Enzon Pharmaceuticals Announces New Data On PEG-SN38 At EORTC-NCI-AACR.Enzon's PEGylation Technology Potentially Enables New Cancer Therapeutic BRIDGEWATER, N.J. -- Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced new data providing preclinical proof-of-principle in breast, colorectal and pancreatic cancers for PEG-SN38, a pegylated form of SN38 which is the active moiety moiety: see clan. of Camptosar([R]). The data was presented at the 18th EORTC-NCI-AACR (European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research) annual meeting being hosted in Prague, Czech Republic Czech Republic, Czech Česká Republika (2005 est. pop. 10,241,000), republic, 29,677 sq mi (78,864 sq km), central Europe. It is bordered by Slovakia on the east, Austria on the south, Germany on the west, and Poland on the north. November 7-10, 2006. "To date, SN38 has not been successfully clinically developed by others in the industry. However, we believe that our PEGylation technology has the ability to transform it into an effective and viable compound that could provide important benefits for patients." said Jeffrey H. Buchalter, Enzon's chairman and chief executive officer. "We are encouraged by promising preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. in the potential of PEG-SN38 in breast, colorectal and pancreatic cancers and plan to continue to collect important data to move forward with its development." In addition, the Company also announced data demonstrating a potential correlation between a particular biomarker and sensitivity to Oncaspar([R]) in solid tumors and lymphomas. PEG-SN38 (EZN-2208) in Breast, Colorectal and Pancreatic Cancers (Abstract #145) This study evaluated the pharmacokinetics and therapeutic efficacy of PEG-SN38 in xenograft xenograft /xeno·graft/ (zen´o-graft) a graft of tissue transplanted between animals of different species; it may be concordant, models of human breast, colorectal and pancreatic cancers. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the study: * PEG-SN38 demonstrated potent in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. cytotoxicity cytotoxicity /cy·to·tox·ic·i·ty/ (si?to-tok-sis´i-te) the degree to which an agent possesses a specific destructive action on certain cells or the possession of such action. against several human cancer cell lines and anti-tumor activity in xenograft models of human breast, colorectal and pancreatic cancers. * Treatment with a single or multiple small doses of PEG-SN38 led to complete cures of animals in the breast cancer model. * In colorectal and pancreatic models, PEG-SN38 demonstrated significantly better therapeutic efficacy, at their respective maximum tolerated doses and equivalent dose levels, than Camptosar. * In mice, PEG-SN38 provided a long circulation half-life and exposure to the parent drug, SN38. Oncaspar in Solid Tumors and Lymphomas (Abstract #160) This study evaluated the utility of Oncaspar in solid tumors and lymphomas as well as assessed the correlation of Oncaspar activity with cellular levels of asparagine synthetase Asparagine synthetase (or aspartate-ammonia ligase) is an enzyme which generates asparagine from aspartate. External links
• (ASNS ASNS American Society for Nutritional Sciences ). In particular, the study examined in vitro and in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. efficacy of Oncaspar in pancreatic, ovarian and lymphoma cells with varying expression of ASNS. According to the study: * Oncaspar displayed potent cytotoxicity against several pancreatic, ovarian, and lymphoma cell lines during in vitro studies. * The combination of Oncaspar and Gemzar([R]) were additive in the low ASNS-expressing pancreatic model during in vivo studies; however, in the high ASNS-expressing pancreatic model, treatment with Oncaspar at various doses was ineffective. * Overall, efficacy of Oncaspar correlates with cellular ASNS in some cell lines and hence ASNS could potentially serve as a biomarker in clinic. Abstracts are available on the Company website: www.enzon.com About PEG-SN38 SN38 is the active metabolite active metabolite Therapeutics A drug metabolite with therapeutic activity similar to the parent compound, which must be considered in therapeutic pharmacokinetics of the cancer drug irinotecan, a chemotherapeutic pro-drug marketed as Camptosar[R] in the U.S. Camptosar is a validated topoisomerase topoisomerase an enzyme involved in DNA replication that introduces a single-strand nick in the DNA enabling it to swivel and thereby relieve the accumulated winding strain generated during unwinding of the double helix. I inhibitor. Unmodified SN38 is insoluble and can only be used to treat cancer by administering the pro-drug, Camptosar. A pro-drug is a compound that is converted into the active drug in the body. Only a small percentage of Camptosar is converted into SN38 in cancer cells and the unpredictability of conversion in each patient can result in adverse side effects Side effects Effects of a proposed project on other parts of the firm. . Through the use of its Customized Linker Technology(TM), Enzon designed PEG-SN38 (EZN-2208), a PEGylated conjugate conjugate /con·ju·gate/ (kon´jdbobr-gat) 1. paired, or equally coupled; working in unison. 2. a conjugate diameter of the pelvic inlet; used alone usually to denote the true conjugate diameter; see of SN38, to offer therapeutic advantages over unmodified SN38 and Camptosar. EZN-2208 is designed to deliver the active drug to tumor cells without the need for conversion. The PEGylated version allows for parental delivery, increased solubility, higher exposure, and longer apparent half-life. Preclinical studies have shown that these features lead to greater efficacy over Camptosar. About Oncaspar[R] Oncaspar is a PEG-enhanced version of the naturally occurring enzyme L-asparaginase. L-asparaginase is an enzyme that depletes the amino acid amino acid (əmē`nō), any one of a class of simple organic compounds containing carbon, hydrogen, oxygen, nitrogen, and in certain cases sulfur. These compounds are the building blocks of proteins. asparagine asparagine (əspâr`əjēn), organic compound, one of the 20 amino acids commonly found in animal proteins. Only the l-stereoisomer participates in the biosynthesis of mammalian proteins. , which certain leukemic cells are dependent upon for survival. Oncaspar was initially approved by the U.S. Food and Drug Administration in February 1994 and is now indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia acute lymphoblastic leukemia n. Abbr. ALL Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia. . Through its proprietary PEGylation technology, Enzon designed Oncaspar to offer therapeutic advantages over unmodified L-asparaginase. Oncaspar provides a more convenient, patient-friendly dosing regimen that allows for administration every 14 days, versus twice weekly for unmodified L-asparaginase. Enzon's specialized oncology sales force markets Oncaspar in the United States. About Enzon Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development and commercialization of therapeutics to treat patients with cancer and adjacent diseases. Enzon's specialized sales force markets Abelcet([R]), Oncaspar([R]), Adagen([R]), and Depocyt([R]) in the United States. In addition, Enzon also receives royalties on sales of PEG-INTRON([R]), marketed by Schering-Plough Corporation, and MACUGEN([R]), marketed by OSI Pharmaceuticals and Pfizer Inc. Enzon's product-driven strategy includes an extensive drug development program that leverages its proprietary technologies, including a Customized Linker Technology(TM) PEGylation platform that utilizes customized linkers designed to release compounds at a controlled rate. Enzon complements its internal research and development efforts with strategic initiatives, such as partnerships designed to broaden its revenue base or provide access to promising new technologies or product development opportunities. The Company also engages in contract manufacturing opportunities with third parties to improve its efficiency. Further information about Enzon and this press release can be found on the Company's web site at www.enzon.com. Forward Looking Statements There are forward-looking statements contained herein, which can be identified by the use of forward-looking terminology such as the words "believes," "expects," "may," "will," "should", "potential," "anticipates," "plans" or "intends" and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in such forward-looking statements. Such factors include, but are not limited to the timing, success and cost of clinical studies; the ability to obtain regulatory approval of products, market acceptance of, and continuing demand for, Enzon's products and the impact of competitive products and pricing. A more detailed discussion of these and other factors that could affect results is contained in our filings with the U.S. Securities and Exchange Commission, including our transition report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the six-month period ended December 31, 2005 and our quarterly reports on Form 10-Q Form 10-Q See 10-Q. . These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Enzon does not intend to update this information. |
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