Enzon Files Investigational New Drug Application for PEG-Camptothecin.PISCATAWAY, N.J.--(BUSINESS WIRE)--April 1, 1999--Enzon, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ENZN) announced today that it has filed an Investigational New Drug (IND) application with the 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. ) for PEG-Camptothecin (PROTHECAN(TM)). PROTHECAN is a Pro Drug form of the 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. 1 inhibitor camptothecin, a compound known to be a very efficacious oncolytic agent with significant delivery problems. Using Enzon's third generation PEG technology, scientists at Enzon have been able to overcome the solubility problems that have plagued previous versions of camptothecin. In animal testing, PEG-Camptothecin has shown a significant increase in efficacy in various human tumor models when compared to the water soluble camptothecin analogs currently on the market. Enzon will evaluate several cancer indications in the Phase I clinical trials of this compound. The clinical trials are expected to begin in the second half of 1999. Enzon's third generation PEG technology represents a new direction for the company. To date, Enzon's PEG technology has been used to create improved protein and peptide therapeutics. PROTHECAN is the first application of Enzon's PEG technology to the delivery of small organic and chemical molecules. Enzon's third generation technology can significantly increase the solubility of previously undeliverable un·de·liv·er·a·ble adj. Difficult or impossible to deliver: undeliverable mail. un compounds allowing them to become viable therapeutics. Enzon believes that third generation PEG technology will improve a wide range of drugs on the market, as well as enhance those in development, including chemotherapy agents, antibiotics, anti-fungals and immunosuppressants immunosuppressants, n.pl the agents that lower or reduce immune response; useful in organ transplant surgery to prevent organ rejection. Corticosteroid hormones given in large amounts; cytotoxic drugs, including antimetabolites and alkylating agents; . The third generation technology has particular promise for cancer chemotherapy agents. Enzon believes that covalent co·va·lent adj. Of or relating to a chemical bond characterized by one or more pairs of shared electrons. attachment of PEG has the potential to temporarily mask the active mechanisms of some chemotherapeutics, allowing the drug to circulate in the bloodstream longer and directing accumulation of the drug towards the tumor site. After accumulation in the tumor, the covalent bond covalent bond (kō'vā`lənt): see chemical bond. covalent bond Force holding atoms in a molecule together as a specific, separate entity (as opposed to, e.g., colloidal aggregates; see bonding). is designed to break down, allowing the compound to resume its normal tumor killing activity and achieve targeted efficacy with possibly reduced systemic toxicity. Enzon has several compounds in preclinical development that utilize third generation Pro Drug/Transport technology, including a PEG-paclitaxel. "The filing of this IND signals the beginning of a new era in the development of PEG molecules. This new third generation PEG technology enables us to expand our universe of targets beyond proteins and peptides to small molecules. Data generated in the preclinical and upcoming clinical trials will be critical to the completion of PEG small molecule licenses," said Peter G. Tombros, Enzon's president and chief executive officer. Enzon is a biopharmaceutical company developing advanced therapeutics for life-threatening diseases through the application of its proprietary drug delivery and targeting technologies, PEG Modification, Pro Drug/Transport technology and Single-Chain Antigen-Binding (SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. (R)) Protein technology. Enzon's research activities are focused primarily in the area of oncology. In addition to two FDA approved products, Enzon has several products in various stages of clinical development by itself and with partners, including PEG-INTRON(R) A (pegylated interferon alfa-2b interferon alfa-2b, recombinant Intron A, Viraferon (UK) Pharmacologic class: Biological response modifier Therapeutic class: Antineoplastic, antiviral Pregnancy risk category C ) with Schering-Plough , which is in Phase III clinical trials for hepatitis C Hepatitis C DefinitionHepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. , malignant melanoma, chronic myelogenous leukemia Chronic myelogenous leukemia (CML) Also called chronic myelocytic leukemia, malignant disorder that involves abnormal accumulation of white cells in the marrow and bloodstream. Mentioned in: Bone Marrow Transplantation and in combination therapy with Rebetol(R) for hepatitis C. Enzon develops and markets products on its own and through its alliance partners, which in addition to Schering-Plough, include Alexion Pharmaceuticals, Baxter Healthcare, Bristol-Myers Squibb, Eli Lilly, and Rhone-Poulenc Rorer Pharmaceuticals. Except for the historical information herein, the matters discussed in this news release include forward-looking statements that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors which are described in the Company's Form 10-K, Form 10- Q's and Form 8-K on file with the SEC, including without limitation uncertainties inherent in clinical trials of new pharmaceutical products, risks in obtaining and maintaining regulatory approval for such products and market acceptance of such products. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion