Enzo Biochem Gene Vector for HIV Cleared to Begin Phase I/II Clinical Trial at New York Presbyterian Hospital-Weill Medical College of Cornell University.Business Editors/Health/Medical Writers FARMINGDALE, N.Y.--(BUSINESS WIRE)--Nov. 6, 2003 Enzo Biochem, Inc. (NYSE NYSE See: New York Stock Exchange :ENZ), a leading biotechnology company specializing in gene identification and genetic and immune regulation technologies for diagnostic and therapeutic applications, announced today that Enzo Therapeutics, its wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. has been cleared to proceed with a Phase I/II study of its Stealth Vector(R) HGTV HGTV Home and Garden Television 43(TM) gene construct for HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. infection at the New York Presbyterian Hospital-Weill-Medical College of Cornell University, in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. . Approval by Cornell's Institutional Biosafety Committee (IBC IBC International Building Code IBC Iraq Body Count IBC Institutional Biosafety Committee IBC Inflammatory Breast Cancer IBC International Business Company IBC Independence Blue Cross IBC Insurance Bureau of Canada IBC International Broadcasting Convention ) was the last in a series of regulatory actions that included the U.S Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ), the Recombinant DNA Advisory Committee (RAC See remote access concentrator. ) of the National Institutes of Health and Cornell's Institutional Review Board (IRB IRB See: Industrial Revenue Bond ), after a comprehensive review of the clinical protocol and safety features of the vector. The HGTV43(TM) vector was developed by Enzo to include a proprietary delivery system that overcomes a major challenge in gene medicine - the efficient and safe delivery of the medicine to the appropriate target. The benefits of Enzo's vector technology are that it achieves efficient delivery of the gene into the patient's cells, and that it is "silent" and unlikely to trigger an immune response. In addition, during the development of the vector, two critical safety features designed to prevent the possibility of inadvertently turning on deleterious genes in the subject were incorporated into its design. "The Phase I trial at the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). San Francisco (UCSF UCSF University of California at San Francisco ) demonstrated the safety of Enzo's StealthVector(R) HGTV43(TM) gene construct and the ability of the engineered cells to survive and function in vivo," said Dean L. Engelhardt, Ph.D., Executive Vice President of Enzo. We look forward to this next step, the goal of which is to increase the proportion of immune cells containing anti-HIV-1 antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid). genes, and thus increase resistance to HIV." "We are excited about this special opportunity to move into the next phase of the trial, building on the success of the Phase I study," said Jeffrey Laurence, M.D., Professor of Medicine and Director of the Laboratory for AIDS Virus Research at The New York Presbyterian Hospital-Weill Medical College of Cornell University. "Our objective will be to expand the number of engineered cells containing anti-HIV genes in order to achieve a therapeutic effect. This approach could add a much needed option in the treatment of HIV infection." Dr. Engelhardt noted that the incidence of HIV infection has begun to grow in the U.S. and continues to grow at an alarming rate worldwide. It remains a major global problem with limited long-term treatment options. Current therapies, including HAART HAART highly active antiretroviral therapy. HAART Highly active antiretroviral therapy, triple combination therapy AIDS The concurrent administration of 2 nucleoside reverse transcriptase inhibitors–eg, AZT and 3TC, and a protease (highly active antiretroviral therapy Noun 1. highly active antiretroviral therapy - a combination of protease inhibitors taken with reverse transcriptase inhibitors; used in treating AIDS and HIV drug cocktail, HAART ) cocktails and protease inhibitors have been somewhat effective, but with severe side effects. In addition, an increasing number of patients who have been infected for many years are becoming resistant to these drugs. Enzo's StealthVector(R) HGTV43(TM) gene construct represents a novel strategy for managing patients with AIDS who are resistant to current therapies." In the upcoming trial, Enzo's StealthVector(R) HGTV43(TM) gene construct will be used to transfer three antisense genes designed to interfere with the growth of HIV-1 into blood cells, including CD4+ T-cells, which are the main target of infection by HIV-1. The Phase I study that took place at UCSF demonstrated that these anti-HIV-1 genes could successfully be inserted into stem cells and that the engineered stem cells were able to survive and produce CD4+ cell progeny containing functioning antisense genes, for as long as four years to date. 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 in various stages of clinical evaluation of its proprietary gene medicine for HIV-1 infection and its proprietary immune regulation medicines for hepatitis B and hepatitis C infection and for Crohn's Disease. 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. For more information visit our website www.enzo.com. 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. |
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