IDEC Pharmaceuticals Corp. presented results from two pivotal trials of Zevalin, its non-Hodgkin's lymphoma (NHL) treatment, at the 42nd annual meeting of the American Society of Hematology at San Francisco's Moscone Center.
The randomized, controlled, 143-patient study in patients with relapsed or refractory low-grade, follicular, or CD20-positive transformed B-cell NHL evaluated Zevalin in combination with Rituxan compared to a control arm of Rituxan therapy alone.
In the Zevalin arm, researchers found an overall response rate of 80 percent. The control arm produced a response rate of 56 percent.
Treatment with Zevalin included a Rituxan transfusion followed by infusions of Rituxan and Zevalin a week later.
Researchers found Zevalin-associated hematological toxicity was transient and reversible.
In a separate study, an open-label, 54-patient trial of Zevalin in patients who were refractory to Rituxan, Zevalin showed an overall response rate of 74 percent. Fifteen percent of patients achieved complete responses, and toxicity was similar to earlier results.
Rituxan, also an IDEC product, is marketed by Genentech Inc., of South San Francisco.
IDEC submitted a new drug application for Zevalin to the FDA in early November. Zevalin marketing is partnered with Berlin-based Schering AG outside the U.S. IDEC retained rights to market the drug in the U.S. (See BioWorld Today, November 2, 2000.)
IDEC's stock (NASDAQ:IDPH) closed up $15.50 Tuesday at $188.875.
In other news from the ASH Meeting:
¿ Ariad Pharmaceuticals Inc., of Cambridge, Mass., presented data showing that bone marrow stem cells engineered with the human globin gene and the Argent cell-growth switch produce therapeutic levels of globin protein due to the regulated growth of these cells induced by Ariad's dimerizer drug. Ariad initially plans to use the regulated stem cell therapy product against inherited blood cell disorders such as thalassemia and sickle cell anemia.
¿ Aronex Pharmaceuticals Inc., of The Woodlands, Texas, said data from clinical and preclinical trials of Atragen, a liposomal intravenous formulation of all-trans-retinoic acid (ATRA), indicate the compound produced a complete remission in 77 percent of a target population of 30 patients unable to reliably receive oral ATRA. Data from a Phase II efficacy study of Atragen in treatment of acute promyelocytic leukemia indicated the compound as a monotherapy achieved a complete remission in 53 of 58 newly diagnosed patients, 11 of 16 first-relapse patients who never received ATRA, eight of 16 first-relapse patients who had received ATRA and zero of five patients in second or subsequent relapse.
¿ Bayer AG, of Leverkusen, Germany, completed two trials of intravenous immune globulin for primary immunodeficiency diseases and idiopathic thrombocytopenic purpura. Bayer said the trials were the largest of their kind. Bayer said it expects to file a biologics license application for the product in 2001.
¿ BioTransplant Inc., of Charlestown, Mass., presented results of clinical trials that suggest BioTransplant's AlloMune for Cancer system, a pretransplant preventative regimen that eliminates T lymphocytes in both patient and donor bone marrow, enables patients without suitably matched donors to successfully receive transplants. The treatment is designed to modify recipients' immune systems for acceptance of donor cells or organs following bone marrow transplantation.
¿ Celgene Corp., of Warren, N.J., presented data on laboratory studies evaluating Celgene's IMiDs, structural analogues of thalidomide, in multiple melanoma. The data demonstrated a dose dependence for IMiDs on multiple melanoma cell growth and an antitumor effect, including enhancement of cancer cell apoptosis and cell cycle arrest.
¿ Genitope Corp., of Redwood City, Calif., had Phase II results presented from research at the Stanford University School of Medicine indicating a tumor-specific protein produced with Genitope's recombinant DNA technology can stimulate a positive immune response in indolent B-cell non-Hodgkin's lymphoma patients. Of the 25 patients enrolled in the study, 10 received five subcutaneous injections of the custom-made tumor-derived protein. Of the 10 treated patients, seven demonstrated significant immune responses against the recombinant protein.
¿ Immunomedics Inc., of Morris Plains, N.J., reported in an oral presentation that its lead therapeutic, epratuzumab, is active against diffuse large-cell non-Hodgkin's lymphoma. In a 26-patient study, five of 22 evaluable patients showed an objective response to a single course of the compound, a humanized, non-radioactive antibody targeting the CD22 receptor of NHL cells.
¿ SuperGen Inc., of San Ramon, Calif., presented clinical results from its study of Nipent (pentostatin), the company's anticancer agent. The study evaluated Nipent's safety and efficacy in 13 allogenic bone marrow transplant patients. The study administered Nipent as a preparative regimen prior to transplantation, and researchers found the compound well tolerated and safe.
¿ Transkaryotic Therapies Inc., of Cambridge, Mass., reported Phase I results of its trial evaluating Factor VIII gene therapy in patients with hemophilia A. Data from six patients demonstrated nonviral delivery of Factor VIII using patients' genetically modified cells was safe and well tolerated. Four of the six patients showed clinical benefit, and two patients had no spontaneous bleeds for close to a year after treatment.
¿ V.I. Technologies Inc., of Watertown, Mass., said Dartmouth-Hitchcock Medical Center researchers presented data showing Inactine-treated virally inactivated red blood cells can be stored for 28 days with retention of their viability and can be safely reinfused into human volunteers. Additional study is under way to determine the viability of storing treated cells for longer periods.