SAN DIEGO--(BUSINESS WIRE)--Feb. 24, 1998--IDEC Pharmaceuticals
(NASDAQ:IDPH) today announced that it has initiated a Phase III
pivotal trial incorporating both of the company's treatments for
relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL): the
investigational radioimmunotherapy, IDEC-Y2B8, and the recently
approved immunotherapy, Rituxan(TM) (Rituximab). IDEC-Y2B8 is a
monoclonal antibody tightly conjugated to the radioisotope
yttrium-90, which targets the CD20 antigen on mature normal and
malignant B cells.
The pivotal trial is being conducted in patients with relapsed or
refractory, low grade or follicular NHL at 30 centers throughout the
United States. The IDEC-Y2B8 regimen under investigation consists of
a single infusion of Rituxan, followed by tumor imaging with
IDEC-In2B8 (an indium-labeled version of IDEC's anti-CD20 antibody),
on day one. Seven days later, patients receive a second infusion of
Rituxan, followed by IDEC-Y2B8 therapy. Rituxan is used to clear
malignant and normal B cells from the blood, allowing IDEC-Y2B8
to penetrate the lymphatic system and target radiation to lymphatic
tumors. IDEC is developing this potential treatment regimen for use
by radiation oncologists and nuclear medicine specialists as an
outpatient therapy.
Clinical results to date from Phase I/II trials of the
IDEC-Y2B8 regimen have shown an 82% response rate (complete
and partial responses) for those patients with low grade or
follicular NHL who were treated at one of three escalating doses:
0.2mCi/kg, 0.3mCi/kg and 0.4mCi/kg. Adverse events associated with
the treatment regimen were primarily hematologic and dose-dependent.
Human anti-mouse or anti-chimeric antibody (HAMA/HACA) reactions
were not a therapy-limiting factor. Based on the overall safety and
efficacy profile in low grade or follicular NHL patients, 0.4mCi/kg
was chosen as the standard dose for the Phase III trial.
"The acceptable level of myelosuppression experienced in
Phase I/II trials supports the results from preclinical
biodistribution studies demonstrating the stability of this yttrium
radioconjugate," said Christine A. White, M.D., IDEC's senior
director of clinical oncology and hematology. "Unlike earlier generation
chelates used to attach the yttrium radioisotope to antibodies, the
MX-DTPA used to create IDEC-Y2B8 exhibits excellent in vivo
retention of yttrium. Published data and our studies in mice have
shown minimal loss of the radioisotope from the conjugate and no
significant accumulation of yttrium in bone."
Rituxan was approved by the U.S. Food and Drug Administration
for the treatment of relapsed or refractory, low grade or follicular
CD20-positive B-cell non-Hodgkin's lymphomas in November, 1997.
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 Rituxan in
the United States. Roche will be responsible for marketing the
product in the rest of the world, excluding Japan where the drug
will be marketed by Zenyaku Kogyo.
IDEC Pharmaceuticals focuses on developing targeted therapies
for the treatment of cancer and autoimmune diseases. 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 Plus. 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
businesswire.com and
shareholdernews.com.
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, 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
Connie Matsui, 619/550-8656
KEYWORD: CALIFORNIA
INDUSTRY KEYWORD: PHARMACEUTICAL
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