lecturer in Hematology at University College London.

About CNDO-109

CNDO-109 is a novel anti-cancer drug that primes natural killer (NK) cells without the need for cytokine (IL-2) treatment and shows significant potential for the treatment of hematological and solid tumors. CNDO-109 has produced impressive results in a Phase I clinical trial in patients with AML and demonstrated preclinical activity in multiple myeloma, breast cancer, prostate cancer and ovarian cancer. Coronado plans to file an IND and initiate a Phase I/II dose escalation trial in AML patients in early 2012. 

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: 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

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 the Company's 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 risks relating to the results of research and development activities, uncertainties relating to preclinical and clinical testing, financing and strategic agreements and relationships, the early stage of products under development, our need for substantial additional funds, government regulation, patent and intellectual property matters; our dependence on third party suppliers and 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 Information:

Investor Relations

Noah D. Beerman, Executive Vice President & Chief Operating Officer
Coronado Biosciences, Inc.
781-238-6619; [email protected]

Marcy Nanus, Vice President
The Trout Group, LLC.
646-378-2927; [email protected]

Media Relations

Dennis S. Dobson Jr., CEO
Dobson Media Group
203-258-0159; [email protected]

SOURCE Coronado Biosciences, Inc.