Endpoint in Medical Technology

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

INDIANAPOLIS and EDMONTON, Alberta, July 27 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ) and BioMS Medical Corp. (TSX: MS) today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (...

Micromet's Blinatumomab Achieves Primary Endpoint in Phase 2 Study with Acute Lymphoblastic Leukemia Patients

German Multicenter ALL Study Group Presented Data at the 14th Congress of the European Hematology Association Showing High Response Rate in Patients with Minimal Residual Disease BERLIN, June 8 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI ), a biopharmaceutical company developing ...

Essentialis Meets Primary Endpoint in Phase 2b Trial of DCCR for Treatment of Hypertriglyceridemia and is Granted Extensive Patent Coverage in the US

CARLSBAD, Calif., May 17 /PRNewswire/ -- Essentialis Inc, a clinical stage pharmaceutical company, announced today that it met its primary endpoint of statistically significant triglyceride reduction in a 90-patient Phase 2b trial of DCCR in dyslipidemic patients. The study encompassed both patien...

Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis

Top-line data indicate statistically significant improvement in ACR20 responses over placebo PRINCETON, N.J., May 14 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX ) today announced that the MDX-1100 Phase 2 proof-of-concept trial in patients with active rheumatoid arthritis (RA) rec...

Anthera's Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome

- Favorable results for secondary endpoints support outcomes benefit HAYWARD, Calif., May 6 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that FRANCIS (Fewer Recurrent Acute coronary events ...

Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study

A Phase II Study Published in The Lancet of Fast-Tracked Antiplatelet Agent Showed No Increase in TIMI Major and Minor Bleeding and was Well Tolerated When Given With Standard Platelet Therapy KENILWORTH, N.J., March 12 /PRNewswire-FirstCall/ -- Results of a Schering-Plough Corporation (NYSE:...

VirtualScopics' Quantitative Imaging Provides Primary Endpoint in Cartilage Repair Pivotal Clinical Trial

Pioneering study uses quantitative imaging endpoints from MRI analyses ROCHESTER, N.Y., March 12 /PRNewswire-FirstCall/ -- VirtualScopics, Inc. (Nasdaq: VSCP ), a leading provider of quantitative imaging for clinical trials, today announced that BioSyntech Inc., a Canadian medical device co...

Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial

MOUNTAIN VIEW, Calif., Dec. 9 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) today announced positive results from its second Phase 3 clinical trial of AZ-004 (Staccato(R) loxapine). This Phase 3 clinical trial was conducted in patients with bipolar disorder experiencing...

TorreyPines Therapeutics Muscarinic Agonist NGX267 Meets Primary Endpoint in a Phase II Clinical Trial in Patients with Xerostomia

LA JOLLA, Calif., Dec. 2 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX ) today announced positive results from a 26 patient Phase II trial evaluating three doses of NGX267 as a treatment for xerostomia, or dry mouth, in patients with Sjogren's syndrome. NGX267 met the primary end...

Schering-Plough Reports Preladenant Meets Primary Endpoint in Phase II Dose-Finding Trial for Parkinson's Disease

KENILWORTH, N.J., Nov. 24 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today reported that preladenant, its novel and selective adenosine2a receptor antagonist, met the primary endpoint in a Phase II dose-finding trial in patients suffering from moderate to severe Parkinson...

Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients

Conference Call Scheduled for Today - Tuesday, September 2, 2008 at 5:00 p.m. Eastern Time MOUNTAIN VIEW, Calif., Sept. 2 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) today announced positive results from its first Phase 3 clinical trial of ...

Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial

- Product appears safe with no dose-limiting toxicities - - Chemophase dose for pivotal trials successfully determined - - Halozyme to seek input from regulatory authorities in order to advance into pivotal clinical program in 2009 - SAN DIEGO, June 30 /PRNewswire-F...

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...

Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytren's Contracture

XIAFLEX also Meets Primary Endpoint (p III Study Pharmacokinetic Study Demonstrates Lack of Systemic Exposure of XIAFLEX Serious Adverse Events Occurring at a 0.33% Rate per XIAFLEX injection Conference call scheduled for today, June 3, at 8:45 a.m. Eastern T...

Alexza's AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache

Initial Analysis Shows Statistically Significant Pain Relief with the 2.5 and 5 mg Doses Compared to Placebo MOUNTAIN VIEW, Calif., March 3 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today positive top-line results from its 168 patient Ph...

Primary Endpoint of Pivotal Phase III Clinical Trial Achieved for Remoxy(TM)

CUPERTINO, Calif., Dec. 6 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX ) announced today that the pivotal Phase III trial for Remoxy had successfully met its primary endpoint (p<0.01) that was prospectively defined by the U.S. Food and Drug Administration (FDA) during the Specia...

CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary Angioedema

KING OF PRUSSIA, Pa., Nov. 26 /PRNewswire/ -- CSL Behring announced today that it has reached the primary endpoint of a Phase III clinical trial of human pasteurized C1-inhibitor (C1-INH) concentrate to treat patients with hereditary angioedema (HAE), a rare genetic disorder that can lead to p...

ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study

SAN DIEGO, Nov. 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX ) today announced positive results from its marketing-enabling clinical study of ANX-530 (vinorelbine emulsion). Pharmacokinetic equivalence, the primary endpoint of the study, was observed between ANX-530 ...

Tezampanel Meets Primary Endpoint in Phase IIb Clinical Trial in Acute Migraine Headache

- Company Plans to Move Compound Forward into Phase III - - Conference Call Scheduled for Today at 9:00 A.M., Eastern Time - LA JOLLA, Calif., Oct. 22 /PRNewswire-FirstCall/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX ) today announced that tezampanel met the primary endpoint in ...

Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults

Company Plans to File Supplemental New Drug Application with FDA in First Quarter 2008 SOUTH SAN FRANCISCO, Calif., Oct. 16 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV ) today announced positive top-line results from its pivotal Phase 3 trial. The multi-c...

ERBITUX(R) Meets Primary Endpoint of Increasing Survival in Phase III Lung Cancer Study

NEW YORK, Sept. 11 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated (Nasdaq: IMCL ) and Bristol-Myers Squibb Company (NYSE: BMY ) today announced that a Phase III study of ERBITUX(R) (Cetuximab) in combination with platinum-based chemotherapy (vinorelbine plus cisplatin) met its primar...

MADIT-CRT Trial Meets Primary Endpoint

Landmark trial shows Boston Scientific CRT-Ds slow the progression of heart failure in asymptomatic and mildly symptomatic patients NATICK, Mass., June 23 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) and the University of Rochester Medical Center today announced th...

Phase 3 Trial of Nexavar in Chemotherapy-Naive Patients with Advanced Melanoma Does Not Meet Primary Endpoint

WAYNE, N.J. and EMERYVILLE, Calif., April 27 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX ) today announced that a Phase 3 trial evaluating Nexavar(R) (sorafenib) tablets in patients with unresectable stage III or stage IV melanoma was s...

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

Complete Remission / Unconfirmed Complete Remission Rate 3.5 Fold Higher Compared to Standard Chemotherapy SEATTLE, Nov. 11 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it achieved the primary efficacy endpoint of its pha...

Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed to Meet its Primary Efficacy Endpoint

Company to host a conference call Monday, March 10, 2008 at 8:30am NEW YORK, March 7 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ) today announced top-line results from its SUN-MICRO Phase 3 clinical trial of Sulonex (sulodexide) for the treatment of diabetic nep...

Second Phase III Study of Avastin in 1st Line Metastatic Breast Cancer Meets its Primary Endpoint

- Results of This Trial Further Confirm the Benefit Avastin Brings to Patients With Breast Cancer. BASEL, Switzerland, Feb. 13 /PRNewswire/ -- Roche announced today that a phase III study in metastatic breast cancer investigating Avastin (bevacizumab) in combination with ...

Clinical Studies of OvaRex in Advanced Ovarian Cancer Fail to Meet Primary Endpoint

Preliminary Analysis Demonstrates Studies Failed to Reach Statistical Significance SILVER SPRING, Md. and WELLESLEY HILLS, Mass., Dec. 5 /PRNewswire- FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR ) and its wholly- owned subsidiary, Unither Pharmaceu...

Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint

Estimates Peak Worldwide Transplant Opportunity of Over $400 Million Annually CAMBRIDGE, Mass., Aug. 2 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ ) today announced that its second phase 3 trial of Mozobil(TM) (plerixafor) has successfully met its pr...

Primary Endpoint Met in Phase 2 Trial of Daclizumab in Patients With Relapsing Multiple Sclerosis

- Anti-IL-2 receptor antibody significantly reduced the number of new or enlarged lesions compared to placebo; data to be submitted for presentation at upcoming medical meeting - CAMBRIDGE, Mass. and FREMONT, Calif., March 12, 2007 /PRNewswire-FirstCall/ -- Biogen Idec, Inc. and PDL BioPharma, Inc...

Alexza's AZ-004 Phase IIa Trial Meets Primary Endpoint in Treating Schizophrenic Patients With Acute Agitation

Initial Analysis Shows Statistically Significant Changes in Agitation Levels With 10 mg AZ-004 PALO ALTO, Calif., March 26, 2007 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. today announced positive initial results from its Phase IIa clinical trial of AZ-004 (Staccato(R) loxapine) in sch...

Repros' Proellex Shows Statistically Significant Improvement in Primary Endpoint in Phase 2 Trial in the Treatment of Uterine Fibroids

THE WOODLANDS, Texas--(BUSINESS WIRE)--Apr 3, 2007 - Repros Therapeutics Inc. (NasdaqGM:RPRX) announced final results of a U.S. Phase 2 study of Proellex(TM), an oral drug being developed to relieve symptoms of uterine fibroids. This study suggests that treatment with Proellex results in a statisti...

YM BioSciences Reports AeroLEF Randomized Phase IIb Trial Meets Primary Endpoint in Patients with Post-Surgical Pain

MISSISSAUGA, ON, May 02, 2007 /PRNewswire-FirstCall/ - YM BioSciences Inc. , an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced top-line results from its randomized, placebo-controlled Phase IIb trial of AeroLEF(TM) in o...

BDSI Announces Positive Key Secondary Efficacy Endpoint Results for Bema Fentanyl

MORRISVILLE, N.C.--(BUSINESS WIRE)--May 14, 2007 - BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced additional statistically significant results with BEMA Fentanyl in cancer patients with breakthrough pain in its Phase III efficacy clinical trial for the product. Results were base...

Gilead Announces Achievement of Primary Efficacy Endpoint in Second Phase III Study of Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 29, 2007 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Phase III AIR-CF1 (CP-AI-007) study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) me...

SciClone and Sigma-Tau Report Thymalfasin Meets Primary Endpoint in Phase 2 Malignant Melanoma Trial

-- Data Presented at Annual Meeting of the American Society of Clinical Oncology -- SAN MATEO, Calif. -- June 4, 2007 -- SciClone Pharmaceuticals, Inc. (Nasdaq:SCLN) and Sigma-Tau S.p.A today announced that SciClone's lead product candidate thymalfasin (ZADAXIN(r), thymosin alpha 1) achieved its...

Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia Clinical Trial

CHICAGO, June 21, 2007 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , today announced positive results from Trial CL-06, the first of two pivotal Phase 3 clinical trials designed to assess the safety and effectiveness of cethromycin, a novel once-a-day antibiotic, for the treatm...

Coronary Artery Disease ARISE Trial Showed AGI-1067 Did Not Meet Primary Endpoint

LONDON, March 19, 2007-AstraZeneca today announced that its collaboration partner AtheroGenics, Inc. (Nasdaq: AGIX) revealed first results from the ARISE (Aggressive Reduction of Inflammation Stops Events) phase III clinical outcomes trial which studied AGI-1067, an investigational anti-atheroscle...

Corcept Therapeutics Announces Phase 3 Study Evaluating Corlux for Psychotic Major Depression Misses Primary Endpoint

STATISTICALLY SIGNIFICANT CORRELATION BETWEEN PLASMA LEVELS AND CLINICAL OUTCOME ACHIEVED DURING TREATMENT Management will host a conference call and live webcast on March 20, 2007 at 9:00 a.m. EDT MENLO PARK, Calif. (March 19, 2007) – Corcept Therapeutics Incorporated (NASDAQ: CORT), to...

Scios Announces Results From Exploratory Nesiritide Study Providing Important New Renal and Mortality Safety Data with a Neutral Effect on the Primary Endpoint

-- Data from Serial Outpatient Infusion Study in Patients with Chronic Decompensated Heart Failure Presented at the American College of Cardiology 56th Annual Scientific Session -- MOUNTAIN VIEW, Calif. and NEW ORLEANS, March 25, 2007 /PRNewswire/ -- Scios Inc. announced today that an exploratory,...

Phase III Study Evaluating Gilead's Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun 6, 2007 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced that Study 102, a Phase III clinical trial evaluating the company's once-daily anti-HIV drug Viread (tenofovir disoproxil fumarate or tenofovir DF) 300 mg as a potential treatment for chronic hep...