I'd say C225 offers an excellent chance of stopping or eliminating pancreatic cancer:|
IMCLONE?S LEAD CANCER THERAPEUTIC, C225, DEMONSTRATES
ANTI-TUMOR ACTIVITY IN PRECLINICAL MODELS OF PANCREATIC CARCINOMA
Philadelphia, PA -- April 14, 1999 -- ImClone Systems Incorporated (Nasdaq: IMCL) announced today findings from two preclinical studies of the company?s lead cancer therapeutic, C225, demonstrating anti-tumor activity in animal models of human pancreatic carcinoma. The findings were presented at the annual meeting of the American Association for Cancer Research (AACR). C225, a monoclonal antibody, is an inhibitor of the epidermal growth factor receptor (EGFr) which is associated with cancer cell growth in a number of solid tumors.
In a poster session on Sunday, researchers in the laboratory of Dr. Robert Radinsky, Assistant Professor of Cell Biology at MD Anderson Cancer Center in collaboration with ImClone scientists, presented data on the use of C225 in combination with the anti-cancer drug gemcitabine in a mouse model of pancreatic cancer. Combined administration of C225 plus gemcitabine caused a 90 percent reduction in pancreatic tumors, compared with a 27 percent response rate using gemcitabine alone. In addition, C225 used alone resulted in significant tumor regression and destruction of liver metastases when compared to treatment with gemcitabine.
Dr. Radinsky?s laboratory also presented data which showed an anti-angiogenic mechanism for C225 treatment in the pancreatic carcinoma model. It was shown that the expression of the angiogenic factors, vascular endothelial growth factor (VEGF) and interleukin-8 (IL-8), were significantly reduced in response to C225 treatment.
In a mini-symposium today, researchers from the laboratory of Dr. Daniel Hicklin at ImClone Systems presented additional findings demonstrating that C225 caused reduction of pancreatic cancer cell proliferation and significantly inhibited growth of established pancreatic tumors compared to untreated controls in a nude mouse model. Pancreatic tumors treated with C225 showed a decrease in tumor cell proliferation and massive tumor necrosis (tissue death).
"These data in pancreatic cancer models provide further evidence that C225 as a single therapy or in combination with standard therapies can inhibit the growth and spread of a wide variety of cancer cells, including pancreatic cancer cells," stated Samuel D. Waksal, President and CEO of ImClone Systems. "What we have learned from these preclinical studies in a very difficult cancer model is now going to allow us to move forward in clinical trials for pancreatic carcinoma this quarter."
ImClone has conducted several Phase Ib/IIa clinical trials using C225 in several cancer indications. In March 1999, the Company initiated a Phase III clinical trial of C225 in patients with advanced squamous cell head and neck cancer.
In addition to C225, ImClone?s other late stage clinical development program is an anti-cancer vaccine, BEC2. In May 1998, ImClone and its corporate partner Merck KGaA initiated a Phase III multinational clinical trial in limited disease small cell lung cancer patients. Also in preclinical development, ImClone is evaluating the therapeutic potential of its anti FLK-1/KDR monoclonal antibody as an anti-angiogenic agent, especially against tumors known to secrete vascular endothelial growth factor.
ImClone Systems Incorporated, headquartered in New York, is a biopharmaceutical company developing novel therapeutic products including interventional therapeutics, cancer vaccines and blood cell growth factors for the treatment of cancer and cancer-related disorders.
Except for the historical information contained herein, the matters discussed in this news release may 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. The Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.