Biotech Values

[jbog]

I guess they saw a advantage.

Genmab has conducted a study of HuMax-CD20 to treat patients with active RA who have failed one treatment with one or more disease modifying anti-rheumatic drugs (DMARDs). Initial results announced in March 2006 showed a 77% (20/26 patients) ACR20 response rate in patients who received two doses of HuMax-CD20. Even on an intent to treat basis, which included six patients who did not receive both doses of HuMax-CD20, 63% (20/32) of patients obtained an ACR20 response. For comparison, none of the seven patients who received placebo achieved ACR20.

Three dose levels were treated in the study. In the lowest dose group (300 mg), 75% (6/8) patients who received both doses obtained ACR20. In both the 700 and 1000 mg dose groups, 78% of patients who received both doses obtained ACR20 (7/9 patients per group). The study included 39 patients and 33 received either two infusions of HuMax-CD20 or placebo, given 2 weeks apart. The primary objective of the study was safety and efficacy was assessed by the ACR score at week 24.

Twenty-six of the 39 patients in the study had previously received treatment with TNF inhibitors. Twenty-two were intolerant or refractory to TNF inhibitors and four stopped treatment for other reasons. Efficacy among these patients was in the same range as for the rest of the group on an intent to treat basis.

The maximum tolerated dose was not reached. Two infusion-related serious adverse events and a common terminology criteria (CTC) grade 3 event were observed in the 300 mg cohort. Consequently, pre-medication with corticosteroids was implemented and further intensified for the 700 mg and 1000 mg cohorts where 2 patients reported infusion-related CTC grade 3 events.

The Phase I/II study was expanded into a Phase II study in August 2005.
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Previous Clinical Studies
Phase I/II Results
The Phase I/II dose escalation trial was designed for 40 patients divided into 4 dose cohorts to receive 4 weekly infusions of HuMax-CD20 at doses of 300, 500, 700 and 1000 mg and were followed for 12 months. Patients in the study had relapsed or refractory follicular NHL and had previously received a median of 2 treatment regimens, including the possibility of rituximab.

In 37 evaluable patients, objective responses at each dose level were 63% (300 mg), 33% (500 mg), 20% (700 mg) and 60% (1000 mg). These response rates include 5 complete responses (CR), 2 complete responses unconfirmed (CRu) and 9 partial responses (PR). A CRu meets and exceeds the criteria for partial response.

The objective response rate in patients who previously responded to rituximab treatment was 64% (9 of 14 patients), including 3 CR, 1 CRu and 5 PR for a 29% complete response rate. Immediate, profound depletion of B-cells was seen at all dose levels. This depletion was generally maintained during the follow up period.

The median duration of response and median time to disease progression in responding patients had not been reached after 12 months of follow up. Of the 16 patients who responded to treatment, 12 had not progressed at the end of the follow up period.

HuMax-CD20 was well tolerated by the patients in the study. No dose limiting toxicities were reported during the study and the maximum tolerated dose was not reached. The most frequently reported adverse events were rigors, fatigue, headache and rash. Hematological toxicity was low with only 6 of 40 patients reporting grade 1 neutropenia and no patients reporting thrombocytopenia.