Enzo Biochem Announces Study in Leading Scientific Journal Linking Idiopathic Pulmonary Fibrosis, a Deadly Human Disease with No Effective Treatment Options, to Presence of a Monkey Virus

Discovery Expected to Provide Reliable Marker for Diagnosis and Potential Treatment

Enzo Developing Early Diagnostic

NEW YORK--(BUSINESS WIRE)-- Enzo Biochem Inc. (NYSE:ENZ) today announced publication of a study in a leading scientific journal, Modern Pathology, a Nature Publishing Group publication, that shows a strong association of idiopathic pulmonary fibrosis (IPF), a pulmonary disease with 100% mortality within five years, with the presence of the herpesvirus saimiri virus, a virus native to squirrel monkeys. The breakthrough discovery of the IPF’s origin is expected to result in a clinical diagnostic that could lead to screening and diagnosis, and perhaps result in potential treatment, for this fatal disease.

The publication was authored by scientists from Enzo Biochem, Ohio State University, the Medical College of Wisconsin and Cornell University. The discovery is the subject of a patent application that is exclusively assigned to Enzo Biochem. “The significance of this discovery, beyond providing a reliable marker for screening and diagnosis, is the potential for development of new therapeutic strategies and better understanding of the progression of the disease in humans,” said Elazar Rabbani, study co-author and Chief Executive Officer of Enzo. “This may also translate into a patient's ability to live with the disease or even be cured if the fibrosis is not too advanced.”

Pulmonary fibrosis affects about one million people in the United States, of which IPF represents about 200,000 cases (20%). There is currently no effective way to diagnose IPF prior to the clinical manifestation of symptoms and treatments are largely ineffective. This new marker for IPF could address the urgent critical requirement for early diagnosis and screening of the pulmonary fibrosis population (over a million subjects).

“Discovering the origin of IPF gives us hope that both diagnostics and treatments will be developed to help patients survive and live with this devastating illness,” said Gerard J. Nuovo, MD, study co-author and Professor (retired), Ohio State University Comprehensive Cancer Center. “While the sample size is small there are multiple data points that support our findings that herpesvirus saimiri infection may be the cause of IPF. For example, there was a 100% correlation –both positively and negatively-where the virus was present in all IPF samples and absent in all non-IPF controls. Additionally, the virus was found in the cell that orchestrates IPF and a key gene expressed in the tissue was identified as viral, and not human, in nature.”

Methodology and Findings

The goal of the study was to evaluate the role of the herpesviruses family in IPF. Researchers used 21 paraffin embedded lung biopsies from patients diagnosed with IPF, and 21 lung biopsies from age matched controls with pulmonary fibrosis that is not IPF.

DNA studies demonstrated that two labeled probes derived from the herpesvirus saimiri genome reacted with the DNA in regenerating epithelial cells in 21/21 IPF biopsies and didn’t react with DNA in 21/21 of the control samples. Subsequent immunological evaluation found that four proteins known to be expressed from the genome of various herpesviruses (cyclin D, thymidylate synthase, dihydrofolate reductase, and interleukin-17) were strongly co-expressed in the regenerating epithelial cells of each of the 21 idiopathic pulmonary fibrosis cases, and not in the benign epithelia of the controls. Among herpesviruses, only herpesvirus saimiri is known to express all four proteins. Future research efforts will also be directed towards investigations of other diseases, for any possible role of this virus in their etiology.

Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized by a progressive decline in the ability of the lungs to function. The disease progresses by thickening the lining of the lungs via scarring, causing an irreversible loss of the tissue’s ability to transport oxygen. Symptoms include dry, persistent cough lasting longer than a month and chronic shortness of breath. IPF ultimately robs the sufferer of the ability to breathe. Approximately 200,000 people, or 20% of all pulmonary fibrosis patients, have an idiopathic form of the disease. Mortality is almost 100% within five years after diagnosis.

The full article that appeared in Modern Pathology is expected to be available shortly on www.enzo.com

About Herpesviruses

Herpesviruses are a large family of DNA viruses known to cause diseases in animals. All herpesviruses are nuclear-replicating—the viral DNA is transcribed to mRNA within the nucleus of the infected cell. Herpesvirus saimiri is present in virtually all squirrel monkeys, and in its natural host, the virus does not cause disease. However, infection of other monkey species such as tamarins, marmosets and owl monkeys leads to a fatal T-cell lymphoma. In addition, a related mouse Herpesvirus, MuHV4, is used as an animal model for IPF.

About Enzo Biochem

Enzo Biochem is a pioneer in molecular diagnostics, leading the convergence of clinical laboratories, life sciences and therapeutics through the development of unique diagnostic platform technologies that provide numerous advantages over previous standards. A global company, Enzo Biochem utilizes cross-functional teams to develop and deploy products systems and services that meet the ever-changing and rapidly growing needs of health care both today and into the future. Underpinning Enzo Biochem’s products and technologies is a broad and deep intellectual property portfolio, with patent coverage across a number of key enabling technologies.

Except for historical information, the matters discussed in this news release may be considered "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management, including those related to cash flow, gross margins, revenues, and expenses are dependent on a number of factors outside of the control of the company including, inter alia, the markets for the Company’s products and services, costs of goods and services, other expenses, government regulations, litigations, and general business conditions. See Risk Factors in the Company’s Form 10-K for the fiscal year ended July 31, 2013. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this press release.

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Source: Enzo Biochem Inc.

Released November 15, 2013