Today's PR from MLNM broken down into readable chunks...
Millennium Announces Promising Findings from Novel Antibody-Chemotherapeutic MLN2704 Prostate Cancer Clinical Trial
prnews
ORLANDO, Fla., Feb. 20 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced final results from a
phase I clinical trial of MLN2704 in patients with advanced hormone-refractory
prostate cancer. These results were presented at the 2005 Prostate Cancer
Symposium taking place this week in Orlando, Fl.
The findings from this first in human MLN2704 single ascending dose trial
indicated the molecule was well tolerated and produced sustained anti-tumor
activity, including one patient who achieved a durable partial response in
measurable disease for 11 months, as well as a sustained prostate specific
antigen (PSA) decline of more than 50 percent. This patient received 14 doses
prior to measurable disease progression at 47 weeks. MLN2704 is composed of a
deimmunized monoclonal antibody (MLN591) directed at prostate specific
membrane antigen (PSMA) conjugated to the chemotherapeutic agent DM1.
"We are encouraged by these findings with MLN2704 in prostate cancer, and
we are continuing to assess the dose and schedule," said David Schenkein,
M.D., senior vice president, clinical research, Millennium. "These results
allow us to continue to pursue this important area of unmet medical need, and
we are hopeful that further development can lead to new therapeutic options
for patients with hormone-refractory prostate cancer."
Interim data from the Company's ongoing multiple ascending dose trial
evaluating MLN2704 in patients with prostate cancer has been accepted for
presentation at the 41st Annual Meeting of the American Society of Clinical
Oncology (ASCO) scheduled for May 13-17 in Orlando, Fl.
Also presented at the meeting were results from two VELCADE studies in
patients with progressive hormone-refractory prostate cancer: a phase I/II
clinical trial of VELCADE in combination with docetaxel and a phase II study
of VELCADE with and without steroids. The findings from the study evaluating
VELCADE(R) (bortezomib) for Injection and 40mg docetaxel in combination weekly
indicated the combination was well tolerated and showed promising activity.
Specifically, in the higher VELCADE dose cohort, there were two partial
responses in 18 patients with measurable disease and there were confirmed PSA
declines of at least 50 percent in 36 percent of the 28 evaluable patients.
VELCADE is being co-developed by Millennium and Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. Millennium is responsible for
commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are
responsible for commercialization in Europe and the rest of the world. Janssen
Pharmaceutical K.K. is responsible for Japan.
"We are continuing to evaluate the data from the VELCADE trials in the
prostate cancer population to better assess and understand the activity we
have seen in these and past trials," said Dr. Schenkein. "We anticipate
finalizing our evaluation and determining next steps in prostate cancer with
VELCADE later this year in collaboration with our partner, Johnson & Johnson
Pharmaceutical Research & Development, L.L.C."
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