Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)
... Food and Drug Administration (FDA) has issued a complete
Response Letter regarding the New Drug ... )
Response Letter raises issues regarding the ... Acura and King are currently evaluating the FDA's complete
Response Letter, and at this stage believe they ...
Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th
... period, pixantrone had a significantly higher complete
remission rate compared to the patients who ... standard chemotherapy arm achieved a confirmed complete
remission at this point. The ORR was also ... that we are seeing more patients convert to complete
remission after the initial assessment period ...
VivoMetrics(R) Introduces Next Generation LifeShirt Prototype, a Smart Garment That Delivers Real-time Vital Signs Remotely to Healthcare Providers
... monitoring (RPM), announced today the first complete
prototype of their next generation LifeShirt for ... care providers. The system also provides a more complete
understanding of patient health status by ... in relation to one another, create the most complete
remote picture of a patient's well being ...
Enrollment in Delcath's Pivotal Phase III Metastatic Melanoma Clinical Trial Achieves Seventy-Five Percent Accrual
... patients and the Company remains on target to complete
enrollment this year.
(Logo: ... Safety Monitoring Board for evaluation once we complete
the collection of follow-up data on the recently ... relating to our ability to successfully complete
Phase III clinical trials and secure regulatory ...
Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial
... 33% overall response rate (ORR) is defined as complete
or partial tumor shrinkage (95% confidence ... in poor-risk patients with DLBCL who achieved complete
remission with first-line rituximab combined with ... of patients who will relapse after achieving a complete
response on initial treatment, demonstrating an ...
Definitive Outcomes of Radiofrequency Ablation for Barrett's Esophagus Using the HALO Ablation System Reported at the Digestive Disease Week Meeting for Gastroenterologists and Esophageal Surgeons
... sham-controlled trial demonstrating high rates of complete
eradication of Barrett's and dysplasia in the ... that had baseline evidence of dysplasia, 100% had complete
eradication of all signs of dysplasia. These ... system. While both interventions had very high complete
eradication rates (95-100%), endoscopic resection ...
Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment
... Duration of Remission among Patients Achieving a complete
Remission with Pixantrone than complete
Remissions Achieved with Standard Chemotherapy
... of these 25 patients (40%) achieved a confirmed complete
remission ("CR"), unconfirmed remission ("CRu") ...
Catalyst Pharmaceutical Partners Announces Top-Line Results of CPP-109 Phase II Trial for Cocaine Addiction
... any unexpected "serious" adverse events.
analyses of the clinical trial data (secondary ... for cocaine addiction. Catalyst expects to complete
the analyses during the third quarter after fully ... previously reported, we have sufficient cash to complete
the analysis of the results from our cocaine ...
Poniard Pharmaceuticals Announces Progression-Free Survival Data From Phase 2 Clinical Trial of Picoplatin in Metastatic Colorectal Cancer
... 75 percent achieved disease control (defined as complete
response, partial response or stable disease); two patients with a complete
response, nine patients with a partial response ... achieved disease control; three patients with a complete
response, 11 patients with a partial response and ...
BioVex to Report Phase I/II Clinical Trial Results for the Front Line Treatment of Head and Neck Cancer With OncoVEX GM-CSF at the 2009 American Society of Clinical Oncology Meeting
... With respect to efficacy, 94% of patients had a complete
pathological response noted at surgery, with five patients achieving a complete
response after only 2 or 3 viral doses. No ... generation of an unprecedented number of durable complete
remissions in a Phase II study using OncoVEX ...
Corgenix, Tulane Announce Award of NIH Grant Extending Hemorrhagic Fever Virus Product Development Program
... will enable us to further develop the assays, complete
the clinical studies and achieve full ... will conduct a five-year study designed to complete
the tests for VHFs, some of which are potential ... defense. Now, under the new NIH award, we will complete
the development and move to commercialization of ...
Cardium Announces Completion of Patient Recruitment in Phase 2b Clinical Trial of Excellarate(TM) for the Potential Treatment of Diabetic Foot Ulcers
... the study. The primary endpoint of the study is complete
wound closure at or before the initial 12-week ... Other key efficacy endpoints include time to complete
wound closure, absolute and percent change in ... Food and Drug Administration (FDA) to review the complete
safety and efficacy database from this Phase 2b ...
Glycotex' Investigational Compound GLYC-101 Achieves Accelerated Wound Closure Based on Interim Analysis
... the effect of investigational GLYC-101 gel on complete
wound closure and cosmetic outcomes in cosmetic ... with respect to the primary endpoint (time to complete
wound closure) shows positive results when ... primary efficacy endpoint of the study is time to complete
wound healing, and the secondary efficacy point ...
Studies Show Combination Laser Therapy Effective At Clearing Acne, Reducing Oil Production
... in the ALA PDT treatment group experienced complete
clearance of their acne. She reported that an ... energy alone or conventional therapy achieved complete
clearance of their acne.
"The ... therapy to be the first such treatment to achieve complete
clearance of acne up to 13 months post treatment ...
Hana Biosciences Announces New Positive Interim Efficacy Results in Pivotal rALLy Clinical Trial of Marqibo in Acute Lymphoblastic Leukemia
... - 31% complete
- MEDIAN SURVIVAL OF 10.5 MONTHS IN complete
- FINAL DATA TARGETED FOR 2009 ... of the first 29 evaluable subjects achieved a complete
response (CR) or CR without full blood count ...
Hana Biosciences Announces Successful Planned Independent Safety Analysis Supports Ability to Complete Pivotal rALLy Clinical Trial of Marqibo, Its Lead Novel Anti-Cancer Compound
... evaluable patients. Recruitment is on target to complete
mid-2009. Results of the Company's planned ... Society of Hematology Annual
Meeting for a complete
data presentation and look forward to submitting ... that Hana will have
sufficient capital to complete
the development of Marqibo, that the ...
Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for Pixantrone
... results showing significantly higher rate of complete
remission and improvement in progression-free ... years later some of our patients are still in complete
response. These positive results have been ... achieved a high rate of confirmed and unconfirmed complete
remissions compared to patients treated with ...
Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkin's Lymphoma Trial
... higher rate of confirmed
(CR) and unconfirmed complete
remissions (CRu) compared to patients ... chemotherapy arm achieving a confirmed complete
Additionally, pixantrone treatment ... physician. The
trial was designed to examine the complete
remission or unconfirmed complete
remission rate, ...
Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission
... achieved a high rate of
confirmed and unconfirmed complete
remissions compared to patients treated
with ... chemotherapy arm achieved a confirmed complete
remission compared to
8/70 (11%) of pixantrone ... including, without
limitation, the results of complete
safety information, the ability of the
company to ...
Chemoembolization Improving as Liver Cancer Treatment
... blood vessel feeders, the better the chance for a complete
Improvements in Chemoembolization
... in 27 of the patients (51 percent) showed a complete
response, 18 (34 percent) showed a partial ... months later 19 of 34 patients (55.9 percent) had complete
tumor response, eight (23.5 percent) had a ...
ASGE Urges Patients to Seek a Qualified Endoscopist Before Undergoing a Colonoscopy for Colorectal Cancer
... to have undergone any attempted colonoscopy or complete
colonoscopy was strongly associated with fewer ...
"Bowel prep and withdrawal time are key to a complete
and thorough colonoscopy. Experts in ...
Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia
... (Ph+ CML) in early chronic phase achieved a complete
cytogenetic response (CCyR) after six months of ... 3/4 neutropenia, thrombocytopenia, and anemia. complete
blood counts should be performed every 2 weeks ... adverse reactions in 2.4% to 5% of patients. complete
blood counts should be performed weekly for the ...
Prolonged Progression-Free Survival Demonstrated by VELCADE(R) (Bortezomib) for Injection Based Induction Regimens in Transplant-Eligible Previously Untreated Multiple Myeloma Patients
... to deliver high response rates,
responses," said Nancy Simonian, M.D., Chief ... in the VAD arm (p=0.0115).
-- Post-induction complete
response (CR)/near complete
rates were 15 percent in ...
Dacogen(R) (decitabine for injection) Data Presented on a Phase II Clinical Trial in Elderly Patients with Acute Myeloid Leukemia (AML)
Data from the Phase II study reported a complete
response rate of 24 percent. A complete
response designation requires that the patient ... Phase II trial was to establish the morphologic complete
response (CR) rate. Dacogen(R) was administered ...
Sunesis Pharmaceuticals Announces Presentation of Voreloxin Clinical Data in Patients with Acute Myeloid Leukemia at the 50th Annual Meeting of the American Society of Hematology
... agent Phase 2 trial show that voreloxin induces complete
remissions in poor risk frontline elderly AML ... for three weeks. Eleven patients achieved a complete
remission (CR) or complete
remission without full platelet recovery (CRp) ...
Alfacell Provides ONCONASE(R) NDA Submission Update
... The pre-NDA meeting is an important step to complete
prior to the planned submission of the final ... company intends to seek the FDA's permission to complete
the submission of the rolling NDA at the pre-NDA ... that the FDA will not allow the company to complete
the submission of its NDA.
ISTA Pharmaceuticals Announces Phase III Results for Once-Daily Topical Xibrom(TM) 0.09%
... a confirmatory Phase III trial that it expects to complete
According ... post surgery, and the proportion of patients with complete
absence of ocular inflammation was assessed on ... Phase III trial for Xibrom and expecting to complete
such trial in 2009, ISTA's expectation of ...
Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab)
In September, Roche received a complete
response letter from the FDA for the ACTEMRA BLA. ... requirements, and we anticipate submitting the complete
response for ACTEMRA to the Agency in the third ... two-year study, which is expected to report complete
data evaluating the effects of ACTEMRA on the ...
Celator(R) Pharmaceuticals Announces Enrollment of First Patient in Phase 2 Study with CPX-351
... patients. The primary endpoint of the study is complete
remission rate. Secondary endpoints are duration of complete
remission, time to treatment failure, survival at ...
Interim Phase 1 data with CPX-351, where complete
remissions were obtained in patients with ...
Cell Therapeutics' Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint
Remission / Unconfirmed complete
Remission Rate 3.5 Fold Higher ... achieved a high rate of
confirmed and unconfirmed complete
remissions compared to patients treated
Cadence Pharmaceuticals Reports Third Quarter 2008 Financial Results and Provides Clinical Development Programs Update
... in two of the three clinical trials remaining
our clinical development program for Acetavance ... in the final clinical trial required to complete
Acetavance clinical development program, ... and the timeframes in
which Cadence expects to complete
and announce the results of clinical
trials of ...
Sunesis Pharmaceuticals Presents Clinical Trial Data of Voreloxin in Patients with Acute Myeloid Leukemia and Ovarian Cancer at the Chemotherapy Foundation Symposium
... first three cohorts, 3 patients have
achieved a complete
remission (one at 20 mg/m2 of voreloxin and two ... in cohort 4 (50 mg/m2 of
voreloxin) and one had complete
remission and one had a complete
without full platelet recovery.
Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial
... closed. The primary endpoint for the
study is the complete
remission (CR) and unconfirmed complete
(uCR) rate in patients receiving either ... physician. The trial was designed to examine
remission (CR) or ...
Landmark Study Demonstrates Potential of Radioimmunotherapy for Treatment of Indolent B-Cell Non-Hodgkin's Lymphoma
... lymphoma who had
achieved a partial response or a complete
response after receiving a
variety of first-line ... (29.3 v 6.2 months
p<0.0001 without Zevalin) or complete
remission (53.9 v 29.5 months
p=0.0154). ... partial remission (PR) after induction
therapy to complete
SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibuprofen
... reported, the Company will also be
required to complete
a label comprehension and consumer use study ... to successfully develop
new formulations and complete
research and development, including
pre-clinical ... trials are not successful
or take longer to complete
than we expect, we may not be able to develop
Complete Genomics and the Institute for Systems Biology Announce Partnership to Conduct the First Human Genome Population Study
... genome studies.
In phase one of the project, complete
Genomics will use its proprietary
DNA sequencing ... in 2009 and 2,000 individuals in 2010.
Genomics' human genome sequencing services to ... Dr. Leroy Hood, president of ISB and member
Genomics' Scientific Advisory Board.
Despite Advances in the Accuracy of CT Colonography in Detecting Polyps, Digestive Health Experts Urge Patients to Consider Risks and Realities
... abdomen: the potential need for follow-up
colonoscopy in many cases, the real risk of ... screened by CTC would have
to be referred for complete
colonoscopy depending on the size threshold ... CT colonography
in this study were referred for complete
colonoscopy-referral rate would ...
F.D.A. Approves SANCUSO(R), the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy
... with my daily activities,
and I was able to complete
my cancer treatment without feeling nauseous ... met its primary endpoint of achieving complete
control of CINV, working
as well as oral granisetron. complete
control was defined as no vomiting
Human Genome Sciences Reports Initial Results of Randomized Phase 2 Trial of HGS-ETR1 in Combination With Bortezomib in Advanced Multiple Myeloma
... including the following findings:
-- Three complete
responses (8.3%; N=36) were observed among ... of bortezomib and
mapatumumab at 20 mg/kg, vs. no complete
responses in the group receiving
bortezomib ... the
treatment group receiving bortezomib alone (0 complete
and 18 partial). The
response rate observed for ...
New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients
... survival benefit as well as a 30 percent complete
CAMBRIDGE, Mass., Aug. 27 ... a significant survival
benefit and a 30 percent complete
remission (CR) rate with VELCADE,
melphalan and ... leads to a survival benefit and a high complete
previously untreated patients with ...