UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
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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 14, 1997
IMCLONE SYSTEMS INCORPORATED
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(Exact Name of Registrant as Specified in its Charter)
Delaware 0-19612 04-2834797
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(State or other Jurisdiction (Commission File Number) (IRS Employer
of Incorporation) Identification Number)
180 Varick Street, New York, New York 10014
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(Address of Principal Executive Offices) (Zip Code)
(212) 645-1405
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Registrant's telephone number, including area code
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ITEM 5. OTHER EVENTS
On April 14, 1997, ImClone Systems Incorporated (the "Company") announced
promising results of a preclinical study of the Company's lead cancer
therapeutic, C225, an epidermal growth factor receptor (EGFr) antagonist at the
88th annual meeting (the "AACR Meeting") of the American Association for Cancer
Research in San Diego, CA. As presented by Robert Radinsky, Ph.D., Assistant
Professor, Department of Cell Biology, MD Anderson Cancer Center in Houston,
Texas, treatment with C225 in human bladder carcinoma cells growing
orthotopically in mice resulted in a significant inhibition of tumor growth
(p<0.05) compared with controls. The orthotopic approach utilized in this study
is a cancer model that implants human tumor cells into the tissue of origin in
the mouse, thus making the model a more realistic indicator of tumor
progression.
The Company also announced promising preclinical data on its anti-flk-1
monoclonal antibody program at the AACR Meeting. Anti-flk-1 is a monoclonal
antibody that blocks a key tyrosine kinase receptor, FLK-1/KDR, located on
tumor-associated vascular endothelial cells. Activation of flk-1 by VEGF, the
vascular endothelial growth factor secreted by certain tumor cells, mediates
blood vessel formation associated with tumor growth. By blocking this activity,
the Company believes that anti-flk-1 may have therapeutic value as an
anti-angiogenic agent, especially against tumors known to secrete VEGF.
As presented by Patricia Rockwell, Ph.D., Senior Scientist of the Company,
anti-flk-1 was shown to significantly suppress tumor growth in human
glioblastoma and ovarian carcinoma in murine xenograft animal models in
preclinical studies. The data also showed that the antibody suppressed tumor
growth presumably by blocking the development of new blood vessels critical to
the invasive growth of the cancer. In the study, this effect was maintained well
beyond final treatment.
On May 1, 1997 the Company also announced that it is entitled to receive
two milestone payments totaling $1 million from Abbott Laboratories as a result
of a patent issuance in Europe for the Company's proprietary Repair Chain
Reaction ("RCR") DNA probe technology. The issuance of this patent also
initiates royalty payments on sales in covered European countries for products
using RCR technology. Developed by the Company, RCR is a highly-effective
in-vitro DNA diagnostic approach that allows amplification and detection of DNA
targets, such as infectious disease pathogens and cancer genes, in a rapid,
highly sensitive and specific manner.
Except for the historical information contained herein, the matters
discussed herein include forward-looking statements. Actual results may differ
materially from those predicted in such forward-looking statements due to the
risks and uncertainties inherent in the Company's business, including, without
limitation, risks and uncertainties in obtaining and maintaining regulatory
approval, market acceptance of and continuing demand for the Company's products,
the impact of competitive products and pricing, and the Company's ability to
obtain additional financing to support its operations and achieve its
objectives.
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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 thereunto duly authorized.
IMCLONE SYSTEMS INCORPORATED
Date: May 1, 1997 By: /s/ John B. Landes
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John B. Landes
Vice President,
Business Development
and General Counsel
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