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Positive results from Phase 2 clinical trial of ARX-03 announced

AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical trial of ARX-03, a proprietary sublingual dosage form combining an opioid, sufentanil, with a benzodiazepine, triazolam.

23 Oct 2009

KemPharm commences KP106 Phase 1 clinical trial for ADHD

KemPharm, Inc. today announced that it has commenced a Phase 1 clinical trial in healthy volunteers of its novel prodrug compound, KP106, which is in development for the treatment of attention-deficit hyperactivity disorder (ADHD). KP106, a new chemical entity (NCE) composed of d-amphetamine and a ligand, is the lead investigational candidate from KemPharm’s proprietary ligand activated therapy (LAT) platform, which creates improved versions of FDA-approved drugs. KemPharm began the KP106 program in 2007 and has initiated the Phase 1 clinical trial of this candidate in less than 24 months.

22 Oct 2009

Positive results from Aerie Pharmaceuticals’ Phase 2a study of its Rho-kinase inhibitor

Aerie Pharmaceuticals, a biotechnology company focused on the discovery and development of novel treatments for glaucoma, today announced positive results from a Phase 2a study of its Rho-kinase (ROCK) inhibitor, AR-12286. The study evaluated the safety, tolerability and efficacy of three different doses of AR-12286 in 88 patients with primary open angle glaucoma or ocular hypertension.

22 Oct 2009

PacificGMP selected by ArmaGen Technologies to produce its proprietary protein for a Phase 1 clinical trial

PacificGMP, the leader in single-use bioprocessing for development and manufacturing for its client partners, announced that ArmaGen Technologies has selected it to produce its proprietary protein for a Phase 1 clinical trial.

22 Oct 2009

Pharmos announces results of its Phase 2b Dextofisopam trial

Pharmos Corporation (Pink Sheets: PARS); on September 14, 2009, Pharmos announced the results of its Phase 2b Dextofisopam trial for the treatment of diarrhea predominant and alternating diarrhea and constipation irritable bowel syndrome.

22 Oct 2009

Highlights of Cell Therapeutics' pixantrone study to be presented at the Lymphoma and Myeloma Conference

Cell Therapeutics, Inc. announced that Dr. Richard Van der Jagt of the Ottawa General Hospital will present at the Lymphoma and Myeloma 2009 Conference in New York an overview of CTI's pixantrone phase II and phase III clinical studies that demonstrated high rates of complete remission (CR) in relapsed/refractory aggressive and indolent non-Hodgkin's lymphoma (NHL) patients.

22 Oct 2009

Sosei Group announces Phase III trials update on NVA237 and QVA149

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), announces that the Phase III trials with NVA237, which commenced in June 2009, are proceeding to plan. Initiation of Phase III studies with QVA149 is now expected to occur during 2010.

22 Oct 2009

ISTA Pharmaceuticals' presentations on Phase 3 clinical results of Bepreve

ISTA Pharmaceuticals, Inc. today announced poster presentations of results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies in allergic conjunctivitis. The studies demonstrated Bepreve was safe and well-tolerated when given twice daily for six weeks in a healthy pediatric population as young as three years of age.

22 Oct 2009

Dose optimization data from Tolerx's Phase 2 clinical study of otelixizumab

Tolerx, Inc., a biopharmaceutical company developing novel therapies intended to treat diabetes, other autoimmune diseases and cancer by specifically modulating T-cell activity, today presented dose optimization data from its Phase 2 clinical study of otelixizumab in subjects with type 1 diabetes. Otelixizumab is a targeted T-cell immunomodulator currently being evaluated in DEFEND, a Phase 3 clinical study in subjects with new-onset autoimmune type 1 diabetes.

22 Oct 2009

Peregrine Pharmaceuticals reports positive results from Phase II trial of bavituximab

Peregrine Pharmaceuticals, Inc. today reported positive results from its Phase II trial evaluating bavituximab in combination with docetaxel in patients with advanced breast cancer.

22 Oct 2009

Halozyme Therapeutics commences patient dosing in Phase 3 Enhanze trial with Herceptin

Halozyme Therapeutics, Inc. and Roche today announced dosing of the first patient in a Phase 3 registration trial using Enhanze™ technology (rHuPH20, recombinant human hyaluronidase) in a subcutaneous formulation with Roche’s anticancer biologic, Herceptin (trastuzumab).

22 Oct 2009

Study compares effects of clin-BPO 2.5% and clin-BPO 5% on epidermal functions

Dermatologists agree that topical fixed-combination products containing clindamycin (clin) and benzoyl peroxide (BPO) are effective in the treatment of acne. However, products containing BPO concentrations at 5% or higher may limit use due to associated dryness and irritation in some patients.

22 Oct 2009

New findings from ADVANCE clinical trial presented

New analyses of the largest-ever clinical trial of patients with type 2 diabetes show that the combination of blood pressure lowering treatment and intensive glucose (blood sugar) control improved patients' vascular condition and resulted in a significant 18 percent reduction in the risk of death from all causes.

22 Oct 2009

Millennium commences Vc-R-CHOP Phase II trial for diffuse large B-cell lymphoma

Millennium: The Takeda Oncology Company today announced the initiation of a Phase II clinical trial examining rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) with or without VELCADE® (bortezomib) for Injection for patients with a common type of lymphoma. The study will examine previously untreated patients with a genomically defined subtype of lymphoma called non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma.

22 Oct 2009

Positive results from Isis Pharmaceuticals' ISIS 113715 Phase 2 study in type 2 diabetes patients

Isis Pharmaceuticals, Inc. today announced positive top-line results from a Phase 2 study evaluating the safety and efficacy of ISIS 113715 in patients with type 2 diabetes. ISIS 113715 is a novel insulin sensitizer that reduces the expression of protein tyrosine phosphatase-1B (PTP-1B). The study showed consistent and statistically significant reductions in multiple short and intermediate measures of glucose control.

22 Oct 2009

Positive results from Argos Therapeutics' personalized immunotherapy candidate AGS-004 Phase 2a trial

Argos Therapeutics today announced two presentations at the AIDS Vaccine 2009 conference, detailing positive viral load, immune response and safety data from an ongoing Phase 2a trial of AGS-004, its personalized immunotherapy candidate. AGS-004 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden.

21 Oct 2009

Northwest Biotherapeutics announces long-term data from Phase I and Phase I/II clinical trials of DCVax-Brain

Northwest Biotherapeutics, Inc. today announced further long-term follow-up data, for the period from January through September 2009, from its prior Phase I and Phase I/II clinical trials conducted at UCLA with DCVax®-Brain in patients with Glioblastoma multiforme ("GBM"). GBM is the most rapid and lethal type of brain cancer. During the update period, only one of the twenty patients treated with DCVax®-Brain (in addition to standard of care) died, and that patient had survived for nearly 7 years (80.5 months).

21 Oct 2009

CombinatoRx announces Synavive Phase 2 extension trial results at the 2009 ACR meeting

CombinatoRx, Incorporated today announced the results of a 12 month knee osteoarthritis (OA) Phase 2 extension trial for Synavive™ (CRx-102) at the American College of Rheumatology (ACR) 2009 Annual Meeting in Philadelphia. The data demonstrated that Synavive-treated subjects maintained efficacy levels throughout the 12 month extension trial.

21 Oct 2009

Celsion completes patient enrollment in its global Phase III ThermoDox trial

Celsion Corporation announced today that it has completed a critical regulatory step in the countries of China and Japan to rapidly enroll patients in its global Phase III ThermoDox trial for the treatment of Hepatocellular Carcinoma (HCC), also known as primary liver cancer.

21 Oct 2009

Delcath Systems completes its pivotal Phase III Metastatic Melanoma Trial enrollment

Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that its pivotal Phase III Metastatic Melanoma Trial has met its goal of 92 patients and is fully enrolled.

21 Oct 2009

Drug Trial News

Positive results from Phase 2 clinical trial of ARX-03 announced

KemPharm commences KP106 Phase 1 clinical trial for ADHD

Positive results from Aerie Pharmaceuticals’ Phase 2a study of its Rho-kinase inhibitor

PacificGMP selected by ArmaGen Technologies to produce its proprietary protein for a Phase 1 clinical trial

Pharmos announces results of its Phase 2b Dextofisopam trial

Highlights of Cell Therapeutics' pixantrone study to be presented at the Lymphoma and Myeloma Conference

Sosei Group announces Phase III trials update on NVA237 and QVA149

ISTA Pharmaceuticals' presentations on Phase 3 clinical results of Bepreve

Dose optimization data from Tolerx's Phase 2 clinical study of otelixizumab

Peregrine Pharmaceuticals reports positive results from Phase II trial of bavituximab

Halozyme Therapeutics commences patient dosing in Phase 3 Enhanze trial with Herceptin

Study compares effects of clin-BPO 2.5% and clin-BPO 5% on epidermal functions

New findings from ADVANCE clinical trial presented

Millennium commences Vc-R-CHOP Phase II trial for diffuse large B-cell lymphoma

Positive results from Isis Pharmaceuticals' ISIS 113715 Phase 2 study in type 2 diabetes patients

Positive results from Argos Therapeutics' personalized immunotherapy candidate AGS-004 Phase 2a trial

Northwest Biotherapeutics announces long-term data from Phase I and Phase I/II clinical trials of DCVax-Brain

CombinatoRx announces Synavive Phase 2 extension trial results at the 2009 ACR meeting

Celsion completes patient enrollment in its global Phase III ThermoDox trial

Delcath Systems completes its pivotal Phase III Metastatic Melanoma Trial enrollment

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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