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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) April 1, 1999
ENZON, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-2372868
(State or other jurisdiction (Commission (IRS EMPLOYER
or 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
- --------------------------------------------------------------------------------
(Former name or former address, if changed since last report)
Item 5. Other Events
Enzon, Inc. has filed an Investigational New Drug ("IND") application with
the Food and Drug Administration ("FDA") for PEG-Camptothecin ("PROTHECAN(TM)").
PROTHECAN is a Pro Drug form of the topoisomerase 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 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.
The third generation technology has particular promise for cancer
chemotherapy agents. Enzon believes that covalent 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 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.
Except for the historical information herein, the matters discussed in this
Form 8-K 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 Enzon's Form 10-K, Form 10-Qs and Form 8-Ks on
file with the Securities and Exchange Commission, 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.
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: April 5, 1999
ENZON, INC.
(Registrant)
By: /s/ Kenneth J. Zuerblis
-------------------------------------
Kenneth J. Zuerblis
Vice President, Finance
and Chief Financial Officer (Principal
Financial Officer and Principal
Accounting Officer)