Clinical Trial News and Research

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Obesity treatments falter, but researchers announce gene links

The Wall Street Journal: "An international research consortium says it has identified 18 new gene sites linked to obesity and 13 others associated with how fat is distributed in the body, advances that shed new light on the complex biology underlying one of the world's most pressing public-health problems. The findings are based on studies involving nearly 250,000 people, making the effort the largest so far to unravel the genetic basis of common human traits, researchers said.

11 Oct 2010

Varian and Stanford scientists receive $3.6M NIH grant to develop advanced imaging technology

Scientists from Stanford University and from the Ginzton Technology Center at Varian Medical Systems have jointly received a $3.6 million five-year research grant from the U.S. National Institutes of Health (NIH) to develop advanced imaging technology for improving the quality of CT images for patients with metal objects in their bodies such as hip implants and dental fillings.

11 Oct 2010

Arable introduces CTMS and EDC software for clinical organizations

Arable Corporation has announced the launch of Arable Perform to bring unique CTMS technologies to the clinical trial industry. Whereas traditional CTMS systems have been costly and require months to implement, Perform brings CTMS and EDC capabilities without the traditionally high start-up costs.

11 Oct 2010

Innate Therapeutics initiates MIS416 Phase 2a clinical study in patients with progressive multiple sclerosis

Innate Therapeutics today announced that the company has begun treating patients in a Phase 2a clinical study of its lead molecule, MIS416, in patients with progressive multiple sclerosis (MS).

11 Oct 2010

Genentech initiates GDC-0449 Phase II clinical trial in BCC patients

Curis, Inc. a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Genentech, a member of the Roche Group, has initiated a Phase II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, as a single-agent therapy for patients with operable basal cell carcinoma (BCC).

11 Oct 2010

AVEO presents tivozanib Phase 2 study results at ESMO Congress

AVEO Pharmaceuticals, Inc. a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) were presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

11 Oct 2010

Geron commences GRNOPC1 hESC-based cell therapy in patients with spinal cord injury

Geron Corporation today announced the enrollment of the first patient in the company's clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1. The primary objective of this Phase I study is to assess the safety and tolerability of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.

11 Oct 2010

ArQule announces ARQ 197 Phase 2 clinical trial results at ESMO annual meeting

ArQule, Inc. today announced the presentation of final results from a Phase 2 clinical trial in non-small cell lung cancer (NSCLC) of ARQ 197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, at the annual meeting of the European Society for Medical Oncology (ESMO).

11 Oct 2010

ALung Technologies announces closing of $14 Million Series A financing round

ALung Technologies, Inc. today announced that the Company has closed a $14 Million Series A financing round. The investment will support ongoing clinical trials of the Hemolung™ Respiratory Assist System and its subsequent commercialization. The Company's Hemolung device is expected to help many patients with acute respiratory failure to avoid intubation and invasive mechanical ventilation.

11 Oct 2010

MOH approves BrainStorm's NurOwn stem cell therapy for Phase I/II clinical trial

BrainStorm Cell Therapeutics Inc. a leading developer of adult stem cell technologies and therapeutics, today announced that the Israeli Ministry of Health (MOH) has granted clearance for a Phase I/II clinical trial using the company's autologous NurOwn stem cell therapy in patients with amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease.

11 Oct 2010

TTF therapy with chemotherapy increases survival time in patients with non-small cell lung cancer

Novocure reported today that patients with advanced non-small cell lung cancer (NSCLC) achieved a significant increase in survival time when tumor treating fields (TTF) therapy was added to chemotherapy, as compared to previously reported outcomes for patients receiving chemotherapy alone.

11 Oct 2010

Afinitor-Sandostatin LAR Depot combination extends median PFS in patients with advanced carcinoid tumors

A Novartis Pharmaceuticals Corporation Phase III study of Afinitor® (everolimus) tablets in combination with Sandostatin® LAR Depot (octreotide acetate for injectable suspension) extended median progression-free survival (PFS), or time without tumor growth, in patients with advanced carcinoid tumors compared to taking octreotide LAR alone.

11 Oct 2010

Millennium, Seattle Genetics announce positive top-line results of SGN-35 phase II clinical trial

Seattle Genetics, Inc. and Millennium The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive top-line results from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30. The trial was conducted in 58 relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) patients.

11 Oct 2010

Seattle Genetics reports SGN-75 phase I clinical trial data

Seattle Genetics, Inc. today reported data from a phase I clinical trial of SGN-75 in patients with non-Hodgkin lymphoma or renal cell carcinoma (RCC). Preliminary results demonstrate tolerability and antitumor activity, including two objective responses in the first 16 patients treated. Dose-escalation is continuing.

11 Oct 2010

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first subject has been dosed in the global phase III program of XIAFLEX® for the treatment of Peyronie's disease. Peyronie's disease is the development of scar tissue on the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient.

11 Oct 2010

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

BiondVax Pharmaceuticals Ltd., an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, today announced that it has begun to immunize subjects in a Phase IIa clinical trial of the Multimeric-001 Universal Flu Vaccine candidate. The study will evaluate the safety and immunogenicity of the Multimeric-001 vaccine.

11 Oct 2010

UT Southwestern initiates study on hormone leptin for people with type 1 diabetes

A clinical trial at UT Southwestern Medical Center aims to determine whether adding the hormone leptin to standard insulin therapy might help rein in the tumultuous blood-sugar levels of people with type 1 (insulin-dependent) diabetes.

11 Oct 2010

Phase-II clinical trial of MLN8237 drug shows promising results for treating ovarian cancer

A drug being developed as a treatment for ovarian cancer has shown single agent activity with durable disease control in some patients in a Phase-II clinical trial, an international research group has reported.

11 Oct 2010

FDA designates NeuRx Diaphragm Pacing System as HUD device for ALS patients

Synapse Biomedical Inc. announces today that they have received the U.S. Food and Drug Administration (FDA) designation of the NeuRx Diaphragm Pacing System (DPS) as a Humanitarian Use Device (HUD) for amyotrophic lateral sclerosis (ALS) patients with a stimulatable diaphragm who are experiencing chronic hypoventilation and has now submitted for Humanitarian Device Exemption (HDE) approval.

11 Oct 2010

Infinity announces preliminary results of IPI-926 Phase 1 study in patients with solid tumors

Infinity Pharmaceuticals, Inc. today announced promising preliminary results from a Phase 1 study of IPI-926, its novel, oral small molecule that targets the Hedgehog pathway.

11 Oct 2010

Clinical Trial News and Research

Obesity treatments falter, but researchers announce gene links

Varian and Stanford scientists receive $3.6M NIH grant to develop advanced imaging technology

Arable introduces CTMS and EDC software for clinical organizations

Innate Therapeutics initiates MIS416 Phase 2a clinical study in patients with progressive multiple sclerosis

Genentech initiates GDC-0449 Phase II clinical trial in BCC patients

AVEO presents tivozanib Phase 2 study results at ESMO Congress

Geron commences GRNOPC1 hESC-based cell therapy in patients with spinal cord injury

ArQule announces ARQ 197 Phase 2 clinical trial results at ESMO annual meeting

ALung Technologies announces closing of $14 Million Series A financing round

MOH approves BrainStorm's NurOwn stem cell therapy for Phase I/II clinical trial

TTF therapy with chemotherapy increases survival time in patients with non-small cell lung cancer

Afinitor-Sandostatin LAR Depot combination extends median PFS in patients with advanced carcinoid tumors

Millennium, Seattle Genetics announce positive top-line results of SGN-35 phase II clinical trial

Seattle Genetics reports SGN-75 phase I clinical trial data

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

UT Southwestern initiates study on hormone leptin for people with type 1 diabetes

Phase-II clinical trial of MLN8237 drug shows promising results for treating ovarian cancer

FDA designates NeuRx Diaphragm Pacing System as HUD device for ALS patients

Infinity announces preliminary results of IPI-926 Phase 1 study in patients with solid tumors

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