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Alert Number 113

Genmab's HuMax-CD20 Clinical Trial

Date: August 1, 2005

In the middle of December last year we discussed the mechanism of how anti-CD20 monoclonal drugs work and brought to your attention a brand new clinical trial opening for testing of GenMab’s HUMAX-CD20 in CLL patients. You can refresh your memory by clicking on the link below. The clinical trial information is all the way at the end of our article. There is hope that this new anti-CD20 monoclonal will work better than Rituxan, the other anti-CD20 monoclonal drug. I had a feeling this trial was going to get sold out fast.

Sons of Rituxan and Campath

Well, as I expected the patient recruitment got off to a brisk start, dare we hope our review publicizing this trial had something to do with it? It turns out that Ohio State (Dr. John Byrd, et al.) dropped out of this clinical trial, but it went ahead at the second center, the University of Iowa. As you can see from the company’s press release below, this is a dose escalation study. It seems the first two dose cohorts tolerated the drug fine, they are now into the third, last and highest dose level. They are not recruiting any more patients, so you guys out there who wanted to be in this trial - but did not get on the horn right away – will have to wait until the next phase opens up. You can count on us to bring you a heads-up as soon as we hear anything about how this Phase I/II trial worked out and when they are likely to start recruiting for the next phase. I will finish this Alert with a nice guilt trip, a quotation from our December 13, 2004 article:

"If you do succeed in registering for this clinical trial, remember where you heard about it, remember your friends at CLL Topics. You have an open invitation to write about your experiences with this interesting new drug, and we will publish you on our Patient's corner. Total anonymity guaranteed, you can make up a name and persona for yourself. Here is your one chance to be a blond bombshell, if that is your fantasy."

Be well,

Chaya
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Corporate Press Release

GENMAB COMPLETES ACCRUAL IN HUMAX-CD20™ PHASE I/II CLL STUDY

Summary: All patients have been enrolled in Genmab’s HuMax-CD20 Phase I/II study to treat patients with chronic lymphocytic leukemia.

Copenhagen, Denmark; March 29, 2005 – Genmab A/S (CSE: GEN) announced today that it has completed enrolment in the HuMax-CD20 Phase I/II study to treat patients with chronic lymphocytic leukemia (CLL). A total of 33 patients are enrolled in this study, with 27 patients included in the highest dose group, where they receive an initial dose of 500 mg followed by three weekly doses of 2000 mg.

"The team at Genmab has worked hard to ensure rapid recruitment in this study," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We look forward to seeing efficacy data from this study.”

About the study:

The study is an open-label dose escalation trial treating 33 patients with CLL. The trial has three dose cohorts. Three patients in the first dose cohort received an initial dose of 100 mg followed by three weekly doses of 500 mg, in the second dose cohort three patients received a dose of 300 mg followed by three weekly doses of 1000 mg and in the third cohort 27 patients receive an initial dose of 500 mg followed by three weekly doses of 2000 mg. Treatment is ongoing at the highest dose level.

The first important milestone for this study, the safety of using HuMax-CD20 in these patients at the planned dose levels, seems to have been achieved since no si de effects limiting the continued recruitment of patients were observed. The total follow up period for this study is 12 months from treatment start and the primary endpoint of the trial is objective response over the period from screening to week 19.

Fast Track Status:

HuMax-CD20 received a Fast Track designation from the US Food and Drug Administration in December 2004 for Genmab’s CLL development program.
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