Genmab Initiates Study of Zalutumumab With Radiotherapy in Head and Neck Cancer
24/06/2008 22:36
PR Newswire
COPENHAGEN, June 24 /PRNewswire/ --
- Summary: Genmab Initiates a Phase I/II Study of Zalutumumab in
Combination With Radiotherapy for the Treatment of Advanced Head and Neck
Cancer.
Genmab A/S (OMX: GEN) announced today it has initiated a Phase I/II study
of zalutumumab (HuMax-EGFr(TM)) in combination with radiotherapy for the
treatment of advanced head and neck cancer. The study will include a maximum
of 36 patients who are ineligible for platinum based chemotherapy.
"Platinum based chemotherapy is currently considered to be the best
available standard treatment for advanced head and neck cancer. We hope
zalutumumab may some day provide a treatment option for patients who are in
need of less toxic therapies," said Lisa N. Drakeman, Ph.D., Chief Executive
Officer of Genmab.
About the trial
In the dose-escalation part of the study, 6 to 24
patients will be enrolled in cohorts of 3 patients per dose level of
zalutumumab. The dose level for each successive cohort will be determined by
the aggregate safety data observed in the prior cohorts. When the maximum
tolerated dose of zalutumumab is established, an additional cohort of 12
patients will be enrolled and treated at this level.
Patients in the study will receive 8 weekly infusions of zalutumumab with
the first cohort receiving an initial dose of 12 mg/kg of zalutumumab
followed by 7 maintenance doses of 8 mg/kg of zalutumumab in addition to
radiotherapy. Patients will be evaluated at 4 weeks following the last dose
of zalutumumab and will be followed for a total of 2 years.
The objective of the study is to evaluate the safety of repeat dosing and
establish the maximum tolerated dose of zalutumumab in combination with
radiotherapy in patients with advanced head and neck cancer who are
ineligible for platinum based chemotherapy. The primary endpoint of the study
is adverse events.
About Genmab A/S
Genmab is a leading international biotechnology company
focused on developing fully human antibody therapeutics for unmet medical
needs. Using cutting-edge antibody technology, Genmab's world class
discovery, development and manufacturing teams have created and developed an
extensive pipeline of products for potential treatment of a variety of
diseases including cancer and autoimmune disorders. As Genmab advances
towards a commercial future, we remain committed to our primary goal of
improving the lives of patients who are in urgent need of new treatment
options. For more information on Genmab's products and technology, visit
http://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-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM);
HuMax-CD38(TM); HuMax-CD32b(TM) and UniBody(R) 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
Contact: Helle Husted, Sr. Director, Investor Relations T: +45-33-44-77-30, M: +45-25-27-47-13, E: hth@genmab.com
-