IMCL has two cancer drugs well along in phase III. They both could get approval this year. Here is some good info.
ImClone Presents Clinical Findings On C225 At American Society of Clinical Oncology Meeting
ATLANTA--(BW HealthWire)--May 17, 1999--
Data Shows Activity of Combined C225 Plus Cisplatin Treatment
in Patients Previously Unresponsive to Cisplatin
ImClone Systems Incorporated (Nasdaq: IMCL) announced today findings from two clinical studies of the company's lead cancer therapeutic, C225, demonstrating clinical response in combination with standard radiotherapy and with chemotherapeutic agents. The findings were presented at the annual meeting of the American Society of Clinical Oncology (ASCO). 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.
John Mendelsohn, M.D., President of M.D. Anderson Cancer Center, presented data on a Phase Ib/IIa study of 9 treated and evaluable patients with refractory advanced squamous cell head and neck carcinoma who were treated with C225 in combination with cisplatin. The results demonstrated a response rate of 66 percent. There were 1 complete response (100 percent tumor regression) and 5 partial responses (greater than 50 percent tumor regression).
All of the responders had failed previous treatment regimens, including standard chemotherapy, radiotherapy or experimental treatments. In particular, three of the six responders (including the complete responder) had previously failed treatment with cisplatin. Patients who have failed cisplatin therapy typically do not respond to further treatment with cisplatin.
"The cisplatin study is a significant step in the development of C225 because of the impressive response rate and because we observed that patients who have progressed after cisplatin therapy respond when it is then combined with C225," stated Dr. Mendelsohn. "With further clinical evaluation, C225 with cisplatin may prove to be an effective initial therapy and an effective treatment for patients who have failed previous chemotherapy. These patients currently have few treatment options."
Also during ASCO, Mark Ezekiel, M.D., Department of Radiation Oncology, University of Alabama Medical Center, Birmingham, presented findings on a Phase Ib/IIa dose escalation study of combination C225 and radiation therapy in 15 treated patients with stage III and IV locally advanced head and neck cancer. The findings demonstrated that combination C225 and radiotherapy resulted in a 100 percent response in all 15 evaluable patients. There were 13 complete responses (100 percent tumor regression) and two partial responses (greater than 50 percent tumor regression). This response was compared with published rates of 30 to 40 percent using radiation therapy alone. In addition, the median duration of response for these patients is greater than 12 months.
"These clinical findings demonstrate that C225 in combination with radiation has produced a 100 percent response rate in these patients as well as yielding a median duration of response greater than 12 months," stated Harlan W. Waksal, M.D., Executive Vice President and Chief Operating Officer of ImClone Systems.
"The data presented at the ASCO conference is extremely encouraging, not only because it adds to the positive clinical data we have accumulated on C225 in this cancer area, but also because it may prove to benefit patients who have failed prior chemotherapy treatment," stated Samuel D. Waksal, President and CEO of ImClone Systems. "We intend to initiate a Phase II study in this refractory patient population in the near term."
ImClone has recently initiated two Phase III clinical trials, evaluating C225 in combination with chemotherapy and with radiotherapy in patients with advanced squamous cell head and neck carcinoma.
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. ImClone is in preclinical development, 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.
--30--et/ny*
CONTACT: ImClone Systems Incorporated
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