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Dual antiplatelet therapy study expanded into Australia and New Zealand

The Harvard Clinical Research Institute (HCRI) announced today that the DAPT Study has expanded into Australia and New Zealand. Professor Ian Meredith, MBBS, Ph.D., interventional cardiologist at MonashHeart in Melbourne, Australia and National Coordinating Investigator for the DAPT Study in Australia, was the first Pacific Rim investigator to enroll patients into the study.

26 Oct 2010

Sanofi Pasteur presents Fluzone quadrivalent Phase II trial data for influenza at IDSA Annual Meeting

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group announced today the results of a clinical trial of its investigational Fluzone Quadrivalent (Influenza Virus Vaccine) compared to the currently licensed Fluzone (Influenza Virus Vaccine). Data from the Phase II trial assessing the immunogenicity and safety of the investigational quadrivalent vaccine were presented at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia.

26 Oct 2010

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.

26 Oct 2010

Repros commences randomization in Androxal Phase II study in T2DM men with low testosterone

Repros Therapeutics Inc. today announced it has commenced randomization of subjects into its Phase II Androxal® study in the treatment of type 2 diabetes (T2DM) in men with low testosterone. Low testosterone and T2DM are co-morbid conditions in a significant number of men. The study is being conducted at nine sites across the US including both academic and private practices and will enroll up to 150 patients.

25 Oct 2010

Inviragen commences Phase 1 clinical trial of DENVax dengue vaccine in Colombia

Inviragen, a company developing vaccines to protect against infectious diseases worldwide, and the Program for the Study and Control of Tropical Diseases (PECET), jointly announced the initiation of a Phase 1 clinical trial of DENVax™ in Colombia. DENVax is an investigational vaccine designed to provide protection against all four dengue virus serotypes. The trial will measure the safety of DENVax as well as the immune responses induced by the vaccine in healthy adults in Rionegro, Colombia.

25 Oct 2010

Positive results from Alkermes combination Phase 1 study of ALKS 33 and buprenorphine for cocaine addiction

Alkermes, Inc. today announced positive topline results from a phase 1 clinical study of an investigational combination of ALKS 33, one of Alkermes' proprietary candidates, and buprenorphine, an existing medication for the treatment of opioid addiction, for the treatment of cocaine addiction.

25 Oct 2010

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

ViroPharma Incorporated today announced that it has completed enrollment in its Phase 2 study evaluating subcutaneous delivery of Cinryze™ (C1esterase inhibitor [human]). This multi-center, open-label, multi-dose Phase 2 study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze in adolescent and adult subjects with hereditary angioedema (HAE).

25 Oct 2010

Seattle Genetics, Millennium to feature SGN-35 in three poster presentations at ISHL symposium

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced that brentuximab vedotin (SGN-35) will be featured in three poster presentations at the 8th International Symposium on Hodgkin Lymphoma (ISHL) being held October 23-26, 2010 in Cologne, Germany.

25 Oct 2010

Soligenix reports Phase 2 clinical trial results of orBec for GVHD

Soligenix, Inc. a late-stage biopharmaceutical company, today reported preliminary results from its Phase 2 "proof-of-concept" exploratory clinical trial of orBec for the prevention of acute Graft-versus-Host disease (GVHD) in patients undergoing myeloablative conditioning regimens with initiation of dosing prior to hematopoietic cell transplantation (HCT) and continuing through the post-transplantation period.

25 Oct 2010

NovaBay delivers two poster presentations on Aganocide compounds at IDSA Annual Meeting

NovaBay Pharmaceuticals, Inc. a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, delivered two poster presentations on its compounds at the 48th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Vancouver, Canada.

25 Oct 2010

Antigenics expands HSPPC-96 Phase 2 clinical study in glioma

Antigenics, Inc. today announced the expansion of a phase 2 clinical study of HSPPC-96 (Oncophage® vaccine; vitespen), Antigenics' personalized therapeutic cancer vaccine, in patients with newly diagnosed glioma.

25 Oct 2010

Intercell's IC43 Phase II trial against Pseudomonas aeruginosa infections meets primary endpoint

Intercell AG today announced results from a Phase II clinical trial involving the company's investigational nosocomial vaccine candidate (IC43) against infections with the bacterium Pseudomonas aeruginosa, a leading cause of hospital-acquired infections with increasing antibiotic resistance and hence a very high unmet medical need.

25 Oct 2010

Chimerix to present CMX001 data for viral infections at IDSA Annual Meeting

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, will present promising clinical data for CMX001 in a late-breaker poster session at the Infectious Diseases Society of America (IDSA) 48th Annual Meeting.

25 Oct 2010

Novartis informs Emisphere on First Interpretable Results of two-year Phase III Study 2301 in osteoarthritis

Emisphere Technologies, Inc. announced today that Novartis Pharma AG provided Emisphere with information regarding the First Interpretable Results of the two-year Phase III Study 2301 in osteoarthritis conducted by its license partner Nordic Bioscience with oral calcitonin (SMC021).

25 Oct 2010

Optimer presents two fidaxomicin Phase 3 trials data for CDI infection at IDSA Annual Meeting

Optimer Pharmaceuticals, Inc. announced today the presentation of combined data from its two fidaxomicin Phase 3 trials in patients with Clostridium difficile infection (CDI) at the 48th Annual Meeting of the Infectious Disease Society of America (IDSA) in Vancouver, British Columbia, Canada.

25 Oct 2010

Pharmaxis announces combined results of Bronchitol Phase III trial for cystic fibrosis

Pharmaceutical company Pharmaxis today announced significant results of pooled data from its two large scale six month Phase III trials of Bronchitol (inhaled mannitol) in people with cystic fibrosis.

25 Oct 2010

Revance presents results of RT001 two Phase 2b clinical trials for lateral canthal lines at Chicago annual meeting

Revance Therapeutics, Inc. today announced that the results of two Phase 2b clinical trials on RT001, a topical botulinum toxin type A which is under investigation for the treatment of lateral canthal lines (crow's feet wrinkles) were presented at the annual meeting of the American Society of Dermatologic Surgery in Chicago.

25 Oct 2010

Astellas suspends patient enrollment from ACT 5 study of KYNAPID

Cardiome Pharma Corp. today announced that its co-development partner, Astellas Pharma US., Inc., has suspended patient enrollment in the ACT 5 study of KYNAPIDTM (vernakalant hydrochloride) Injection following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received KYNAPID.

22 Oct 2010

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Inspire Pharmaceuticals, Inc. announced today that data will be presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the 24th Annual North American Cystic Fibrosis Conference (NACFC) October 21-23, 2010 in Baltimore, Maryland.

22 Oct 2010

Talecris announces publication of PROLASTIN-C study results for AAT deficiency in BML journal

Talecris Biotherapeutics today announced the publication of results from a study showing that PROLASTIN-C (Alpha1-Proteinase Inhibitor [Human]) (A1PI) is as effective as PROLASTIN (Alpha1-Proteinase Inhibitor [Human]) in raising levels of alpha-1 protein in patients with alpha1-antitrypsin (AAT) deficiency.

22 Oct 2010

Drug Trial News

Dual antiplatelet therapy study expanded into Australia and New Zealand

Sanofi Pasteur presents Fluzone quadrivalent Phase II trial data for influenza at IDSA Annual Meeting

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Repros commences randomization in Androxal Phase II study in T2DM men with low testosterone

Inviragen commences Phase 1 clinical trial of DENVax dengue vaccine in Colombia

Positive results from Alkermes combination Phase 1 study of ALKS 33 and buprenorphine for cocaine addiction

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

Seattle Genetics, Millennium to feature SGN-35 in three poster presentations at ISHL symposium

Soligenix reports Phase 2 clinical trial results of orBec for GVHD

NovaBay delivers two poster presentations on Aganocide compounds at IDSA Annual Meeting

Antigenics expands HSPPC-96 Phase 2 clinical study in glioma

Intercell's IC43 Phase II trial against Pseudomonas aeruginosa infections meets primary endpoint

Chimerix to present CMX001 data for viral infections at IDSA Annual Meeting

Novartis informs Emisphere on First Interpretable Results of two-year Phase III Study 2301 in osteoarthritis

Optimer presents two fidaxomicin Phase 3 trials data for CDI infection at IDSA Annual Meeting

Pharmaxis announces combined results of Bronchitol Phase III trial for cystic fibrosis

Revance presents results of RT001 two Phase 2b clinical trials for lateral canthal lines at Chicago annual meeting

Astellas suspends patient enrollment from ACT 5 study of KYNAPID

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Talecris announces publication of PROLASTIN-C study results for AAT deficiency in BML journal

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