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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 ... ) The complete 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. complete 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 RESPONSE RATE - MEDIAN SURVIVAL OF 10.5 MONTHS IN complete RESPONDERS - 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 in 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 remission. 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 cure." 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. 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, including complete responses," said Nancy Simonian, M.D., Chief ... in the VAD arm (p=0.0115). -- Post-induction complete response (CR)/near complete response (nCR) 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. About ...

ISTA Pharmaceuticals Announces Phase III Results for Once-Daily Topical Xibrom(TM) 0.09%

... a confirmatory Phase III trial that it expects to complete in 2009. Study Design 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)

... ACTEMRA. 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

... complete Remission / Unconfirmed complete Remission Rate 3.5 Fold Higher ... achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with ...

Cadence Pharmaceuticals Reports Third Quarter 2008 Financial Results and Provides Clinical Development Programs Update

... in two of the three clinical trials remaining to complete our clinical development program for Acetavance ... in the final clinical trial required to complete our 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 remission without full platelet recovery. A ...

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 remission (uCR) rate in patients receiving either ... physician. The trial was designed to examine the complete 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 remission ...

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 and ...

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. "Using complete Genomics' human genome sequencing services to ... Dr. Leroy Hood, president of ISB and member of complete Genomics' Scientific Advisory Board. "This ...

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 with complete 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, the 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 and/or ...

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 response - 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 remission in previously untreated patients with ...
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