Looks like this was worth all of 4 cents on the stock price...
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Two New Studies in the British Journal of Haematology Show Potential Role of VELCADE(R) (Bortezomib) for Injection in Treating Patients with Front-Line Multiple Myeloma
CAMBRIDGE, Mass., June 8 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced publication in The
British Journal of Haematology of two phase II studies which showed strong
single agent and very high combination response rates in front-line multiple
myeloma (MM). Overall response rates ranged from 88 to 95 percent with
complete and near complete responses ranging from 25 to 29 percent. Use of
VELCADE in the front-line setting allowed for successful stem cell transplants
for these patients. A complete and near complete response rate of 57 percent
was reported following single stem cell transplant preceded by induction with
VELCADE, doxorubicin and dexamethasone (PAD). This response rate was similar
to the complete and very good partial response rates previously published for
tandem transplants.(1)
The results from these studies add to the growing body of VELCADE front-
line data supporting the phase III development program that includes two
trials with a third expected to be initiated in the coming weeks. VELCADE, the
first of a new class of medicines called proteasome inhibitors, is the first
treatment in more than a decade to be approved for patients with MM and is
currently approved for the treatment of patients who have received at least
one prior therapy. More than 12,000 patients have been treated in the U.S.
with VELCADE to date and VELCADE is the only drug therapy to demonstrate a
significant survival advantage when compared to a standard treatment in
relapsed MM patients.
"These data indicate that earlier use of VELCADE may improve overall
response outcomes for multiple myeloma patients," said James Cavenagh, M.D.,
FRCP, FRCPath, principal investigator of the PAD study at St. Bartholomew's
Hospital, West Smithfield, London. "We are extremely excited about these
findings as they may offer greater hope for newly diagnosed multiple myeloma
patients." VELCADE is being co-developed by Millennium Pharmaceuticals, Inc.
and Johnson & Johnson Pharmaceuticals Research & Development L.L.C. (J&JPRD).
VELCADE(R) (bortezomib) for Injection Alone and In Combination with
Dexamethasone
The multicenter phase II study, led by Sundar Jagannath, M.D., assessed
the efficacy and safety of VELCADE as a single agent and in combination with
standard therapy dexamethasone in patients with previously untreated,
symptomatic MM. Patients were treated for up to six cycles with VELCADE.
Dexamethasone was administered the day of and the day after VELCADE if less
than a partial response (PR) after cycle two or less than a complete response
(CR) after cycle four was achieved. Patients received a median of six cycles.
Response was assessed according to the European Group for Blood and Marrow
Transplantation (EBMT) criteria. Results from 32 evaluable patients included:
* Overall response rate (CR+PR) for VELCADE alone or in combination with
dexamethasone was 88 percent with a complete and near complete response
rate of 25 percent;
* After two cycles of therapy, single agent VELCADE achieved a response
rate of 40 percent;
* Six of eight patients who achieved complete or near complete responses
did so on VELCADE alone;
* Survival at one year was 87 percent with a median follow-up of 5.5
months; and
* Improved response after the addition of dexamethasone was observed in 68
percent of patients who received dexamethasone.
Stem cell harvesting and engraftment was successful for all transplant
patients in this study. Adverse events were reported to be manageable and
included gastrointestinal events, neuropathy, myalgia, fatigue, and
hematologic toxicities.
PAD Induction Therapy Prior to Stem Cell Transplant
The multicenter phase I/II study, led by Dr. Cavenagh, assessed VELCADE in
combination with doxorubicin and dexamethasone (PAD) as induction therapy
prior to stem cell transplant in previously untreated MM patients. Four cycles
of PAD therapy were administered to patients. Thereafter, patients underwent
stem cell mobilization, and the ability to adequately harvest peripheral blood
stem cells was evaluated. High-dose melphalan was administered, peripheral
blood stem cells were infused, and the rate of hematologic recovery was
assessed. Response, based on EBMT criteria, was measured after each cycle of
PAD and three months after transplantation. Results from the 21 patients
included:
* Overall response rate (CR+PR) was 95 percent with a complete and near
complete response rate of 29 percent;
* Stem cell collection was adequate in 20 of 21 patients;
* Eighteen of 20 patients were successfully transplanted as two patients
declined transplant;
* Post-transplantation, the overall response rate at three months was 95
percent with a 57 percent complete and near complete response rate; and
* No dose limiting toxicities occurred and adverse events included
infections, hyperglycemia, peripheral neuropathy, postural hypotension,
gastrointestinal events and atrial fibrillation.
"These data support our pursuit for a front-line indication for VELCADE,"
said David Schenkein, M.D., senior vice president, clinical research,
Millennium. "We, in collaboration with J&JPRD, have initiated a robust phase
III program to further evaluate the clinical benefit of VELCADE in front-line
multiple myeloma. The first international, multicenter trial, named VISTA and
initiated January 2005, is evaluating VELCADE(R) (bortezomib) for Injection in
combination with melphalan-prednisone in nontransplant patients. The second
trial, the newly initiated HOVON trial, will assess patients who will go on to
transplant."
Initiation of the HOVON Phase III Front-Line Trial
Millennium, in collaboration with its development partner J&JPRD,
supported the recent commencement of a large, multicenter, randomized phase
III international trial led by the cooperative group Stichting Hemato-
Oncologie voor Volwassenen Nederland (HOVON) in newly diagnosed MM patients.
The HOVON clinical trial will assess PAD prior to stem cell transplant
followed by maintenance therapy with VELCADE compared to vincristine,
adriamycin, and dexamethasone (VAD) as induction therapy prior to transplant
with thalidomide maintenance. Led by Pieter Sonneveld, M.D., Ph.D., Erasmus
Medical Center Rotterdam, The Netherlands, the study is planning to enroll 800
patients and will compare progression free survival, response rate, survival
and the overall safety and tolerability of the two regimens.
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