Phase in Medical News

GeoVax Labs, Inc. Announces Six Month 2009 Financial Results and Provides Operational Update

... "In February, we began patient injections in our phase 2a clinical trial for our candidate vaccine for ... of HIV/AIDS vaccines and has sponsored over 80 phase 1 trials for the initial evaluation of safety and ... vaccines; of these, only five have progressed to phase 2 trials since 1992. Achieving ...

AspireHR Completes Phase 1 SAP HR Initiative for Shire Pharmaceuticals

... AspireHR and Shire Pharmaceuticals complete phase 1 of their shared SAP human resources initiative. ... is proud to announce the successful Go-Live of phase 1 of their SAP HR initiative at Shire ... and an HR budget that exceeded expectations. phase 1 of the initiative was customized to lower costs ...

Orexigen(R) Therapeutics Announces Second Quarter 2009 Financial Results

... with the completion of the Company's Contrave(R) phase 3 clinical trials, reduced product formulation ... costs. "The recent completion of the COR phase 3 program was a major milestone for Orexigen, and ... Orexigen announced that the three remaining phase 3 trials in the Contrave Obesity Research, or ...

ViroPharma Announces Initiation Of Non-Toxigenic Clostridium Difficile Phase 1 Program

... ) today announced that dosing has begun in the phase 1 clinical trial for NTCD (non-toxigenic ... until normal GI flora returns." The phase 1 study will determine the safety and ... press release. There can be no assurance that our phase 1 programs will yield positive results or that we ...

Bellicum Pharmaceuticals Announces Initiation of Phase I/II Clinical Trial of Novel Vaccine for Patients With Advanced Prostate Cancer

... today announced dosing of the first patient in a phase I/II clinical trial of BP-GMAX-CD1, a novel ... has not progressed at the end of this acute phase will be eligible to receive booster vaccinations ... well-tolerated with defined pharmacokinetics in a phase 1 clinical trial. "This is an exciting ...

Micromet, Inc. Reports Second Quarter 2009 Financial Results

... the presentation of adecatumumab (MT201) phase 1b combination data at the American Society of ... (ASCO) meeting, the presentation of blinatumomab phase 2 data in acute lymphoblastic leukemia (ALL) at ... 1, Micromet presented an update at ASCO 2009 on a phase 1b combination study of its human monoclonal ...

EntreMed Reports Second Quarter 2009 Financial Results

... clinical results as we set the stage for our phase 2 program and continue our active discussions for ... treatment of cancer. ENMD-2076 is currently in phase 1 studies in advanced cancers, multiple myeloma, ... against the mTOR pathway currently in multiple phase 2 clinical trials for cancer, and ENMD-1198, a ...

Ferring Pharmaceuticals Announces Trade Name FIRMAGON(R) (degarelix for injection) for Advanced Prostate Cancer Treatment

... that stimulates prostate cancer growth.(1-3) phase III pivotal studies showed that FIRMAGON is as ... randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU ... -- results from a 1-yr, multicentre, randomised phase 2 dosage-finding study in the treatment of ...

Keryx Biopharmaceuticals Settles License Dispute With Alfa Wassermann

... non-dilutive cash to move our compounds into phase 3 trials." ABOUT KERYX ... complexes. Zerenex has recently completed a phase 2 clinical program as a treatment for ... and cell survival. KRX-0401 is currently in phase 2 clinical development for multiple tumor types, ...

Bionovo Presents Positive Results from Phase 1B Trial of Bezielle for Metastatic Breast Cancer

... BNVI ) today announced positive results from the phase 1B clinical trial of Bezielle (formerly BZL101), ... in a difficult-to-treat population. The phase 1B clinical trial was conducted at eight US ... metastatic breast cancer were enrolled to the phase 1B trial. To date, 48 women with advanced ...

Lexicon Initiates Phase 2 Clinical Trial of LX2931 in Patients With Rheumatoid Arthritis

... disease, announced today that it has initiated a phase 2 clinical trial of LX2931 in patients with ... drug candidate that has recently completed phase 1 testing in normal volunteers. Lexicon also ... inflammation and transplantation. The phase 2 clinical trial is designed as a 12-week, ...

DURECT Corporation Announces Second Quarter 2009 Financial

... enrollment in our approximately 60 patient phase IIb clinical study in shoulder surgery. ... Nycomed continued enrollment in a phase IIb study in hysterectomy patients and a phase IIb study in shoulder surgery patients. ...

Quark Pharmaceuticals to Participate in IBC's Oligonucleotide Therapeutics: From Concept to Implementation Conference

... which includes PF-04523655, a synthetic siRNA in phase II clinical studies licensed by Pfizer in ... indications, and QPI-1002, a synthetic siRNA in phase I/II studies for two renal indications. The ... PF-4523655 (RTP801i-14), currently in phase II clinical trials, is a synthetic, chemically ...

Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Multiple Myeloma

... Protocol Assessment (SPA) on the design of a phase 3 trial for its PI3K/Akt pathway inhibitor, ... The SPA provides agreement that the phase 3 study design adequately addresses objectives in ... a regulatory submission. The trial, entitled, "A phase 3 Randomized Study to Assess the Efficacy and ...

IDEAL LIFE's Remote Monitoring System Benefits Rural North Carolina Communities

... communities. The $870,000 grant is the largest phase II Health Disparities Grant awarded by the NC ... preventative health. The grant provides funds for phase II of a HWTF Health Disparities Initiative; phase I was a successful three-year telehealth program ...

Boehringer Ingelheim to Commence Phase III Study Investigating the Role of BIBW 2992 as First-Line Treatment for Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR Mutations

... (WCLC), San Francisco, CA, the initiation of a phase III clinical study of BIBW 2992 as first-line ... dual inhibitor of EGFR and HER2,(1) to reach phase III development in NSCLC.(2) The LUX-Lung ... LUX-Lung trial program currently includes two phase III trials assessing the efficacy and safety of ...

MAP Pharmaceuticals Reports Second Quarter of 2009 Financial Results

... "We are very pleased that in the first phase 3 trial for our LEVADEX(TM) migraine therapy, all ... to presenting the data from our successful phase 3 trial of LEVADEX at the 14th Congress of the ... and other project expenses to support the UDB phase 3 clinical program, partially offset by increases ...

Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)

... the safety and efficacy of KRYSTEXXA in its phase 3 clinical trials. The FDA stated that the ... process used to produce KRYSTEXXA for the phase 3 clinical trials or conducting additional ... process used to produce KRYSTEXXA for the phase 3 clinical trials. The complete response ...

Advanced targeted therapies effective as first-line treatment for lung cancer

... cancer cell division. IPASS is a randomized phase III study that compared oral gefitinib with ... WITH CHEMOTHERAPY: RESULTS FROM THE phase III SATURN STUDY (ABSTRACT # A2.1) Erlotinib ... chemotherapy, aimed at extending survival. The phase III SATURN study was initiated to evaluate the ...

BioMarin Announces Second Quarter 2009 Financial Results

... quarter, we reported encouraging results from the phase I PEG-PAL study, initiated the phase I/II study for GALNS for MPS IVA and recently ... for PKU: BioMarin reported results from the phase I trial in early June. The FDA has accepted the ...

AstraZeneca Submits New Drug Applications for ZACTIMA(TM) in Second-Line Advanced Non-Small Cell Lung Cancer

... European submissions are supported by data from phase III clinical studies evaluating the safety and ... study in EGFR failures in advanced NSCLC, phase III) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer, phase III) studies will be presented in the first half ...

BioCryst Reports Second Quarter 2009 Financial Results And Provides Corporate Update

... traditional regulatory pathway. The successful phase 3 studies conducted by our partner Shionogi add ... Ltd. recently announced positive results from two phase 3 studies of i.v. peramivir in patients with ... is currently finalizing its plans for peramivir phase 3 studies intended to support U.S. regulatory ...

QuatRx Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) in Postmenopausal Vaginal Atrophy

... of two patient cohorts in its second pivotal phase 3 trial of the investigational compound, ... safety extension studies from its first pivotal phase 3 studies. QuatRx intends to use these results in ... "We are delighted with the progress in our phase 3 program of Ophena(TM) , which provides further ...

Medivation Announces Second Quarter 2009 Financial Results Teleconference and Webcast on August 5, 2009

... development program that includes several phase 3 trials assessing the efficacy and safety of ... disease is also planned. In addition, a phase 1-2 clinical trial of MDV3100 in patients with ... prostate cancer is ongoing, and a phase 3 trial is expected to begin this year. For more ...

QLT announces interim data from a Phase II clinical trial and a device study for the Punctal Plug Drug Delivery System

... encouraging interim data from an ongoing phase II clinical trial and a device study for the ... Preliminary interim results from the ongoing phase II clinical trial of the 44-(micro)g Latanoprost ... well tolerated. These results from the ongoing phase II clinical trial evaluating the safety, ...

QLT Announces Second Quarter Results for 2009

... the 12-month primary analysis results from the phase II RADICAL study for Visudyne combination ... announced, we released this morning data from our phase II study investigating a high dose of ... * Announced interim data from an ongoing phase II clinical trial and a device study for the ...

Lexicon Pharmaceuticals Provides Clinical Pipeline Update and Reports 2009 Second Quarter Financial Results

... to progress, including the recent initiation of a phase 2 study of LX1032 in patients with carcinoid ... to advance LX2931 for rheumatoid arthritis into a phase 2 clinical trial in the very near future." ... U.S. Food and Drug Administration (FDA), into a phase 2a study in patients with carcinoid syndrome . ...

Alexza to Announce 2009 Second Quarter Financial Results and Update Its Clinical Pipeline Status on Wednesday, August 5, 2009

... positive results from both of its AZ-004 phase 3 clinical trials, and is projecting a New Drug ... it has advanced AZ-104 ( Staccato loxapine) into phase 2b testing. Both product candidates are being ... AZ-002 ( Staccato alprazolam) has completed phase 1 testing and ...

Delcath Systems Provides Update on Progress

... Screened 40 Additional Patients for Enrollment in phase III Metastatic Melanoma Trial Since Late ... to achieve patient enrollment milestones in our phase III Metastatic Melanoma Trial. Based on recent ... technology and I look forward to completing our phase III trial and submitting for FDA approval in a ...

Amgen's Second Quarter 2009 Adjusted Earnings Per Share Increased 13 Percent To $1.29

... the previously announced results of its pivotal, phase 3, head-to-head study where denosumab ... indicated that enrollment has resumed for the phase 3 MONET1 trial evaluating motesanib in ... The Company also noted that the data from phase 2 study evaluating motesanib in combination with ...

Lilly to Unveil More Than 30 Studies at Premier Lung Cancer Meeting

... An analysis of three large, randomized, phase III trials (* vs. the respective comparators in ... p.m. PDT Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) +/- ... NSCLC: Results from an open label randomized phase II study PD8.1.3: Poster ...

Scientists discover key event in prostate cancer progression

... a group of genes involved in a different, later, phase of cell division, triggering rapid cell growth. ... disease, androgen receptors regulate an early phase of cell cycle. In hormone-independent prostate ... in actual cell division, that is, the mitotic phase of the cycle. A gene called UBE2C was a ...

Glenmark Brings to the Notice of the Authorities Irregularities of the Clinical Investigator at its Jamnagar Site in Gujarat

... General of India(DCGI) for a multi-centre phase IIb clinical study for its lead ... were completed prior to initiating this phase IIb asthma study. Being a multi-centre clinical ... from this site pertaining to the study. The phase IIb study continues to progress as per plan at ...

Human Genome Sciences Announces Second-Quarter 2009 Financial Results and Key Developments

... Officer. "Results of the first of two pivotal phase 3 trials of BENLYSTA demonstrated that BENLYSTA ... are on track to have data from our second phase 3 trial of BENLYSTA in November 2009. We and ... sufficient to take us through the availability of phase 3 data, the filing of marketing applications and ...

Nexavar in Combination with Chemotherapy Shown to Extend Progression-Free Survival in Patients with Advanced Breast Cancer

... first cooperative group-sponsored randomized phase 2 trial in advanced metastatic breast cancer met ... The randomized, double-blind, placebo-controlled phase 2 study evaluated Nexavar in combination with the ... Among these trials are three ongoing randomized phase 2 studies, including a trial to evaluate Nexavar ...

AcelRx Announces Perfect Performance of Handheld Component of ARX-01 Sufentanil NanoTab PCA System in a Phase 2 Study

... today announced positive results from its first phase 2 clinical study evaluating the functionality of ... reported for the 15 mcg dose in two earlier phase 2 placebo-controlled studies. ARX-01 was ... AcelRx has conducted two placebo-controlled phase 2 studies of ARX-01 Sufentanil NanoTabs in ...

US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201

... will participate in the BiPar Sciences' phase III, Multi-center, Open-Label, Randomized Trial ... Texas, will lead the study as a follow-up to the phase II study presented in a plenary session at the ... "We are extremely pleased to be launching the phase 3 clinical trial so rapidly after the close of ...

New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies

... study GRACE is a multi-center, open-label phase 4 trial that compared gender differences in the ... RNA levels and CD4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral ... treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically ...

-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments-

... OREX ) today announced that all three remaining phase 3 trials evaluating Contrave(R) (bupropion ... of 2010. Key top-line data from the COR phase 3 program include the following: 48.0% ... Key secondary endpoints met across the entire COR phase 3 program included significant improvements in ...

Raptor Pharmaceuticals Corp. to Present at 2009 Cystinosis Research Network Family Conference

... will present an update on the Company's ongoing phase 2b study of delayed-release cysteamine bitartrate ... progress and enrollment criteria for our phase 2b trial. We realize the effort necessary for ... not limited to the following statements: that the phase 2b study of DR Cysteamine will be fully enrolled; ...