Three Clinical Studies of bioTheranostics Molecular Breast Cancer Diagnostics Presented at San Antonio Breast Cancer Symposium
... Oncotype DX Recurrence Score (RS) of high,
intermediate or low was
previously reported. The study found ... survival. Patients with a high or
intermediate HOXB13
expression did not experience a distant ... by
providing a more informative picture of the
intermediate risk group. We look
forward to further expanding ...
/C O R R E C T I O N -- Agendia B.V./
... uncertain."
In addition, the panel cautioned that so-called
intermediate scores are
not useful in clinical decision making. Currently, MammaPrint ... assay available that accurately yields a binary
result, without an
intermediate group, addressing the panel's
recommendations. The FDA-cleared assay is ...
Agendia's Breast Cancer Recurrence Test MammaPrint Included in International St. Gallen Expert Consensus Recommendations
... uncertain."
In addition, the panel cautioned that so-called
intermediate scores are
not useful in clinical decision making. Currently, MammaPrint ... assay available that accurately yields a binary
result, without an
intermediate group, addressing the panel's
recommendations. The FDA-cleared assay is ...
Dacogen(R) (decitabine for injection) Data Presented on a Phase II Clinical Trial in Elderly Patients with Acute Myeloid Leukemia (AML)
... and 100,000/uL, respectively. The majority of patients in the trial had
intermediate or poor risk cytogenetics (bone marrow tests to identify abnormal ...
Of the 55 patients enrolled in the trial, most patients had
intermediate (53 percent) or poor (42 percent) risk cytogenetics, which are associated ...
Callisto Pharmaceuticals Completes Enrollment of Phase II Trial of Atiprimod in Neuroendocrine Cancer
... enrollment of its Phase II clinical trial of Atiprimod to
treat low to
intermediate grade neuroendocrine carcinoma (advanced
carcinoid cancer) was ... trial was to evaluate
efficacy of Atiprimod in patients with low to
intermediate grade
neuroendocrine carcinoma who have metastatic or unresectable cancer ...
Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009
... Our partnership strategy not only allows our drugs to move forward effectively toward the market but also provides us with significant short and
intermediate term financial benefits that enable us to continue to advance the technology and fill the pipeline with more exciting new drugs," said B. Lynne ...
Prospective Clinical Advantages of Trabecular Metal(TM) Technology Highlighted in Comparative Study
... Trabecular Metal cups versus titanium cups with a similar geometry. This is the first study to quantify bone-remodeling around hip implants at an
intermediate term (mean of 7.7 years) follow-up. Bone mineral density adjacent to acetabular implants was evaluated using quantitative computed tomography (QCT). ...
Genomic Health Study Shows Breast Cancers in Men Display Very Similar Gene Signatures to Those in Women
... The proportion of tumors with low risk of recurrence based on the Recurrence Score(R) was 53.6 percent in males versus 53.4 percent in females,
intermediate risk of recurrence was 35.2 percent in males versus 36.3 percent in females, and high risk of recurrence was 11.2 percent in males versus 10.3 ...
Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)
... for the efficacy outcome measures of change in percent predicted FVC, PFS and DLco. On each of these outcome measures, the effect of 1197 mg was
intermediate as compared to placebo and 2403 mg pirfenidone, indicative of a consistent dose-effect relationship. Similarly, a dose-response relationship was ...
Video: ev3 Inc. Announces First Patient Enrollments in DEFINITIVE LE Post-Market Study
... were recently enrolled in the DEFINITIVE LE post-market study. DEFINITIVE LE is a prospective, multi-center, single-arm study to evaluate the
intermediate and long-term effectiveness of stand-alone SilverHawk(R) Plaque Excision therapy for endovascular treatment of lower extremity peripheral arterial ...
SYNTAX Analysis Finds Treatment With TAXUS(R) Express2(TM) Stents More Cost Effective Than Bypass Surgery in Many Patients With Complex Coronary Artery Disease
... CABG patients, driven by the expected higher rate of revascularization in the PCI group. PCI and CABG patients whose scores fell into the lower or
intermediate terciles of complexity had similar rates of MACCE at 12 months. The SYNTAX Score characterizes coronary anatomy based on lesion frequency, ...
Phase IV Multi-center Clinical Study of Kutai Concludes in Nanjing
... Kutai is a non-depolarizing skeletal muscle relaxant for intravenous administration. Compared to other neuromuscular blocking agents, it is
intermediate in its onset and duration of action.
More than 30 clinical experts from seven participating medical centers within China gathered in Nanjing ...
Freezing Prostate Cancer Does a Man's Body Good
... invasive treatments can cause side effects such as bladder control problems and erectile dysfunction (impotence). Men are classified as being at low,
intermediate or high risk. The criteria used to categorize the risk include the results of the prostate-specific antigen (PSA) blood test (which looks for a ...
Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients
... Interim data from an ongoing Phase 2 multicenter, randomized,
double-blind, placebo-controlled study evaluating Nplate in patients with low
or
intermediate risk MDS receiving azacytidine were also presented (n=40).
The interim analysis showed that Nplate reduced the incidence of clinically
significant, ...
MGuard(TM) Coronary Stent System Approved in Israel
... up to six months. The study's primary endpoints are complete
resolution of ST-segment elevation and restoration of flow through the
occluded artery.
intermediate results will be presented this week at the ICI
'08 Meeting in Tel-Aviv. iMOS (international MGuard Observational study) will
be launched soon. The ...
SYNTAX Data Show Comparable Safety for Complex Patients Treated with TAXUS(R) Express2(TM) Stents and Bypass Surgery
... each patient. The analysis of the raw SYNTAX Score
data presented today demonstrated that PCI and CABG patients whose scores
fell into the lower or
intermediate terciles of complexity had similar
rates of MACCE (Major Adverse Cardiovascular or Cerebrovascular Event rate,
including all-cause death, stroke, MI ...
Video: Large, Multi-Center Trial Demonstrates Comparable Accuracy for Virtual Colonoscopy and Standard Colonoscopy
... findings were evaluated using
standard colonoscopy as the reference standard. CT colonography was found
to be highly accurate for the detection of
intermediate and large polyps.
Ninety percent of the polyps 1 centimeter or larger were detected by CT
colonography. Even polyps as small as one half centimeter ...
MultiVu Video Feed: Major Trial Demonstrates Comparable Accuracy of Virtual Colonoscopy and Standard Colonoscopy
... of Health (NIH), enrolled more than 2,600 patients at 15 sites
nationwide and found that CT colonography was highly accurate for the
detection of
intermediate and large polyps.
For further information about the ACRIN National CT Colonography Trial,
please visit: ...
Pharmasset Reports Preliminary Results of a 4-week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
... therapy for chronic HCV infection. Cohort 1
administered R7128 500mg BID, Cohort 2 administered R7128 1500mg BID, and
Cohort 3 administered an
intermediate dose of 1000mg BID, all given in
combination with pegylated interferon and ribavirin for 28 days. All
subjects then went on to receive a total of 48 ...
Diverse Approaches to Alzheimer's Therapies Continue to Show Progress at ICAD
... the lowest persistency group (1st quartile) were 2.4 times
more likely to die than those in the highest persistency group (4th
quartile). Those with
intermediate drug exposure had increased risk of
death of 2.2 times (2nd quartile) and 1.5 times (3rd quartile) compared to
the most persistent users. More ...
Two New Alzheimer's Disease Studies Show Advances Against Different Treatment Targets
... it becomes necessary to identify patients at the
earliest point in the disease. Mild Cognitive Impairment (MCI) is the term
used to describe the
intermediate state between normal aging and the very
earliest features of Alzheimer's, but its frequency in the population is
not known.
Ronald C. Petersen, MD, ...
Journal of Antimicrobial Chemotherapy Paper Supports Additional Role for Cethromycin as Potential Treatment for Infections Caused by Community- Associated Methicillin Resistant Staphylococcus Aureus (CA-MRSA)
... range of < / = 0.002-1.0 mg/L, with the MBC50 of < / = 0.002 mg/L and
the MBC90 of < / = 0.008 mg/L. Of the 170 CA-MRSA isolates, 169 (99.4%)
were
intermediate or resistant to at least one macrolide. In contrast, 164
(96.5%) isolates were susceptible to clindamycin. Only six (3.5%) isolates
demonstrated ...
Vion Pharmaceuticals Announces Presentation of Data of Cloretazine(R) (VNP40101M) in Elderly Patients with High-Risk Myelodysplastic Syndromes at the EHA Annual Meeting
... diagnosed with RAEB-t. Five
patients were diagnosed with either chronic myelomonocytic leukemias (CMML)
(3) or as unknown (2). Fifteen patients had
intermediate cytogenetics and
11 had unfavorable cytogenetics. Sixteen of the patients were classified as
Intermediate-2 risk by the International Prognostic ...
New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes
... Dose and timing of administration
may need to be adjusted to reduce the risk of hypoglycemia in patients
being switched to Levemir from other
intermediate or long-acting insulin
preparations. The dose of Levemir may need to be adjusted in patients with
renal or hepatic impairment.
Prescribing ...
DURABLE Clinical Trial Results Show GlycoMark is Key Test for Managing Patients with Diabetes
... aspart 30 and insulin
glargine.
Reference: Diabetic Medicine 2008 (Alan Moses)
About GlycoMark
GlycoMark is an FDA approved test for monitoring
intermediate glycemic
control by measuring the levels of a monosaccharide 1,5-anhydroglucitol
(1,5- AG) in blood. Multiple published studies in peer-reviewed ...
Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients
... factors: age greater than or equal to 70, pre-existing
hematological disorder such as myelodysplastic syndrome (MDS), poor health
performance, or
intermediate or unfavorable cytogenetics. Patients also had
to be previously untreated and unlikely to benefit from conventional
induction chemotherapy (7+3 ...
Genomic Health Announces Results of Initial Studies to Develop Predictive Tests for Targeted Therapies
... in patients with hormone receptor positive disease
who had an Oncotype DX Recurrence Score(TM) result greater than 18 (i.e.,
who were classified as
intermediate risk of recurrence or above), a number
of candidate genes strongly predicted benefit from treatment with docetaxel
(Taxotere), a type of taxane ...
Sunesis Pharmaceuticals Initiates Phase 2 Clinical Trial of Voreloxin (SNS-595) in Acute Myeloid Leukemia
... patients must be at least age 60 with previously
untreated AML and satisfy at least one of the following factors: poor
performance status (PS 2);
intermediate or unfavorable cytogenetics; prior
antecedent hematologic disorder; or age greater than or equal to 70 years.
Patients enrolled in the trial will ...
AviaraDx Confirms That Combination of Two Molecular Biomarkers Improves Prediction of Disease Recurrence in Early Stage Breast Cancer Patients
... The clinical data published this month
demonstrate that Aviara MGI accurately identifies Grade 1 and 3 tumors, and
successfully re-classifies
intermediate tumor grade (Grade 2) into cases
with Grade 1-like or Grade 3-like outcomes.
"The importance of accurate tumor grading cannot be understated," ...
iCAD Announces Partnership for Initiating Clinical Testing of Its Virtual Colonoscopy CAD Product
... several national trials including the National CT
Colonography Trial that recently demonstrated that CTC is highly accurate
for the detection of
intermediate and large polyps and that the accuracy of
CTC is similar to colonoscopy.
About ACR Image Metrix
ACR Image Metrix is a subsidiary of the American ...
Phase II Study of Zevalin(R) Consolidation Following Fludarabine and Mitoxantrone Chemotherapy Results in 100 Percent Complete Remission Rate and 89 Percent Three-Year Progression Free Survival in Patients with Previously Untreated Non-Follicular Indolent
... (16 patients).
"This single arm, non-randomized phase II trial provides additional
insights into the potential utility of RIT in
intermediate grade NHL, a
subtype where CRs are infrequent with rituximab therapy," noted Jack W.
Singer, M.D., Chief Medical Officer of CTI.
The study results ...
10 Million Square Feet of Turf Set to be Treated in 2008 in Response to MRSA Outbreaks Nationwide
... the NFL's New England Patriots,
Minnesota Vikings, Cleveland Browns; the University of South Carolina and
University of Tulsa; and the entire Plano
intermediate School District in
Texas.
TurfAide made headlines in 2007 when the exclusive provider of
AstroTurf(R) USA, General Sports Venue, made the choice to ...
Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML
... factors: age greater than or equal to
70, prior hematological disorder such as myelodysplastic syndromes (MDS),
poor health performance, or
intermediate or unfavorable cytogenetics.
The primary endpoint is overall remission rate measured as either
complete remission or complete remission with ...
Patient Enrollment Complete in First Trial to Compare Physiologic Guidance vs. Angiographic Guidance of Stent Deployment in Patients with Multivessel Disease
... often in patients with
increasingly complex CAD, including multivessel disease," said Dr. De
Bruyne. "Furthermore, some physicians are stenting all
intermediate lesions
with DES regardless of the physiologic significance of those lesions. DES
are expensive and have been associated with potential late ...
Feeling Anxious or Distracted? New Research Shows a Cup of Tea Could Help
... tea flavonoids provide support for cardiovascular health
by promoting healthy endothelial function. In his studies, subjects were
given either low,
intermediate or high doses of tea flavonoids and then the
researchers measure endothelial dysfunction via flow-mediated dilation of
the brachial artery and ...
Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
... for combination therapy over monotherapy during the first 12 months
of treatment." CombAT Two-Year Results The findings reported today are
intermediate results from a study that
remains active. Researchers will issue a final report at the end of four
years regarding the efficacy of AVODART, ...
Callisto Reports on Second-Quarter 2007 Milestones
... Phase II clinical trial in neuroendocrine carcinoma is a
multiple-center, open-label study of the safety and efficacy of Atiprimod
in low to
intermediate grade neuroendocrine carcinoma patients. The trial,
designed to enroll 40 patients, presently has 29 patients on study, and
Callisto anticipates ...
Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
... for this Phase II clinical trial. The primary objective of the Phase II clinical trial is to evaluate
efficacy of Atiprimod in patients with low to
intermediate grade
neuroendocrine carcinoma who have metastatic or unresectable cancer and who
have progression of their disease despite standard therapy ...
Oncophage Cancer Vaccine Significantly Prolongs Recurrence-Free
Survival by 45 Percent in Patients With Intermediate-Risk Kidney
Cancer
... collection, showed that in a substantial
subset of patients (n = 362) at
intermediate risk for disease
recurrence, Oncophage demonstrated a clinically ... is defined by the Eastern Cooperative Oncology
Group (ECOG) as at
intermediate risk for disease recurrence*.
Although the median survival has not yet ...