Enzon Receives FDA Clearance of Its Recently Filed PEG-SN38 IND Application.-- Company plans to move compound into clinical trials in first half of year -- BRIDGEWATER, N.J. -- Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that 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. ) has approved its Investigational New Drug (IND) application for PEG-SN38, Enzon's PEGylated form of SN38, 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 Camptosar([R])(irinotecan HCl injection). The Company plans to begin a Phase I trial investigating PEG-SN38 in patients with solid tumors or lymphoma lymphoma, a cancer of the tissue of the lymphatic system. There are two categories of lymphomas. One type is termed Hodgkin's disease, the other, non-Hodgkin's lymphoma (see lymphoma, non-Hodgkin's). See also neoplasm. in the fist half of this year. "This milestone is particularly exciting because it combines our new PEGylation technology with a potent anti-cancer compound - another example of how our PEGylation technology is helping us develop new chemical entities with multiple mechanisms of action," said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. "By using our new PEGylation technology, our goal is to transform this compound into a new anti-cancer agent that offers advantages over current therapies." About PEG-SN38 SN38 is the active metabolite of the widely used cancer drug irinotecan, marketed as Camptosar([R]) in the U.S. Although unmodified Adj. 1. unmodified - not changed in form or character unqualified - not limited or restricted; "an unqualified denial" modified - changed in form or character; "their modified stand made the issue more acceptable"; "the performance of the modified aircraft SN38 is significantly more potent than Camptosar, to date it has not been converted into a viable drug candidate. Using Enzon's new PEGylation technology, the Company developed PEG-SN38 (EZN-2208), which results in a compound with excellent pharmaceutical properties as shown in animal models: increased solubility solubility Degree to which a substance dissolves in a solvent to make a solution (usually expressed as grams of solute per litre of solvent). Solubility of one fluid (liquid or gas) in another may be complete (totally miscible; e.g. , higher exposure, and longer half-life than unmodified SN38. Preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. data presented at the 2007 American Association for Cancer Research Wikipedia is not the place for advertisement or self-advertising. The American Association for Cancer Research (AACR) is an organization based in Philadelphia, Pennsylvania, that focuses on all aspects of cancer research including basic, clinical and translational (AACR AACR American Association for Cancer Research AACR Anglo-American Cataloging Rules AACR Australasian Association of Cancer Registries AACR African Armed Conflicts Resolved ) Annual Meeting and the 2006 annual EORTC-NCI-AACR (European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research) meeting showed that these features led to greater efficacy over Camptosar in breast, colorectal and pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. models in animals. About Enzon Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development, manufacturing, commercialization of important medicines for patients with cancer and other life-threatening conditions. Enzon has a portfolio of four marketed products, Oncaspar([R]), DepoCyt([R]), Abelcet([R]) and Adagen([R]). The Company's drug development programs utilize several cutting-edge approaches, including its industry-leading PEGylation technology platform used to create product candidates with benefits such as reduced dosing frequency and less toxicity. Enzon's PEGylation technology was used to develop two of its products, Oncaspar and Adagen, and has created a royalty revenue stream from licensing partnerships for other products developed using the technology. Enzon also engages in contract manufacturing for several pharmaceutical companies to broaden the Company's revenue base. 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 annual 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 year ended December 31, 2006 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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