Business Wire - November 12 ,2001
In a presentation here at a meeting of the American Association for the Study of Liver Diseases, physician investigators conducting the trial reported that among the 42 patients tested thus far a dramatic improvement was observed in key liver necroinflammatory scores. In these Enzo trials being conducted at Hadassah Hospital in Israel, 33% of the subjects tested to date showed improvement in liver necroinflammatory scores, the crucial measure of liver inflammation. These numbers compare favorably to the numbers obtained with interferon, currently the most widely used macromolecular treatment.
The Phase 2 study indicated that oral administration of EHT899 to patients with HBV associated chronic active hepatitis resulted in a reduction in the viral load and liver inflammation, a decrease in liver enzymes circulating in the blood and/or an enhancement of anti-viral T-cell response. Approximately 75% of the 42 patients in the trial, as announced previously, experienced improvement in one or more of these important criteria, a result in line with those of a previous Phase 1 trial involving Enzo's EHT899. In addition, Enzo has defined both the dosage and method of delivery of EHT899 for the double-blind study.
"If our data holds in the double-blind study, EHT899 could very well become the premier treatment for individuals with HBV," said Dean Engelhardt, Ph.D., Chief Scientist and Executive Vice President of Enzo. "We would still have to conduct a Phase III trial, using a much larger universe of subjects. But EHT899, if proven as effective as our studies suggest, and if approved, could, we believe, earn a position in treating chronic HBV sufferers as both a more effective and less expensive treatment."
The study presented at the conference involved an open labeled, non-randomized, one center trial with 27 males and 15 females, ages 27 to 79. All had either HBV associated chronic active hepatitis, or were HBV-infected post liver transplantation. HBV- associated chronic active hepatitis afflicts an estimated 350 million people worldwide. Enzo's clinical approach involves the use of a proprietary protein complex to manage chronic hepatitis B in the belief that regulation of the immune function is critical in managing the disease.
HBV is a non-cytopathic virus. The infection itself does not lead to cellular destruction. Rather, hepatocellular injury, that is the killing of the liver cells, is mediated by a defective host immune response. In acute HBV infections, the host immune response works effectively to clear the virus. Chronic HBV hepatitis results from immune-mediated liver injury. Patients with HBV associated chronic active hepatitis mount an effective immune attack on their own liver cells that can lead to liver scarring, cirrhosis, liver failure and primary liver cancer. Enzo's EHT899 was used to adjust the body's immune response to prevent or alleviate this debilitating chronic liver disease.
About Enzo
Enzo Biochem is engaged in the research, development and manufacture of innovative health care products based on molecular biology and genetic engineering techniques, and in providing diagnostic services to the medical community. The Company's proprietary labeling and detection products for gene sequencing and genetic analysis with approximately 200 patents worldwide are sold to the life sciences market throughout the world. The Company's therapeutic division is conducting clinical trials for HIV-1-infected patients and for patients infected with hepatitis B and hepatitis C viruses. The Company also holds a patent covering a method and materials for correcting point mutations or small insertions or deletions of genetic material that would allow for editing and correcting certain abnormalities in genes.
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. 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.
CONTACT: Enzo Biochem
Steve Anreder, 212/532-3232
SOURCE: Enzo Biochem
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