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IIB in Medical Technology

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

Start of trial triggers $10 million milestone payment to Pharmasset PRINCETON, N.J., April 24 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS ) and Roche (Roche SWX: RO, ROG; Pink Sheets: RHHBY) today announced that the first patient has been dosed in a Phase IIb study of R7128, th...

DURECT Reports Positive Phase IIb Data from TRANSDU(TM)-Sufentanil Clinical Program

CUPERTINO, Calif., March 16 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX ) announced today positive results from a 74 patient Phase IIb clinical trial conducted by Endo Pharmaceuticals of TRANSDUR(TM)-Sufentanil, a proprietary seven day patch under development for the treatment of ...

Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrolled Asthma

BERKELEY, Calif., March 2 /PRNewswire/ -- Aerovance Inc. today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate Aerovance's Phase IIb clinical trial, AeroTrial(TM), of inhal...

ISTA Pharmaceuticals Announces Positive Results for Phase IIb Study of Ecabet Sodium

IRVINE, Calif., Jan. 22 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA ), today announced positive results from the Company's Phase IIb clinical study of ecabet sodium, which is being developed as a treatment for dry eye disease. Patients treated with ecabet sodium achieved ...

AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Cognitive Dysfunction in Schizophrenia

WILMINGTON, Del. and WINSTON-SALEM, N.C., Dec. 8 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN ) and Targacept, Inc. today announced top-line results from a Phase IIb clinical trial of AZD3480 (TC-1734) conducted by AstraZeneca in cognitive dysfunction in schizophrenia (CDS), known as the HAL...

Alba Therapeutics Announces Enrollment of Its First European Patient in Global Phase IIb Study of Larazotide Acetate for Treatment of Active Celiac Disease

- Milestone Marks the First Time a European Patient with Active Celiac Disease has Enrolled in a Clinical Trial for an Investigational Medication from Alba Therapeutics - BALTIMORE, Nov. 11 /PRNewswire/ -- Alba Therapeutics Corporation announced today that for the firs...

BioSpecifics Technologies Corp. Announces Initiation of Phase IIb Trial for Peyronie's Disease

LYNBROOK, N.Y. Sept. 17 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (OTC Bulletin Board: BSTC), a biopharmaceutical company developing first in class collagenase based products, announced today the initiation of a U.S. Phase IIb clinical trial in Peyronie's disease for its inject...

AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Alzheimer's Disease

WILMINGTON, Del., Sept. 15 /PRNewswire-FirstCall/ -- -- Results inconclusive, as primary outcome measure not statistically significant for either donepezil or AZD3480; results impacted by improvement in placebo group -- Improvements shown on secondary outcome measures ADCS-CGIC an...

Meditrina Pharmaceuticals, Inc. Opens Investigational New Drug (IND) Application for Phase IIb Clinical Trial With MPI-676 in Endometriosis

- Approval of Second IND Marks Major Corporate Milestone and Advances Clinical Program - ANN ARBOR, Mich., July 17 /PRNewswire/ -- Meditrina Pharmaceuticals, Inc. today announced the approval of its second investigational new drug (IND) application for a Phase IIb do...

Orexigen(R) Initiates Second Phase IIb Empatic(TM) Trial on Schedule

Orexigen is the only company with two late-stage product candidates to address a broad spectrum of obesity patients SAN DIEGO, July 9 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX ) announced today that it has begun randomizing patients in ZB-202, a seco...

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...

New Diabetes Compound AVE0010 Showed Clear Dose Response Results With Once-A-Day Injection in Phase IIb Study

Results Presented at the ADA's Annual Scientific Sessions SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the results of the dose-finding study for its new injectable diabetes compound AVE0010, a GLP-1 agonist, were presented at the American Diabetes ...

Clinical Proof of Concept for TGF-beta 2-Inhibitor AP 12009 in Phase Iib EMEA provides Guidance on Phase III Design and Approval Requirements

CHICAGO and REGENSBURG, Germany, June 2 /PRNewswire/ -- "A two-year survival rate of more than 80 percent in recurrent or refractory anaplastic astrocytoma suggests a breakthrough in this devastating disease by targeted therapy," commented Prof. Ulrich Bogdahn, Neuro-Oncologist and Coordinatin...

ThromboGenics Completes Patient Enrolment in the Phase IIb Trial of Microplasmin in Vitrectomy (MIVI III)

LEUVEN, Belgium, April 1 /PRNewswire-FirstCall/ -- - Trial Results Expected Mid-2008 ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on vascular diseases, eye diseases and cancer, today announces that it has completed patient enrolment for its Phase IIb MIVI III ...

Fundamental Applied Biology, Inc. Is Awarded SBIR Phase IIB Grant for the Commercialization of Protein Therapeutics Using Cell Free Technology

MENLO PARK, Calif., Jan. 16 /PRNewswire/ -- Fundamental Applied Biology, Inc. (FAB) announced today that it has been awarded a Small Business Innovative Research (SBIR) Phase IIB grant from the National Science Foundation. The $500,000 grant will be used to continue to develop FAB's cell-free ...

Positive Results from Phase IIa Study Pave Way for Phase IIb Trial of DG051 for the Prevention of Heart Attack

REYKJAVIK, Iceland, Jan. 9 /PRNewswire-FirstCall/ -- deCODE genetics (Nasdaq: DCGN ) today announced positive topline results from its Phase IIa clinical trial for DG051, the company's leukotriene A4 hydrolase inhibitor being developed for the prevention of heart attack. With these results, t...

Trubion Pharmaceuticals Announces Presentation of Positive Data From Phase IIb and Re-treatment Studies With TRU-015 in Patients With Rheumatoid Arthritis

SEATTLE, Nov. 8 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN ) today announced presentation of positive data from a Phase IIb study that showed that Trubion's TRU-015 for rheumatoid arthritis (RA) provided statistically significant efficacy after a single infusion of 8...

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 ...

Rockwell Medical Technologies, Inc. Begins Dosing Patients for SFP Phase IIb Clinical Study

WIXOM, Mich., Oct. 3 /PRNewswire-FirstCall/ -- Rockwell Medical Technologies, Inc. (Nasdaq: RMTI ), a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end- stage-renal-disease market (ESRD), announced today that it has begun dosing pa...

Alba Therapeutics Announces Phase IIb Clinical Trial for Oral AT-1001 for the Treatment of Celiac Disease

BALTIMORE, Sept. 19 /PRNewswire/ -- Alba Therapeutics Corporation today announced that it has dosed its first patient in a six-week Phase IIb trial with oral AT-1001, an inhibitor of gastrointestinal barrier dysfunction, for the maintenance of remission in patients with Celiac Disease (CD). Th...

Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis

Results Show Improvements in RA Signs and Symptoms Compared to Placebo SEATTLE, Sept. 10 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN ) today announced preliminary analysis of results from a Phase IIb randomized, double-blind, placebo-controlled, multicenter clinical ...

TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache

- Top Line Results Expected to Be Reported in 4Q 2007 - LA JOLLA, Calif., Aug. 6 /PRNewswire-FirstCall/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX ) today announced that it has completed enrollment in its Phase IIb clinical trial of tezampanel for the treatment of acute migraine ...

Avexa Reports Positive Phase IIb Result

VICTORIA, Australia--(BUSINESS WIRE)--Mar 20, 2007 - Australian biotechnology company Avexa (ASX:AVX) today announced highly successful results from its Phase IIb trial for apricitabine (ATC). ATC is Avexa's novel nucleoside reverse transcriptase inhibitor (NRTI) being developed for the treatment o...

Idenix Reports Results from Two Phase IIb Studies of the Combination of Valopicitabine and Pegylated Interferon in Hepatitis C Genotype-1 Patients at the 42nd Annual Meeting of the European Association for the Study of the Liver

Additional Preclinical Data Presented on Valopicitabine Combined with an Investigational Protease Inhibitor BARCELONA, Spain, April 12, 2007 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. today announced results from two phase IIb studies of the novel combination of valopicitabine (NM283) ...

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...

DP-b99 Phase IIb Trial Results to be Presented at the European Stroke Conference

REHOVOT, Israel, May 29, 2007 /PRNewswire/ -- D-Pharm announced today that the results of the Phase IIb trial for its neuroprotective compound DP-b99 in the treatment of acute ischemic stroke patients will be presented at the European Stroke Conference. The data will be presented by the study's Ge...

Alexza Pharmaceuticals to Present AZ-001 Phase IIb Clinical Data at the American Headache Society Meeting

PALO ALTO, Calif., May 31, 2007 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. announced today that it will present at the 49th Annual American Headache Society Meeting the results of a Phase IIb clinical trial of Staccato(R) prochlorperazine (AZ-001) for the acute treatment of migraine he...

ISTA Pharmaceuticals Announces Positive Preliminary Results from Ecabet Sodium Phase IIb Study

- Pending Final Analysis of the Results, ISTA Plans to Initiate Phase III Studies in Dry Eye in 2008 - IRVINE, Calif., May 31, 2007 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. , today announced positive results from the preliminary analysis of the Company's Phase IIb clinical study of eca...

Antisense Pharma: Promising Phase IIb Results of Targeted Therapy with AP 12009 in Recurrent Anaplastic Astrocytoma

CHICAGO and REGENSBURG - June 21, 2007 - “In anaplastic astrocytoma, AP 12009 as a monotherapy is actually clearly superior to temozolomide,” Prof. Albert Wong, M.D., Stanford University, California, U.S.A. commented on the international Phase IIb study with the TGF-beta 2-inhibitor AP...

YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial

- Company Announces Lead Investigator for U.S. Trial - MISSISSAUGA, ON, July 11, 2007 /PRNewswire-FirstCall/ - YM BioSciences Inc. , an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced results of secondary endpoint data f...

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

... July 15 /PRNewswire/ -- A sub-analysis of a Phase iib multinational study(1) with edoxaban(2) - an inves... This pharmacokinetic (PK) analysis of the Phase iib study examined the relationship between bleeding e...nkyo Pharma Development. About the Phase iib Safety Study A total of 1,146 patients with ...

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

... elderly men aged 65 years or more with a history of nocturia. Based on these results, Vantia now plans to advance VA106483 into a larger Phase iib clinical efficacy study in the second half of 2009. Dr Jim Phillips, CEO of Vantia Therapeutics, said 'VA106483 was discovered and has been dev...

Boehringer Ingelheim Unveils Diabetes Pipeline

...tors (SGLT-2 inhibitors), which are a new, emerging class of antidiabetic compounds that block tubular reabsorption of glucose in the kidney.(4) Phase iib clinical trials for this innovative approach to diabetes treatment are underway. There are currently no SGLT-2 inhibitors approved by the U.S. Food a...

Study Showed Lilly's GEMZAR(R) (gemcitabine HCl for injection) Improved Progression-Free Survival in Cervical Cancer Patients

...bine, Cisplatin, And Radiation Followed By Adjuvant Gemcitabine And Cisplatin Versus Concurrent Cisplatin And Radiation In Cancer Of The Cervix Stages iib To Iva. Abstract #CRA5507, 45th American Society of Clinical Oncology (ASCO) annual meeting 2009. (3) World Health Organization. Vaccine resea...

Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma

...e failed two or more previous therapies, and talactoferrin in combination with chemotherapy in previously untreated patients), and is planning a Phase iib trial in patients with renal cell cancer, and Phase II trials in other cancer indications. The company has recently agreed to merge its busine...

Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009

...patients after failure with a second-line or third-line reversible EGFR inhibitor (i.e., erlotinib or gefitinib). This study recently moved from Phase iib into Phase III.(5) "The LUX-Lung 1 study is important as it investigates BIBW 2992 in a group of patients for whom there are no other approved tr...

Metabolic Solutions Development Company Announces Preliminary Results from Phase IIa Clinical Trial

...he complications inherent in current therapies." Additional safety and expanded efficacy data will be gathered in a 90-day, multinational Phase iib study that is planned for late 2009. According to the American Diabetes Association, approximately $1 in every 10 health care dollars spent is ...

D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients

...I clinical studies. Both preclinical and clinical studies indicate a favorable efficacy and safety profile for DP-b99. In the recently completed Phase iib trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that completely recovered from ischemic stroke. DP-b99 ...

Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen

...eron alfa-2a) and COPEGUS(R) (ribavirin). A Phase iib study with R7128 has now begun, while a Phase iib study with R7227 is slated to begin in the summer....ollaboration with Roche, and is initiating a Phase iib trial. Racivir, which is being developed for the t...

Medgenics' Phase I/II Clinical Trial Now Shows EPODURE Continuous Anemia Treatment Lasting 5 Months in Kidney Disease Patients

...EPODURE and INFRADURE. Medgenics plans to raise the requisite funds during 2009 to enable it to follow the current trial of EPODURE with a Phase iib clinical trial in the US starting in 2010, and in addition, to commence a Phase I/II trial of INFRADURE in Hepatitis-C patients in Israel also during ...
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