T-Cell Lymphoma Patients Achieve Long Lasting Responses With Genmab's HuMax-CD4
Copenhagen, Denmark (ots/PRNewswire)
Genmab A/S (CSE: GEN) announced today that cutaneous T-cell lymphoma (CTCL) patients in the HuMax-CD4 Phase II studies achieved long lasting responses, with an average response duration of more than 6.6 months. This duration of response data is based on an analysis of responding mycosis fungoides (MF) patients at all dose levels, 280, 560 and 980 mg.
In addition, median time to disease progression of all 38 MF patients in the two Phase II studies is more than 5.7 months. Disease progression is defined as an increase in disease that is more than 25% above the baseline measurement taken when patients entered the study.
The average duration of response for the high dose patients, who received either 560 mg or 980 mg, is also more than 6.6 months. In addition, median time to progression is more than 5.7 months. The median event time has not yet been reached for the high dose patients for either measure as more than half the responding patients maintain their responses and more than half of the high dose patients have not experienced disease progression. Genmab will continue to follow these patients.
Six of seven patients who achieved a response at the 560 mg dose continue to maintain those responses as of the analysis date. These were early stage patients and generally less heavily pre-treated than the patients who received the 980 mg dose.
Advanced stage patients, who received either 280 or 980 mg, obtained a median response duration of 5.3 months and median time to progression of 4.8 months.
Data for duration of response and time to disease progression have been calculated as of the end of August, 2004.
These data are being presented at the "Fourth International Congress on Monoclonal Antibodies in Cancer" in Colorado Springs, Colorado by Dr. Jan van de Winkel, Genmab's Chief Scientific Officer.
Dr. van de Winkel is also presenting data about the amount of HuMax-CD4 that was found in patients' bloodstream (serum concentration) during the study. In these studies, high serum concentration of HuMax-CD4 appeared to increase the likelihood of a clinical response.
"I believe the length of the Phase II responses is a positive sign, especially as the product has been well tolerated in clinical studies to date," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "Furthermore, we are encouraged that so many early stage patients who received the 560 mg dose all seem to be maintaining their responses. This Phase II data shows the potential to provide a benefit to patients at a variety of disease stages."
About HuMax-CD4
HuMax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes. Genmab has run two Phase II studies using HuMax-CD4 to treat CTCL, one in early stage patients and the other for patients with advanced disease, both of which achieved positive results. Thirty-eight CTCL patients with MF, the most common form of CTCL, were treated in these studies. Genmab has a US Orphan Drug designation for HuMax-CD4 to treat MF patients and is making plans for a pivotal study with HuMax-CD4 under an FDA Fast Track Designation for patients who have failed available therapies.
Conference Call
Genmab will hold a conference call to discuss the news today Wednesday,
September 1, 2004 at:
3:30 pm CET
2:30 pm BST
9:30 am EDT
The conference call will be held in English.
The dial in numbers are as follows:
+1-800-500-0177 (in the US) and ask for the Genmab conference call
+1-719-457-2679 (outside the US) and ask for the Genmab conference callAbout 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 and Amgen. A broad alliance provides Genmab with access to Medarex, Inc.'s array of proprietary technologies, including the UltiMAb(TM) platform for the rapid creation and development of human antibodies to virtually any disease target. Genmab is headquartered in Copenhagen, Denmark, and has operations in Utrecht, The Netherlands, and Princeton, New Jersey in the US. For more information about Genmab, visit http://www.genmab.com .
Except for the historical information presented herein, matters discussed in this press release are forward looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements, e.g. unforeseen exchange rate and interest rate fluctuations, delayed or unsuccessful development projects.
Statements that are not historical facts, including statements preceded by, followed by, or that include the words "believes"; "anticipates"; "plans"; "expects"; "estimates"; or similar statements are forward-looking statements. 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.
HuMax-CD4(TM) is a trademark of Genmab A/S. UltiMAb(TM) is a trademark of Medarex, Inc.
Web site: http://www.genmab.com
Contact:
Rachel Gravesen, VP IR&PR of Genmab A/S, +45-33-44-77-34, or mobile,
+45-25-40-30-01, rcg@genmab.com