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Interim Results on IDEC-Y2B8!

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  • BEN HAINES
    Tuesday December 9, 6:42 pm Eastern Time Company Press Release IDEC Pharmaceuticals Reports Interim Results of Phase I/II Trial of IDEC-Y2B8 in the Treatment
    Message 1 of 1 , Dec 10, 1997
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      Tuesday December 9, 6:42 pm Eastern Time

      Company Press Release

      IDEC Pharmaceuticals Reports Interim Results of Phase I/II
      Trial of IDEC-Y2B8 in the Treatment of Relapsed or Refractory
      Non-Hodgkin's Lymphoma

      SAN DIEGO--(BW HealthWire)--Dec. 9, 1997--IDEC Pharmaceuticals
      (Nasdaq: IDPH - news) today reported interim results from a Phase I/II
      clinical trial incorporating both of the company's treatments for
      relapsed or refractory B-cell non-Hodgkin's lymphoma: the investigational
      immunotherapy, IDEC-Y2B8, and the newly approved immunotherapy,
      RITUXAN(tm) (Rituximab). IDEC-Y2B8 is a murine monoclonal
      antibody tightly conjugated to the radioisotope yttrium-90, which targets
      the CD20 antigen on mature normal and malignant B cells. The objectives
      of the Phase I/II trial were to evaluate IDEC-Y2B8's safety and activity in
      a variety of types of non-Hodgkin's lymphoma (NHL) across three dose
      levels, 0.2mCi/kg, 0.3mCi/kg and 0.4mCi/kg.

      Clinical results to date showed an overall response rate (complete and
      partial responses) of 82% (14/17) across all dose groups in all low
      grade or follicular NHL patients, with a 100% response rate (7/7) for
      patients with low grade or follicular disease who received the standard
      0.4mCi/kg dose of IDEC-Y2B8. Response rates in patients with other
      forms of NHL were lower: 50% (3/6) in intermediate grade disease, and
      no responses to treatment in three patients with mantle cell disease. The
      interim study results are being presented today by Dr. Thomas Witzig of
      the Mayo Clinic at the annual meeting of the American Society of
      Hematology (ASH) held in this city.

      Interim analysis of 31 patients for whom full safety data was available
      indicated that adverse events associated with the treatment regimen
      were primarily hematologic (grade 3 or 4 cytopenia (blood cell count
      reductions) in 18/31 patients) and dose-dependent. Investigators
      reported no renal, hepatic, pulmonary or cardiac dysfunction, and human
      anti-mouse or anti-chimeric antibody (HAMA/HACA) reactions were not a
      therapy-limiting factor.

      ``The treatment regimen employed in this study is designed to provide
      therapeutic benefit for patients with bulky, rapidly growing or refractory
      disease who otherwise would typically be candidates for aggressive
      and potentially toxic combination chemotherapies,'' said Antonio
      Grillo-Lopez, M.D., IDEC's senior vice president of medical and regulatory
      affairs. ``In this trial, Rituxan is first used as pretreatment to clear
      malignant and normal B cells from the patient's blood. This allows the
      subsequent IDEC-Y2B8 treatment to penetrate the lymphatic system and
      attach to lymphoma tumors where radiation from the yttrium-90 isotope
      has its killing effect.'' In addition, IDEC-Y2B8 treatment is completed in
      approximately one week, whereas the typical course of chemotherapy
      requires four to eight months of repeat treatment.

      Dr. Grillo-Lopez noted that patient accrual in the trial is now complete,
      and that the Food and Drug Administration has accepted IDEC's protocol
      design for a Phase III pivotal trial of the IDEC-Y2B8/Rituxan
      therapy. IDEC anticipates beginning patient enrollment in the Phase III trial
      by early 1998.

      The Phase I portion of the Phase I/II trial examined the safety and
      appropriate dosing for both the pretreatment dose of Rituxan and the
      therapeutic dose of IDEC-Y2B8. Based on those results, patients
      participating in the Phase II portion of the trial received a pretreatment
      dose of Rituxan (250mg/m2). This was followed by a 5.0mCi/kg dose of
      IDEC-In2B8, an anti-CD20 antibody conjugated to the radioisotope indium,
      which enabled imaging of the patient's disease. One week later, patients
      received a second pretreatment dose of Rituxan (250 mg/m2) followed
      by a therapeutic dose of IDEC-Y2B8. This dose of IDEC-Y2B8 was
      standardized at 0.4mCi/kg, except for patients with mild depletion of
      pretreatment platelet counts who received a reduced dose
      of 0.3mCi/kg.

      ``IDEC is committed to developing IDEC-Y2B8 as an additional tool in the
      management of lymphoma,'' said William H. Rastetter, IDEC chairman,
      president and chief executive officer. ``Rituxan is approved for single
      agent use in the management of relapsed or refractory low grade or
      follicular CD20-positive B-cell NHL. We believe Rituxan will be used
      primarily in the community-based oncology practice where the majority of
      lymphomas are treated today. In contrast, IDEC-Y2B8 is intended for use
      by radiation oncologists and nuclear medicine specialists as an outpatient
      therapy which combines both immunotherapy and radiation therapy.''

      IDEC is developing IDEC-Y2B8 as a treatment for low grade or follicular,
      relapsed or refractory non-Hodgkin's B-cell lymphomas. The company
      currently plans to commercialize IDEC-Y2B8 on its own in
      the United States, and is in various stages of discussion with potential
      corporate partners for product commercialization in the rest of the world.


      IDEC discovered Rituxan and developed the product in collaboration with
      Genentech, F.Hoffmann-La Roche Ltd. of Switzerland and Zenyaku
      Kogyo Co. Ltd of Japan. Genentech and IDEC co-promote the product in
      the United States. Roche will be responsible for marketing Rituxan in the
      rest of the world, excluding Japan here the drug will be marketed by
      Zenyaku Kogyo.

      IDEC Pharmaceuticals focuses on developing targeted therapies for the
      treatment of cancer and autoimmune iseases. IDEC's antibody products
      act chiefly through immune system mechanisms, exerting their effect by
      binding to specific, readily targeted immune cells in the patient's blood or
      lymphatic systems.

      IDEC Pharmaceuticals' news releases are available at no charge through
      Business Wire's News on Demand Pus. For a menu of IDEC's current
      news releases and quarterly reports or to retrieve a specific release,
      call (888) 329-2309. On the Internet see
      http://www.businesswire.com/cnn/idph.htm and
      http://www.shareholdernews.com/idph .

      The statements made in this press release contain certain
      forward-looking statements that involve a number of risks and
      uncertainties. Actual events or results may differ from the company's
      expectations. In addition to the matters described in this press release,
      timelines for ongoing and future clinical activity are subject to change,
      results of pending or future clinical trials cannot be accurately predicted,
      the costs of increased commercial manufacturing activities may vary
      from period to period as the company establishes appropriate inventories
      and reserves, and decisions by the FDA and other regulatory agencies,
      including their determination as to whether there is sufficient clinical data
      and compliance with all other requirements to support product licensure,
      as well as the risk factors listed from time to time in the company's SEC
      filings, including but not limited to its Annual Reports on Form 10-K for the
      year ended December 31, 1996, and Form 10-Q filed November 14, 1997,
      may affect the actual results achieved by the company.

      Formerly known as IDEC-C2B8, Rituxan (Rituximab) is a trademark, and
      IDEC Pharmaceuticals is a registered U.S. trademark of the company. The
      company headquarters is located at 11011 Torreyana Road,
      San Diego, CA 92121.

      Contact:

      IDEC Pharmaceuticals, San Diego
      Connie Matsui, Vice President,
      Planning & Resource Development
      619/550-8656
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