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Remission in Medical Technology

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

... pixantrone had a significantly higher complete remission rate compared to the patients who received ... chemotherapy arm achieved a confirmed complete remission at this point. The ORR was also significantly ... we are seeing more patients convert to complete remission after the initial assessment period with ...

Data Demonstrated ACTEMRA(R) (tocilizumab) Significantly Inhibited Progression of Structural Joint Damage in Rheumatoid Arthritis Patients

... RA. In the one-year LITHE study, disease remission (DAS28(1) <2.6) was demonstrated in 30 percent ... RA from progressing further by achieving disease remission provides real-life benefits to patients, while at ... DAS28<2.6 corresponds to being in remission according to the criteria of the American College ...

New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease

... REMICADE More Likely to Maintain Steroid-Free remission in Patients Naive to Immunomodulators and ... REMICADE (infliximab) maintained steroid-free remission at one year, compared with patients receiving ... in patients maintaining steroid-free remission through one year." The SONIC clinical trial ...

Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment

... Panel Discussant Focuses on Longer Duration of remission among Patients Achieving a Complete remission with Pixantrone than Complete Remissions Achieved ... 25 patients (40%) achieved a confirmed complete remission ("CR"), ...

Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for Pixantrone

... showing significantly higher rate of complete remission and improvement in progression-free survival for ... is an important new treatment with impressive remission and progression-free survival data," said Dr. ... chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients. ...

Zevalin Consolidation in Patients With Complete Remission After Induction Therapy Results in Durable Remission of More Than 67 Months

... the Zevalin recipients that achieved a complete remission (CR) after induction therapy has not yet ... lymphoma who had achieved a partial remission (PR) or a complete remission / complete remission unconfirmed (CR/CRu) after receiving ...

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

... three weeks. Eleven patients achieved a complete remission (CR) or complete remission without full platelet recovery (CRp) for an overall remission rate of 38 percent. An additional 5 patients had ...

Cell Therapeutics' Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint

... Complete remission / Unconfirmed Complete remission Rate 3.5 Fold Higher Compared ... The trial was designed to examine the complete remission (CR) or ...

Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial

... primary endpoint for the study is the complete remission (CR) and unconfirmed complete remission (uCR) ... The trial was designed to examine the complete remission (CR) or unconfirmed complete remission (uCR) rate, time to tumor progression, and ...

ACTEMRA (R) (tocilizumab) Significantly Reduced Signs and Symptoms of Rheumatoid Arthritis in Patients Who Failed Prior Treatments

... all ACTEMRA (8 mg/kg) patients achieved disease remission (as defined by DAS28 <2.6(2)) and ACTEMRA ... and ACR70, respectively. Furthermore, disease remission (DAS28 <2.6) was demonstrated in 30 percent and 8 ... (3.2 5.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College ...

Landmark Study Demonstrates Potential of Radioimmunotherapy for Treatment of Indolent B-Cell Non-Hodgkin's Lymphoma

... tiuxetan) in consolidation therapy after remission induction in previously untreated patients with ... of whether patients were in partial remission (29.3 v 6.2 months p<0.0001 without Zevalin) or complete remission (53.9 v 29.5 months p=0.0154). Furthermore, ...

CIMZIA(R) (Certolizumab Pegol) Provides Long-Term Benefit Without Dose Escalation in Crohn's Disease Patients

... with CIMZIA, 72 percent of patients were in remission based upon responder analysis. These ... failing infliximab therapy achieved clinical remission within six weeks. Additionally, there were ... failing infliximab therapy achieved clinical remission at Week 6 as measured by the Crohn's ...

New Findings Show Efficacy of REMICADE(R) Compared With Azathioprine in Treatment of Crohn's Disease According to First-of-its Kind Study

... Therapy is More Likely to Induce Steroid-Free remission and Mucosal Healing Compared with Standard ... or as monotherapy, experienced steroid-free remission and mucosal healing compared with patients ... In addition to improved rates of steroid-free remission in patients receiving REMICADE, the data showed ...

CIMZIA(R) (certolizumab pegol) Reduces Intestinal Lesions and Induces Endoscopic Improvement in Crohn's Patients

... and more than 40 percent achieved endoscopic remission at Week 10 in data from a 54-week open-label ... in secondary endpoints, including endoscopic remission and response rates, histological CD score, clinical remission rate and decrease in C-reactive protein level, ...

CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

... on use of Zevalin as consolidation therapy after remission induction in previously untreated patients with ... tiuxetan) as consolidation therapy after remission induction in previously untreated patients with ... concluded that Zevalin consolidation of first remission in advanced stage follicular ...

Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients

... agent clofarabine exhibited a 45 percent overall remission rate based on investigator assessment, with ... response data show a 45 percent overall remission rate among patients treated with single ... with 40 percent of patients achieving a complete remission to therapy and 5 percent attaining a ...

Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission

... Three of Four HUMIRA Patients from CHARM Study in remission at One Year Maintained remission at Two Years ABBOTT PARK, Ill., May 21 ... (adalimumab) achieved long-term clinical remission and clinical response, respectively, according to ...

Cimzia(R) Provides Long-Term Efficacy with Stable Dosing in Crohn's Disease

... Crohn's disease. Data also showed continued remission amongst the majority of responders and the ... patients can achieve long-term symptom relief and remission regardless of the magnitude and rapidity of onset ... showed that eight out of ten patients who were in remission at six months ...

New Analysis Shows Efficacy of REMICADE(R) in Treatment of Ulcerative Colitis in Patients with Recent Disease Onset or Long-Standing Disease

... response. Significant improvements in disease remission and mucosal healing were also reported at weeks 8 ... significant improvements in clinical response, remission and mucosal healing, all goals of therapy in ... at least three years. Clinical response, clinical remission and mucosal healing rates at week 8 for the ...

Fludarabine, Mitoxantrone and Zevalin(R) Produces 96% Complete Remission Rate in First-Line Treatment of Patients with Follicular Non-Hodgkin's Lymphoma

... achieved 96 percent complete remission (CR), an estimated three-year progression-free ... of patients tested (5 of 23) achieved a molecular remission following chemotherapy. Zevalin consolidation induced a molecular remission in 14 of 18 patients (78 percent) tested who did ...

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

... and effective, producing a 100 percent complete remission at end of treatment with an estimated 89 percent of patients remaining in remission at three years. The study, conducted at the ... in 50 percent of patients achieving a complete remission (CR) and 30 percent achieving a ...

Genasense Plus Chemotherapy Is Associated With Prolonged Survival in Patients With Relapsed/Refractory CLL Who Achieve Complete Remission

... new data show that patients who achieved complete remission (the primary endpoint of the trial) with ... survival compared with patients whose complete remission was induced with chemotherapy alone. The data ... plus chemotherapy who achieved complete remission (CR, defined as complete plus nodular partial ...

Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML

... cytogenetics. The primary endpoint is overall remission rate measured as either complete remission or complete remission with incomplete platelet recovery. Secondary ...

New Analysis of Study Data Shows That Asacol(R) (Mesalamine) Delivers Rapid Symptom Relief for Ulcerative Colitis Patients

... based on stringent endpoint of clinical remission is more clinically relevant, beneficial to ... indicated that the median time to clinical remission was 26 days. A subgroup of patients with mild UC ... faster, in 14 days. Time to clinical remission was defined as the first day of three consecutive ...

New Analyses of Long-Term LIALDA(TM) (mesalamine) Data Presented at ACG

... is well-tolerated and effective at inducing remission in patients with active, mild to moderate UC. ... to review the efficacy of LIALDA for maintaining remission in patients with mild versus moderate ulcerative ... with moderate ulcerative colitis were in remission at 12 months. LIALDA for Maintenance ...

Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints

... including time-to-disease progression, complete remission rate, progression-free survival and ... including time-to-disease progression, complete remission rate, progression-free survival and overall ... survival, progression-free survival, complete remission rate and safety. Side effects of the ...

EpiCept Reports Regulatory Progress on Ceplene(TM)

... Application for AML remission Maintenance Therapy Advances on ... important clinical benefit in the maintenance of remission for patients with Acute Myeloid Leukemia (AML). ... goal of providing hematologists with the first remission maintenance immunotherapy for AML ...

Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets

... treatment of mildly to moderately active UC and for the maintenance of remission of UC. The recommended dosage for active UC is two 400 mg tablets TID, ... food, for a total daily dose of 2.4 g for 6 weeks. For the maintenance of remission of UC, the recommended dosage is 1.6 g/day in divided doses. Asacol ...

Acute Lymphoblastic Leukemia, the Most Common Childhood Cancer, Is Curable Without Preventive Cranial Radiation

... cells (so-called minimal residual disease) that were present after remission induction treatment. The measurement of minimal residual disease was used ... found that the 71 patients, in fact, had significantly better complete remission than the 56 patients who had been irradiated. "The bottom line is ...

Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial

... everolimus (RAD001) in poor-risk patients with DLBCL who achieved complete remission with first-line rituximab combined with chemotherapy. This worldwide study ... survival in patients with DLBCL. The longer a patient with DLBCL is in remission the higher their likelihood to remain disease-free. There is no approved ...

Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week

... Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC). Safety ... Safety Information Lialda tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and ...

Two-Year Data Reinforce Effect of ACTEMRA(R) (tocilizumab) in Inhibiting Progression of Joint Damage and Improving Physical Function in Rheumatoid Arthritis Patients

... that patients treated with ACTEMRA maintained consistently high disease remission rates according to DAS28 criteria, which measures disease activity in RA ... equal to 5.1) or high (DAS28>5.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College of Rheumatology. ...

St. Jude Finds More Than 100 Gene Variations Linked With Response to Leukemia Treatment

... (MRD). MRD is the small number of leukemic cells that survive after remission induction therapy -- the initial treatment. This measurement helps ... might be cured with milder and less-toxic treatment, and also shows if remission induction therapy will likely fail. The researchers performed a ...

Arzerra(TM) (ofatumumab) Demonstrates High Response Rates in Patients With Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL)

... 47 percent for the BFR group (n=79); all responding patients had a partial remission (PR**) except for one patient with a complete remission (CR***).(1) Median overall survival was 13.7 months for the DR group and ...

Sunesis Pharmaceuticals Presents Clinical Trial Data of Voreloxin in Patients with Acute Myeloid Leukemia and Ovarian Cancer at the Chemotherapy Foundation Symposium

... patients in the first three cohorts, 3 patients have achieved a complete remission (one at 20 mg/m2 of voreloxin and two at 34 mg/m2 of voreloxin). Six patients were enrolled in cohort 4 (50 mg/m2 of voreloxin) and one had complete remission and one had a complete remission without full platelet recovery. A copy ...

New Study Demonstrated ACTEMRA(R) (tocilizumab) Inhibited Progression of Joint Damage in Rheumatoid Arthritis Patients

... the control group achieved ACR20, ACR50 and ACR70, respectively. Disease remission (DAS28 <2.6)(3) was demonstrated in 47 percent and 30 percent of patients ... or equal to 3.2), moderate (3.2 5.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College of Rheumatology. (4) ...

New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients

... results showed a significant survival benefit and a 30 percent complete remission (CR) rate with VELCADE, melphalan and prednisone (VcMP) compared to 4 ... melphalan and prednisone leads to a survival benefit and a high complete remission in previously untreated patients with multiple myeloma," said Professor ...

Sunesis Pharmaceuticals Presents Data from Clinical Trials of Voreloxin (formerly SNS-595) in Patients with Acute Myeloid Leukemia at the 13th Congress of the European Hematology Association

... four age 60 or older and two younger than age 60, achieved complete remission (CR) or complete remission without platelet recovery (CRp) or complete remission with incomplete recovery of hematopoeitic elements (CRi) when voreloxin ...

VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma

... adriamycin and dexamethasone (VAD). Results showed high complete remission (CR) rates of 19 percent in the VcD arm as induction therapy and 35 ... demonstrate the ability of VELCADE to deliver consistently high complete remission rates that lead to improved clinical benefit, including survival," said ...

Sunesis Pharmaceuticals Initiates Phase 2 Clinical Trial of Voreloxin (SNS-595) in Acute Myeloid Leukemia

... as a single agent, measured as either complete remission (CR) or complete remission without full platelet recovery (CRp). The study will also measure the ... five percent, and five of those 13 achieved either CR, CRp or complete remission with incomplete recovery of normal hematopoietic blood elements. Voreloxin ...
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