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HuMax-CD20 Induces Rapid Responses in Relapsed CLL Patients.

Article Excerpt
COPENHAGEN, Denmark, Dec. 12 /PRNewswire-FirstCall/ -- Genmab A/S announced today that HuMax(R)-CD20 induces rapid responses in patients with relapsed chronic lymphocytic leukemia (CLL) in the ongoing phase I/II study. Responses generally appeared early with 67% evaluable patients treated at the highest dose level (2,000 mg) responding to treatment at week 4. Twelve of 26 patients (46%) obtained objective responses lasting at least 8 weeks by the NCI working group guidelines for CLL including 2 nodular partial remissions.

(Photo: http://www.newscom.com/cgi-bin/prnh/20051212/PHM035 )

The 67% responding patients observed at week 4 included 16 patients showing responses by physical examination and peripheral blood evaluation. Ten patients showed complete responses by absence of enlarged lymph nodes, spleen and liver, and by normalization of blood counts at any time point during the 19 week follow up period.

By the NCI working group guidelines for CLL, complete response must be confirmed with CT scan and bone marrow samples. Under the protocol, these were not scheduled to occur until week 19 at the minimum and could take place up to week 26, which could be over 5 months since the response was initially observed.

HuMax-CD20 also induced marked effects in the bone...

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