�A late published article by
Sanchez-Velasco et al. in Clinical Transplantation has expanded our
understanding of the clinical potential of monitoring cell-mediated
immunity in adult patients at risk for organ rejection or infection
subsequent to kidney transplantation.
Pablo Sanchez-Velasco and his colleagues in the Cantabria Health System
and at the University of Cantabria, in Santander, Spain, used the Cylex
ImmuKnow assay to prospectively monitor intracellular adenosine
triphosphate (ATP) concentrations following CD4 cell activation as a
amount of cell mediated immune function in 81 immunosuppressed adults wHO
underwent kidney transplantation. The objective of their study was to
examine the association between cell-mediated immunity and risk for hammond organ
rejection (in under- immunosuppressed patients) or systemic infection (in
over-immunosuppressed patients). Their data were also compared to
intracellular ATP levels in 52 (non-transplanted) healthy controls.
Their results demonstrated a clear correlation betwixt intracellular
ATP levels for the goodish control mathematical group, a group of stable transplant
patients, and infected transplant patients, with a statistically
meaning difference betwixt the average ATP levels for these three
groups:
-- Infected transplant group (n = 24): mean ATP level = 197 +/- 114 ng/mL
-- Stable transpose group (n = 54): mean ATP level = 313 +/- 193 ng/mL
-- Healthy control radical (n = 52): beggarly ATP horizontal surface = 409 +/- 177 ng/mL
Only trio patients in this trial underwent an acute rejection episode
during the course of this study. The authors state that this was an
insufficient number of patients to formalise the part of the ImmuKnow assay
in monitoring risk for organ rejection. The hateful ATP layer of the three
patients who underwent acute organ rejection was 247 +/- 193 ng/mL.
"We ar pleased to see the data from this study support to begin with
published data on the use of the ImmuKnow assay in monitoring adult
patients later on a nephritic transplant," declared Brad L. Stewart, president of
Cylex. "Clearly there is farther research requisite to shed light on the
seize standards for use of cell-mediated immunity to monitor risk for
infection and rejection in selected patient categories. However, this
publication further illustrates the potency risks for infection
associated with over-immunosuppression in renal transplant patients, and
the potential economic value of the ImmuKnow assay in monitoring immune condition."
Sanchez-Velasco P, Rodrigo E, Valero R, et al. Intracellular ATP
concentrations of CD4 cells in kidney transplant patients with and without
infection. Clin Transplant. 2008;22:55-60.
About ImmuKnow(R)
ImmuKnow is the immune cell function assay clear by the FDA to detect
cell-mediated immunity (CMI) in adult patient populations undergoing
immunosuppressive therapy for organ transplantation by measure the
assiduousness of adenosine triphosphate (ATP) released from CD4 cells
following cell stimulation.
The ImmuKnow test is a qualitative assay and does not directly quantify
the level of immunosuppression. Results of ImmuKnow assays should be secondhand
in conjunction with clinical presentation, aesculapian history, and other
clinical indicators when assessing the immune status of whatsoever individual
patient. The uses of the ImmuKnow assay as described in these studies get
not been approved or cleared by the FDA. The Company may use data from
these or similar studies to support future FDA marketing applications for
similar indications.
About Cylex, Inc.
Cylex(TM) is a privately held global life sciences company that is the
loss leader in the development and manufacture of in vitro diagnostic products
intended to illuminate immunity. The Company's patented engineering provides
an innovative platform allowing clinical researchers to simply and
reproducibly bar immune cell function for the evolution of new
diagnostics, biomarkers, and comrade assays. The Company is based in
Columbia, MD, USA.
Cylex(TM)
http://www.cylex.net
More info
Sunday, 24 August 2008
Thursday, 14 August 2008
Medarex Announces Initiation Of Phase 2 Clinical Development Program For The Treatment Of Lupus
�Medarex, Inc.
(Nasdaq: MEDX) announced that its partner MedImmune, Inc. has
initiated a Phase 2A multi-dose clinical trial of MEDI-545 for the
potential discourse of systemic lupus erythematosus (SLE or lupus).
MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human
Antibody Development System(R). Under the damage of the agreement, Medarex
will receive a milestone payment of an undisclosed amount.
The Phase 2A clinical visitation is intentional to assess the safety and
tolerability of multiple subcutaneous vD schedules of MEDI-545 or placebo
in adult patients with moderate to terrible active lupus. The study will also
assess the effects of MEDI-545 on disease activity in lupus patients. This
randomized, double blind, placebo-controlled trial is expected to recruit 80
patients and will be conducted at 20 sites in the United States.
MedImmune is likewise conducting a Phase 1 clinical run for MEDI-545 in
idiopathic inflammatory myositis, an immunological disease that involves
chronic muscle firing, pain and weakness.
"Data from an earlier reported placebo-controlled Phase 1 report
suggested therapeutical activity with single doses in patients with lupus and
demonstrated an acceptable safety profile," said Geoffrey M. Nichol,
M.B.Ch.B., Senior Vice President of Product Development at Medarex. "We are
very excited about the role of the interferon alpha inflammatory nerve pathway
and look forward to exploring its potential in treating patients with lupus
and other autoimmune diseases."
About MEDI-545
MEDI-545 (previously known as MDX-1103) is a fully human monoclonal
antibody targeting interferon-alpha. Published information indicate that levels of
interferon-alpha are elevated in many patients with active SLE and other
autoimmune disorders, and may be associated with disease activity.
Preclinical information from creature models indicate that MEDI-545 may suppress the
abnormal immune action associated with lupus by binding to multiple
interferon-alpha subtypes seen in the serum of lupus patients.
In November 2004, MedImmune entered into a collaboration with Medarex
to focus on two specific antibodies, one of which was MDX-1103 (now known
as MEDI-545). Under the price of the agreement, MedImmune is responsible
for all ongoing clinical development activities. Prior to the beginning of
polar studies, Medarex may elect to co-develop the products in return for
the opportunity to co-promote and to get a parcel of the commercial
lucre in the United States. In all other cases, Medarex will be entitled
to get milestone payments and royalties.
About Lupus
Approximately 350,000 individuals in the United States are affected
with lupus, a chronic inflammatory disease that causes the body to attack
its own tissues and organs, including the skin, joints, blood and kidneys.
Treatments for lupus include anti-inflammatory drug drugs, antimalarials,
corticosteroids and drugs approved for other purposes, such as
immunosuppressant agents granted to genus Cancer patients undergoing chemotherapy
or medicines developed to process arthritis patients. Lupus occurs about 10
times more frequently in adult females than adult males, and is two to
deuce-ace times more common among African Americans, Hispanics, Asians and
Native Americans.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,
maturation and potentiality commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
malignant neoplastic disease, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing have to generate, support and potentially commercialise
a full range of fully human antibody product candidates for itself and its
partners. More than 40 of these healing product candidates derived from
Medarex applied science are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase 3 clinical trials or the theme of regulative
applications for marketing authorisation. Medarex is committed to building
value by developing a diverse pipeline of antibody products to address the
world's unmet healthcare needs. For more selective information about Medarex, visit
its website at http://www.medarex.com.
Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995, that are national to
certain risks and uncertainties that could causa actual results to take issue
materially from any future results, performance or achievements expressed
or implied by such statements. Statements that are non historical facts,
including statements preceded by, followed by, or that include the words
"expect"; "potential" or "may"; or similar statements are advanced
statements. Medarex disclaims, however, any intent or indebtedness to update
these forward-looking statements. Risks and uncertainties include
uncertainties related to the result of clinical trials, slower than
expected rates of patient recruitment, unforeseen base hit issues resulting
from the administration of MEDI-545 in patients, as well as risks elaborate
from metre to time in Medarex's public revealing filings with the U.S.
Securities and Exchange Commission (SEC), including its Annual Report on
Form 10-K for the fiscal year ended December 31, 2007 and its quarterly
reports on Form 10-Q. There can be no pledge that such development
efforts will come through or that other developed products volition receive compulsory
regulatory clearance or that, even if such regulative clearance were
received, such products would ultimately attain commercial success. Copies
of Medarex's world disclosure filings are useable from its investor
relations department.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved
Medarex, Inc.
http://www.medarex.com
More info
(Nasdaq: MEDX) announced that its partner MedImmune, Inc. has
initiated a Phase 2A multi-dose clinical trial of MEDI-545 for the
potential discourse of systemic lupus erythematosus (SLE or lupus).
MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human
Antibody Development System(R). Under the damage of the agreement, Medarex
will receive a milestone payment of an undisclosed amount.
The Phase 2A clinical visitation is intentional to assess the safety and
tolerability of multiple subcutaneous vD schedules of MEDI-545 or placebo
in adult patients with moderate to terrible active lupus. The study will also
assess the effects of MEDI-545 on disease activity in lupus patients. This
randomized, double blind, placebo-controlled trial is expected to recruit 80
patients and will be conducted at 20 sites in the United States.
MedImmune is likewise conducting a Phase 1 clinical run for MEDI-545 in
idiopathic inflammatory myositis, an immunological disease that involves
chronic muscle firing, pain and weakness.
"Data from an earlier reported placebo-controlled Phase 1 report
suggested therapeutical activity with single doses in patients with lupus and
demonstrated an acceptable safety profile," said Geoffrey M. Nichol,
M.B.Ch.B., Senior Vice President of Product Development at Medarex. "We are
very excited about the role of the interferon alpha inflammatory nerve pathway
and look forward to exploring its potential in treating patients with lupus
and other autoimmune diseases."
About MEDI-545
MEDI-545 (previously known as MDX-1103) is a fully human monoclonal
antibody targeting interferon-alpha. Published information indicate that levels of
interferon-alpha are elevated in many patients with active SLE and other
autoimmune disorders, and may be associated with disease activity.
Preclinical information from creature models indicate that MEDI-545 may suppress the
abnormal immune action associated with lupus by binding to multiple
interferon-alpha subtypes seen in the serum of lupus patients.
In November 2004, MedImmune entered into a collaboration with Medarex
to focus on two specific antibodies, one of which was MDX-1103 (now known
as MEDI-545). Under the price of the agreement, MedImmune is responsible
for all ongoing clinical development activities. Prior to the beginning of
polar studies, Medarex may elect to co-develop the products in return for
the opportunity to co-promote and to get a parcel of the commercial
lucre in the United States. In all other cases, Medarex will be entitled
to get milestone payments and royalties.
About Lupus
Approximately 350,000 individuals in the United States are affected
with lupus, a chronic inflammatory disease that causes the body to attack
its own tissues and organs, including the skin, joints, blood and kidneys.
Treatments for lupus include anti-inflammatory drug drugs, antimalarials,
corticosteroids and drugs approved for other purposes, such as
immunosuppressant agents granted to genus Cancer patients undergoing chemotherapy
or medicines developed to process arthritis patients. Lupus occurs about 10
times more frequently in adult females than adult males, and is two to
deuce-ace times more common among African Americans, Hispanics, Asians and
Native Americans.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,
maturation and potentiality commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
malignant neoplastic disease, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing have to generate, support and potentially commercialise
a full range of fully human antibody product candidates for itself and its
partners. More than 40 of these healing product candidates derived from
Medarex applied science are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase 3 clinical trials or the theme of regulative
applications for marketing authorisation. Medarex is committed to building
value by developing a diverse pipeline of antibody products to address the
world's unmet healthcare needs. For more selective information about Medarex, visit
its website at http://www.medarex.com.
Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995, that are national to
certain risks and uncertainties that could causa actual results to take issue
materially from any future results, performance or achievements expressed
or implied by such statements. Statements that are non historical facts,
including statements preceded by, followed by, or that include the words
"expect"; "potential" or "may"; or similar statements are advanced
statements. Medarex disclaims, however, any intent or indebtedness to update
these forward-looking statements. Risks and uncertainties include
uncertainties related to the result of clinical trials, slower than
expected rates of patient recruitment, unforeseen base hit issues resulting
from the administration of MEDI-545 in patients, as well as risks elaborate
from metre to time in Medarex's public revealing filings with the U.S.
Securities and Exchange Commission (SEC), including its Annual Report on
Form 10-K for the fiscal year ended December 31, 2007 and its quarterly
reports on Form 10-Q. There can be no pledge that such development
efforts will come through or that other developed products volition receive compulsory
regulatory clearance or that, even if such regulative clearance were
received, such products would ultimately attain commercial success. Copies
of Medarex's world disclosure filings are useable from its investor
relations department.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved
Medarex, Inc.
http://www.medarex.com
More info
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