Initial data from a Phase III comparative study suggest efficacy
and safety with Campath(R), even in poor-prognosis patients
CAMBRIDGE, Mass. and WAYNE, N.J., June 3 /PRNewswire-FirstCall/ --
Genzyme Corporation (NASDAQ:GENZ) and Berlex Oncology, a business
unit of Berlex Laboratories, a U.S. affiliate of Schering AG,
Germany (FSE: SCH; NYSE: SHR), today announced interim results from
CAM307, an international confirmatory Phase III clinical trial
comparing Campath(R) (alemtuzumab) with chlorambucil in previously
untreated patients with progressive B-cell chronic lymphocytic
leukemia (B-CLL). Preliminary results of the secondary endpoint
from this study showed that patients who received the monoclonal
antibody Campath exhibited significantly higher overall and
complete response rates, with a manageable safety profile, compared
with those patients who were treated with chlorambucil. The data
were presented at the 42nd Annual Meeting of the American Society
of Clinical Oncology (ASCO) in Atlanta. Study Results The
open-label, randomized trial with 297 patients compared the
efficacy and safety of Campath to chlorambucil, which is considered
by many to offer the most tolerable safety profile for previously
untreated patients. The study examined a primary endpoint of
progression free survival and secondary endpoints that included
safety, response rate and overall survival. As reported at ASCO, a
pre-specified independent interim review of the secondary endpoint
data showed a nearly 30 percent greater (83% vs. 56%) overall
response rate (ORR) among patients treated with Campath vs.
chlorambucil (p< 0.0001), and a 12-fold increase (24% vs. 2%) in
complete response rates (CRR) in patients receiving Campath therapy
(p< 0.0001). In the comparison of safety parameters of Campath
vs. chlorambucil, the rates of grade 3-4 thrombocytopenia, anemia,
and serious infections, other than CMV, were found to be comparable
between treatment arms. Although the rates of CMV, neutropenia and
leukopenia were higher in the Campath arm, the difference in the
incidence of febrile neutropenia was found to be insignificant. A
correlation between the cytogenetic profile of the patients
participating in the CAM307 trial suggest a statistically
significant ORR and CRR were observed in patients with certain
cytogenetic abnormalities. Statistically significant higher
response rates to Campath were observed in patients with a 13q
deletion, a common genetic event observed in patients with B-CLL,
and in the ORR of patients with 11q deletions, a cytogenetic
abnormality typically associated with poor prognosis. In patients
with a 17p deletion, another marker of poor prognosis, ORR was 3
times higher among patients receiving Campath vs. those receiving
chlorambucil, 64% vs. 20% respectively; however, due to the small
number of patients in this group (10 patients in the Campath arm
and 11 patients in the chlorambucil arm), this trend did not reach
statistical significance. Lead investigator Peter Hillmen, MB, ChB,
of the Leeds General Infirmary, Leeds, United Kingdom, stated, "In
addition to the excellent overall safety and efficacy findings we
are observing thus far in CAM307, we also saw impressive responses
in patients with poor prognostic cytogenetic abnormalities when
treated with Campath. This group of poor risk patients have very
low response rates and a short survival when treated with
conventional chemotherapy. The good results seen with Campath
promise a novel, more effective therapeutic option for these
patients with poor risk CLL. We therefore look forward to receiving
the final study results of Campath in relation to responses and
survival in these difficult-to-treat populations." Campath received
accelerated approval in 2001 and is currently indicated for the
treatment of B-CLL in patients who have been treated with
alkylating agents and who have failed fludarabine therapy.
Determination of the effectiveness of Campath is based on overall
response rates. Comparative, randomized trials demonstrating
increased survival or clinical benefit such as improvement in
disease-related symptoms have not yet been conducted. Genzyme and
Berlex's parent company, which holds exclusive worldwide marketing
and distribution rights to Campath, are co-developing Campath in
oncology and other indications. The product is marketed in the U.S.
by Berlex Laboratories. The results presented at ASCO represent
interim safety and efficacy data to be released from CAM307, a
comparative, confirmatory trial being conducted to satisfy
post-approval commitments to U.S. and European health authorities
(FDA and EMEA). Once the final data from the study's primary
endpoint of progression-free survival are available, Genzyme and
Berlex expect to file an application seeking to expand the
product's current label to include previously untreated B-CLL
patients who require therapy. "Based on these preliminary results,
Campath may have significantly better efficacy with manageable
safety against chlorambucil as front-line therapy in B-CLL," stated
Mark Enyedy, senior vice-president and general manager of Genzyme's
oncology business unit. "We look forward to advancing Campath
further in its clinical development and to working with the FDA
regarding a supplement to the product label to treat patients
earlier in the course of their disease. We are also very pleased to
have conducted this post-approval commitment study in the timeframe
we committed to the FDA." "These impressive interim results from
the CAM307 study are very encouraging for our ongoing efforts to
bring new treatment options to patients with CLL, and particularly
to those with high-risk disease," stated Richard Nieman, M.D., Vice
President and Head of Medical Affairs at Berlex. Safety Results and
Study Design Interim efficacy and safety data suggest that
previously untreated B-CLL patients who received Campath as a
single agent have an excellent response rate with a manageable
toxicity profile. As expected, the most common drug
administration-related events noted to date were pyrexia, rigors,
nausea, hypotension, and vomiting. Overall, nausea and vomiting
were more frequent in the chlorambucil arm. In the interim results
of this trial, serious adverse events related to treatment occurred
in 25 percent of Campath patients and 6 percent of patients on
chlorambucil. The difference in SAE frequency observed may be
explained by CMV viremia/infection that was treated in hospitals in
some countries, therefore classified as grade 3-4 SAEs, and which
all seem to have been managed successfully. The incidence of grade
3-4 thrombocytopenia and anemia appear to be comparable in both
treatment arms. Grade 3-4 neutropenia and leukopenia as well as
serious infections (due largely to the incidence of CMV infections)
appear to be more frequent in the Campath arm. However, the
difference in the incidence of febrile neutropenia was found to be
insignificant. One likely treatment-related death occurred in the
chlorambucil arm. The trial randomized 297 previously untreated
patients with progressive disease requiring treatment at 44 medical
centers in Europe and the United States. Patients were treated with
either 30 mg of Campath IV three times per week for a maximum of 12
weeks, inclusive of dose escalation periods, or 40 mg/m2 of
chlorambucil PO once every 28 days to a maximum of 12 cycles. About
Chronic Lymphocytic Leukemia CLL is the most prevalent form of
adult leukemia, affecting approximately 120,000 people in Europe
and the United States. The disease is most commonly diagnosed among
people age 50 or older. CLL is characterized by the accumulation of
functionally immature white blood cells (lymphocytes) in the bone
marrow, blood, lymph tissue, and other organs. Two types of
lymphocytes are present in the blood, B cells and T cells. About 95
percent of CLL cases involve cancerous B cells. Because these B
cells have a longer than normal life span, they begin to build up
and "crowd out" the normal, healthy blood cells. The accumulation
of functionally immature cells in the bone marrow excludes the
generation of healthy cells and can become fatal. Symptoms include
fatigue, bone pain, night sweats, fevers, and decreased appetite
and weight loss. Bone marrow involvement also leads to weakening of
the immune system, exposing the patient to a higher risk of
infection. About Campath Campath is the first and only humanized
monoclonal antibody approved for the treatment of B-CLL in patients
who have failed both alkylating agents and fludarabine phosphate
treatment. Campath works by targeting the "CD52" antigen, which is
one of the most common antigens found on B and T cells. When
Campath binds to this CD52 antigen, it activates the immune system
to destroy targeted cells not only in the blood but also in the
bone marrow. Campath is not currently indicated as a first-line
treatment in CLL. Campath should be administered under the
supervision of a physician experienced in the use of antineoplastic
therapy. Campath has a boxed warning which includes events of
hematologic toxicity, infusion reactions, and
infections/opportunistic infections. Campath is contraindicated in
patients who have active systemic infections, underlying
immunodeficiency (e.g., seropositive for HIV), or known Type 1
hypersensitivity or anaphylactic reactions to Campath or to any one
of its components. The most commonly reported infusion-related
adverse events were rigors, drug-related fever, nausea, vomiting,
and hypotension. Hematologic toxicities included
pancytopenia/marrow hypoplasia, anemia, thrombocytopenia,
neutropenia, and profound lymphopenia, and should be monitored.
Infections reported included sepsis, pneumonia, and opportunistic
infections such as CMV, candidiasis, aspergillosis, and
mucormycosis. About Genzyme One of the world's leading
biotechnology companies, Genzyme is dedicated to making a major
positive impact on the lives of people with serious diseases. This
year marks the 25th anniversary of Genzyme's founding. Since 1981,
the company has grown from a small start-up to a diversified
enterprise with more than 8,000 employees in locations spanning the
globe and 2005 revenues of $2.7 billion. Genzyme has been selected
by FORTUNE as one of the "100 Best Companies to Work for" in the
United States. With many established products and services helping
patients in more than 80 countries, Genzyme is a leader in the
effort to develop and apply the most advanced technologies in the
life sciences. The company's products and services are focused on
rare inherited disorders, kidney disease, orthopaedics, cancer,
transplant and immune diseases, and diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial
development program focused on these fields, as well as heart
disease and other areas of unmet medical need. About Berlex Berlex,
a U.S. affiliate of Schering AG, Germany (FSE: SCH; NYSE: SHR), is
committed to addressing unmet medical needs through research and
development in the areas of oncology, gastroenterology, women's
health, diagnostics and neurology. Berlex also markets diagnostic
imaging agents, innovative treatments in the areas of female health
care and oncology, as well as specialized therapeutics for
life-threatening and disabling diseases of the central nervous
system and cardiovascular system. Berlex has business operations in
New Jersey, California and Washington. For more information, please
visit http://www.berlex.com/. Berlex Oncology is building a
prominent leadership position through research and development of a
range of hematological and solid tumor treatments, and is strongly
invested in bringing to market an innovative and broad oncology
R&D portfolio of systemic and targeted therapies, potentially
offering novel therapeutic options for people with cancer. Certain
statements in this press release that are neither reported
financial results nor other historical information are
forward-looking statements, including but not limited to,
statements that are predictions of or indicate future events,
trends, plans or objectives. Undue reliance should not be placed on
such statements because, by their nature, they are subject to known
and unknown risks and uncertainties and can be affected by other
factors that could cause actual results and Berlex's plans and
objectives to differ materially from those expressed or implied in
the forward-looking statements. Berlex, Inc. undertakes no
obligation to update publicly or revise any of these
forward-looking statements, whether to reflect new information or
future events or circumstances or otherwise. This press release
contains forward-looking statements, including statements about the
results of the CAM307 trial, and regulatory plans and expected
timelines for the expansion of the product label for Campath into
earlier-line CLL. These statements are subject to risks and
uncertainties that could cause actual results to differ materially
from those projected in these forward-looking statements. These
risks and uncertainties include, among others: that final results
of the CAM307 trial demonstrate safety and efficacy comparable to
the preliminary data that have been released to date, the actual
timing and content of submissions to and decisions made by the U.S.
Food and Drug Administration and other regulatory authorities, and
the other risks and uncertainties described in reports filed by
Genzyme with the Securities and Exchange Commission. Please see the
disclosure under the heading "Factors Affecting Future Operating
Results" in the Management's Discussion and Analysis of Financial
Condition and Results of Operations section of Genzyme's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2006 for a more
complete discussion of these and other risks. Genzyme cautions
investors not to place substantial reliance on the forward-looking
statements contained in this press release. These statements speak
only as of the date of this press release, and Genzyme undertakes
no obligation to update or revise the statements. Genzyme(R),
Campath(R), and MabCampath(R) are registered trademarks of Genzyme
Corporation. All rights reserved. Genzyme's press releases and
other company information are available at http://www.genzyme.com/
and by calling Genzyme's investor information line at
1-800-905-4369 within the United States or 1-703-797-1866 outside
the United States. Berlex press releases and other company
information are available at http://www.berlex.com/ and by calling
1-888-BERLEX-4 or 1-888-237-5394. Genzyme Contacts: Berlex
Contacts: Maria Cantor (media) Kimberley Jordan (media) (617)
768-6690 (973) 305-5340 Kristen Galfetti (investors) Joanne Marion
(investors) (617) 768-6563 (973) 487-2164 DATASOURCE: Genzyme
Corporation; Berlex Oncology CONTACT: Maria Cantor (media),
+1-617-768-6690, Kristen Galfetti (investors), +1-617- 768-6563,
both of Genzyme; or Kimberley Jordan (media), +1-973-305-5340, or
Joanne Marion (investors), +1-973-487-2164, both of Berlex Web
site: http://www.genzyme.com/ http://www.berlex.com/ Company News
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