Combination of QUADRAMET(R) and Chemotherapy to be Evaluated in New Clinical
Trial By Researchers at Memorial Sloan-Kettering Cancer Center that will
Enroll Patients with Metastatic Bone Disease Arising from Prostate Cancer
PRINCETON, N.J., March 17 /PRNewswire-FirstCall/ -- Cytogen Corporation
(Nasdaq: CYTO), a product-driven biopharmaceutical company, today provided an
update regarding clinical development and commercialization activities for
QUADRAMET(R) (samarium Sm-153 lexidronam injection). QUADRAMET, Cytogen's
flagship product, is a fast-acting, long-lasting non-opioid therapeutic
alternative for the relief of pain due to metastatic bone disease arising from
prostate, breast, multiple myeloma and other types of cancer.
"QUADRAMET's demonstrated ability to reduce pain and the need for opioid-
based treatments, along with its safety, simplicity, convenience of
administration, and cost-effectiveness underscores our long-held belief that
this unique product addresses a significant and unmet medical need," said
Michael D. Becker, Cytogen's President and Chief Executive Officer. "Today we
have a 60-person-plus core commercial organization including sales, marketing,
and medical affairs functions to tap the full potential of QUADRAMET. Key
components of this effort in 2005 include the successful execution of the
Company's national bone pain registry, broadening the use of QUADRAMET within
its current palliative indication, and expansion of new clinical development
initiatives that currently include more than nine ongoing studies designed to
evaluate the effectiveness of QUADRAMET as a tumoricidal agent in paradigm-
shifting combination approaches, for which important preliminary data has been
presented during the past year."
Clinical Development Update
Cytogen today announced that researchers at Memorial Sloan-Kettering
Cancer Center will investigate the use of QUADRAMET in combination with
docetaxel (Taxotere(R), Aventis Pharmaceuticals, a member of the sanofi-
aventis Group) for the treatment of metastatic bone disease arising from
prostate cancer. This new clinical study will evaluate the safety profile and
preliminary incidence and duration of clinical benefits of docetaxel in
combination with QUADRAMET. The study will be carried out under Cytogen's
Investigational New Drug (IND) application.
The principal investigator for this new study is Michael Morris, MD, of
Memorial Sloan-Kettering Cancer Center. In a presentation at the 2002
American Society of Clinical Oncology (ASCO) annual meeting, Dr. Morris and
his colleagues discussed their research on 56 hormone-refractory prostate
cancer patients with metastatic disease who were treated in a clinical trial
with chemotherapy. The researchers, led by Howard Scher, MD, examined the
relapse patterns that led to the initiation of chemotherapy, as opposed to the
relapse patterns that took the patients off the trial, or ultimately, led to
their death. The team found that, in patients who had progression in both
bone and soft-tissue disease before their chemotherapy, the primary site of
relapse was in bone following the chemotherapy.
"Prostate cancer is unique among solid tumors in that the greatest threat
to a patient's survival and quality of life is posed by metastatic bone
disease," commented Dr. Morris. "Soft-tissue and visceral involvement, though
common in most solid tumors, are not prominent features of this disease. The
skeleton represents the primary reservoir of disease in metastatic prostate
cancer and the primary site of relapse after chemotherapy. These findings lead
us to believe that the treatment that should be either added to, or sequenced
into, chemotherapy should be a bone-directed strategy. Although previous
efforts to treat metastatic bone disease have focused on palliation, there is
increasing recognition that targeting tumors in the bone will be necessary to
achieve curative outcomes."
Docetaxel, a drug in the taxoid class of chemotherapeutic agents, inhibits
cancer cell division by essentially "freezing" the cell's internal skeleton,
which is comprised of microtubules. Microtubules assemble and disassemble
during a cell cycle. Docetaxel promotes their assembly and blocks their
disassembly, thereby preventing many cancer cells from dividing and resulting
in death in some cancer cells. Docetaxel also exhibits a potent
radiosensitizing capability that may act synergistically with QUADRAMET. For
this reason, current and planned trials are exploring the optimal dose and
schedule of administration of docetaxel with concurrent QUADRAMET
radiotherapy.
Cytogen has identified the following areas for further clinical
development related to QUADRAMET:
-- clinical investigations to develop new data supporting the expanded
and earlier use of QUADRAMET in various cancers;
-- conducting novel research supporting combination uses of QUADRAMET
with other therapies, such as chemotherapy and bisphophonates;
-- establishing the use of QUADRAMET at higher doses and earlier in the
course of the disease to target and treat primary bone cancers; and
-- obtaining FDA marketing approval for these expanded indications,
where appropriate.
Ongoing clinical studies in these areas include:
-- TAXSAM studies (TAXoid-based chemotherapy and SAMarium Sm-153
lexidronam injection)
-- A Phase I/II study at The University of Texas M. D. Anderson
Cancer Center in Houston evaluating the potential benefits of
treatments including multiple doses of QUADRAMET in combination
with weekly dosing of docetaxel in patients whose cancer has
progressed after receiving hormonal therapy.
-- A Phase I/II study at Johns Hopkins Kimmel Cancer Center to
investigate the use of QUADRAMET in combination with standard
docetaxel dosing every three weeks for the treatment of
metastatic bone disease arising from prostate cancer. The
clinical study will evaluate the safety profile and preliminary
incidence and duration of clinical benefits of novel escalating
dose and administration schedules of docetaxel in combination
with multiple doses of QUADRAMET in hormone refractory prostate
cancer patients.
-- A Phase I/II study at Memorial Sloan-Kettering Cancer Center to
investigate the use of QUADRAMET in combination with standard
docetaxel dosing every three weeks for the treatment of
metastatic bone disease arising from prostate cancer.
-- A Phase I/II study at Northwestern University in Illinois using
QUADRAMET, paclitaxel (Taxol(R)), and estramustine phosphate
sodium (Emcyt(R)) in hormone refractory prostate cancer patients.
The study utilizes escalating single doses of QUADRAMET in
combination with paclitaxel and estramustine phosphate sodium in
order to evaluate the dose level at which dose limiting toxicity
is obtained.
-- NEOSAM studies (NEOadjuvant use of SAMarium Sm-153 lexidronam
injection)
-- A Phase I study at Thomas Jefferson University in Pennsylvania
using escalating single doses of QUADRAMET combined with ongoing
hormonal therapy prior to external beam radiation therapy in men
with high risk clinically localized prostate cancer. The
objectives of this study are to assess the safety and determine
the maximum tolerated dose of QUADRAMET in this clinical
setting. The goal of this type of therapy is to prevent or delay
the progression of metastatic bone disease.
-- A Phase I/II study at Johns Hopkins Hospital evaluating the use
of QUADRAMET in the adjuvant treatment of osteogenic sarcoma.
The objective of this study is to determine the maximum
tolerated dose of QUADRAMET in this clinical setting that will
result in marrow recovery in a time frame that does not
significantly delay further chemotherapy.
-- SAMBIS studies (SAMarium Sm-153 lexidronam injection and
BISphosphonates)
-- Two Phase I/II studies at the University of Maryland in
Baltimore evaluating the potential benefits of combination
treatments including QUADRAMET and zoledronic acid (Zometa(R))
in patients with advanced prostate cancer. One study involves
patients who are chemotherapy naove while the other involves
patients who have previously received chemotherapy.
-- A Phase I/II study at the Mayo Clinic evaluating the use of
QUADRAMET in combination with bisphosphonates for the treatment
of pain associated with metastatic bone disease in patients with
recurrent or refractory multiple myeloma. The escalating dose
clinical study will evaluate both the safety profile and effects
on painful symptoms and analgesic use. In addition, preliminary
information regarding the effect of QUADRAMET on the underlying
disease will be determined by monitoring levels of M-protein, a
marker for multiple myeloma activity.
"In addition to these nine ongoing clinical studies, we anticipate that
several new programs will be initiated throughout 2005," said William
Goeckeler, Ph.D., Senior Vice President of Operations at Cytogen. "The
breadth and depth of our clinical development program for QUADRAMET reflects
our belief that new bone-targeted approaches might allow therapy to progress
beyond symptom palliation in advanced disease to early intervention for
survival gain."
Commercialization Update
As previously reported, following the appointment of a new Senior Vice
President for Sales and Marketing in April 2004, the Company undertook a
comprehensive assessment of the size, structure and capabilities of its sales
and marketing organization. As a result of this assessment, the Company
identified the need for realignment and expanded reach of its field force, and
increased call frequency to high potential oncology practices necessary to
support QUADRAMET and PROSTASCINT(R), Cytogen's marketed products. To address
these needs, the Company launched an initiative to build a 60-person-plus core
commercial organization including sales, marketing, and medical affairs
functions, which was completed in January 2005.
In addition, Cytogen announced the initiation of a national bone pain
registry program in November 2004. During the first quarter of 2005 more than
50 oncology sites were participating in the registry program and the Company
expects to collect data regarding both the use of QUADRAMET and best practices
in bone pain management from more than 500 patients. Results of this
initiative are expected to be presented at key medical meetings following the
conclusion of the program in 2005.
"I am pleased with the progress and recent direction of our commercial
organization following an aggressive expansion that was completed by early
2005 and believe that the impact of our activities will ultimately be
evidenced by growth in product sales," said Thomas Lytle, Senior Vice
President of Sales and Marketing at Cytogen. "We are working to establish a
substantial corporate presence for Cytogen in the oncology arena and position
ourselves amongst an elite group of biotechnology companies with proven
capabilities from clinical development through to commercialization."
About QUADRAMET
QUADRAMET is an oncology product that pairs the targeting ability of a
small molecule, bone-seeking phosphonate (EDTMP) with the therapeutic
potential of radiation (samarium Sm-153). Combined, these agents form an
innovative molecule with a short radioactive half-life that selectively
concentrates in osteoblastic sites (areas of new bone formation). 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 many characteristics which the Company believes are
advantageous for the treatment of metastatic bone disease including early
onset of pain relief, predictable and reversible bone marrow toxicity or
myelosuppression, ease of administration, and length of pain relief, lasting,
on average, four months with a single injection. QUADRAMET is administered as
an intravenous injection on an outpatient basis, and exhibits selective uptake
in bone with little or no detectable accumulation in soft tissue.
QUADRAMET Indication Information
QUADRAMET is indicated for the relief of pain in patients with confirmed
osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
This press release describes clinical applications that differ from that
reported in the QUADRAMET package insert. QUADRAMET should not be given
concurrently with chemotherapy or external beam radiation therapy unless the
benefit outweighs the risk. QUADRAMET should not be given after either of
these treatments until there has been time for adequate marrow recovery.
A copy of the full prescribing information for QUADRAMET may be obtained
in the United States from Cytogen Corporation by calling toll-free 800-833-
3533 or by visiting the web site at http://www.cytogen.com, which is not part
of this press release.
ABOUT CYTOGEN CORPORATION
Founded in 1980, Cytogen Corporation of Princeton, NJ is a product-driven
biopharmaceutical company that develops and commercializes innovative
molecules that can be used to build leading franchises across multiple
markets. Cytogen's marketed products include QUADRAMET(R) (samarium Sm-153
lexidronam injection) and PROSTASCINT(R) (capromab pendetide) kit for the
preparation of Indium In-111 capromab pendetide in the United States. Cytogen
also has exclusive United States marketing rights to COMBIDEX(R) (ferumoxtran-
10) for all applications, and the exclusive right to market and sell
ferumoxytol (previously Code 7228) for oncology applications in the United
States. COMBIDEX, an investigational functional molecular imaging agent
consisting of iron oxide nanoparticles, is currently being developed for use
in conjunction with magnetic resonance imaging to aid in the differentiation
of cancerous from non-cancerous lymph nodes, and is under review by the U.S.
Food and Drug Administration. Cytogen's development pipeline consists of
therapeutics targeting prostate-specific membrane antigen (PSMA), a protein
highly expressed on the surface of prostate cancer cells and the
neovasculature of many solid tumors. Full prescribing information for the
Company's products is available at http://www.cytogen.com or by calling 1-800-
833-3533. For more information, please visit the Company's website at
http://www.cytogen.com, which is not part of this press release.
This press release contains certain "forward-looking" statements within
the meaning of the Private Securities Litigation Reform Act of 1995 and
Section 21E of the Securities Exchange Act of 1934, as amended. All
statements, other than statements of historical facts, included in this press
release regarding our strategy, future operations, financial position, future
revenues, projected costs, prospects, plans and objectives of management are
forward-looking statements. Such forward-looking statements involve a number
of risks and uncertainties and investors are cautioned not to put any undue
reliance on any forward-looking statement. There are a number of important
factors that could cause Cytogen's results to differ materially from those
indicated by such forward-looking statements. In particular, Cytogen's
business is subject to a number of significant risks, which include, but are
not limited to: the risk of obtaining the necessary regulatory approvals; the
risk of whether products result from development activities; the risk of
shifts in the regulatory environment affecting sales of Cytogen's products
such as third-party payor reimbursement issues; the risk associated with
Cytogen's dependence on its partners for development of certain projects, as
well as other factors expressed from time to time in Cytogen's periodic
filings with the Securities and Exchange Commission (the "SEC"). As a result,
this press release should be read in conjunction with Cytogen's periodic
filings with the SEC. The forward-looking statements contained herein are made
only as of the date of this press release, and Cytogen undertakes no
obligation to publicly update such forward-looking statements to reflect
subsequent events or circumstances.
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