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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) May 7, 2001
ENZON, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-2372868
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification)
20 Kingsbridge Road, Piscataway, New Jersey 08854
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (732) 980-4500
N/A
(Former name or former address, if changed since last report)
Item 5. Other Events
Enzon, Inc. announced the initiation of patient dosing in a Phase I
clinical trial for PEG-paclitaxel. The trial is designed to determine the
safety, tolerability, and pharmacology of PEG-paclitaxel in patients with
advanced solid tumors and lymphomas. Up to 40 patients will be enrolled in this
study.
PEG-paclitaxel is a PEG modified version of paclitaxel formulated for ease
of administration. Preclinical animal studies have demonstrated that
PEG-paclitaxel can be dosed at higher levels than TAXOL(R) (paclitaxel), a
leading cancer drug. The ability to dose PEG-paclitaxel at higher levels may
allow increased efficacy when compared to TAXOL.
TAXOL is a powerful chemotherapeutic agent with delivery limitations. It is
used to treat various types of cancers, including ovarian, breast, non-small
cell lung, and AIDS-related Kaposi's sarcoma. In 2000, sales of TAXOL were
reported to be approximately $1.6 billion.
Using Enzon's proprietary PEG technology, scientists at Enzon have modified
paclitaxel through the chemical attachment of PEG using a linker designed to
deteriorate over time, giving PEG-paclitaxel prodrug attributes. PEG-paclitaxel
was designed to be delivered without the need for solubilizing agents or
premedications. TAXOL, a commercial formulation of paclitaxel, contains the
solubilizing agent CREMOPHOR(R) and patients are required to take premedications
prior to treatment to reduce the potential for adverse reactions, which may be
caused by CREMOPHOR.
To date, Enzon's PEG technology has been used to create three approved
protein therapeutics, including PEG-INTRON(TM), currently marketed by
Schering-Plough for the treatment of hepatitis C. PEG-paclitaxel is the second
application of Enzon's PEG technology to deliver small organic chemical
molecules. PROTHECAN(R), a PEG modified version of the topoisomerase inhibitor
camptothecin, is currently in two Phase I clinical trials. PROTHECAN is expected
to commence Phase II clinical trials in the near future.
Except for the historical information herein, the matters discussed herein
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/A, Form 10-Q's and Form
8-Ks on file with the SEC, including without limitation, risks in obtaining and
maintaining regulatory approval for indications and expanded indications, market
acceptance of and continuing demand for Enzon's products and the impact of
competitive products and pricing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: May 7, 2001
ENZON, INC.
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(Registrant)
By: /s/ Kenneth J. Zuerblis
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Kenneth J. Zuerblis
Vice President, Finance and Chief Financial
Officer