Cytogen Corporation
(Nasdaq: CYTO) today reported that an abstract relating to QUADRAMET(R)
(samarium Sm-153 lexidronam injection) for patients with refractory and
relapsed multiple myeloma has been published by the American Society of
Hematology (ASH). The abstract (#3544) will be presented at the 2006 ASH
Annual Meeting in Orlando, Florida, December 9th to 12th during a poster
session on Monday, December 11, 2006 from 10:30 am EST to 7:00 pm EST.
The Phase 1 dose escalation study is designed to determine safety and
tolerability, as well as response rate, of QUADRAMET in combination with
bortezomib (Velcade(R), Millennium Pharmaceuticals, Inc.) for patients with
relapsed or refractory multiple myeloma. The study involves patients who
failed two or more prior treatments, including previous treatment with
bortezomib.
About QUADRAMET
QUADRAMET is indicated for the relief of pain in patients with
confirmed osteoblastic metastatic bone lesions that enhance on radionuclide
bone scan.
QUADRAMET is an oncology product indicated for pain relief that pairs
the targeting ability of a small molecule, bone-seeking phosphonate (EDTMP)
with the therapeutic potential of radiation (samarium Sm-153). Skeletal
invasion by prostate, breast, multiple myeloma, and other cancers often
creates an imbalance between the normal process of bone destruction and
formation. QUADRAMET selectively targets such sites of imbalance, thereby
delivering radioactivity to areas of the skeleton that have been invaded by
metastatic tumor.
QUADRAMET has demonstrated a range of characteristics that may be
advantageous for the treatment of pain arising from metastatic bone
disease, including early onset of pain relief (patients may experience pain
relief within the first week with maximal relief generally occurring at
three to four weeks after injection), length of pain relief, lasting a
median of four months in responding patients, and predictable and
reversible bone marrow toxicity or myelosuppression that tends to return to
pretreatment levels after eight weeks. QUADRAMET is administered as a
single intravenous injection, usually on an outpatient basis, and exhibits
selective uptake in areas of bone formation with little or no detectable
accumulation in soft tissue.
QUADRAMET Safety Profile
QUADRAMET causes bone marrow suppression. In clinical trials, white
blood cell counts and platelet counts decreased to a nadir of approximately
40% to 50% of baseline in 123 (95%) of patients within 3 to 5 weeks after
QUADRAMET, and tended to return to pretreatment levels by 8 weeks. Because
of the unknown potential for additive effects on bone marrow, QUADRAMET
should not be given concurrently with chemotherapy or external beam
radiation therapy unless the clinical benefits outweigh the risks. Blood
counts should be monitored weekly for at least 8 weeks, or until recovery
of adequate bone marrow function. Non-hematologic adverse events that
occurred in 5% or more of patients and greater than placebo were pain flare
(7%), diarrhea (6%), infection (7%), spinal cord compression (6.5%),
arrhythmias (5%), and hematuria (5%). Patients who receive QUADRAMET should
be advised that for several hours following administration, radioactivity
will be present in excreted urine. To help protect themselves and others in
their environment, precautions need to be taken for 12 hours following
administration.
This press release describes clinical applications that differ from
that reported in the QUADRAMET package insert. A copy of the full
prescribing information for QUADRAMET, including warnings, precautions,
adverse events and other safety information, may be obtained in the U.S.
from Cytogen Corporation by calling toll-free 800-833-3533 or by visiting
the web site at cytogen, which is not part of this press
release.
About CYTOGEN
Founded in 1980, Cytogen is a biopharmaceutical company dedicated to
advancing the care of cancer patients by building, developing, and
commercializing a portfolio of specialty pharmaceutical products. The
Company's specialized sales force currently markets QUADRAMET(R),
PROSTASCINT(R), and SOLTAMOX(TM) to the U.S. oncology market. QUADRAMET is
approved for the treatment of pain in patients whose cancer has spread to
the bone, PROSTASCINT is a PSMA-targeting monoclonal antibody-based agent
to image the extent and spread of prostate cancer, and SOLTAMOX is the
first liquid hormonal therapy approved in the U.S. for the treatment of
breast cancer in adjuvant and metastatic settings. In early 2007, Cytogen
plans to introduce its fourth approved oncology product to the U.S. market,
CAPHOSOL(R), a prescription medical device for the treatment of oral
mucositis and dry mouth. The Company is also developing CYT-500, a
third-generation radiolabeled antibody to treat prostate cancer. Cytogen's
product-focused strategy focuses on attaining sustainable growth through
clinical, commercial, and strategic initiatives.
A copy of the full prescribing information for CAPHOSOL, QUADRAMET,
PROSTASCINT, and SOLTAMOX, including box warnings, may be obtained in the
U.S. from Cytogen Corporation by calling toll-free 800-833-3533 or by
visiting Cytogen's web site at cytogen. The Company's
website is not part of this press release.
Cytogen Corporation
cytogen
View drug information on Quadramet.