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Biotech / Medical : Biotech failure, 2002 -- Ignore unavailable to you. Want to Upgrade?


To: Miljenko Zuanic who wrote (111)9/24/2002 7:21:19 PM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 130
 
What a mediocre plan?
<<Genmab will continue with its Phase IIb development plans using HuMax-CD4 to treat patients with moderate to severe psoriasis.>>

Press Release Source: Genmab A/S

HuMax-CD4 in Combination Therapy Not Effective in Rheumatoid Arthritis
Resume: Genmab's HuMax-CD4 Found Not to be Effective in Combination With Methotrexate in Phase II Study of 155 Patients With Active Rheumatoid Arthritis (RA)
Tuesday September 24, 5:13 pm ET

COPENHAGEN, Denmark, Sept. 24 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN and FSE: GE9D) announced today results from the initial stage of the Phase II clinical trial involving 155 patients with active RA. At the primary endpoint of the study in week 7 there was no significant difference between the ACR scores from patients receiving placebo compared to patients treated with HuMax-CD4 in combination with methotrexate. In the placebo group, 24% of patients achieved an ACR20 compared to between 11% and 29% in the four active dose groups. Treatment with HuMax-CD4 was found to be safe and well tolerated. The number and severity of adverse events was similar across treatment groups including placebo.
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Following these results, Genmab has decided to wind down its anti-CD4 development program for RA. No further patients will be recruited into the Phase III clinical trial in patients with active RA who have failed to respond to treatment with TNF-alpha inhibitor therapies. Genmab will collect data on patients already enrolled in the Phase III study and investigate the difference between using HuMax-CD4 in combination therapy with methotrexate versus the antibody alone. The company will also collect safety data on these patients. In addition, no more patients will be accrued in the ongoing Phase II RA study.

Genmab will continue with its Phase IIb development plans using HuMax-CD4 to treat patients with moderate to severe psoriasis.

"Genmab's strategy has always been to create a broad portfolio of products and therefore to balance risk," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We recently saw very encouraging data from our second product in the clinic, HuMax-IL15, and we will continue to work hard on developing our strong pipeline of pre-clinical products including HuMax-Inflam and HuMax-EGFr."