Psoriasis Patients in Genmab's HuMax-CD4 Phase II Trial Experience Long Lasting Effects
COPENHAGEN, Denmark, April 12 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN and Neuer Markt: GE9D) announced today a number of patients in its HuMax-CD4 Phase II clinical trial for psoriasis have experienced long-lasting effects from the treatment. Out of 68 patients treated with HuMax-CD4 19 achieved at least a 25 percent reduction of the industry recognized PASI score at the trial endpoint at week seven (four weeks after the last treatment). Over half still maintained that score 12 weeks after the last treatment. This means ten (53 percent) of the 19 patients saw long lasting results during the three months after the last injection. Five patients even maintained a 50 percent reduction of PASI 12 weeks after. Genmab will continue to follow these patients in order to collect further data on the length of response.
Genmab's Chief Scientific Officer, Professor Jan GJ van de Winkel, Ph.D. will outline the data at today's UBS Warburg Therapeutic Research Conference: Rheumatoid Arthritis, in London. Dr. van de Winkel's presentation at the conference will center on recent developments made by Genmab in the development of the fully human antibodies HuMax-CD4 and HuMax-IL15 for the treatment of RA and psoriasis.
``We treated patients with severe psoriasis and are encouraged by the long lasting effects of a short course with HuMax-CD4,'' said Lisa N. Drakeman, Ph.D., Chief Executive of Genmab. ``We are working hard at Genmab to develop effective treatments for patients suffering from RA and psoriasis. Currently around 1 percent of the world's population has RA indicating more than two million people in the US have this debilitating disease. Many of these patients do not have safe and effective therapy. This reveals a clear need for products to help patients,'' said Lisa Drakeman, Ph.D., Chief Executive Officer of Genmab.
Psoriasis Phase II Results
Genmab announced the results of its HuMax-CD4 Phase II trial in psoriasis at the end of February 2002. This small, placebo controlled Phase II study was designed to establish the safety and lowest effective dose of HuMax-CD4 in patients with moderate to severe psoriasis. Eighty-five patients received placebo or one of four dose levels (20, 80, 160, 280 mg) of HuMax-CD4 once weekly for four weeks. After the last treatment, the patients were followed over a period of 11 weeks with the primary endpoint being evaluated at week 7. Four weeks HuMax-CD4 treatment was safe and well tolerated. PASI was reduced with increased dose levels. Mean PASI was reduced by 12 percent, 14 percent, 16 percent and 24 percent in the active dose groups, respectively. At the highest dose level, 38 percent of the patients obtained more than 25 percent reduction of PASI and half of those patients obtained more than 50 percent reduction of their PASI.
The efficacy results obtained after just four weeks of treatment indicate that longer treatment could lead to even further reduction of PASI, and Genmab therefore plans to proceed to Phase IIb in psoriasis in the second half of 2002.
About Genmab A/S
Genmab is a Danish biotechnology company creating and developing fully human antibodies for the treatment of life-threatening and debilitating diseases. Genmab has a number of products in development to treat cancer, rheumatoid arthritis and other inflammatory conditions such as psoriasis. Genmab aims to create a broad portfolio of new therapeutic products based on its research and development. At present, Genmab's commercial opportunities are based upon research in its own laboratories, as well as via alliances with leading international companies, including Roche, Immunex Corporation, Oxford GlycoSciences Ltd., Medarex, Inc., deCODE Genetics, Scancell, Ltd., Sequenom, Inc., Eos Biotechnology Inc., Glaucus Proteomics B.V., Bionomics and Paradigm Therapeutics Ltd. Genmab has its headquarters in Copenhagen, Denmark and operations in Utrecht, The Netherlands and Princeton, New Jersey in the US. For more information about Genmab, visit www.genmab.com .
* BACKGROUND
* HuMax-CD4
* HuMax-CD4 is a high affinity fully human antibody that targets the CD4
receptor on T-lymphocytes. These cells are involved in promoting autoimmune
disease and an antibody that targets them has the potential to treat several
inflammatory diseases including rheumatoid arthritis and psoriasis.
Genmab has conducted HuMax-CD4 clinical trials in both Rheumatoid Arthritis (RA) and Psoriasis. A placebo-controlled, multi-center, Phase III clinical trial in rheumatoid arthritis to treat patients who have failed to respond to TNF-alpha inhibitors and methotrexate is currently ongoing, with results expected next year. The study is expected to treat 402 patients, who will be randomly assigned to one of three treatment groups: placebo, 80mg, or 160mg of HuMax-CD4. These patients will be dosed once at the outset, again at two weeks, then once every four weeks until week 22. The primary clinical endpoint proposed is the mean ACR20 response at 26 weeks.
A Phase II study in a broad RA indication for patients with moderate to severe arthritis despite treatment with methotrexate is also ongoing with results from that study expected this year. A Phase IIb study in psoriasis, which will last approximately a year, is due to start later this year.
Fast Track Status
In February, the US Food and Drug Administration (FDA) designated HuMax-CD4 a Fast Track product to treat patients with active rheumatoid arthritis (RA) who have failed to respond to treatment with Methotrexate and TNF-alpha blocking agents.
Under the FDA Modernization Act of 1997 designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition
The PASI scale
PASI is the Psoriasis Area and Severity Index, which is used throughout the dermatology research community as a method of evaluating the effect of treatments. The PASI is scored from 0 - 72. It accounts for the affected area and grades the degree of induration (hardness), erythema (redness) and scaling of the skin lesions. The PASI scale can be used to describe the mean decrease in PASI of the entire patient population or for the percentage of patients that obtain a certain PASI score.
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, eg. 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. |
