Yes. They issued a letter stating that the would seek FDA approval of Paclitaxol, and that the would surely be sued for patent enfringement. More interesting perhaps,is the following release, to wit:
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Immunex Molecules May Inhibit HIV Entry
February 5, 1998 1:30 PM EST
New Scientific Data and Safety Trial Results Presented at Retrovirus Conference
SEATTLE, Feb. 5 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) announced findings of laboratory studies suggesting that Leukine(R) (sargramostim, yeast-derived GM-CSF) or soluble, trimeric CD40 Ligand may block HIV entry into human macrophages. The research was presented earlier this week at the Fifth Annual Retroviruses and Opportunistic Infections Conference in Chicago.
Immunex also presented at the conference positive findings of a safety trial evaluating the use of Leukine in patients on stable anti-retroviral therapy. The findings indicated that Leukine did not increase viral load and may actually have contributed to a reduction in viral load. Viral load is an important marker used by healthcare providers to monitor HIV disease progression. Leukine also was associated with an increase in the number of CD4+ T cells in a significant number of treated individuals relative to the control group. CD4+ T cells are progressively depleted by HIV disease.
"The laboratory data suggest that Leukine may be capable of blocking and decreasing in number the co-receptors necessary for HIV entry. This effect could be responsible for both the reduction in viral load and the increase in CD4+ T cells that was evident in the clinical trial," said Mike Widmer, vice president of biological sciences at Immunex. "We will continue both laboratory and clinical testing to determine if Leukine may have a therapeutic role in treatment of early-stage HIV disease."
Leukine and CD40 Ligand Inhibition of Viral Entry
With the advent of highly active anti-retroviral therapy (HAART) early in the treatment of individuals who are HIV positive, scientists have become increasingly interested in "eradicating" the virus from long-lived cells of the human immune system. Among these are macrophages which circulate in the blood and tissues. Both Leukine and CD40 Ligand cause the differentiation and activation of monocytes and macrophages.
HIV-1 enters macrophages using a co-receptor known as CCR5, a beta chemokine receptor. Another co-receptor, CXCR4, also may play a role in entry of certain dual-tropic HIV strains into these cells.
The pre-clinical study, which also was recently published in AIDS Research and Human Retroviruses, demonstrated that in vitro Leukine directly inhibited the expression of CCR5 and CXCR4, thereby inhibiting entry of HIV-1 into human macrophages. In fact, Leukine-treated macrophages showed a 70- to 100-fold decrease in the entry of HIV-1. Leukine treatment of macrophages increased the production of beta chemokines, soluble proteins which can bind to the chemokine receptors on by-stander T-cells and block HIV from entering T cells. The study also showed that CD40 Ligand decreased CCR5 expression and entry of HIV-1 into macrophages.
Use of Leukine in Patients with HIV
A Phase I trial was conducted in 20 HIV patients with low CD4+ T cell counts (10-590) who were on stable anti-retroviral therapy including ritonavir or indinavir. Patients were randomized to receive either Leukine or a placebo for eight weeks.
During the eight weeks of study and four weeks of follow up, eight of the 10 patients receiving Leukine had an increase of 30 percent or more in CD4+ T cells as compared to three of the 10 patients receiving placebo. Further analysis showed this increase in CD4+ T cell counts in nearly all patients treated with Leukine (p=0.01) who had a CD4+ T cell count of greater than 50 at baseline. Six of these seven patients receiving Leukine had an increase in CD4+ T cells of greater than or equal to 30 percent; only one in eight patients receiving placebo who had baseline CD4+ T cell count of 50 or greater demonstrated a similar rise in CD4+ T cells.
Viral loads decreased at least 0.5 log10 or more in five of seven patients treated with Leukine who had baseline CD4+ T cell counts of greater than 50; none of the eight patients receiving placebo experienced this reduction in HIV load. The CD4+ T cell increase of 30 percent or more and the viral load decrease were sustained in four of the seven patients treated with Leukine. Beyond mild injection site reactions with Leukine, no significant toxicity was reported.
"The findings we are reporting this week demonstrate that Leukine was administered safely to patients receiving anti-retroviral therapies that include protease inhibitors," said Peggy Phillips, senior vice president of pharmaceutical development at Immunex. "Not only did the study demonstrate safety in these patients, but we are beginning to better understand the biologic action of Leukine and its potential role in HIV therapy."
Clinical Development of Leukine in HIV
Immunex continues to evaluate Leukine in HIV. The AIDS Clinical Trial Group is conducting a 24-patient, multi-center, pilot study to determine if Leukine has a role in eliminating HIV from long-lived, immune system cells. In addition, Immunex has recently completed enrollment of a 300-patient, Phase III trial evaluating Leukine in reducing the incidence of infections and death among patients with AIDS. Results of the trial are anticipated in early 1999.
Immunex Corporation is a biopharmaceutical company dedicated to developing immune system science to protect human health. The company's products offer hope to patients with cancer, inflammatory and infectious diseases.
American Home Products owns a majority interest in Immunex. AHP is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, agricultural products, and animal health care.
NOTE: This news release contains forward-looking statements that involve risks and uncertainties, including risks associated with clinical development, regulatory approvals, patent litigation, product commercialization, and other risk described from time to time in the SEC reports filed by Immunex, including the most recently filed Form 10-K and 10-Q.
An electronic version of this news release -- as well as additional information about Immunex of interest to investors, customers, future employees and patients -- is available on the Immunex home page at www.immunex.com. SOURCE Immunex Corporation
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