COPENHAGEN, Denmark, Dec. 12 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN) announced today preliminary results in the Phase II study using HuMax-CD4(TM) to treat patients with refractory or relapsed non-cutaneous T-cell lymphoma. At week 6, according to the Cheson criteria, 3 patients achieved objective responses as assessed by CT scan and clinical investigation, including 1 complete response unconfirmed (CRu) and 2 partial responses (PR). Two of the patients (CRu and PR) had progressive disease at week 12, whereas the third patient had only the week 6 CT scan to date and is still being treated in the study.
In addition to the responses verified by CT scan, study investigators reported significant improvement in another 3 patients. Following treatment with 2 and 3 infusions of HuMax-CD4, most of the lymph nodes in 2 patients returned to normal size lasting for a period of 3 and 6 weeks, respectively, after which both patients were withdrawn from the study due to disease progression. The third patient had received 7 infusions of HuMax-CD4 and described an overall improvement in general condition during the course of treatment, however, CT scan at week 6 demonstrated progressive disease.
A total of 14 patients were enrolled in the study. The efficacy data represent 11 patients who received at least 1 infusion of HuMax-CD4 and were followed for at least 6 weeks or were withdrawn for safety reasons. Three of the 11 patients have received all 12 infusions. The remaining 8 patients received 2 to 7 infusions. One of the 11 patients is still being treated.
Safety
The safety data include all 14 patients. HuMax-CD4 was generally well tolerated in this patient population. Four patients had serious adverse events (SAE) considered treatment related by investigator: 1 patient had 2 grade 1 SAEs, hyperthermia and hypotension; 1 patient had a grade 2 SAE, infusion related reaction, 2 patients had 2 grade 4 SAEs, febrile neutropenia and thrombocytopenia. The incident of thrombocytopenia was observed the day after the patient’s first infusion. Eight hours after the first measurement, the thrombocyte count had returned to normal and the patient received 5 additional infusions of HuMax-CD4 without reoccurrence.
“We are encouraged by the responses with this intractable disease where there is currently no approved therapy available, and believe further development of HuMax-CD4 for non-cutaneous T-cell lymphoma is warranted,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer.
The poster was presented today at the 2005 Annual Meeting of the American Society of Hematology and is available at http://www.genmab.com.
Conference Call
Genmab will hold a conference call about this news, as well as news from the HuMax-CD20 presentation at ASH, 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 CTCL and NCTCL
Cutaneous T-cell lymphomas (CTCL) are a group of lymphomas characterized by abnormal accumulation of malignant T-cells in the skin, resulting in the development of rashes, plaques and tumors. The most common types of CTCL include mycosis fungoides (MF) and Sezary syndrome (SS). CTCL result from transformation of T-lymphocytes into malignant cells. Abnormal, uncontrolled growth and multiplication of malignant T-lymphocytes result in accumulation of these lymphocytes in the skin and may in some cases spread and affect the lymph nodes and other body tissues and organs, resulting in life-threatening complications.
Non-cutaneous T-cell lymphoma (NCTCL) is defined by highly malignant diseases, which have localized to the lymph nodes even at the earliest stage of presentation, and include angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma (ALCL) and unspecified peripheral T-cell lymphoma. This disease entity is characterized by aggressive progression with average survival time of approximately two years.
About HuMax-CD4 (Zanolimumab)
HuMax-CD4(TM) (zanolimumab) is a human monoclonal antibody currently in Phase III development for cutaneous T-cell lymphoma (CTCL) and in Phase II for non-cutaneous T-cell lymphoma. These types of lymphomas express the CD4 receptor, which is the target of HuMax-CD4. In April 2005, Genmab and the United States Food and Drug Administration (FDA) reached an agreement on the design of its pivotal study protocol for HuMax-CD4 to treat CTCL under the Special Protocol Assessment process (SPA). The pivotal study will include patients with mycosis fungoides (MF) who are refractory to or intolerant of Targretin and one other standard therapy, and will treat a total of 88 patients.
In March 2004, Genmab announced that HuMax-CD4 had been designated a Fast Track Product by the US Food and Drug Administration (FDA). This designation covers patients with CTCL for whom no available therapy exists, i.e. have failed at least two systemic treatment regimens. HuMax-CD4 for the treatment of MF has also been granted Orphan Drug status in the US and Europe.
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 update 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.
Genmab A/S
CONTACT: Helle Husted, Director, Investor Relations, Genmab, +45 33 44 7730, Mobile: +45 25 27 47 13, Email: hth@genmab.com
Web site: http://www.genmab.com/
