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Enzon and INEX Present Promising Follow-up Data at American Society of Clinical Oncology Showing Onco TCS Potential in First-line Lymphoma.


Business Editors/Health/Medical Writers

BRIDGEWATER, N.J.--(BUSINESS WIRE)--June 7, 2004

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) and 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 IEX Ion Exchange (chromatography)
IEX Inter-Exchange Carrier
) today released follow-up results from a phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 that indicate Onco TCS (Transportation Control System) A widely used integrated information system for railroad transportation developed by the Missouri Pacific Railroad Company in the late 1960s and early 1970s. It was later implemented by Union Pacific when the companies merged.  (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) has potential to be used in combination with other cancer drugs for the first-line treatment of patients with aggressive non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ).

The follow-up results were reported at the Annual Meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas.  (ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company
) in New Orleans, Louisiana. One-year interim results were released in December 2002 at the American Society of Hematology meeting and provided the initial data analysis. The ASCO results provide data analysis after a longer period of follow-up.

David Main, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of INEX, said the follow-up results are very encouraging. "These data support the commercial strategy of seeking marketing approval for Onco TCS as a treatment for relapsed aggressive NHL, as well as our goal to continue to expand its potential in additional indications including first-line aggressive NHL. Importantly, after 22 months, patient survival data continues to support our positive expectations for this product in the first line setting."

Follow-up results were released from 68 evaluable patients in a phase II open-label clinical trial conducted at The University of Texas M. D. Anderson Cancer Center in Houston, Texas in which Onco TCS was used as part of a combination regimen in the first-line treatment of aggressive NHL. Sixty-three patients, or 93% of patients, responded to the therapy. Sixty-two patients had their tumors completely eliminated for a complete response rate of 91% and one patient's tumor volume decreased by more than 50% for a partial response rate of 1% and an overall response rate of 93%.

Of the 68 patients, 37 patients were over the age of 60 years and 91% of these patients were complete responders. In the 31 patients under the age of 60 years, 90% were complete responders and 3% were partial responders. Treatment was well tolerated by both groups with only 6% of patients withdrawing from treatment due to adverse events.

Investigators also presented positive patient survival data. At a median follow-up of 22 months, median progression-free survival and median overall survival had not yet been reached. Overall survival was 99% (one death) and progression-free survival was 87% (nine relapses). Progression-free survival for the elderly patient group was 86% (five relapses) and 87% for the younger patient group (four relapses).

In December 2002, INEX reported at the ASH annual meeting that at a median follow-up of 12 months after treatment, progression free survival for the elderly group was 89% (four relapses) and 94% for the younger patient group (two relapses). Therefore, the progression free survival at a median of 22 months presented today at ASCO compares favorably with the previously reported results.

Arthur Higgins, Enzon's chairman, said, "These results continue to demonstrate the excellent potential for Onco TCS as part of first-line combination therapy for aggressive NHL. The rate and duration of response in the context of the therapy being very well tolerated is especially important for elderly patients. Further, these data are particularly encouraging when reviewed in the context of published studies for CHOP and CHOP plus Rituximab."

The current standard first-line treatment for the aggressive form of NHL is the CHOP chemotherapy combination, comprising the drugs cyclophosphamide cyclophosphamide /cy·clo·phos·pha·mide/ (-fos´fah-mid) a cytotoxic alkylating agent of the nitrogen mustard group; used as an antineoplastic, as an immunosuppressant to prevent transplant rejection, and to treat some diseases , doxorubicin hydrochloride, Oncovin(R) (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 ) and prednisone prednisone (prĕd`nĭsōn): see corticosteroid drug. . This phase II trial treated patients with CHOP in which the Oncovin(R) (vincristine) component was substituted with Onco TCS. Patients diagnosed with B-cell lymphoma also received Rituxan(R) (rituximab).

In addition to the first-line lymphoma study, data were also presented at ASCO on an Onco TCS pharmacokinetics trial in patients with metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 melanoma. The data presented supports the extended release formulation and longer circulation half-life of Onco TCS compared to vincristine.

About Onco TCS

Onco TCS is a proprietary drug comprised of the widely used off-patent anticancer drug vincristine encapsulated in INEX's sphingosomal drug delivery technology. This technology provides prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are designed to increase the effectiveness and reduce the side effects of the encapsulated drug.

About Non-Hodgkin's Lymphoma (NHL)

NHL is the fifth-leading cause of cancer deaths in the United States (19,400 estimated in 2004) and the sixth-leading cause of cancer deaths in Canada (2,900 estimated in 2004), according to estimates of the American Cancer Society American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research,
 and the Canadian Cancer Society The Canadian Cancer Society is a volunteer-based organization which seeks to eradicate cancer and to enhance the quality of life of those suffering from it.

The Society
. Approximately 53,400 and 6,400 new cases were diagnosed in the U.S. and Canada respectively in 2003.

About INEX

INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Further information about INEX and this press release can be found at www.inexpharm.com.

About Enzon

Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases. Further information about Enzon and this press release can be found at www.enzon.com.

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 Onco TCS may not receive regulatory approval from the 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.
 under Subpart H of the Food and Drug Act and the fact that any such approval, if granted, will include post approval commitments, as well as those described in Enzon's Form 10-K and Forms 10-Q on file with the SEC and INEX's publicly filed periodic reports and others, such as, (i) as to Enzon, Enzon's ability to successfully launch and market Onco TCS, Enzon's ability to sustain profitability, and positive cash flow; risks in obtaining and maintaining regulatory approval for indications and expanded indications for Enzon's products; market acceptance of and continuing demand for Enzon's products; timing and results of clinical trials and the impact of competitive products and pricing and (ii) as to INEX, INEX's stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market INEX's products, risks associated with the failure to secure all necessary intellectual property from third parties, the ability to protect its intellectual property and dependence on collaborative partners. 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 June 7, 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".
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jun 7, 2004
Words:1156
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