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
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
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
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
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
randomized, double-blind, placebo-controlled, multicenter
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
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
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
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
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 ...