very encouraging results: CLL Ofatumumab

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http://www.medicalnewstoday.com/articles/116862.php

Genmab And GlaxoKline Announce Positive Top-Line Results In

Ofatumumab Chronic Lymphocytic Leukemia Pivotal Study

Genmab A/S (OMX: GEN) and GlaxoKline (LSE and NYSE: GSK)

announced positive top-line results from an interim analysis of the

Phase III pivotal study evaluating ofatumumab (HuMax-CD20®) to treat

two groups of chronic lymphocytic leukemia (CLL) patients with high

unmet medical need. At the interim analysis, the study met the primary

endpoint in both populations and the results from the secondary

endpoints also support the primary endpoint.

The activity of ofatumumab was evaluated in 154 patients in this

interim analysis of whom 138 patients with refractory CLL were

evaluable. About half of the patients (59) in the study were

refractory to both fludarabine and alemtuzumab. The analysis also

included a second group (79) who were refractory to fludarabine and

considered inappropriate candidates for alemtuzumab due to bulky tumor

in their lymph nodes. An objective response rate of 51% (p<0.0001)

consisting of 30 partial responses (PR) was achieved in the group of

patients refractory to fludarabine and alemtuzumab. In the fludarabine

refractory, alemtuzumab inappropriate patient group, an objective

response rate of 44% (p<0.0001) was achieved, including 1 complete

response (CR), and 34 PR. Achievement of the reported objective

response rates are based on evaluations by an independent committee

and are subject to review and confirmation by the regulatory authorities.

Ofatumumab was generally well tolerated by CLL patients in the study.

The most frequently reported adverse events (those that occurred at a

greater than 15% frequency) were: pyrexia, diarrhea, fatigue, cough,

neutropenia, anemia and pneumonia. There were no unexpected safety

findings. None of the 14 patients tested for human anti-human

antibodies (HAHA) demonstrated their presence at 12 months.

A pre-BLA (Biologics License Application) meeting has been requested

with the FDA during which these data will be discussed with the

potential of a 2008 BLA filing. There is also the potential to submit

to the EU regulatory authorities in this time frame. The full data

will be submitted for presentation to an academic meeting in due course.

" We are thrilled to report a positive outcome for the CLL patients in

this trial, " said N. Drakeman, Ph.D., Chief Executive Officer of

Genmab. " This also represents a significant achievement for Genmab as

we now move toward filing of the first marketing applications for a

Genmab antibody and we look forward to working with GSK on the

submissions. "

" These very encouraging results suggest that ofatumumab has the

potential to provide benefits to CLL patients with very refractory

disease and limited treatment options, " said Kathy Rouan, Vice

President and Medicine Development Leader at GSK. " GSK and Genmab are

collaborating on a comprehensive development program for CLL as well

as non-Hodgkin's lymphoma (NHL), which we hope will make a significant

contribution to the management of these haematologic malignancies for

both patients and their physicians. "

Ofatumumab is an investigational new generation fully human monoclonal

antibody that uniquely targets the small loop epitope (specific

antibody binding site) of the CD20 molecule on B cells. Ofatumumab is

being developed to treat chronic lymphocytic leukemia, follicular

non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid

arthritis and relapsing remitting Multiple Sclerosis under a

co-development and commercialization agreement between Genmab and

GlaxoKline. It is not yet approved in any country.

About the trial The study includes CLL patients who are refractory to

both fludarabine and alemtuzumab and patients who are refractory to

fludarabine who are considered inappropriate candidates for

alemtuzumab due to bulky tumor in their lymph nodes. All patients in

the study receive 8 weekly infusions of ofatumumab, followed by 4

monthly infusions of ofatumumab. Patients receive 300 mg of ofatumumab

at the first infusion and 2000 mg of ofatumumab at each subsequent

infusion. Disease status is assessed every 4 weeks until week 28 and

then every 3 months until disease progression or month 24. Patient

recruitment is ongoing and a final analysis will be conducted on the

full study population, expected to be 100 patients in each group.

The primary endpoint of the study is objective response over a 24 week

period from start of treatment as assessed according to the National

Cancer Institute Working Group guidelines. The secondary endpoints are

duration of response, progression free survival, time to next CLL

therapy, overall survival and 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.

About GlaxoKline One of the world's leading research-based

pharmaceutical and healthcare companies - is committed to improving

the quality of human life by enabling people to do more, feel better

and live longer.

Forward Looking Statement for Genmab: 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. For a further

discussion of these risks, please refer to the section " Risk

Management " in Genmab's Annual Report, which is available on

http://www.genmab.com. Genmab does not undertake any obligation to

update or revise forward looking statements in this press release nor

to confirm such statements in relation to actual results, unless

required by law.

GlaxoKline Cautionary statement regarding forward-looking

statements Under the safe harbor provisions of the U.S. Private

Securities Litigation Reform Act of 1995, GSK cautions investors that

any forward-looking statements or projections made by GSK, including

those made in this announcement, are subject to risks and

uncertainties that may cause actual results to differ materially from

those projected. Factors that may affect GSK' s operations are

described under 'Risk Factors' in the 'Business Review' in the

company' s Annual Report on Form 20-F for 2007.

Genmab A/S

http://www.genmab.com