ImClone Updates

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ImClone Systems UPDATES

At the ASCO conference ImClone announced results of a Phase Ib/IIa study involving nine patients with advanced squamous cell head and neck cancer treated with C225 in combination with cisplatin. These patients were refractory to different treaments including chemptherapy, radiotherapy or experimental treatments. Of the patients treated, there was a 66% response rate which included one with 100% tumor regression and five with 50% regression. Three of the six responders had previously failed cisplatin. IMCL also discussed the Phase Ib/IIa study combining C225 and radiation. These results had been previously announced and showed 100% tumor regression in 13 of 15 patients with 50% regression in the other two. This compares with a 30-40% response rate with radiation alone. They also mentioned that the median duration of the response was greater than 12 months.

The results that were announced serve to bolster my belief in the future of this company. Though the C225/radiation results had been previously announced (as good as they are I don't mind hearing them one more time!) the median response duration caught my attention. It certainly suggests that the response that is seen is not just a transient effect on the inexorable march. Certainly this brings multiple questions to mind about the ability of this drug when combined with more than one other treatment. I do believe that the best chance we will have of a "cure" will be through the use of multiple treatment modalities. The results with C225/cisplatin certainly suggest that C225 will be quite useful with the older treatment options we have and hopefully with the newer treatments in the pipeline.

ImClone announced that the FDA is allowing the initiation of a second Phase III clinical trial of C225 in patients with advanced squamous cell head and neck carcinoma. The clinical trial will evaluate the effect of C225 in combination with cisplatin in 114 patients with advanced squamous cell head and neck carcinoma. Patients with advanced squamous cell head and neck carcinoma and metastatic disease will be treated with cisplatin alone or cisplatin plus of C225. The primary endpoint of the trial will be response and time to disease progression. Achievement of this milestone is triggering a $3 million milestone payment to ImClone from its corporate partner for C225, Merck KGaA of Germany. In March 1999, ImClone initiated its first Phase III clinical trial of C225 in combination with radiation for patients with advanced squamous cell head and neck cancer. Samuel D. Waksal, Ph.D., President and CEO of ImClone stated that "our global strategy with C225 is to develop this promising compound in combination with standard therapies such as chemotherapy and radiation." The new trial is another step in the expansion of therapeutic options involving C225. I believe the company's strategy involves proving the efficacy of C225 in association with different modalities. This could give physicians the comfort to quickly expand the usage of the drug into new areas of disease.