Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (276)	9/23/2002 4:00:45 PM
From: keokalani'nui	Respond to of 631

Am Coll Rheum abstracts available soon (eom)?

To: scaram(o)uche who wrote (276)	9/24/2002 6:50:08 PM
From: scaram(o)uche	Respond to of 631

[ anti-CD4/RA/Genmab ] >> Anti-CD4 as a therapeutic has been of interest since the days of Noel Warner and BD's therapeutic program. What makes this effort different? There is tons of data saying that epitope selection might be important, but nobody has made it stick re. data on human cells, IMO. Is there any sophistication here? << 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. ADVERTISEMENT 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." About the study Genmab's HuMax-CD4 Phase II trial for 155 patients with RA in combination with Methotrexate was launched in December 2000 with trials held in Denmark, Sweden, the UK, Iceland and the US. The trial contained four active dose groups of 280mg, 160 mg, 80 mg and 20 mg plus a placebo arm. Patients were given HuMax-CD4 and methotrexate at weekly intervals for a total of four weeks. The clinical response as defined by the industry recognized ACR20 criteria was measured at the primary endpoint of the study in week 7. (snip)