�GlaxoSmithKline (LSE and NYSE: GSK) and Genmab A/S (OMX: GEN) announced today positive top-line results from an interim analysis of the Phase III polar study evaluating ofatumumab (HuMax-CD20�) in deuce difficult to treat groups of patients with chronic lymphocytic leucaemia (CLL). At the interim analysis, the study met the primary endpoint in both populations and the results from the secondary endpoints also support the primary terminus.
The bodily process of ofatumumab was evaluated in 154 patients in this lag 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 analytic thinking also included a second group (79) who were refractory to fludarabine and considered inappropriate candidates for alemtuzumab referable to bulky tumour in their lymph nodes. An objective response rate of 51% (p
Ofatumumab was broadly 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, diarrhoea, fatigue, coughing, 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) merging has been requested with the FDA during which these information will be discussed with the potential drop of a 2008 BLA filing. There is likewise the potentiality to accede to the EU regulatory authorities in this time frame. The full data will be submitted for presentation to an academic meeting in due course.
"These very encouraging results suggest that ofatumumab has the potential to provide benefits to CLL patients with very recalcitrant disease and limited treatment options," aforementioned Kathy Rouan, Vice President and Medicine Development Leader at GSK. "GSK and Genmab are collaborating on a comprehensive development programme for CLL as well as non-Hodgkin's lymphoma, which we hope will ready a significant contribution to the direction of these haematologic malignancies for both patients and their physicians."
"We are thrilled to report a positive outcome for the CLL patients in this trial," said Lisa N. Drakeman, Chief Executive Officer of Genmab. "This also represents a meaning achievement for Genmab as we like a shot move toward filing of the first marketing applications for a Genmab antibody and we look onward to working with GSK on the submissions."
Ofatumumab is an investigational new genesis fully human monoclonal antibody that unambiguously targets the small loop epitope (specific antibody binding site) of the CD20 molecule on B cells. Ofatumumab is being developed to regale chronic lymphocytic leukaemia, follicular non-Hodgkin's lymphoma, diffuse big B-cell lymphoma, rheumatoid arthritis and backsliding remitting multiple sclerosis below a co-development and commercialization agreement betwixt Genmab and GlaxoSmithKline. It is non yet sanctioned in whatever country.
About the Trial
The study includes CLL patients world Health Organization are refractory to both fludarabine and alemtuzumab and patients world Health Organization are stubborn to fludarabine who are considered inappropriate candidates for alemtuzumab due to bulky tumour in their lymph nodes. All patients in the report receive 8 weekly infusions of ofatumumab, followed by 4 monthly infusions of ofatumumab. Patients receive ccc mg of ofatumumab at the first infusion and 2,000 mg of ofatumumab at each subsequent infusion. Disease status is assessed every 4 weeks until hebdomad 28 and then every 3 months until disease progression or month 24. Patient recruitment is ongoing and a final depth psychology will be conducted on the full study population, expected to be 100 patients in each group.
The primary endpoint of the study is objective reply over a 24 week period from start of treatment as assessed according to the National Cancer Institute Working Group guidelines. The secondary endpoints ar duration of response, patterned advance free selection, time to next CLL therapy, overall survival and adverse events.
GlaxoSmithKline one of the world's leading research-based pharmaceutical and healthcare companies is attached to up the lineament of human life by enabling people to do more, experience better and live longer. For further information please visit http://www.gsk.com
About Genmab A/S Genmab is a preeminent international biotechnology company focussed on developing fully human antibody therapeutics for unmet medical necessarily. Using knife edge antibody engineering, Genmab's world class discovery, development and manufacturing teams have created and developed an across-the-board pipeline of products for potential intervention of a variety of diseases including cancer and autoimmune disorders. As Genmab advances towards a commercial future, we remain committed to our primary end of improving the lives of patients who are in urgent need of new intervention options. For more entropy on Genmab's products and technology, chitchat www.genmab.com.
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Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that whatever forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may causal agent actual results to differ materially from those relieved. 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.
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This press release contains forward looking for statements. The words "believe", "expect", "foresee", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or carrying into action may differ materially from any future results or performance verbalised or implied by such statements. The important factors that could cause our actual results or performance to take issue materially include, among others, risks associated with product discovery and development, uncertainties related to the upshot and conduct of clinical trials including unforeseen rubber issues, uncertainties related to product fabrication, the want of mart acceptance of our products, our inability to do growth, the competitive environs in relation to our business area and markets, our inability to appeal and hold back suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietorship rights, our relationships with affiliated entities, changes and developments in technology which may return our products obsolete, and other factors. For a further treatment 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 guarantee any obligation to update or revise forward looking statements in this press release nor to support such statements in relation to actual results, unless required by law.
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