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ARCA receives approval to commence enrollment of first therapeutic trial using HIV vaccine candidate

News on the progress of a new trial may give new hope to patients with HIV who are dependent on anti-HIV drugs. The AIDS Research Consortium of Atlanta has received approval to begin enrollment of the first therapeutic trial ever conducted using a promising HIV vaccine candidate from Atlanta-based, GeoVax Inc, a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines.

14 Jun 2010

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the final analysis of the Phase 3 NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib) tablets in patients with advanced non-squamous non-small cell lung cancer (NSCLC) showed that the study did not meet its primary endpoint of improving overall survival in the first-line setting.

14 Jun 2010

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Celgene International Sàrl announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomized, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival, the primary endpoint of the study.

14 Jun 2010

Chiasma successfully completes Phase I clinical study of Octreolin

Chiasma, Inc., a privately held biopharma company, announced that it has successfully completed a Phase I clinical study evaluating the safety and pharmacokinetics (PK) of its proprietary product Octreolin, which contains the active ingredient octreotide actetate and is administered orally

14 Jun 2010

$Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010$

Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010

Allos Therapeutics, Inc. today announced updated data from its ongoing dose finding Phase 1 study of FOLOTYN (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma, a group of often slow-growing non-Hodgkins lymphomas that primarily manifest in the skin. These data were presented during a poster presentation at the European Hematology Association meeting being held June 10-13, 2010 in Barcelona, Spain.

11 Jun 2010

Phase II study results of riociguat for CTEPH and PAH published online

Bayer HealthCare Pharmaceuticals, Inc. today announced that the study "Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study" was published online this week by the European Respiratory Journal. Results of this study to assess the safety, tolerability and the feasibility of individual dose titration of riociguat were previously presented at the 2009 International Conference of the American Thoracic Society.

11 Jun 2010

Trevena's scientists present research data on GPCR biased ligands at two scientific conferences

Trevena Inc., a leader in the discovery of G-protein coupled receptor biased ligands, today announced that its scientists are presenting research data at two scientific conferences. These oral presentations highlight Trevena's research demonstrating that ligand bias at the angiotensin II type I receptor translates into differentiable and beneficial cardiovascular pharmacology in vivo.

11 Jun 2010

Otonomy completes $10 million Series A financing with Avalon Ventures

Otonomy, Inc. announced today that it has completed a $10 million Series A financing with Avalon Ventures. Proceeds from the financing will be used to support the ongoing clinical trial for OTO-104 in Meniere's disease, initiate IND-enabling studies for OTO-203, and continue early-stage development of a third program.

11 Jun 2010

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced data from a subgroup analysis of a Phase 2 randomized discontinuation trial showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell renal cell carcinoma (RCC) who had undergone a prior nephrectomy was 14.8 months.

11 Jun 2010

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either lenalidomide (REVLIMID), melphalan and prednisone or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of lenalidomide plus low-dose dexamethasone (Rd) were presented at the American Society of Clinical Oncology annual meeting.

11 Jun 2010

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Abraxis BioScience, Inc. presented trial design information from its ongoing phase 3 registration trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), in melanoma, an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year.

11 Jun 2010

Repros receives FDA confirmation on lifting of full clinical hold on Proellex

Repros Therapeutics Inc. today announced it has received written confirmation from the FDA noting the full clinical hold on Proellex® has been lifted. The Company will be allowed to run a single study under the new partial clinical hold status. The new low dose study is designed to explore both safety and signals of efficacy in an escalating dose fashion.

11 Jun 2010

$Cell Therapeutics presents data on PIX301 trial of Pixuvri for relapsed or refractory, aggressive NHL$

Cell Therapeutics presents data on PIX301 trial of Pixuvri for relapsed or refractory, aggressive NHL

Cell Therapeutics, Inc. today reported exploratory analyses of the data at study completion from the Company's pivotal PIX301 trial of Pixuvri, the first randomized controlled trial in patients with relapsed or refractory, aggressive non-Hodgkin's lymphoma.

11 Jun 2010

Helix BioPharma third-quarter revenues increase 20.6%

Helix BioPharma Corp. today announced financial results for the third quarter ended April 30, 2010.

11 Jun 2010

Bevacizumab effective for treatment of wet AMD: Study

An inexpensive, but unlicensed drug to help prevent severe sight loss in older people has been shown to be safe and effective, finds a study published on bmj.com today.

11 Jun 2010

AFREZZA non-inferior to standard therapy insulin lispro in reducing HbA1c levels of Type 1 diabetics

MannKind Corporation today announced that results of a new 16-week trial show that the investigational ultra rapid acting mealtime insulin, AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin, also combined with basal insulin, in reducing HbA1c levels in subjects with inadequately controlled Type 1 diabetes.

11 Jun 2010

Phase 3 AVERROES clinical trial of apixaban for atrial fibrillation closes early due to clear evidence of efficacy

Bristol-Myers Squibb Company and Pfizer today announced that the companies have agreed to stop the Phase 3 AVERROES clinical trial of apixaban in patients with atrial fibrillation. The study will be stopped early because a predefined interim analysis by the independent Data Monitoring Committee (DMC) revealed clear evidence of a clinically important reduction in stroke and systemic embolism in patients with atrial fibrillation considered intolerant of or unsuitable for vitamin K antagonist therapy who received apixaban as compared to aspirin.

11 Jun 2010

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval.

11 Jun 2010

Idenix initiates IDX320 proof-of-concept study for HCV infection

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has initiated a 3-day proof-of-concept study of IDX320, a protease inhibitor for the treatment of hepatitis C virus (HCV) infection, under a Clinical Trial Application (CTA). The study is evaluating IDX320 in treatment-naive hepatitis C genotype 1-infected patients.

10 Jun 2010

FDA grants Collegium Fast Track designation for COL-172 opioid formulation

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of COL-172 for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

10 Jun 2010

Drug Trial News

ARCA receives approval to commence enrollment of first therapeutic trial using HIV vaccine candidate

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Chiasma successfully completes Phase I clinical study of Octreolin

Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010

Phase II study results of riociguat for CTEPH and PAH published online

Trevena's scientists present research data on GPCR biased ligands at two scientific conferences

Otonomy completes $10 million Series A financing with Avalon Ventures

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Repros receives FDA confirmation on lifting of full clinical hold on Proellex

Cell Therapeutics presents data on PIX301 trial of Pixuvri for relapsed or refractory, aggressive NHL

Helix BioPharma third-quarter revenues increase 20.6%

Bevacizumab effective for treatment of wet AMD: Study

AFREZZA non-inferior to standard therapy insulin lispro in reducing HbA1c levels of Type 1 diabetics

Phase 3 AVERROES clinical trial of apixaban for atrial fibrillation closes early due to clear evidence of efficacy

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Idenix initiates IDX320 proof-of-concept study for HCV infection

FDA grants Collegium Fast Track designation for COL-172 opioid formulation

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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