Farletuzumab Data Presented on Phase II Clinical Trial in First-Relapsed
Ovarian Cancer Subjects
BERLIN, Sept. 24 /PRNewswire/ -- Morphotek(R), Inc., a subsidiary of Eisai
Corporation of North America, today announced preliminary data from a Phase II
trial evaluating the safety and efficacy of farletuzumab in platinum-sensitive
epithelial ovarian cancer subjects experiencing their first relapse.
Farletuzumab (MORAb-003) is a humanized monoclonal antibody that targets the
Folate Receptor Alpha (FRA).

These data were presented today at the joint 15th( )Congress of the European
Cancer Organisation (ECCO) and the 34th Congress of the European Society for
Medical Oncology (ESMO) by Deborah Armstrong, M.D., Associate Professor of
Oncology, Johns Hopkins Kimmel Cancer Center and a farletuzumab study
investigator.

Preliminary data from the study indicate that farletuzumab, in combination
with standard platinum and taxane chemotherapy, shrank or eliminated the tumor
in 69.8% of subjects; in addition, 23% of the subjects had their tumor
stabilized. The results of the study also showed that in more than 20% of
subjects the second progression-free interval was as long as or longer than
the first.

The most common drug-related adverse events observed in this study were fever
and chills related to infusion, which tended to be mild. No significant
increase in severe adverse events above those expected with chemotherapy alone
was reported during combination therapy.

"The rate of relapse of ovarian cancer is high, and over time standard
chemotherapeutic agents become ineffective in treating relapsed ovarian cancer
patients," said Martin D. Phillips, M.D., Chief Medical Officer at Morphotek.
"We are excited about these new data and look forward to seeing results from
our ongoing global Phase III trial testing farletuzumab in combination with
platinum and taxane in platinum-sensitive ovarian cancer."

"The results of this Phase II study presented today support our commitment to
continue to develop farletuzumab for ovarian cancer," said Nicholas C.
Nicolaides, Ph.D., President and CEO of Morphotek.  "Our research with
farletuzumab is consistent with our human health care(hhc) mission -
addressing unmet medical needs by developing new treatment options that will
improve the lives of patients."

Study Details
The primary objectives of the open-label Phase II study included: to measure
overall response rate (ORR), to compare the length of a subject's second
remission with her first remission and to measure change in CA-125 level.(
)Approximately 20 centers in the United States, Germany and the Netherlands
participated in the study.

Thirty-nine (88.6%) of the 44 eligible subjects receiving farletuzumab in
combination with platinum and taxane had their CA-125 blood levels normalized,
and three additional subjects had a 50% decrease.( )(According to the National
Cancer Institute, CA-125 is a tumor marker frequently elevated in ovarian
cancer.  It is typically used to evaluate tumor response, as CA-125 levels
generally correlate with tumor activity.) In nine (20.5%) of these 44
subjects, the second remission was equal to or longer than the first
remission.