Clinical Trial News and Research

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Euthymics announces EB-1010 Phase II data for major depressive disorder at ACNP meeting

9 Dec 2010

Euthymics's EB-1010 effective in treatment of major depressive disorder: Study

Euthymics Bioscience, Inc. today will present Phase II clinical data demonstrating that its lead product candidate EB-1010, a next-generation antidepressant, is effective for treating major depressive disorder (MDD) based on multiple standard measures of outcome for depression. EB-1010 also improved measures of anhedonia, a hallmark symptom of MDD, which is characterized by the inability to experience pleasure.

9 Dec 2010

Alkermes announces preliminary results from ALKS 33 Phase 2 study in alcohol dependence

Alkermes, Inc. today announced preliminary results from a phase 2 clinical study of ALKS 33, one of Alkermes' proprietary candidates for the treatment of reward disorders and other central nervous system (CNS) disorders. The 12-week study was designed to assess the safety and efficacy of daily oral administration of three different dose levels of ALKS 33 compared to placebo in 400 alcohol dependent patients.

9 Dec 2010

Bavarian Nordic receives SPA for Phase 3 study of PROSTVAC for advanced prostate cancer

Bavarian Nordic A/S announced today that the company has received a letter of concurrence from the U.S. Food and Drug Administration on a Special Protocol Assessment for a Phase 3 study required for product registration for its product candidate, PROSTVAC, for the treatment of patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.

8 Dec 2010

Study comparing subcutaneous, intravenous administration of VELCADE in relapsed MM patients presented at ASH

Millennium: The Takeda Oncology Company today reported results from a randomized, international Phase III clinical trial comparing subcutaneous and intravenous administration of VELCADE (bortezomib) in patients with relapsed multiple myeloma. These data were presented at the 52nd annual meeting of the American Society of Hematology, held December 4-7 in Orlando, Florida.

8 Dec 2010

SORIN uses KIKA's advanced EDC platform to evaluate effectiveness of Heart Valves

KIKA™ Clinical Solutions announced that SORIN Group is using KIKA's advanced EDC platform for clinical trial asset management on two open observational, multi-center, Real Life Registries to evaluate the effectiveness of SORIN Heart Valves.

8 Dec 2010

Video games effective in improving diet behaviors of children

Obesity in youngsters has risen dramatically in recent decades. Fruit and vegetable (FV) consumption and increased water intake can lower the risk of obesity, as can increased physical activity, but it is not always easy to convince children to eat better and exercise more. In a new study published in the January 2011 issue of the American Journal of Preventive Medicine, researchers found that video games designed to encourage these behaviors were effective.

8 Dec 2010

Vision community, FDA discuss use of PROs to improve labeling of ophthalmic treatments, products

The vision community is discussing with the Food and Drug Administration how vision-related patient-reported outcomes might be used in improving the labeling of ophthalmic treatments and products. The group — composed of researchers, clinicians, policymakers and representatives from industry and vision associations — attended a one-day symposium sponsored by the National Institutes of Health's National Eye Institute and the FDA on October 13, 2009.

8 Dec 2010

First standard-of-care guidelines for children with congenital muscular dystrophy

In 2008, Eunice and Andrew Kim were facing a situation that would bewilder any parents: Two expert pediatric surgeons were giving opposing advice about treatment for their daughter.

8 Dec 2010

Journal of Hand Surgery publishes XIAFLEX CORD II phase III clinical trial

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that The Journal of Hand Surgery (JHS) has published in its December 2010 online edition pivotal CORD II phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic, conducted by BioSpecifics' strategic partner Auxilium Pharmaceuticals Inc., for the nonsurgical treatment of adult Dupuytren's contracture patients with a palpable cord.

8 Dec 2010

UC researchers launch clinical trial to study post-stroke brain injury

The largest clinical trial of therapeutic brain cooling after stroke has launched, led by researchers at the University of California, San Diego, the University of Texas Health Science Center at Houston, and at Cedars-Sinai Medical Center in Los Angeles. This study looks at whether hypothermia can safely be used in elderly stroke patients.

8 Dec 2010

Case Western Reserve School of Medicine researchers receive NIH grant for four research endeavors

Case Western Reserve University School of Medicine faculty members are reaping the rewards of funding from the National Institutes of Health, in the form of grants and contracts. The funding totals more than $6.4 million for four different research endeavors.

8 Dec 2010

BioMimetic Therapeutics to assess safety, clinical utility of Augment Rotator Cuff Graft

BioMimetic Therapeutics, Inc. today announced it initiated enrollment in a pilot clinical trial to assess the safety and clinical utility of AugmentTM Rotator Cuff Graft for the repair of large rotator cuff tears. The randomized, controlled pilot trial is expected to include enrollment of up to 30 patients.

8 Dec 2010

Swissmedic authorizes Phase I/II clinical trial of human neural stem cells for chronic spinal cord injury

A therapy developed by Aileen Anderson and Brian Cummings of UC Irvine's Sue and Bill Gross Stem Cell Research Center in collaboration with researchers at StemCells Inc. will be the basis of the world's first clinical trial using human neural stem cells to treat spinal cord injury.

8 Dec 2010

MP receives FDA IND approval for clinical trial with HTLV-I/II ELISA 4.0 and HTLV Blot.2.4

MP Biomedicals LLC announced today that it has received approval of its investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to start pivotal clinical trials in the USA with the MP Diagnostics™ HTLV-I/II ELISA 4.0 and HTLV Blot.2.4. Studies will be conducted within the American Red Cross, the California Department of Public Health, and LABS, Inc. The company is working closely with the principal investigator of the American Red Cross sites, Dr. Susan Stramer, Executive Scientific Officer.

From MP Biomedicals, LLC 7 Dec 2010

$Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL$

Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive data from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35) in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, a defining marker of ALCL. The data were presented today during an oral session at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL.

7 Dec 2010

StemCells receives Swissmedic authorization to initiate HuCNS-SC Phase I/II clinical trial in spinal cord injury

StemCells, Inc. announced today that is has received authorization from Swissmedic, the Swiss regulatory agency for therapeutic products, to initiate a Phase I/II clinical trial in Switzerland of the Company's proprietary HuCNS-SC® product candidate (purified human neural stem cells) in chronic spinal cord injury. The trial is designed to assess both safety and preliminary efficacy in patients with varying degrees of paralysis who are three to 12 months post-injury, and will progressively enroll patients based upon the severity of injury.

7 Dec 2010

John Theurer Cancer Center presents research findings at ASH meeting

The John Theurer Cancer Center at Hackensack University Medical Center announced today important research findings presented at the annual meeting of the American Society of Hematology taking place December 4-7, 2010 in Orlando, Florida. The ASH meeting is the world's leading scientific gathering of hematologists and hematology researchers.

7 Dec 2010

Roche completes enrollment in Herceptin SC Phase 3 trial for HER2-positive breast cancer

Halozyme Therapeutics, Inc. today announced that Roche has completed patient enrollment for the pivotal Phase 3 study of Herceptin SC (trastuzumab subcutaneous), a subcutaneous formulation that uses Halozyme's Enhanze™ technology (rHuPH20, recombinant human hyaluronidase).

7 Dec 2010

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced interim results from a Phase I clinical trial of its investigational drug candidate, recombinant human Interleukin-7 (CYT107), in the treatment of post-transplant patients with T-cell depleted (TCD) bone marrow or peripheral blood stem cell transplants.

7 Dec 2010

Clinical Trial News and Research

Euthymics announces EB-1010 Phase II data for major depressive disorder at ACNP meeting

Euthymics's EB-1010 effective in treatment of major depressive disorder: Study

Alkermes announces preliminary results from ALKS 33 Phase 2 study in alcohol dependence

Bavarian Nordic receives SPA for Phase 3 study of PROSTVAC for advanced prostate cancer

Study comparing subcutaneous, intravenous administration of VELCADE in relapsed MM patients presented at ASH

SORIN uses KIKA's advanced EDC platform to evaluate effectiveness of Heart Valves

Video games effective in improving diet behaviors of children

Vision community, FDA discuss use of PROs to improve labeling of ophthalmic treatments, products

First standard-of-care guidelines for children with congenital muscular dystrophy

Journal of Hand Surgery publishes XIAFLEX CORD II phase III clinical trial

UC researchers launch clinical trial to study post-stroke brain injury

Case Western Reserve School of Medicine researchers receive NIH grant for four research endeavors

BioMimetic Therapeutics to assess safety, clinical utility of Augment Rotator Cuff Graft

Swissmedic authorizes Phase I/II clinical trial of human neural stem cells for chronic spinal cord injury

MP receives FDA IND approval for clinical trial with HTLV-I/II ELISA 4.0 and HTLV Blot.2.4

Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

StemCells receives Swissmedic authorization to initiate HuCNS-SC Phase I/II clinical trial in spinal cord injury

John Theurer Cancer Center presents research findings at ASH meeting

Roche completes enrollment in Herceptin SC Phase 3 trial for HER2-positive breast cancer

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

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