COPENHAGEN, Denmark, Dec. 12 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN) announced today that HuMax(R)-CD20 induces rapid responses in patients with relapsed chronic lymphocytic leukemia (CLL) in the ongoing phase I/II study. Responses generally appeared early with 67% evaluable patients treated at the highest dose level (2,000 mg) responding to treatment at week 4. Twelve of 26 patients (46%) obtained objective responses lasting at least 8 weeks by the NCI working group guidelines for CLL including 2 nodular partial remissions.
(Photo: http://www.newscom.com/cgi-bin/prnh/20051212/PHM035 )
The 67% responding patients observed at week 4 included 16 patients showing responses by physical examination and peripheral blood evaluation. Ten patients showed complete responses by absence of enlarged lymph nodes, spleen and liver, and by normalization of blood counts at any time point during the 19 week follow up period.
By the NCI working group guidelines for CLL, complete response must be confirmed with CT scan and bone marrow samples. Under the protocol, these were not scheduled to occur until week 19 at the minimum and could take place up to week 26, which could be over 5 months since the response was initially observed.
HuMax-CD20 also induced marked effects in the bone marrow of several patients in the study.
The median time to progression in the 12 responding patients has not yet been reached, but will exceed 19 weeks. The time to response is very short with 16 of 26 patients obtaining a clinical complete or partial response at week 4.
The pharmacokinetics in the study support the use of HuMax-CD20 in CLL and indicate that responses and their duration may further improve with continued treatment.
HuMax-CD20 was well tolerated by CLL patients in the study and the maximum tolerated dose was not reached.
Professor Herve Tilly of Centre Henri Becquerel in Rouen, France, presented the data today during an oral presentation at the 2005 Annual Meeting of the American Society of Hematology. Selected slides from the presentation will be available at http://www.genmab.com.
“According to the results of this ongoing study, HuMax-CD20 shows promise in the treatment of relapsed CLL patients on several fronts,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We are very pleased with the way patients are responding to treatment and look forward to moving this product into pivotal studies.”
Conference Call
Genmab will hold a conference call about the news today, Monday, December 12, 2005 at
8:45 p.m. CET 7:45 p.m. GMT 2:45 p.m. EST The dial-in numbers are as follows: +1 800-289-0743 (in the US) and ask for the Genmab conference call +1 913-981-5546 (outside the US) and ask for the Genmab conference call The conference call will be held in English. About the study
The study is an open-label dose escalation trial that enrolled 33 patients with CLL who had failed previous therapy. The trial has three dose levels. Three patients at the first dose level received an initial dose of 100 mg followed by three weekly doses of 500 mg, at the second dose level three patients received a dose of 300 mg followed by three weekly doses of 1,000 mg and at the third level, 27 patients received an initial dose of 500 mg followed by three weekly doses of 2,000 mg.
The total follow up period for this study is 12 months from treatment start and the primary endpoint of the trial is objective response over the period from screening to week 19.
NCI working group guidelines
Responses criteria were those defined by the National Cancer Institute Working Group. Under these criteria responses are assessed by physical evaluation, peripheral blood counts, and by CT scan, and bone marrow biopsy for responders. Response (complete or partial) must be maintained for a period of at least 2 months.
The National Cancer Institute - sponsored Working Group (NCI-WG) on CLL published guidelines for the design and conduct of clinical trials in CLL with the objective to facilitate comparisons of results of clinical trials in CLL by providing standardized eligibility, response and toxicity criteria. According to the guidelines, a complete remission (CR) is obtained when there is an absence of lymphadenopathy by physical examination and appropriate radiographic technique, spleen and liver are normal in size, absence of constitutional symptoms, and normal peripheral blood counts. A bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results have demonstrated that all above mentioned criteria has been fulfilled. The examination must show: normocellular for age, lymphocytes < 30% and no nodules. A nodular partial remission has the same definition as for CR but with persistent nodules in the bone marrow. A partial remission requires a more than 50% decrease in peripheral blood lymphocyte count, a more than 50% reduction in lymphadenopathy, a more than 50% reduction in size of liver and spleen if abnormal at baseline and a more than 50% improvement in peripheral blood cell counts if not normal. Response must be maintained for a period of at least 2 months.
Fast Track Status
HuMax-CD20 received a Fast Track designation from the US Food and Drug Administration in December 2004 for Genmab’s CLL development program.
About CLL
CLL is the most common leukemia in adults in the US and most of Western Europe. The incidence is 8,100 to 12,500 new cases in the US per year and 85-95% of the cases are of B-cell origin. CLL is a subgroup of non-Hodgkin’s lymphoma (NHL) and together with small lymphocytic lymphoma (SLL) corresponds to around 20% of all NHL cases.
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. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies including agreements with Roche, Amgen and Serono. A broad alliance provides Genmab with access to Medarex, Inc.'s array of proprietary technologies, including the UltiMAb(R) platform for the rapid creation and development of human antibodies to virtually any disease target. Genmab has operations in Copenhagen, Denmark, Utrecht, the Netherlands, and Princeton, New Jersey in the US. For more information about Genmab, 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.
UltiMAb(R) is a trademark of Medarex, Inc.
Genmab(R); HuMax(R); HuMax-CD4(TM) and the Y-shaped Genmab logo are all trademarks of Genmab A/S.
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CONTACT: Helle Husted, Director, Investor Relations of Genmab A/S, +45 3344 77 30, or Mobile, +45 25 27 47 13, hth@genmab.com
Web site: http://www.genmab.com/
