Here is the CD20 news release....
IDEC Pharmaceuticals And Genentech Announce Positive Final Results For Pivotal Phase III Trial Of IDEC-C2B8 As Single Agent
Results Of Phase II Combination Trial Also Reported
ORLANDO, Dec. 9 /PRNewswire/ -- IDEC Pharmaceuticals Corporation (Nasdaq:
IDPH) and Genentech, Inc. (NYSE: GNE) have announced positive final results
from a pivotal Phase III trial of IDEC-C2B8 as a single agent therapy for
relapsed low grade or follicular non-Hodgkin's lymphoma. The trial, conducted
in a total of 166 patients, confirmed the antibody's overall response rate and
safety profile as seen in an earlier Phase II study. The companies
additionally reported final results from a Phase II combination trial of IDEC-
C2B8 and CHOP chemotherapy. Results of both trials are being presented today
by clinical investigators Myron Czuczman, M.D. of the Roswell Park Cancer
Institute and Peter McLaughlin, M.D. of the M.D. Anderson Cancer Center at the
annual meeting of the American Society of Hematology (ASH) held in this city.
In Phase III open label, single arm testing of IDEC-C2B8 as a single agent
therapeutic, each of the patients participating at over 30 trial centers
received four infusions of the antibody on an outpatient basis during a 22-day
period. Of 151 evaluable patients, 76 responded to treatment with IDEC-C2B8,
for an overall response rate of 50%. Nine of these responses were complete
responses (6%) and 67 were partial responses (44%). At over nine months'
median followup, the median time to disease progression for responders
following treatment with IDEC-C2B8 has not yet been reached. Of the
responding patients, 70% remain in remission. Patients continue to be
followed.
The adverse events associated with IDEC-C2B8 were mostly infusion-related.
These side effects consist primarily of mild to moderate flu-like symptoms
(e.g., fevers, chills) and occur with greatest frequency upon initial
administration. The symptoms are limited in duration to the period of
infusion, may be ameliorated with oral acetaminophen and diphenhydramine and
decrease significantly in frequency with subsequent infusions.
As a matter of scientific interest, patients were also monitored for the
presence of a tumor marker gene known in medical research as bcl-2. Results
presented at ASH revealed that the tumor marker gene reverted to negative in
the peripheral blood of over 70% of the patients who were positive at
baseline, and in the bone marrow of over 50% of patients who were positive at
baseline. Researchers have previously reported clearance of this marker from
bone marrow with marrow transplantation regimens incorporating 'ex vivo'
marrow purging and only rarely with chemotherapy regimens. However, the
clinical significance of bcl-2 conversion has not yet been determined.
"IDEC-C2B8 has completed all Phase III clinical testing in support of
regulatory filing and we are very gratified by the results we have seen for
this agent to date," said Antonio J. Grillo-Lopez, M.D., IDEC's senior vice
president of medical and regulatory affairs. "We have confirmed IDEC-C2B8's
potential as an effective, alternative therapy with limited toxicity for
patients with B-cell lymphoma. Based on these results, we expect to file a
Biological License Application for IDEC-C2B8 as a single agent therapy for
relapsed patients with low grade or follicular non-Hodgkin's lymphoma in the
first half of 1997."
IDEC and Genentech are also investigating the use of IDEC-C2B8 in
combination with other therapies for lymphoma and reported positive results in
a Phase II open label, single arm trial combining IDEC-C2B8 with CHOP
chemotherapy (a standard regimen of cyclophosphamide, doxorubicin, vincristine
and prednisone). In this trial, patients with low grade or follicular
lymphoma received six doses of IDEC-C2B8 over 21 weeks. Within this same time
period, they also received six cycles of CHOP chemotherapy. Of the 35
patients completing all treatments, 35 responded to treatment, for an overall
response rate of 100%. Twenty-two patients (63%) achieved a complete response
and 13 (3%) achieved a partial response. Patients tolerated the combination
of IDEC-C2B8 and CHOP well; adverse events did not exceed those routinely
observed with CHOP alone or those associated with IDEC-C2B8 alone, indicating
compatibility of the two therapies.
"Based on the limited toxicity and patient response rates observed to date
for IDEC-C2B8 as a single agent therapeutic, Genentech and IDEC are committed
to exploring further uses for IDEC-C2B8, both as a frontline therapy, and in
combination with other anti-cancer treatments," said Sue Hellmann, M.D.,
Genentech vice president, medical affairs. "Genentech is currently conducting
a study of IDEC-C2B8 in combination with chemotherapy in patients with
intermediate grade disease and additional combination therapy trials are
planned."
B-cell lymphomas are malignancies of the body's antibody-producing immune
system cells. Non-Hodgkin's lymphomas currently afflict roughly 225,000
Americans, with over 50,000 new diagnoses expected this year. Low grade and
follicular lymphomas comprise about 65% of the total lymphoma. prevalence in
the United States.
IDEC-C2B8 is a monoclonal antibody that is therapeutically active on its
own and does not require the attachment of radioisotopes or toxins to elicit
its anti-tumor effect. The antibody targets a protein (the CD20 antigen) that
is expressed on the surface of mature B cells and on B-cell tumors, but not on
B-cell precursors or other body tissues. IDEC-C2B8 works by binding to its
target antigen and recruiting the patient's natural defenses to attack and
kill both malignant and normal mature B cells. In trials to date, the normal
B cells regenerate from stem cells and return to normal levels within months
following treatment with IDEC-C2B8. In addition, clinical results to date
have shown that IDEC-C2B8 does not exhibit any significant toxicities that
overlap with those produced by chemotherapy or high dose radiation. Thus,
treatment with IDEC-C2B8 has not precluded patients from receiving subsequent
chemotherapeutic treatments. In addition, IDEC-C2B8 is administered over 22
days, versus the four- to eight-month course required for most conventional
chemotherapies.
IDEC and Genentech are developing IDEC-C2B8 in collaboration with
F.Hoffmann-La Roche, Ltd. of Switzerland and Zenyaku Kogyo Co. Ltd. of Japan.
Genentech, Inc. is a leading international biotechnology company that
discovers, develops, manufactures and markets human pharmaceuticals for
significant unmet medical needs. The company has headquarters in South San
Francisco, California and is traded on the New York and Pacific Stock
Exchanges under the symbol GNE.
IDEC Pharmaceuticals focuses on developing targeted immunotherapies for
the treatment of cancer and autoimmune diseases. IDEC's products are
primarily designed to act through immune mechanisms and offer greater
specificity of action, longer therapeutic effect and lower toxicity than is
typical of existing therapies. All of IDEC's products are designed for
administration in outpatient settings, providing the opportunity to reduce
overall treatment costs.
IDEC Pharmaceuticals' press releases and are available at no charge
through PR Newswire's "Company News On Call" fax service. For a menu of
IDEC's current press releases and quarterly reports or to retrieve a specific
release, call (800) 758-5804, ext. 432581 or internet
prnewswire.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 clinical ongoing 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,
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, 1995, and form S-3 filed May 3, 1996, may affect the
actual results achieved by the company.
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: Connie Matsui of IDPH, 619-550-8656; or Laura Leber of GNE, 415-225-5759 |
