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Endpoints in Medical Technology

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

SOUTH SAN FRANCISCO, Calif., July 23 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL ) today announced that in the TASKi3 Phase 2b clinical trial in rheumatoid arthritis (RA) patients who had failed to respond to at least one biologic treatment, the group treat...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

- Late-Breaking Data from Pivotal BLOOM Trial Presented at the American Diabetes Association's 69th Scientific Sessions Expand on Previously Announced Positive Top-Line Results - NEW ORLEANS, June 6, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA ) announced today...

Isolagen, Inc. Reports Positive Top-line Results from Phase II/III Study of Isolagen Therapy(TM) to Treat Moderate to Severe Acne Scars: Study Meets All Primary Efficacy Endpoints and is Statistically Significant

-Company Provides Update on Cash Position- -Biologics License Application for Wrinkles/Nasolabial Folds Indication Expected To Be Filed Within Two Weeks- EXTON, Pa., March 5 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE ) announced today positive top-line efficacy results ...

Abbott's XIENCE V(TM) Drug Eluting Stent Outperforms TAXUS(R) in Key Efficacy and Safety Endpoints Out to Two Years

New Analysis of SPIRIT II and SPIRIT III Data Confirms Patients Treated with XIENCE V Are at Lower Risk of Experiencing Death, a Heart Attack or a Repeat Procedure Compared to TAXUS(R) at Two Years WASHINGTON, Oct. 13 /PRNewswire-FirstCall/ -- Data from an independent meta-analysis ...

NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect

PARIS, September 15 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced successful top-line results from the second phase 3 study for naproxcinod in 1020 patients with osteoarthritis of the knee (the 302 study). Both doses of naproxcinod (750 mg and 375 mg bid) met the t...

Agile Therapeutics Achieves Phase 2 Study Endpoints in Key Clinical Trials with New, Innovative Low-Dose Contraceptive Patch

Company to Discuss Phase 3 Plans with FDA PRINCETON, N.J., Sept. 3 /PRNewswire/ -- Agile Therapeutics, Inc., announced today that it successfully completed two key clinical trials in the development of the company's new, innovative low-dose, once-weekly, contraceptive patch, whi...

Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant

Investor Conference Call to be held on Wednesday, August 6, 2008 at 8:00 a.m. EXTON, Pa., Aug. 5 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE) announced today positive top-line efficacy and safety results from two pivotal, Phase III clinical studies ...

Data Presented at American Headache Society's Annual Scientific Meeting Show Primary Endpoint Met as Well as Improvement on Important Secondary Endpoints in Phase IIb Acute Migraine Trial of TorreyPines Therapeutics' Tezampanel

Company's End-of-Phase II Meeting with FDA Set for Sept. 29 LA JOLLA, Calif., June 30 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX ) today announced that data presented at the 50th Annual Scientific Meeting of the American Headache Society showed that, in addition to mee...

Phase III Study of Abbott's Investigational TriLipix(TM) in Combination With AstraZeneca's CRESTOR(R) Meets Primary Endpoints on Key Lipids

Data Show TriLipix (ABT-335) in Combination with CRESTOR (rosuvastatin calcium) Improved LDL, HDL and Triglycerides and Had Reported Safety Consistent with Monotherapies SEATTLE, May 31 /PRNewswire-FirstCall/ -- New Phase III data showed that in patients with multiple lip...

Abbott's Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL

TriLipix in Combination With Statins Improved All Three Key Lipids and Had Reported Safety Consistent With TriLipix or Statin Monotherapies CHICAGO, March 31 /PRNewswire-FirstCall/ -- New data from two Phase III studies show that in patients with multiple lipid problems, Abbott's ABT-335 com...

Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of Pneumonia

- Trial CL-05 Results Showed Cethromycin had 94.0% Clinical Cure Rate Compared to 93.8% Clinical Cure Rate for Biaxin(R), a Current Standard of Care Treatment - - Trial CL-05 and Trial CL-06 to Form the Core of New Drug Application - CHICAGO, Nov. 15 /PRNewswire-...

A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females

REHOVOT, Israel, Nov. 6 /PRNewswire/ -- Meditor Pharmaceuticals Ltd. announced today that the primary end point and safety evaluation in the Phase II, Randomized Double Blind, Placebo-Controlled Dose-Escalating Study in Migraine patients was successfully completed. This event marks a major mil...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

Preliminary top-line results of second Phase III study show highly significant decreases in pain and fatigue and improved daily function in fibromyalgia patients and confirm results from the first Phase III study PALO ALTO, Calif., and BRUSSELS, June 24 /PRNewswire-FirstCall/ -- press releas...

MAP Pharmaceuticals Announces Phase 3 Study of Unit Dose Budesonide in Children With Asthma Did Not Meet Primary Endpoints

MOUNTAIN VIEW, Calif., Feb. 23 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ) announced today results of its initial Phase 3 clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma. The Company announced that the clinical trial d...

AstraZeneca's Partner, MAP Pharmaceuticals, Announces Phase 3 Study of Unit Dose Budesonide in Children with Asthma Did Not Meet Primary Endpoints

LONDON, Feb. 23 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. announced today that its initial Phase 3 clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma did not meet its co-primary endpoints: asthma control as assessed by changes from baseline i...

Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints

SKOKIE, Ill., Dec. 2 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that two pivotal Phase 3 trials evaluating its lead investigational product candidate, HZT-501, met all primary endpoints. HZT-501, a novel, proprietary fixed-dose combinati...

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

- Millennium on track to file sNDA in first quarter 2008 - CAMBRIDGE, Mass., Sept. 18 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM ) today announced that the interim analysis results of the large, international Phase III VISTA(1) trial in patients with newly...

Acuity One-Year Findings Meet All Primary Endpoints in Favor of Angiomax (Bivalirudin) Alone Treatment Group

Major Bleeding in Patients Treated for Acute Coronary Syndromes (ACS) Nearly Triples the Risk of Death at One Year NEW ORLEANS, March 26, 2007 /PRNewswire/ -- One-year findings from the landmark ACUITY trial show that acute coronary syndrome (ACS) patients in the "Angiomax(R) (bivalirudin) alone" ...

Randomized Phase III Trial Showed Erbitux Significantly Improved Secondary Endpoints of Progression-Free Survival and Disease Control in Metastatic Colorectal Cancer Patients

- As previously announced, primary endpoint not met; plausibly confounded by survival benefit of post-study treatment with ERBITUX - NEW YORK, April 16, 2007 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated and Bristol-Myers Squibb Company today announced detailed results from the EPIC study...

GlaxoSmithKline’s Hib-MenCY-TT Combination Vaccine Meets Phase II Study Endpoints of Immunogenicity and Safety Compared to Licensed Vaccines

Investigational vaccine could offer protection for infants against Haemophilus influenzae type b and meningococcal disease TORONTO, Canada, May 11, 2007 — GlaxoSmithKline (GSK) announced results from a Phase II vaccine clinical study presented this week at the Pediatric Ac...

Medivation's Dimebon Maintains Statistically Significant Benefit on All Five Efficacy Endpoints in Alzheimer's Disease Trial After One Year of Therapy

- Aggregate Benefit over Placebo Larger at One Year than at Six Months - SAN FRANCISCO and WASHINGTON, June 11, 2007 /PRNewswire-FirstCall/ -- Medivation, Inc. today announced that the benefits of Dimebon over placebo in its double-blind, placebo-controlled Phase 2 study in mild-to- moderate Alzhe...

Ceragenix Announces Results from Phase IV Study of EpiCeram Meet All Primary and Secondary Endpoints

DENVER--(BUSINESS WIRE)--Apr 24, 2007 - Ceragenix Pharmaceuticals Inc. (OTCBB:CGXP) today announced positive results from its post-clearance marketing study comparing EpiCeram's(TM) efficacy to that of Cutivate(R) cream, a mid-strength topical steroid in the treatment of moderate-to-severe atopic d...

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

...FOLFOX4 once every two weeks (Q2W) or FOLFOX4 alone Q2W. The primary endpoint of the study is progression-free survival by KRAS status and secondary endpoints include overall survival, objective response rate, time to progression, duration of response and safety. Long-term follow up for overall survival is o...

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

...of treatment with mipomersen versus 3% for placebo and all of its secondary endpoints in a highly statistically significant manner. We are very pleased with the...% for placebo (p<0.001). The study also met each of its three secondary endpoints of reduction in apoB, total cholesterol and non-HDL-C. Genzyme cont...

Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

...he study. Treatment was randomized to Forteo(R) or one of three doses of BA058 (20, 40, or 80 micrograms), or matching placebo. The study's co-primary endpoints were change from baseline in lumbar spine BMD and changes in anabolic bone markers. BMD is a measurement of mineralized bone tissue used to diagnose o...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

...SREs, caused by the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases studies use a composite endpoint of four S...st and prostate cancer) or multiple myeloma and bone metastases. Secondary endpoints were to evaluate if denosumab is superior to Zometa with respect to the fir...

Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

...rogressive multiple sclerosis (SPMS). In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study. The data also showed that dirucotide was generally well tolerated. There were no unexpected safety or tolerability issues. The mo...

Unlikely Treatment Identified by BrainCells Neurogenesis Platform Improved Clinical Outcomes in Patients Suffering From Depression

...7), buspirone (n=34) or placebo (n=33). Co-primary endpoints were the Clinical Global Impression-Improvement (C... Depressive Symptomatology (QIDS SR-16). Secondary endpoints included the CGI-S, IDSC30 and HAMA. The data pres...52 also demonstrated improvements on the secondary endpoints of the IDSC30, HAMA and CGI-S. These improvements ...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

... variable dose determined by patient blood sugar levels. There was no lead-in or wash-out period. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes. Subj...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... were consistent with the overall improvement shown for the primary endpoint. -- Results for prespecified major secondary efficacy endpoints were: -- A significantly greater percentage of patients receiving belimumab achieved a reduction in SELENA SLEDAI score of at ...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

...th single and multiple doses were generally safe and well-tolerated in these trials. Further analyses of the study data, including secondary efficacy endpoints and detailed safety is underway. Additional data will be submitted for presentation at an upcoming medical meeting. "The clinical outcomes ...

Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)

...points, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologic...n (BLA). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This trial received Fast Track designation by the FDA last ye...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... for the study was the percent of patients assigned to the R788 100 mg bid dose who were ACR 20 responders at the end of 6 months. Secondary efficacy endpoints included a comparison of response rates for the R788 100 mg bid and R788 150 mg qd doses at the ACR 20, ACR 50 and ACR 70 scores, as well as Disease A...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

...vanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zom...are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases studies use a com...anced breast cancer and bone metastases. Secondary endpoints were to evaluate if denosumab was superior to Zome...

AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain

... Study in major abdominal surgery patients achieved primary and secondary endpoints REDWOOD CITY, Calif., June 29 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced positive results from the second Phase 2 clinical stud...

Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237

...point of the study will be the change from baseline in FEV1 (forced expiratory volume in one second) over 12 weeks of treatment. A number of secondary endpoints will also be evaluated. NVA237 was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Novartis intends to laun...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

...The primary endpoint will be the change in the amount of kidney interstitial capillary GL-3 as measured in kidney biopsies using histology. Secondary endpoints will include safety and tolerability, kidney GL-3 as measured in urine, and an assessment of renal function (including glomerular filtration rate (GFR...

MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes

...es. The primary composite endpoint for PROTEGE includes both the patient's total daily insulin usage and his/her HbA1c levels at 12 months. Secondary endpoints are evaluated at 24 months. Longer term safety and efficacy data from patients who complete the PROTEGE trial are being collected in a separate Phase ...

Published Study Shows VNUS ClosureFAST(TM) System Significantly Superior to Laser for Varicose Vein Treatment

...ocedures in 69 patients, comparing the ClosureFAST radiofrequency catheter to the 980 nm endovenous laser system. The study found that for all primary endpoints in the trial, the ClosureFAST radiofrequency catheter was statistically superior to laser treatment in providing a fast and comfortable recovery for t...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

...l trial, namely median time-to-treatment failure through Day 50 (p-value 0.1177), orBec(R) did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005) and the median time to treatment failure through D...
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