Phase in Medical Technology

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

... Milestones Report full data from a phase 3 study evaluating mipomersen in homozygous ... patient populations Report data from a phase 2 study evaluating ISIS 113715 in combination ... additional expenses associated with the broad phase 3 clinical program for mipomersen, the lead drug ...

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

... Radius Health ("Radius") today announced topline phase 2 data demonstrating that in women with ... study. The objective of the 221-patient phase 2 clinical trial was to assess safety and ... will submit additional detailed results from the phase 2 study for presentation at an upcoming medical ...

NewCardio Announces Master Services Agreement With Dedicated Phase I

... services company, today announced that Dedicated phase I, an innovative, Phoenix, Arizona-based provider ... Under terms of this agreement, Dedicated phase I will receive a license to use NewCardio's ... obtained. It is anticipated that Dedicated phase I, by utilizing QTinno(TM) in addition to its ...

NOVAVAX Achieves Pandemic H1N1 Influenza Production Milestone

... Novavax, Inc has successfully completed a phase I/IIa clinical study with a candidate H5N1 influenza VLP vaccine and is currently in phase II trials with a VLP based seasonal flu vaccine candidate. The Company plans to initiate a phase II study with its Seasonal Flu vaccine candidate ...

Nektar Therapeutics Reports Second Quarter 2009 Financial Results

... Executive Officer of Nektar. "We completed our phase 2 clinical program for NKTR-118, and we are poised to report phase 2 data for NKTR-102 and phase 1 data for NKTR-105 by year-end. These ...

Telik Announces Publication of Positive Phase 1 Results of a Multicenter Study of Ezatiostat Hydrochloride (TELINTRA(R), TLK199) Tablets In Patients With Myelodysplastic Syndrome

... today announced that the positive results from a phase 1 multicenter, dose escalation study of ... pp. 6533-6540. Positive results from a separate phase 1-2a study in MDS patients involving an ... support the further development of TELINTRA. phase 2 studies are ongoing in MDS (enrollment ...

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

... reported positive results from the first of three phase III studies of velaglucerase alfa, its enzyme ... with those previously reported from the phase I/II and extension studies. We will continue to ... is the largest and most comprehensive set of phase III clinical trials conducted to date for Gaucher ...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

... today positive preliminary results from its phase I clinical trial of PSI-7851 for the treatment of ... polymerase inhibitor of HCV. PSI-7851 phase 1 Multiple Ascending Dose Study Overview In June 2009, Pharmasset initiated a phase 1 multiple ascending dose study with PSI-7851. ...

Is Your Hair Taking a Break?

... grow new hair, it works by prolonging the growth phase of hair -- providing more time for hair to grow ... in the number of hairs in the telogen, or rest, phase of the hair cycle, which typically lasts three ... of stress, causing more hair to enter the rest phase than the normal 10 percent. For example, surgery, ...

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

... in Fertility and Sterility of data from a phase 3 clinical study that showed that the ... double-blind, placebo- and active-controlled phase 3 study that evaluated 3,397 healthy, ... expressed in the referenced publication. The phase 3 clinical trial data presented and published to ...

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

... RIGL ) today announced that in the TASKi3 phase 2b clinical trial in rheumatoid arthritis (RA) ... manageable, and we look forward to planning our phase 3 program for R788 with a corporate partner," he ... In July 2009, Rigel announced results from its phase 2b TASKi2 clinical trial showing significant ...

Lilly and New York City Mayor Michael R. Bloomberg Announce Lilly Agrees to be First Tenant of East River Science Park; Issue Urgent Call for Healthcare Reform that Protects Innovation and Jobs

... One of those molecules, IMC-1121B, already in phase III development for breast cancer, will be evaluated in another phase III trial, this time for gastric cancer. The purpose of the phase III gastric cancer study is to evaluate the ...

Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing

... therapies, today announced results from a phase 1 cardiac safety study of picoplatin, a new ... and anticipated efficacy data from our ongoing phase 3 SPEAR study will provide a strong database to ... The Company plans to present data from the phase 1 cardiac safety trial at a medical conference ...

R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study on RK-023

... R-Tech Ueno, Ltd. announced on July 17 that as a phase 1 clinical study on the new compound RK-023 that ... the note below) has been completed. The phase 1 clinical study of RK-023 consisted of a patch ... to announce the successful completion of a phase 1 clinical study on our self-developed RK-023 ...

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

... US Oncology Research Network Participates in phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201 phase II of the trial was presented in 2009 ASCO ... will participate in the BiPar Sciences' phase III, Multi-center, Open-Label, Randomized Trial ...

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

... endpoint in BLISS-52, the first of two pivotal phase 3 trials in patients with serologically active ... positive results in November from our second phase 3 trial of BENLYSTA, we and GSK plan to submit ... active subgroup of SLE patients at Week 52 in our phase 2 trial," said David C. Stump, M.D., Executive ...

Orexigen(R) Therapeutics Schedules July 20, 2009 Teleconference and Webcast Discussion of Contrave(R) Phase 3 Results

... to announce the results of the three remaining phase 3 clinical trials in the Contrave program on ... targeted for obesity are Contrave(R), which is in phase III clinical trials, and Empatic(TM) which is in the later stages of phase II development. Both product candidates take ...

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

... BCRX ) today announced positive results from two phase 3 studies of intravenous (i.v.) peramivir in ... randomized, double-blind, multi-national phase 3 study of i.v. peramivir that compared the ... Shionogi conducted a double-blind, multi-center phase 3 study of i.v. peramivir with dosing over ...

Oncolytics Biotech(R) Inc. Announces Publication of Research on Synergistic Activity of Reovirus and Chemotherapy in NSCLC

... and head and neck cancers in two separate U.S. phase II studies." The investigators examined in ... clinical program includes a variety of phase I/II and phase II human trials using REOLYSIN(R), its ...

Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV

... that it has extended to stage two an ongoing phase II clinical study with vicriviroc, its ... infarction.(5-7) About the phase II Naive Study This randomized, ... also is being studied in two large ongoing phase III clinical studies in treatment-experienced HIV ...

Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing

... N.J., July 15 /PRNewswire/ -- A sub-analysis of a phase IIb multinational study(1) with edoxaban(2) - an ... of both arterial and venous thromboembolism; a phase III trial is underway among patients with AF. This pharmacokinetic (PK) analysis of the phase IIb study examined the relationship between ...

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

... KERX ) announced today the initiation of a phase 1 clinical study to evaluate KRX-0401 ... solid tumors in pediatric patients. This phase 1 study is now open for enrollment at Memorial ... mice bearing neuroblastoma tumors. Moreover, in a phase 2 study conducted at Memorial Sloan-Kettering ...

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

... bladder cancer that is currently undergoing phase III clinical testing. Under the agreement ... Urocidin ." Bladder Cancer and the Ongoing phase III Clinical Program for Urocidin(TM) ... into the bladder. The first of two phase III U.S. Food and Drug Administration ...

CEL-SCI to Present Data from Multikine Clinical Trials at National Institutes of Health (NIH), National Cancer Institute (NCI) Seminar Series

... clinical findings from the different Multikine phase II clinical trials which highlight the advantages ... during the impending Multikine Pivotal Global phase III trial and these samples will be tested by the ... Multikine(R) which is being readied for a global phase III trial in advanced primary head and neck ...

Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial

... has demonstrated safety and efficacy in a phase 2 clinical trial. About the Trial: The trial conducted was a phase 2, double-blind, randomized, placebo-controlled, ... for this fall and plans to embark on pivotal phase 3 trials in early 2010. ...

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

... (RA) patients in the recently completed TASKi2 phase 2b clinical trial of 457 patients treated for up ... uniformly greater. Consistent with the previous phase 2a clinical trial (TASKi1), the onset of effect ... discussions with respect to R788 and initiate a phase 3 clinical program with R788 in RA in the first ...

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

... (Nasdaq: AMGN ) today announced that a pivotal, phase 3, head-to-head trial evaluating denosumab versus ... had not been observed in previously reported phase 3 studies with denosumab, was seen infrequently ... forward to reviewing the results from a second phase 3 study of denosumab effects in advanced cancer ...

Thiarabine Demonstrates a Reduction of Both Inflammatory and Erosive Disease Parameters in Rheumatoid Arthritis

... from Southern Research. It has been in two phase 1/2 solid tumor trials and was shown to have ... and lymphoma specialists to initiate additional phase 2 clinical trials in acute myeloid leukemia ... products include ProLindac(TM), currently in phase 2 clinical testing of patients with ovarian ...

Alcon Commences Phase 2 Clinical Trial of NovaBay's NVC-422 for Viral Conjunctivitis

... today that Alcon has begun treating patients in a phase 2 clinical trial of NovaBay's patented lead ... of microbes to traditional antibiotics. The phase 2 viral conjunctivitis study follows a recently completed phase 1 trial in which safety and tolerability were ...

ThromboGenics and BioInvent Start Recruitment of Second 100 Patient Cohort in Phase II DVT Prophylaxis Study With TB-402

... of a second cohort of patients for their phase II trial of TB-402. This follows completion of ... proceed using a higher dose of TB-402. The phase II trial is an active (enoxaparin)-controlled, ... data from the earlier successful phase I studies at the XXII Congress of the ...

Calixa Therapeutics Announces Initiation of Phase 2 Clinical Trial of Its Antibiotic, CXA-101, in Patients with Complicated Urinary Tract Infections

... Inc. today announced the initiation of a phase 2 clinical trial of CXA-101 in patients with ... the end of therapy. "The preclinical and phase 1 results to date are very promising and indicate ... going to present comprehensive preclinical and phase 1 data at the 49th Interscience Conference on ...

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

... today announced positive results from the second phase 2 clinical study evaluating the safety and ... positive results for ARX-01 from the first phase 2 study which evaluated the safety and efficacy ... replacement surgery. Additionally, an open-label phase 2 study is currently ongoing with the primary ...

Vantia Therapeutics' Lead Candidate VA106483 Demonstrates Positive Anti-diuretic Effect in Phase IIa Trial in Nocturia

... markets, announces positive results from a phase IIa clinical trial of its lead development ... now plans to advance VA106483 into a larger phase IIb clinical efficacy study in the second half of ... Ltd's small molecule R&D, it has two clinical phase products, VA106483 for the treatment of nocturia ...

Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

... The EU approval was based on data from phase II and three phase III, double-blind, randomised, ... Seizures: Pooled Analysis of Three Double-Blind phase III Clinical Studies. Poster presented at the ...

SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

... of SIMPONI have been studied in a comprehensive phase 3 development program that included more than ... active RA, active PsA and active AS. In phase 3 rheumatoid arthritis trials, SIMPONI was shown ... in control-treated patients). In controlled phase 3 trials through Week 16 in RA, PsA and AS, 5.8 ...

Transave Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of ARIKACE(TM)

... that the award will be used to support an ongoing phase II clinical trial in U.S. CF patients with ... today completion of enrollment for its second CF phase II clinical trial; results are expected to be available in July. The first CF phase II trial, completed in June 2008, achieved ...

King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use

... intended to relieve moderate to severe pain. A phase III study evaluated the analgesic efficacy and ... withdrawal or reduction of pain relief. phase II Study to Evaluate the Dose Response for ... unpleasant effect, including flushing. A phase II study was conducted to evaluate the dose ...

ThromboGenics' Microplasmin Phase III Program Progressing According to Schedule

... that its lead product microplasmin, which is in phase III trials for the treatment of ... protocol modification. Microplasmin's phase III program is referred to as the ... trial). The indication for both of the phase III microplasmin trials is the non-surgical ...

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 ... patients and confirm results from the first phase III study PALO ALTO, Calif., and BRUSSELS, ... top-line results from the second of two phase III clinical trials of sodium oxybate (JZP-6) for ...

Spherix Announces Positive Phase 2 Study Results

... Magnitude Lower than the Dose Used in the Current phase 3 Trial. BETHESDA, Md., June 24 ... announced positive preliminary results from a phase 2 clinical trial of its novel compound, ... treatment and management of Type 2 diabetes. The phase 2 trial is expected to be completed in early ....