Singulex, Inc. to Develop Assays to Assess Efficacy of Cancer Therapeutics

ALAMEDA, Calif., July 29 /PRNewswire/ -- Singulex Inc. today announced that it secured the second phase of its Fast Track Small Business Innovation Research (SBIR) contract from the National Cancer Institute (NCI). The company will use the funds to develop biomarker assays that will be useful in determining whether a potential cancer therapeutic is effective.

Because the levels of specific proteins vary depending on disease state, biomarkers, or proteins associated with a disease, can be measured to determine whether a disease is progressing. In addition, by measuring changes to disease-associated biomarkers following treatment with a specific drug, pharmaceutical developers can assess whether a drug candidate demonstrates efficacy. However, despite the identification and validation of cancer- associated biomarkers, technologies have not existed that allow detection sensitively enough to see the subtle changes that enable drug developers or clinicians to use biomarkers to assist in the development of medicines or to make clinical decisions.

"Singulex's powerful assay to detect VEGF, a protein implicated in many cancers, overcomes the limitations of traditional biomarker detection technologies and allows drug developers to see normal levels of VEGF in blood and assess the efficacy of anti-VEGF drugs such as Avastin(R)," said Philippe Goix, president and CEO of Singulex. "The development of the VEGF assay was supported with Phase I of the Fast Track SBIR contract, and with Phase II, we will have the resources to develop 12 more assays to different biomarkers that will provide insights into drug efficacy in additional oncology areas."

Singulex has established collaborations with multiple pharmaceutical companies and research institutions to develop biomarker assays through its Erenna(TM) Technology Access Program (ETAP). The company offers access to custom biomarker assays as well as a growing menu of biomarker assays that are applicable to many disease states, including oncology, neurodegenerative disorders and cardiac and metabolic disease. The oncology assays developed with the NCI SBIR funds will be available to ETAP collaborators.

The NCI SBIR contract will continue to support Singulex's assay development in collaboration with researchers at Washington University and Sigma Aldrich. This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261200700047C.

About NCI

The National Cancer Institute (NCI) is a component of the National Institutes of Health (NIH), one of eight agencies that compose the Public Health Service (PHS) in the Department of Health and Human Services (DHHS). NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. More information is located at http://www.cancer.gov.

About Singulex

Singulex develops and commercializes innovative technology solutions that enable disease understanding and management for life science researchers and clinicians. Utilizing proprietary quantitative single molecule detection technology, Singulex develops customized biomarker diagnostic systems that can detect and quantify normal and abnormal protein biomarkers in a variety of biological samples with extreme sensitivity and accuracy. Singulex is currently conducting several pilot studies with academic and molecular diagnostic partners to validate the company's commercial digital molecule detection platform, the Erenna(TM) Immunoassay System. Singulex's research and development facilities are located at the Center for Emerging Technologies in St. Louis, Missouri, and the company's commercial operations are based in Hayward, California. To learn more about Singulex, please visit us at http://www.singulex.com.

About ETAP

The Erenna(TM) Technology Access Program (ETAP) offers select clients the opportunity to use Singulex's flagship Erenna system to improve and validate their vital immunoassays, adding as much as 1-3 logs of improvement in sensitivity and providing less than 20% coefficient of variability. ETAP includes the Erenna system, which is designed to detect and count single molecules, customized immunoassay development services, reagents, software and direct and personal client service.

CONTACT: Carolyn Hawley of Porter Novelli Life Sciences, +1-619-849-5375,
chawley@pnlifesciences.com, for Singulex Inc.

Web site: http://www.singulex.com/