INEX and Enzon Announce Marqibo to be Reviewed by FDA's Oncologic Drugs Advisory Committee.VANCOUVER, British Columbia & BRIDGEWATER, N.J. -- Inex Pharmaceuticals Corporation ("INEX"; TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension : IEX) and Enzon Pharmaceuticals, Inc. ("Enzon"; 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 the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) will review Marqibo(R), (formerly referred to as Onco TCS), at its upcoming Oncologic Drugs Advisory Committee (ODAC ODAC Old Dominion Athletic Conference ODAC Oracle Data Access Components ODAC Oil Depletion Analysis Centre ODAC Oncologic Drugs Advisory Committee ODAC Open Democracy Advice Centre ODAC Open Document Architecture Consortium ODAC Old Dominion Aquatic Club ) session scheduled for December 1, 2004. Marqibo(R) is being developed as a single-agent treatment for patients with relapsed aggressive non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ) previously treated with at least two combination chemotherapy regimens. The New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Marqibo(R) was submitted to the FDA on March 12, 2004 and accepted on May 21, 2004. The FDA has established a target date of January 15, 2005 for completion of its review of the NDA. About Marqibo(R) (vincristine sulfate liposomes Liposomes Aqueous compartments enclosed by lipid bilayer membranes; liposomes are also known as lipid vesicles. Phospholipid molecules consist of an elongated nonpolar (hydrophobic) structure with a polar (hydrophilic) structure at one end. injection) Marqibo(R) is a proprietary drug comprised of the widely used off-patent anticancer drug vincristine vincristine /vin·cris·tine/ (vin-kris´ten) an antineoplastic vinca alkaloid; used as the sulfate salt in the treatment of various neoplasms, including Hodgkin's disease, acute lymphocytic leukemia, non-Hodgkin's lymphoma, Kaposi's encapsulated in INEX's sphingosomal drug delivery technology. INEX's technology is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are intended to increase the effectiveness and reduce the side effects of the encapsulated drug. In the completed multi-center pivotal Phase 2/3 clinical trial, 119 patients with aggressive NHL who had not responded to their previous therapy or had responded and subsequently relapsed were treated with Marqibo(R). Prior to enrolment in this study, patients had received on average four other therapies. After treatment with Marqibo(R) as a single-agent, an overall response rate of 25% was attained. Currently, there is no standard treatment for patients with aggressive NHL who have not responded to or have relapsed following at least two prior treatment regimens. The results of this pivotal trial were released in June 2003 and presented in December 2003 at the American Society of Hematology annual conference along with interim results from two ongoing Phase 2 trials in relapsed Hodgkin's disease and relapsed B-cell lymphoma. In addition to the lead indication, relapsed aggressive NHL, Enzon and INEX intend to develop Marqibo(R) for use as a single-agent therapy or in combination therapy for several cancers in which vincristine is now used. About ODAC The Oncologic Drugs Advisory Committee (ODAC) is a committee formed by the FDA of external experts to advise the FDA in the evaluation of marketed and investigational drugs for use in the treatment of cancer. The Committee is comprised of a core of thirteen voting members from the fields of general oncology, pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. oncology, hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. oncology, immunologic oncology, biostatistics and other related professions. About INEX INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. About Enzon Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases. There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimate," "continue," "anticipates," "intends," "expects," 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 future results, events or developments described in the forward looking statements. Such factors include the risk that Marqibo(R) may not receive regulatory approval from the FDA under Subpart H of the Food and Drug Act for the lead indication and the fact that any such approval, if granted, will include post approval commitments, the risk that Inex and Enzon may not be successful in developing Marqibo(R) for other indications, as well as those risks described in Enzon's Form 10-K and Forms 10-Q on file with the SEC and INEX's publicly filed periodic reports. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. All information in this press release is as of September 27, 2004, and Enzon and INEX undertake no duty to update this information. INEX's common shares are traded on the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. under the trading symbol "IEX". Enzon's common shares are traded on NASDAQ under the trading symbol "ENZN". |
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