Source: Brachytherapy  |  Posted 6 years ago

COPENHAGEN, DENMARK -- February 18, 2005 -- Genmab A/S (CSE: GEN) announced additional encouraging duration of response data from one of its HuMax-CD4? (zanolimumab) Phase II studies treating patients with mycosis fungoides (MF) a type of cutaneous T-cell lymphoma (CTCL). Data from all patients in the study showed a median response duration of more than 45 weeks (10.5 months). Furthermore, analysis of the time to response showed that 85% of the responding patients (11/13) obtained clinical response within 8 weeks.

Dose Response

Additionally, previously released data was analyzed to assess the relation between dose and the serum concentration of HuMax-CD4 measured immediately before the next treatment (trough values). Increasing doses of HuMax-CD4 resulted in increased trough values. Furthermore, a 55% response rate was achieved in patients reaching lesser than or equal to 10 mu g/ml serum concentration compared to only 6% (1/16) in patients not reaching this serum level. In the 280 mg dose group, 25% (5/20) were above 10 mu g/ml and a 15% response rate (3/20 patients) was achieved. In the 560 mg dose group, 93% (13/14) were above 10 mu g/ml and a 50% response rate (7/14) was obtained. In the 980 mg group 100% (4/4) were above 10 mu g/ml and a 75% response rate (3/4) was obtained.

These data were presented by Dr. Y. H. Kim, Professor of Dermatology and Director, Multidisciplinary Cutaneous Lymphoma Clinic, Stanford University at the 63rd Annual Meeting of the American Academy of Dermatology in New Orleans, Louisiana, USA. The poster will subsequently be available on http://www.genmab.com.

"This latest set of duration of response data is very encouraging and indicates that HuMax-CD4 may be effective in treating CTCL patients with mycosis fungoides, especially at higher doses," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

About HuMax-CD4

HuMax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes. Genmab has run two Phase II studies using HuMax-CD4 to treat CTCL, one in early stage patients and the other for patients with advanced disease, both of which achieved positive results. Thirty-eight CTCL patients with MF, the most common form of CTCL, were treated in these studies. Genmab has US Orphan Drug designation for HuMax-CD4 to treat MF patients and is making plans for a pivotal study with HuMax-CD4 under an FDA Fast Track designation for patients who have failed available therapies.

International Non-proprietary Name (INN) Zanolimumab has reached the status of recommended INN which is the international non-proprietary name (generic name) for HuMax-CD4, as adopted by WHO.

UltiMAb? is a trademark of Medarex, Inc. HuMax? and HuMax-CD4? are trademarks of Genmab A/S

SOURCE: Genmab A/S