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Phase I Clinical Trial of Rationally Designed Doxorubicin


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Coronado Initiates Phase I Clinical Trial of Rationally Designed Fourth Generation Doxorubicin Analogue

SAN DIEGO, January 07, 2008 /PRNewswire/ -- Coronado Biosciences Inc. today announced that the first patient has been treated in a Phase I clinical trial of CNDO101, a rationally designed fourth generation doxorubicin analogue.

The uniquely designed Phase I dose-escalation study in adult patients with advanced cancer will investigate the safety and preliminary efficacy of CNDO101 (5-imino-13 deoxy-doxorubicin). The trial has eight dose levels and allows patients to move to higher doses with each cycle if there is no evidence of toxicity. This modified design should allow the investigators to demonstrate evidence of anti-cancer activity. Coronado expects to enroll at least 30 patients in this study.

"The initiation of this clinical trial is an important milestone that marks our advancement to a clinical-stage company and is exemplary of our focus on improving cancer care," said RJ Tesi, M.D., president and CEO of Coronado Biosciences. "CNDO101 is a new drug that has been rationally designed to eliminate cardiotoxicity and improve tolerability so that it can potentially be used in combination with taxanes and other therapeutic agents to provide patients with improved treatment options. The strength of the supporting pre-clinical data and known regulatory pathway of the compound can decrease the development risk and increase the value of the compound."

The patient was treated at Holden Comprehensive Cancer Center at the University of Iowa by Raymond Hohl, M.D., Ph.D., professor of internal medicine and pharmacology and associate director of translational research at the cancer center.

"Currently available anthacyclines have some degree of cardiotoxicity that limits their use for treating many types of cancers," said Hohl, who also holds the Holden Family Chair. "As a class they are amongst the most active of chemotherapy drugs and hence, the prospect of a non-cardiotoxic anthracycline is very exciting. Many cancer patients will undoubtedly benefit from a non-cardiotoxic anthracycline."

About CNDO101

Doxorubicin is a topoisomerase II inhibitor, a cornerstone in many treatment protocols for breast cancer, NHL, lung cancer and leukemia. It is already prescribed to nearly half of patients with breast cancer, but use is limited by concerns of cardiotoxicity. CNDO101 is a new, fourth generation, 5-imino-13-deoxy-doxorubicin that is rationally designed to eliminate cardiotoxicity without compromising efficacy. Targets for future drug development may include relapsed breast cancer with a previous response to a doxorubicin and multiple myeloma (with bortezomib) and lung cancer.

About Holden Comprehensive Cancer Center at the University of Iowa

Holden Comprehensive Cancer Center is Iowa's only National Cancer Institute (NCI)-designated comprehensive cancer center. NCI-designated comprehensive cancer centers are recognized as the leaders in developing new approaches to cancer prevention and cancer care, conducting leading edge research and educating the public about cancer. Visit the center online at http://www.uihealthcare.com/depts/cancercenter.

About Coronado Biosciences Inc.

Coronado Biosciences Inc. is a clinical stage biopharmaceutical company that is focused on changing cancer care by improving current therapies. The company's pipeline consists of both clinical and pre-clinical compounds that will offer unique options to physicians and patients. By mitigating scientific, development and financial risk, the company increases the likelihood of developing marketable drugs with the potential for broad indications. For more information, call (858) 731-8517 or visit http://www.coronadobiosciences.com.

Contact: Tracey Milani or David Schull

Russo Partners, LLC


tracey.milani@russopartnersllc.com david.schull@russopartnersllc.com

CONTACT: Tracey Milani, , or DavidSchull, , both of Russo Partners, LLC,+1-619-814-3511, for Coronado Biosciences Inc. tracey.milani@russopartnersllc.com david.schull@russopartnersllc.com

Web site: http://www.coronadobiosciences.com/http ... cercenter/

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