Based on successful first phase testing that utilized an assay technology combining proprietary technologies from each party, the assay was able to differentiate between normal and lung cancer samples. The 1000 patient sample study was performed in the United States at a publicly held third party CLIA certified laboratory.
“Cangen is extremely pleased with the results thus far of this collaboration,” said Chul So Moon, M.D., Ph.D., Chief Executive Officer and Chief Science Officer of Cangen Biotechnologies. “Together with our partners at DNP, we are poised to introduce the first blood test diagnostic for early stage lung cancer.”
Cangen and DNP will begin the clinical trial phase in early 2009 with FDA submission of the test expected by 2011. “As we move forward with this new biotechnology, we are excited about the prospect of being able to offer earlier lung cancer detection with greater accuracy,” said Cathy McDermott, RN, MPH, Vice President, Regulatory Affairs and Technical Development, Cangen Biotechnologies.
To accelerate the project, Cangen will receive a milestone payment as part of the Technical Collaboration Agreement with DNP initiated in March 2007, for its technical contribution to the collaboration. Further development of the product may lead to additional milestone payments to Cangen toward the funding of a Phase 3 trial in the United States.
According to the Centers for Disease Control (CDC), more people die annually from lung cancer than any other type of cancer. The National Cancer Institute estimates over 215,000 new cases and over 160,000 deaths from lung cancer (non-small cell and small cell combined) in the United States in 2008.
Cangen Biotechnologies, Inc. is a cancer-focused biotechnology company developing diagnostic tests for early detection of cancer. The company is currently preparing to file a 510 (k) submission to the FDA for a molecular diagnostic test for the detection of bladder cancer recurrence. Cangen Biotechnologies is headquartered in Baltimore, MD, has laboratories in Rockville, MD and plans to open a research center at the Hopkins BioPark in Baltimore, MD. The company has offices in Korea and Japan.
Dai Nippon Printing Co., Ltd. is one of the world’s largest comprehensive printing companies and conducts a wide range of businesses, including publication printing, commercial printing, smart cards, business forms, packaging, decorative materials, networking and electronic components. DNP has over 38,000 employees and its net sales in fiscal year ending March 31, 2008, were over 1.616 trillion yen. For more information on DNP, please visit www.dnp.co.jp.
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of Cangen Biotechnologies Inc and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the Company’s control, and may turn out to be materially different.
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Rainmaker & Sun, Inc. Tracy M. Smith 818-640-1801 Tracys@rainmakerandsun.com
Source: Cangen Biotechnologies, Inc.
