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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (796)	3/23/2004 7:46:36 AM
From: Icebrg	Respond to of 2240

Humax-CD4 awarded with Fast Track Genmab’s HuMax-CD4 to treat lymphoma awarded Fast Track Status from FDA Copenhagen, Denmark; March 23, 2004 – Genmab A/S (CSE: GEN) announced today that HuMax-CD4 has been designated a Fast Track Product by the US Food and Drug Administration (FDA). This designation covers patients with cutaneous T-cell lymphoma (CTCL) who have failed currently available therapy. This patient group includes those who are refractory as well as those who cannot tolerate currently available treatment. HuMax-CD4 is currently in two Phase II studies to treat CTCL. 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. This fast track designation gives Genmab the opportunity to submit a Biologics License Application (BLA) in sequential sections, and have these sections reviewed as they are submitted, thus saving development time. A BLA is the biologic products’ equivalent to a New Drug Application and is the final stage before a drug is approved for the market by the FDA. Fast track status also opens the possibility for receiving a priority review of the BLA where the review time would be halved to just 6 months. “Fast Track status confirms there is a major unmet medical need for treatment of CTCL patients,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We are encouraged by the results of the clinical trials to date and are looking forward to continued development.” In February, the company announced that results will be presented at the 65TH Annual Meeting of the Society for Investigative Dermatology (SID) in April. At the time the conference abstract was prepared, data was available from 36 patients enrolled in the two ongoing HuMax-CD4 clinical trials using the Composite Assessment of Index Lesion Disease Activity (CA) score. These patients were treated at one of three dose levels as follows: 280 mg (11 early stage and 10 advanced stage), 560 mg (9 early stage) or 980 mg (6 advanced stage). Efficacy Following 280 mg, 33% of 21 patients obtained a 50% or better CA score reduction. Following 560 mg, 67% (six of nine early stage patients) obtained a CA score reduction of 50% or better, including two who obtained a 100% reduction. Three other early stage patients had stable disease. Following 980 mg, 50% (three of six) advanced stage patients obtained a CA score reduction of more than 50% and three patients had stable disease. Safety Following 280 mg dosing, 6 grade 3 adverse events were reported by 4 patients. 5 were unrelated to HuMax-CD4. Following 560 and 980 mg, 1 unrelated grade 3 adverse event was reported. No grade 4 events were reported. HuMax-CD4 has been found to be safe and well tolerated by patients with CTCL in clinical studies to date. Society for Investigative Dermatology Presentation At the time of the SID abstract, 15 early stage patients were enrolled in the 560 mg treatment group and 10 late stage patients were enrolled in the 980 mg treatment group. At the time of the presentation on April 30, 2004, more complete data covering more of these patients for a longer period of time is expected to be available.