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Phase IIa clinical data of EHT 0202 released

Top-line Phase IIa clinical data released today demonstrate that EHT 0202, ExonHit’s lead candidate for the treatment of Alzheimer’s disease, is safe and generally well tolerated in patients and that it could potentially enhance cognition in Alzheimer’s disease patients.

14 Sep 2009

Phase III STARTMRK clinical study on ISENTRESS in comparison to efavirenz

ISENTRESS , an integrase inhibitor from Merck & Co., Inc., was studied in comparison to efavirenz in maintaining viral load suppression to undetectable levels (less than 50 copies/mL) and at improving CD4 cell counts in previously untreated (treatment-naïve) HIV-1-infected patients through 96 weeks in a Phase III study called STARTMRK.

14 Sep 2009

Clinical data on CXA-101 to be presented at ICAAC

Calixa Therapeutics Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel antibiotics for the treatment of antibiotic-resistant infections, will present pre-clinical and clinical data in 20 posters at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) that is being held in San Francisco on September 12 to 15, 2009.

14 Sep 2009

Tobira Therapeutics presents TBR-652 in vitro data for treating HIV at the 49th ICAAC

Tobira Therapeutics Inc., a clinical stage biotechnology company committed to research and product discovery for the treatment of life-threatening and life-altering infectious diseases, today announced results from an in vitro study evaluating TBR-652 in combination with lopinavir (LPV), darunavir (DRV), atazanavir (ATV), tenofovir (TDF), etravirine (ETV), and raltegravir (RAL) using the infectious replicative assay deCIPhR.

14 Sep 2009

Clinical data emphasizing on efficacy and potency of torezolid to be presented

Trius Therapeutics, Inc. announced today that 13 posters will be presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) supporting the potency, efficacy and safety of torezolid as a potential new antibiotic for the treatment of severe skin infections caused by gram positive bacteria including MRSA.

14 Sep 2009

Phase III clinical trial results of DAR-31 published

Gilead Sciences, Inc. today announced the publication of data from DAR-311 (DORADO), a Phase III clinical trial evaluating the company’s once-daily oral endothelin receptor antagonist (ERA) darusentan as an add-on treatment for resistant hypertension, defined as the failure to achieve blood pressure goal while adhering to full doses of an appropriate three (or more) drug antihypertensive regimen that includes a diuretic.

14 Sep 2009

Data from Phase III clinical trial of TYSABRI presented at ECTRIMS

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showing the potential of TYSABRI® (natalizumab) to redefine successful multiple sclerosis (MS) therapy.

14 Sep 2009

Influenza patients treated with Tamiflu has higher survival rates

Roche announced today that two new observational studies concluded that influenza patients treated with Tamiflu(R) (oseltamivir phosphate) had significantly higher survival rates than untreated patients.

14 Sep 2009

Phase IIa trial results of panobacumab released

Kenta Biotech has presented positive Phase IIa results of its lead drug candidate, panobacumab (KBPA101), showing it is safe and well tolerated in patients with hospital-acquired pneumonia caused by Pseudomonas aeruginosa. The compound, a fully human IgM monoclonal antibody, has the potential to reduce mortality rates.

14 Sep 2009

FOCUS 1 and FOCUS 2 clinical trial results released

Forest Laboratories, Inc today presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco new data from a complete analysis of FOCUS 1 and FOCUS 2, two global multicenter Phase III studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients.

14 Sep 2009

NIAID conducts human clinical trials of 2009 H1N1 influenza vaccines

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, also is conducting clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited. The NIAID trials are testing two different dosages (15 micrograms versus 30 micrograms) and evaluating the immune response to one and two doses of these vaccines.

14 Sep 2009

Oral NKTR-118 has low risk for mediating significant drug-drug interactions

Nektar Therapeutics presented clinical study data today demonstrating that the oral tablet formulation of NKTR-118 has favorable systemic bioavailability and a low risk for mediating significant drug-drug interactions.

14 Sep 2009

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Genzyme Corporation reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.

14 Sep 2009

AVONEX results in fewer injection site reactions, according to a clinical study

Data from an observational phase IV study of 499 patients entitled The Swiss MS Skin Project show that multiple sclerosis (MS) patients taking AVONEX (interferon beta-1a IM) reported significantly fewer injection site reactions (ISRs) compared to patients on Betaferon- (interferon beta-1b), Copaxone- (glatiramer Acetate) or Rebif - (interferon beta-1a).

13 Sep 2009

Genspera to commence G-202 Phase I trial following FDA approval

GenSpera, Inc. announced today that the Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to begin a Phase I study with its target activated pro-drug, G-202, for the treatment of cancer.

11 Sep 2009

Results from the BRITE-MD trials published in Psychiatry Research: Aspect Medical Systems

Aspect Medical Systems, Inc. (NASDAQ: ASPM) today announced that two companion articles highlighting results from the BRITE-MD (Biomarkers for Rapid Identification of Treatment Effectiveness trial in Major Depression) were published in the September issue of the journal Psychiatry Research.

11 Sep 2009

Dyax' Phase 3 hereditary angioedema clinical program affirms reliability of its novel PROs

Dyax Corp. (NASDAQ:DYAX) today announced a study published evaluating the Company’s novel Patient Reported Outcome Measures (PROs) used to assess hereditary angioedema (HAE) attacks affirmed the PROs as valuable instruments in capturing HAE symptom severity and impact of treatment.

11 Sep 2009

Delcath Systems to continue Phase III clinical trial

Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that the Data and Safety Monitoring Board ("DSMB") reviewed clinical data on 77 patients enrolled in its pivotal Phase III clinical trial and unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study.

11 Sep 2009

Pluristem begins enrollment following FDA approval for clinical trials of its PLX-PAD stem cell product

Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that it has begun enrolling patients in the U.S. for a Phase I clinical trial with its unmatched placenta-derived stem cell product, PLX-PAD, the Company’s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

11 Sep 2009

First patient enrolled in Phase 2b RADAR clinical trial

Regado Biosciences, a privately held company leading the development of antithrombotic therapeutic aptamers with active control agents, announced that on September 8, 2009 enrollment of the first patient in a Phase 2b, randomized, partially-blinded, multi-center, active-controlled, dose-ranging study of its lead product candidate, the REG1 anticoagulation system (REG1) was achieved.

11 Sep 2009