EATONTOWN, N. With
the new Osteoconforming(TM) Technology, we continue to
develop and implement leading technological
advancements.
"Current therapies for Sjogren's syndrome do not adequately treat the
signs
and symptoms, which is why these results are so encouraging," commented
Ivan D. Fourteen
patients
received all four infusions without reactions with a median infusion
time of fifty minutes. We have
developed
a number of advanced proprietary technologies that allow us to create
humanized antibodies
that can be used either alone in unlabeled or "naked"
form, or conjugated with radioactive isotopes
, chemotherapeutics or toxins, in
each case to create highly targeted agents.
joints dwarfism
Professor Serge D
. Specifically, twenty-four hours after the last treatment,
symptomatic improvements ranging from
100% of patients experiencing tender
joints to 33% of patients with salivary flow were observed.
Sjogren's syndrome can be associated with extraglandular
presentations such as musculoskeletal features
including fatigue and
fibromyalgia in nearly 50% of patients and fewer patients complain of
arthralgias
.conditions back
Owusu-Akyaw continued, "We sized the Xpanse(TM) Bone Insert to fit
within the GraftCage(TM) TLX;
however, it can be utilized alone or with other
spinal implants where allograft or autograft bone
would be used. Any such forward-looking
statements are based on assumptions that the Company believes
are reasonable,
but are subject to a wide range of risks and uncertainties and, therefore,
there
can be no assurance that actual results may not differ materially from
those expressed or implied
by such forward-looking statements., Executive Vice President, Research and Development, and
Chief
Scientific Officer of Immunomedics. Consistent with the Company's past
clinical experience with
epratuzumab, the investigators also found a reduction
of 50% to 60% in circulating B-cells in the
patients enrolled in the trial.fibromyalgia anomalies
915) during the NASS meeting from Wednesday,
September 28, 2005 through
Friday, September 30, 2005.htm. We intend to meet with the FDA shortly to
discuss further development
of epratuzumab in this indication.scleroderma foot
Osteotech to Introduce Two New Products at NASS; Xpanse(TM) Bone Insert
and GraftCage(TM) TLX Vertebral Body Replacement Device
The Xpanse(TM) Bone
Insert and the GraftCage
(TM) TLX are two products in a series of procedure-
specific products we anticipate introducing within
the next year.connective scoliosis
osteotech.com and to Osteotech's Financial Information Request Form
website page at
http://www. Over an eight-week period, patients received
360 mg/m2 of epratuzumab every two weeks
for a total of four doses.connective congenital
The
GraftCage(TM) TLX features a large opening for the insertion of fusion
enhancing materials, including the Xpanse(TM) Bone Insert, to allow for
maximum graft exposure
. A final evaluation is planned for six
months after the last epratuzumab dose. We
believe that
our portfolio of intellectual property, which includes
approximately 90 issued patents in the United
States, and more than 250 other
issued patents worldwide, protects its product candidates and technologies
.com.congenital health
All information in this press release is as of September 12, 2005 and the
Company undertakes
no duty to update this information. Horak, M.spine support
(Nasdaq: OSTE) announced today that it will introduce
two new products at the
20th Annual Meeting of The North American Spine Society (NASS) to be held
at
the Pennsylvania Convention Center in Philadelphia, Pennsylvania; the
Xpanse(TM) Bone Insert
and the GraftCage(TM) TLX vertebral body replacement
device. Factors that
could cause actual
results to differ materially include, but are not limited
to, differences in anticipated and actual
product and service introduction
dates, the timing of approvals, if required, by governing regulatory
bodies,
the ultimate success of those products in the marketplace, the continued
acceptance and
growth of current products and services, the impact of
competitive products and services, the availability
of sufficient quantities
of suitable donated tissue and the success of cost control and margin
improvement
efforts.D. Using these technologies, we have
built a pipeline of therapeutic product candidates
that utilize several
different mechanisms of action.immunomedics.joint spine
The GraftCage(TM) TLX can be implanted
utilizing existing
Osteotech instrumentation for transverse spinal interbody procedures."
Mr. Steinfeld of Erasme University Hospital, Brussels, Belgium,
was the principal investigator.
"Our first set of epratuzumab data
demonstrates clinical improvement in this difficult-to-treat population
of
patients with Sjogren's syndrome. in the last 40 years. The Company is not under any obligation
, and the Company expressly
disclaims any obligation, to update or alter any forward-looking statements
,
whether as a result of new information, future events or otherwise.lupus support
Such statements, including statements
regarding clinical trials,
out-licensing arrangements, and capital raising activities, involve
significant
risks and uncertainties and actual results could differ materially
from those expressed or implied
herein.
For More Information:
Dr.musculoskeletal joints
Epratuzumab
has also demonstrated good
safety, tolerability, and clinical efficacy in more
than 340 patients with non-Hodgkin's lymphoma
, resulting in reports published
in The Journal of Clinical Oncology and Clinical Cancer Research
.com
congenital diseases
J. Food
and Drug Administration.
(Nasdaq: IMMU), a leading biopharmaceutical company
focused on developing
monoclonal antibodies, today reported encouraging results from its Phase I
/II
trial with its compound, epratuzumab, for the treatment of Sjogren's syndrome,
an autoimmune
disease that currently affects between 2 to 4 million Americans. One patient discontinued the third
infusion due to an
acute infusion reaction, but completed the fourth infusion with no further
reaction
. According to the Sjogren's Syndrome Foundation, the condition
affects approximately two million
to four million Americans, mostly middle-age
women.S.
This release, in addition to historical
information, contains forward-
looking statements made pursuant to the Private Securities Litigation
Reform
Act of 1995. Chau Cheng
Associate Director, Investor Relations + Business Analysis
+1-973-605-8200, extension 123
ccheng@immunomedics.back dwarfism
osteotech.
Results were presented
at the 2005 Annual European Congress of Rheumatology in
Vienna, Austria, organized by The European
League Against Rheumatism (EULAR).
About Immunomedics
Immunomedics is a New Jersey
-based biopharmaceutical company focused on
the development of monoclonal antibody-based products
for the targeted
treatment of cancer, autoimmune and other serious diseases. Our lead product candidate
, epratuzumab, is
currently in two pivotal Phase III trials, for the treatment of patients with
moderate
and severe lupus.joints disorders
The GraftCage(TM) TLX is pending 510(k) clearance from the U.
Sam Owusu-Akyaw
, Osteotech's President and Chief Operating Officer,
stated, "We are pleased to continue to bring
new and innovative products to
the market. Used
together, the Xpanse(TM) Bone Insert and the
GraftCage(TM) TLX create a unique
vertebral body spacer allowing for maximum endplate contact, structural
support, osteoinductivity and osteoconductivity, which are the four key
components to a successful
fusion., headquartered in Eatontown, New Jersey, is a leading
provider of human bone and bone connective
tissue for transplantation and an
innovator in the development and marketing of biomaterial and implant
products
for musculoskeletal surgery.
Immunomedics Reports Initial Clinical Results for
Epratuzumab in Sjogren's Syndrome
About Sjogren's Syndrome
Sjogren's syndrome
is a chronic autoimmune syndrome characterized by
lymphocyte infiltration of salivary glands resulting
in symptomatic eye and
mouth dryness.conditions clubfoot
Certain of these factors are detailed from time to time
in
the Company's periodic reports (including the Annual Report on Form 10-K
for the year ended December
31, 2004 and the Form 10-Q for the each of the
first two quarters of 2005) filed with the Securities
and Exchange Commission.support lupus
S. Utilizing Osteotech's patent-pending Osteoconforming(TM)
Technology,
the Xpanse(TM) Bone Insert expands up to 10 millimeters when re-
hydrated in vivo, thus providing
more complete bone surface contact during a
variety of orthopaedic and reconstructive applications
."
Certain statements made throughout this press release that are not
historical facts
contain forward-looking statements (as such are defined in
the Private Securities Litigation Reform
Act of 1995) regarding the Company's
future plans, objectives and expected performance.clubfoot spine
Osteotech
's GraftCage(TM) TLX, manufactured from Invibio's PEEK-OPTIMA(R)
polymer, is a vertebral body replacement
device designed for strength and ease
of insertion. VIENNA, Austria, Immunomedics, Inc.
Patients reported improvements in their clinical signs and symptoms that
include: dry eyes, dry
mouth, fatigue, tender joints, tender points, tear and
salivary flow. Moreover, when
these patients
were evaluated twelve weeks post therapy, 86% of patients who
showed tender joints improvement retained
clinical benefit, as did 20% of
patients with increased salivary flow.lupus joints
For further information regarding
Osteotech or
this press release, please go to Osteotech's website homepage at
http://www."
Evidence suggests that B-cells may play a key role in the inflammatory
cascade of Sjogren's syndrome
or lupus.
This data suggests that B-cell modulation may be the primary mechanism of
action of
epratuzumab, and that complete depletion of B-cells is not necessary
to provide a clinical benefit
.scleroderma congenital
Attendees will be able to view both products at the
Osteotech booth (Booth No.
The Xpanse
(TM) Bone Insert incorporates Osteotech's proprietary
demineralized bone fiber technology and demineralized
cancellous chips to
provide a tissue graft that is osteoinductive, osteoconductive and
osteoconforming
.
Fifteen patients with primary Sjogren's syndrome were enrolled in this
open-label, non-randomized
, two-center study to assess feasibility, safety,
and early evidence of efficacy. The FDA granted
a Fast Track designation to the clinical development
program for epratuzumab for the treatment of
patients with SLE.
Visit the Company's web site at http://www. Factors that could cause such
differences
include, but are not limited to, risks associated with new product
development (including clinical
trials outcome and regulatory
requirements/actions), competitive risks to marketed products and availability
of financing and other sources of capital, as well as the risks discussed in
the Company's Annual
Report on Form 10-K for the fiscal year ended June 30,
2004.tissue scoliosis
, Osteotech, Inc.
Osteotech filed
for 510(k) clearance of the GraftCage(TM) TLX with the FDA in
June 2005 and anticipates receiving
clearance in the fourth quarter of 2005.
About Epratuzumab
Epratuzumab is a humanized
monoclonal antibody that targets CD22 antigen,
found on the surface of B-lymphocytes, a type of white
blood cell. At present, there is no cure for lupus and no new
lupus treatment drug has been approved
in the U.spine disorders
Osteotech, Inc.
Epratuzumab is being evaluated in patients with Sjogren's syndrome
and is also
Immunomedics' lead product candidate in two pivotal Phase III trials for the
treatment
of patients with moderate and severe systemic lupus erythematosus
(SLE).spine connective
The Xpanse(TM) Bone
Insert
is expected to be available to surgeons beginning in October 2005. It also features three titanium
alloy markers to
facilitate intra-operative and post-operative radiographic assessments.com
Julie Huang
Financial Dynamics
+1-212-850-5628
jhuang@fd-us.diseases amputee
com/finrequest
.back arthritis
back fibromyalgia
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