Summary: Final data from two HuMax-CD4 Phase II CTCL studies shows median
response duration of 81 weeks and overall response rate of 56% at highest doses.
Copenhagen, Denmark; June 29, 2007 - Genmab A/S (CSE: GEN) announced today final
data from its two Phase II studies in early and late stage mycosis fungoides
(MF), a form of cutaneous T-cell lymphoma (CTCL), was reported in Blood (Kim,
Y., M. Duvic, E. Obitz, et al. Clinical efficacy of zanolimumab (HuMax-CD4): two
phase 2 studies in refractory cutaneous T-cell lymphoma. Blood 2007; 109:
4655-4662). In the high dose levels of 560 mg and 980 mg, 13 MF patients had
objective responses lasting between 8 and 91 weeks, with median response
duration of 81 weeks (20.3 months), a significant increase compared to
previously reported data. Nine of the responses lasted more than 20 weeks.
Three MF patients treated at the 280 mg dose had responses lasting 12, 13 and 24
weeks and discontinued the study before disease progression.
Responses generally remained the same with 13 of 38 MF patients overall
obtaining an objective response to HuMax-CD4 (zanolimumab). Fifty-six percent
of MF patients treated at 560 mg (7/14 patients) or 980 mg (3/4 patients) of
HuMax-CD4 achieved objective responses compared with 15% at the 280 mg (3/20
patients) dose when evaluated by CA Score.
“The final data from the Phase II CTCL studies shows the duration of response
nearly doubled the duration of 10.5 months we previously reported,” said Lisa N.
Drakeman, Ph.D. “We believe this length of duration could be a significant
advantage for CTCL patients who must often return to their doctors seeking new
treatments after short periods of time.”
About the Studies
Two studies were conducted concurrently - one in early stage CTCL and one in
late stage. In both studies, patients were refractory or intolerant to previous
therapy and were treated with a 280 mg, 560 mg or 980 mg dose of HuMax-CD4 once
a week for 16 weeks. Patients were followed for at least 4 weeks after the end
of treatment or until disease progression. Objective responses were evaluated
using the Composite Assessment of Index Lesion Disease Activity (CA) Score.
About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human antibodies
for the treatment of life-threatening and debilitating diseases. Genmab has
numerous products in development to treat cancer, infectious disease, rheumatoid
arthritis and other inflammatory conditions, and intends to continue assembling
a broad portfolio of new therapeutic products. In addition, Genmab has developed
UniBody(TM), a new proprietary technology that creates a stable, smaller
antibody format. Genmab has operations in Europe and the US. For more
information about Genmab, visit www.genmab.com.
This press release contains forward looking statements. The words “believe”,
“expect”, “anticipate”, “intend” and “plan” and similar expressions identify
forward looking statements. Actual results or performance may differ materially
from any future results or performance expressed or implied by such statements.
The important factors that could cause our actual results or performance to
differ materially include, among others, risks associated with product discovery
and development, uncertainties related to the outcome and conduct of clinical
trials including unforeseen safety issues, uncertainties related to product
manufacturing, the lack of market acceptance of our products, our inability to
manage growth, the competitive environment in relation to our business area and
markets, our inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and proprietary rights,
our relationships with affiliated entities, changes and developments in
technology which may render our products obsolete, and other factors. Genmab is
not under an obligation to up-date statements regarding the future following the
publication of this release; nor to confirm such statements in relation to
actual results, unless this is required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-CD20(R);
HuMax-EGFr(TM); HuMax-Inflam(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM);
HuMax-ZP3(TM); and UniBody(TM) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45 33 44 77 30, M:
+45 25 27 47 13, E: hth@genmab.com
Investor News No. 09/2007
###
