CARLSBAD, California and GENEVA, Switzerland, October 2
/PRNewswire-FirstCall/ -- Micromet, Inc. (NASDAQ:MITI), a
biopharmaceutical company focusing on the development of novel,
proprietary antibody-based products for cancer, inflammatory and
autoimmune diseases, and Serono (virt-x: SEO and NYSE: SRA) today
reported on the outcome of two phase II trials testing the activity
of adecatumumab (MT201) in metastatic breast cancer and in prostate
cancer, respectively. Adecatumumab originated at Micromet and is
developed in collaboration between Micromet and Serono. The product
candidate, a fully human monoclonal antibody targeting tumor cells
overexpressing the epithelial cell adhesion molecule (EpCAM), was
assessed as a single agent for efficacy and safety in patients with
EpCAM-positive metastatic breast cancer (N=109) and in patients
with prostate cancer (N=84). The studies tested adecatumumab at two
dose levels in patients with high and low EpCAM expression. The
results suggested dose dependent activity of adecatumumab as well
as a dependency on relevant levels of target expression. Final
results from a phase II trial with adecatumumab in metastatic
breast cancer were reported at the 31st Congress of the European
Society of Medical Oncology (ESMO) in Istanbul, Turkey. This
randomized, open label study was conducted in 5 European countries
with 26 centers participating. Patients were stratified according
to EpCAM expression into two groups, one with low EpCAM expression
and another with high level EpCAM expression. Each group was then
randomized into two arms treated every two weeks by intravenous
infusion at either 2 mg adecatumumab per kg body weight (2 mg/kg)
or at 6 mg adecatumumab per kg body weight (6 mg/kg). Patients were
treated until disease progression with full tumor assessments every
6 weeks according to standardized RECIST criteria. While the
primary endpoint of the study (i.e., 25 percent clinical benefit
rate at week 24) was not reached, secondary end point analysis
showed a significant prolongation of time-to-progression (TTP) in
patients treated with the higher dose of adecatumumab (p=0.0465)
compared to patients receiving the lower dose. In addition, the
importance of target presence was underscored by a trend towards
increased TTP in patients expressing high EpCAM levels as opposed
to patients with low or moderate EpCAM expression on their primary
tumor tissue. Patients receiving the high dose of adecatumumab and
expressing high EpCAM (high/high) on their tumor tissue had a
significantly longer TTP compared to patients with low EpCAM on
their tumor tissue and treated with the low dose of adecatumumab
(low/low) (p=0.0057). Progression-free survival was 336 days, 128
days and 49 days for 10%, 25% and 50% (median) of patients in the
high/high group with those numbers being 112 days, 59 days and 42
days in the low/low group. "This phase II study indicates activity
of adecatumumab in metastatic breast cancer based on
progression-free survival analysis," commented the principal
investigator, Dr. Ahmad Awada, Head of the Medical Oncology Unit at
Institute Jules Bordet in Bruxelles, Belgium. "If this activity can
be confirmed in additional trials, adecatumumab may offer a
treatment option for patients with breast cancers highly
overexpressing EpCAM. This finding is important because normally
this patient population is believed to have a reduced overall
survival compared to patients with low or no EpCAM expression." The
second trial, a placebo-controlled phase II study in relapse of
prostate cancer, used serum PSA levels as the main readout for
biological and clinical activity (n=84). The primary endpoint of
this study was mean change in PSA at week 24 compared to baseline.
While the primary end point was not reached, the analysis of the
final data of the study indicated that treatment with 6 mg/kg
adecatumumab had a beneficial trend when compared to placebo (0.46
ng/ml versus 1.24 ng/ml; p=0.0879). In a further exploration this
trend was only seen for patients having high EpCAM expression
levels (p=0.0884), but not for patients with low EpCAM expression
(p=0.7947). The patients included in this trial had a high
variability of PSA at study start (variation by a factor of 100
with baseline PSA values ranging from 0.2 to 20 ng/ml in serum).
The clinical experts advising the company in connection with this
trial determined that this high variability of PSA may have
confounded the results and recommended that a retrospective
sub-group analysis of the primary endpoint should be performed in a
more homogeneous patient population. According to the experts,
predominantly patients with PSA levels £1 ng/ml at baseline would
define a minimal residual disease setting. The retrospective
sub-group analysis for this specific patient population with high
EpCAM expression (n=23) showed that both high (6 mg/kg) and low
adecatumumab dose (2 mg/kg) given every other week for seven weeks
led to a statistically significant smaller increase in PSA (0.38
ng/ml; p=0.0356, and 0.21 ng/ml; p=0.0014, respectively) compared
to the placebo group (0.76 ng/ml) in patients with a high EpCAM
expression. Prof. Axel Heidenreich, Head of the Urological Clinic
at the University Hospital of Cologne, Germany, commented:"While
the primary end point was not reached likely due to high
inter-patient variability of PSA, the analysis of the minimal
residual disease subset showed an encouraging effect on PSA
progression, although patient numbers are limited. The fact that
these effects were seen in patients with high EpCAM expression
further validates the concept of adecatumumab being a true targeted
therapy." Adecatumumab was generally well tolerated in both trials
with the observation of a dose-dependent incidence of adverse
events (AE) in both trials. The most frequent AE were fever,
chills, diarrhea, hypertension, lymphopenia, and elevation of
pancreatic enzymes, and most AE were of mild to moderate severity.
The partners continue to investigate opportunities for further
development. Adecatumumab is being explored for tolerability in
combination with docetaxel in an ongoing phase Ib study in Europe.
The information from the current trials will be used to further
refine the targeted patient populations and dosing regimens as well
as to explore other solid tumor settings. Background material For
free B-roll, video and other content for Serono and its products,
please visit the Serono Media Center
http://www.thenewsmarket.com/Serono. You can download print-quality
images and receive broadcast-standard video digitally or by tape
from this site. Registration and video is free to the media. About
Serono Serono is a global biotechnology leader. The Company has
eight biotechnology products, Rebif(R), Gonal-f(R), Luveris(R),
Ovidrel(R)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and
Raptiva(R). In addition to being the world leader in reproductive
health, Serono has strong market positions in neurology, metabolism
and growth and has recently entered the psoriasis area. The
Company's research programs are focused on growing these businesses
and on establishing new therapeutic areas, including oncology and
autoimmune diseases. In 2005, Serono, whose products are sold in
over 90 countries, achieved worldwide revenues of US$2,586.4
million. Reported net loss in 2005 was US$106.1 million, reflecting
a charge of US$725 million taken relating to the settlement of the
US Attorney's Office investigation of Serostim. Excluding this
charge as well as other non-recurring items, adjusted net income
grew 28.4% to US$565.3 million in 2005. Bearer shares of Serono
S.A., the holding company, are traded on the virt-x (SEO) and its
American Depositary Shares are traded on the New York Stock
Exchange (SRA). About Micromet, Inc. (http://www.micromet-inc.com/)
Micromet, Inc. is a biopharmaceutical company focusing on the
development of novel, proprietary antibody-based products for
cancer, inflammatory and autoimmune diseases. Two product
candidates are currently in clinical trials. For adecatumumab
(MT201), a recombinant human monoclonal antibody, two Phase 2
clinical trials for the treatment of patients with breast cancer
and prostate cancer have been completed in Q3 2006. MT103
(MEDI-538), a BiTE(r) product candidate, is being studied in a
Phase 1 clinical trial for the treatment of patients with Non
Hodgkin Lymphoma. Micromet has established a drug development
platform based on its BiTE(r) technology, a unique, antibody-based
format that leverages the cytotoxic potential of T cells, the most
powerful 'killer cells' of the human immune system. Micromet has
established collaborations with MedImmune, Inc. and Serono.
Forward-Looking Statements For Serono: Some of the statements in
this press release are forward looking. Such statements are
inherently subject to known and unknown risks, uncertainties and
other factors that may cause actual results, performance or
achievements of Serono S.A. and affiliates to be materially
different from those expected or anticipated in the forward-looking
statements. Forward-looking statements are based on Serono's
current expectations and assumptions, which may be affected by a
number of factors, including those discussed in this press release
and more fully described in Serono's Annual Report on Form 20-F
filed with the U.S. Securities and Exchange Commission on February
28, 2006. These factors include any failure or delay in Serono's
ability to develop new products, any failure to receive anticipated
regulatory approvals, any problems in commercializing current
products as a result of competition or other factors, our ability
to obtain reimbursement coverage for our products, the outcome of
any government investigations and litigation. Serono is providing
this information as of the date of this press release, and has no
responsibility to update the forward-looking statements contained
in this press release to reflect events or circumstances occurring
after the date of this press release. For Micromet: This release
contains certain forward-looking statements that involve risks and
uncertainties that could cause actual results to be materially
different from historical results or from any future results
expressed or implied by such forward-looking statements. Such
forward-looking statements include statements regarding the
company's clinical development activities; the observation of
clinical activity of MT201 in metastatic breast cancer, based on
the observed prolongation of TTP in patients treated with the
higher dose of MT201, compared to patients receiving the lower dose
and the progression -free survival rates observed in the high EpCAM
/ high dose group, compared to the low EpCAM / low dose group; the
potential for such clinical activity to be confirmed in additional
clinical trials; the potential for adecatumumab to offer a
treatment option for patients with high EpCAM overexpression; the
observation in the prostate cancer trial of the potential benefit
of MT201 in patients with high EpCAM expression levels; the belief
that the variability in baseline PSA for the trial subjects may
have impacted the results of the prostate cancer trial; Micromet's
and Serono's intention to continue the development of adecatumumab
for the treatment of metastatic breast cancer in combination with
docetaxel; the evaluation of other solid tumor settings for
additional development opportunities; and Micromet's and Serono's
intention to continue to explore the future development
opportunities; and Micromet's and Serono's intention to continue to
explore the future development of MT201 as a single agent in
prostate cancer or breast cancer.. Factors that may cause actual
results to differ materially include the risk that product
candidates that appeared promising in early research and clinical
trials do not demonstrate safety and/or efficacy in larger-scale or
later clinical trials, the risk that encouraging results from
clinical trials may not be confirmed upon further analysis of the
detailed results of a trial and additional information relating to
the safety, efficacy or tolerability of our product candidates may
be discovered upon further analysis of the trial data, the risk
that we will not obtain approval to market our product candidates,
the risks associated with reliance on outside financing to meet
capital requirements, and the risks associated with reliance on
collaborative partners, including Serono, for further clinical
trials, development and commercialization of product candidates,
including MT201. You are urged to consider statements that include
the words "ongoing", "may", "will", "would", "could", "should",
"believes", "estimates", "projects", "potential", "expects",
"suggests", "plans", "anticipates", "intends", "continues",
"forecast", "designed", "goal", or the negative of those words or
other comparable words to be uncertain and forward-looking. These
factors and others are more fully discussed in our periodic reports
and other filings with the SEC. Any forward-looking statements are
made pursuant to Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, and, as such, speak only as of the date made. Micromet,
Inc. undertakes no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future events or otherwise. For more information, please contact:
Serono Corporate Media Relations: Tel: +41-22-739-36-00 Fax:
+41-22-739-30-85 http://www.serono.com/ Corporate Investor
Relations: Tel: +41-22-739-36-01 Fax: +41-22-739-30-22 Media
Relations, USA: Tel: +1-781-681-2340 Fax: +1-781-681-2935
http://www.seronousa.com/ Investor Relations, USA: Tel:
+1-781-681-2552 Fax: +1-781-681-2912 Micromet, Inc. Media Europe:
Evelyn Wolf +49(0)89-895277-220 Investors: Ines-Regina Buth
+1-760-494-4235 (US) +49(0)89-895277-221 (Europe) Media US: Susan
Noonan +1-212-966-3650 DATASOURCE: Serono International S A
CONTACT: For more information, please contact: Serono - Corporate
Media Relations: Tel: +41-22-739-36-00, Fax: +41-22-739-30-85,
http://www.serono.com/, Corporate Investor Relations: Tel:
+41-22-739-36-01, Fax: +41-22-739-30-22, Media Relations, USA: Tel:
+1-781-681-2340, Fax: +1-781-681-2935, http://www.seronousa.com/,
Investor Relations, USA: Tel: +1-781-681-2552, Fax:
+1-781-681-2912; Micromet, Inc. - Media Europe : Evelyn Wolf,
+49(0)89-895277-220, , Investors : Ines-Regina Buth,
+1-760-494-4235 (US), +49(0)89-895277-221 (Europe), , Media US:
Susan Noonan, +1-212-966-3650,
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