77% Achieve ACR20 With Genmab's HuMax-CD20 in Rheumatoid Arthritis Study

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77% Achieve ACR20 With Genmab's HuMax-CD20 in Rheumatoid Arthritis Study

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104 & STORY=/www/story/03-08-200\

6/0004315848 & EDATE

Initial Phase I/II Study Data

COPENHAGEN, Denmark, March 8 -- Genmab A/S

announced today positive results in the HuMax-CD20 Phase I/II

dose escalation study to treat patients with active rheumatoid arthritis

(RA).

In patients who received two doses of HuMax-CD20, 77% (20/26) obtained

ACR20.

Even on an intent to treat basis, which included six patients who did not

receive both doses of HuMax-CD20, 63% (20/32) obtained an ACR20. For

comparison, among the 7 placebo patients none achieved ACR20.

There were three dose levels tested in the study. In the lowest dose

group, (300 mg), 75% (6/8) of 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 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. Efficacy was assessed by the ACR score at week 24.

Patients in this study had previously failed at least one disease

modifying anti-rheumatic drug (DMARD). In addition 26 of the 39 had

previously received treatment with TNF inhibitors. Twenty-two were

intolerant or refractory to TNF inhibitors and four stopped 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 has not been reached. 2 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.

In August 2005, the study was expanded into a Phase II trial which will

include 200 additional patients.

The data will be presented at the 10th Anniversary Inflammation and

Immune

Diseases, Drug Discovery and Development Summit in New Brunswick, New Jersey

21 March 2006 by Dr. Mikkel Ostergaard, Professor of Rheumatology at

Hvidovre Hospital.

" The initial results of this Phase I/II study in RA are very

encouraging, "

said N. Drakeman, Ph.D., Chief Executive Officer of Genmab. " We are

looking forward to the ongoing development of HuMax-CD20 in RA. "