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Title: New Drug Looks Promising In Fight Against Cancer And Infections
URL: http://www.pslgroup.com/dg/2AEFA.htm
Doctor's Guide
June 5, 1997


SEATTLE, June 5, 1997 -- Results presented yesterday from the first test in humans of a new drug, Flt3 ligand, show that it safely increased numbers of important immune system cells, which can potentially improve patients' defenses when fighting diseases such as cancer and infections.

In the study, presented at the Third International Society of Hematotherapy of Graft Engineering meeting in Bordeaux, France, numbers of both stem cells and dendritic cells were significantly increased after daily administration of Flt3 ligand, developed by Immunex Corporation.

"Flt3 ligand appears promising as an agent to mobilize stem cells in cancer treatments," according to Peggy Phillips, senior vice president, pharmaceutical development. "The increase in cell counts has been very encouraging."

Phillips said the company plans to continue to study Flt3 ligand in combination with other cytokines with the aim of reducing aphereses, the number of blood collections required for stem cell transplants. The company's researchers will also investigate the role of Flt3 ligand as an anti-tumor agent.

Results of preclinical studies, including a paper published in this week's issue of the journal Nature Medicine, have shown that dendritic cells are important to developing an anti-tumor immune response.

In the randomized, double-blind, placebo-controlled study of 20 healthy volunteers, daily injections of Flt3 ligand at doses of 10 to 100 mcg/kg for 14 days were well tolerated. The following dose levels were tested: 10, 25, 50, 75 and 100 mcg/kg, with three subjects receiving Flt3 ligand and one receiving placebo at each level.

At day 15, the mean level of dendritic cells increased approximately 30 fold in peripheral blood and CD34 cells increased 20 fold as compared to placebo. Circulating CFU-GM, a measure of stem cell growth, increased by a mean of 80 fold. Flt3 ligand was well tolerated by all subjects and there was no evidence of mast cell stimulation, which can lead to allergic reactions.

Flt3 ligand is a cytokine that helps to increase numbers of blood cells including stem cells and dendritic cells. Stem cells are primitive blood cells that can develop into the entire repertoire of blood cells. Peripheral blood stem cells are being increasingly used to reconstitute bone marrow damaged by aggressive cancer treatments. Dendritic cells play a crucial role in processing and presenting antigens to the immune system, which is a critical step in initiating an effective immune response.

Immunex is a biopharmaceutical company engaged in developing immune system science in the areas of cancer and of inflammatory and infectious disease.

American Home Products Corporation owns a majority interest in Immunex. AHPC is one of the world's largest research-based pharmaceutical and health care products companies and is a developer, manufacturer and marketer of prescription drugs and over-the-counter medications, vaccines, biotechnology, agricultural products, animal health care and medical devices.

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