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Biopharmaceuticals Oncology

 News Release - November 29, 2007

Published Data Suggest That ERBITUX(R) Enables Complete Surgical Resection of Colorectal Liver Metastases in Patients Previously Refractory to Conventional Systemic Therapy

NEW YORK--(HSMN NewsFeed)--ImClone Systems Incorporated (NASDAQ: IMCL ), a global leader in the development and commercialization of novel cancer therapeutics, today announced that data published in the Journal of Clinical Oncology suggest that patients with unresectable metastatic colorectal cancer (mCRC) refractory to systemic chemotherapy can achieve substantial regression of their liver metastases with ERBITUX® (cetuximab), thereby increasing the potential for these patients to become candidates for complete surgical resection of their metastatic disease.1

“We are encouraged by the data from this retrospective study that demonstrate that meaningful shrinkage of metastatic disease was achieved in chemotherapy-refractory colorectal cancer patients, since complete resection of metastases offers such patients their only chance for long-term survival,” said Eric K. Rowinsky, M.D., Senior Vice President and Chief Medical Officer of ImClone Systems. “These intriguing results in heavily pretreated patients support similar findings observed in other Phase II and III trials of ERBITUX combined with irinotecan- or oxaliplatin-based chemotherapy in patients who have not received prior chemotherapy for their metastatic disease. Further prospective evaluations in both North America and Europe are ongoing or planned to evaluate the optimal means to combine ERBITUX and chemotherapy to maximize the potential for complete surgical resection of colorectal liver metastases.”

Other data from randomized Phase II and III studies involving ERBITUX have demonstrated consistently high response rates and an up to three-fold higher rate of liver metastases resection when combined with chemotherapy versus chemotherapy regimens alone.2,3,4,5 These studies have also found that treatment with ERBITUX does not lead to an increased risk of surgical or post-operative complications such as bleeding or wound healing.

About 50% of patients with CRC will develop liver metastases during the course of their disease. Surgical resection, or removal, of metastases from the liver is the only curative option in mCRC and has been shown to increase five-year survival from 5% to 50% in previously untreated patients.6 However, surgical resection is currently limited to a small proportion of patients with mCRC, predominantly due to the limited response (i.e., tumor shrinkage) to the best available chemotherapies, which prevents metastases from being shrunk to a size that allows for complete surgical resection. Complete surgical resection, as described in the Journal of Clinical Oncology report, is extremely rare in patients with colorectal liver metastases previously refractory to conventional systemic therapy.

In the Journal of Clinical Oncology report, a total of 27 patients underwent surgery after a median of six cycles of ERBITUX plus irinotecan (20 of 27), oxaliplatin (4 of 27), or both (1 of 27). One patient each received treatment with ERBITUX alone or ERBITUX plus capecitabine. Eighteen patients (67%) had experienced treatment failure after at least two lines of chemotherapy before ERBITUX-based treatment. Twenty-five of the 27 patients who had surgery underwent resection of their liver metastases. Of 133 patients who received all of their treatment at the Paul Brousee Hospital, which was the main center involved with the report, nine patients underwent complete resection of their metastatic disease. Sixteen of 18 patients who were referred from other institutions to undergo surgical resection of their metastases after systemic ERBITUX-based therapy underwent complete resection. However, the report does not indicate the total number of patients who were treated with ERBITUX per referring institution.

Post-operative mortality was 3.7% (1 of 27), with a complication rate of 50%. After a median follow-up of 16 months, 23 of 25 patients (92%) who underwent surgical resection were alive, and 10 patients (40%) were disease-free. Median overall survival and progression-free survival from initiation of ERBITUX therapy were 20 and 13 months, respectively, in patients with unresectable mCRC refractory to conventional chemotherapy.

About Colorectal Cancer

In the U.S., approximately 154,000 people will be diagnosed with cancer of the colon or rectum this year. More than half of these patients have metastatic disease, or cancer that has spread to other organs, at the time of diagnosis. EGFR is expressed in 60-80 percent of colorectal cancer tumors. Colorectal cancer is the third most common cancer in both men and women, excluding skin cancer.

About ERBITUX(R) (cetuximab)

ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. No anti-tumor effects of ERBITUX were observed in human tumor xenografts lacking EGFR expression. EGFR is part of a signaling pathway that is linked to the growth and development of many human cancers, including those of the head and neck, colon and rectum.

ERBITUX, as a single agent, is indicated for the treatment of EGFR-expressing mCRC after failure of both irinotecan- and oxaliplatin-based regimens. ERBITUX, as a single agent, is also indicated for the treatment of EGFR-expressing mCRC in patients who are intolerant to irinotecan-based regimens.

For full prescribing information, including boxed WARNINGS regarding infusion reactions and cardiopulmonary arrest, visit http://www.ERBITUX.com.

Important Safety Information

Grade 3/4 infusion reactions occurred in approximately 3% of patients receiving ERBITUX (cetuximab) in clinical trials with fatal outcome reported in less than 1 in 1000. Reactions characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, hypotension, loss of consciousness, and/or cardiac arrest. Severe infusion reactions require immediate and permanent discontinuation of ERBITUX therapy.

Most reactions (90%) were associated with the first infusion of ERBITUX despite premedication with antihistamines. Caution must be exercised with every ERBITUX infusion as there were patients who experienced their first severe infusion reaction during later infusions. Monitor patients for 1-hour following ERBITUX infusions in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, corticosteroids, intravenous antihistamines, bronchodilators, and oxygen). Longer observation periods may be required in patients who require treatment for infusion reactions.

Severe cases of interstitial lung disease (ILD), which was fatal in one case, occurred in 4 of 1570 (<0.5%) of patients receiving ERBITUX in clinical trials. Permanently discontinue ERBITUX where ILD is confirmed.

In clinical studies of ERBITUX, dermatologic toxicities, including acneform rash, skin drying and fissuring, paronychial inflammation, infectious sequelae (eg, S. aureus sepsis, abscess formation, cellulitis, blepharitis, cheilitis), and hypertrichosis occurred in patients receiving ERBITUX therapy. Acneform rash occurred in 76-88% of 1373 patients receiving ERBITUX in clinical trials with severe acneform rash occurring in 1-17% of patients. Acneform rash usually developed within the first two weeks of therapy and resolved in a majority of the patients after cessation of treatment, although in nearly half, the event continued beyond 28 days. Monitor patients receiving ERBITUX for dermatologic toxicities and infectious sequelae. Sun exposure may exacerbate these effects.

In women of childbearing potential, appropriate contraceptive measures must be used during treatment with ERBITUX and for 6 months following the last dose of ERBITUX. If ERBITUX is used during pregnancy or if patients become pregnant while receiving ERBITUX, patients should be apprised of the potential risk for loss of pregnancy or potential hazard to the fetus.

Hypomagnesemia occurred in 55% (199/365) of patients receiving ERBITUX and was severe (NCI CTC grades 3 & 4) in 6-17%. The onset of hypomagnesemia and accompanying electrolyte abnormalities occurred days to months after initiation of ERBITUX. Monitor patients periodically for hypomagnesemia, hypocalcemia and hypokalemia, during and for at least 8 weeks following the completion of ERBITUX. Replete electrolytes as necessary.

The most serious adverse reactions associated with ERBITUX in mCRC patients are infusion reactions, dermatologic toxicity, sepsis, renal failure, interstitial lung disease, and pulmonary embolus.

The most common adverse reactions with ERBITUX (incidence greater than or equal to 25% in the ERBITUX + plus best supportive care arm (BSC)) (n=288) vs. BSC (n=274), respectively, were fatigue (89%, 76%), rash/desquamation (89%, 16%), abdominal pain (59%, 52%), pain-other (51%, 34%), dry skin (49%, 11%), dyspnea (48%, 43%), constipation (46%, 38%), pruritus (40%, 8%), diarrhea (39%, 20%), vomiting (37%, 29%), infection without neutropenia (35%, 17%), headache (33%, 11%), fever (30%, 18%), insomnia (30%, 15%), cough (29%, 19%), dermatology-other (27%, 6%), and stomatitis (25%, 10%).

About ImClone Systems

ImClone Systems Incorporated is a fully integrated biopharmaceutical company committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company’s research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems’ headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey. For more information about ImClone Systems, please visit the Company’s web site at http://www.imclone.com.

ERBITUX® is a registered trademark of ImClone Systems Incorporated.

References

1. Adam R, et al. Hepatic Resection After Rescue Cetuximab Treatment for Colorectal Liver Metastases Previously Refractory to Conventional Systemic Therapy. J Clin Oncol 25:4593-4602.

2. Van Cutsem E, et al. ASCO 2007 (Abstract No. 4000; updated information presented).

3. Van Cutsem E, et al. ECCO 2007 (Abstract No. 3001).

4. Cervantes A, et al. (2005) Eur J Cancer Suppl 3:181 (Abstract No.642).

5. Schuch G, et al. WCGIC 2007 (Abstract No. 0-0022).

6. Folprecht G, et al. Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates. Ann Oncol 2005;16(8):1311-9.

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those currently expected. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the Company’s most recent annual report of Form 10-K and in its quarterly reports on Form 10-Q and current reports on Form 8-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.


Source: ImClone Systems

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