Clinical Trial News and Research

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Results from Phase 2a clinical trial of Raptor Pharmaceutical's cysteamine bitartrate published

Raptor Pharmaceutical Corp. ("Raptor" or the "Company"), today announced the publication of results from a Phase 2a clinical trial of a prototype formulation of its proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

11 Jan 2010

Vertex Pharmaceuticals plans proof-of-concept clinical trials in RA and epilepsy

Vertex Pharmaceuticals Incorporated today provided an update on key 2010 business priorities in conjunction with the 28th Annual J.P. Morgan Healthcare Conference in San Francisco. The company also discussed recent progress in its lead development programs in hepatitis C virus (HCV) infection and cystic fibrosis (CF) and outlined proof-of-concept clinical trials planned in other serious diseases for 2010.

11 Jan 2010

Autism spectrum disorders result from miswiring of connections in developing brain

Studying a rare disorder known as tuberous sclerosis complex (TSC), researchers at Children's Hospital Boston add to a growing body of evidence suggesting that autism spectrum disorders, which affect 25 to 50 percent of TSC patients, result from a miswiring of connections in the developing brain, leading to improper information flow.

10 Jan 2010

LFB completes conversion of all acquired preferred stock

GTC Biotherapeutics, Inc. announced that LFB Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire Français du Fractionnement et des Biotechnologies S.A., Les Ulis, France) and a strategic shareholder in GTC, has converted the convertible preferred stock it previously purchased in November 2009 under the terms described in the financing agreements approved by GTC shareholders in July 2009 into a total of 5.3 million shares of common stock.

9 Jan 2010

FDA yet to review MannKind’s NDA for insulin therapy

MannKind Corporation announced that it was informed today by the Food and Drug Administration that the FDA will not be able to complete the review of MannKind’s new drug application (NDA) for its ultra rapid-acting insulin therapy by the action date of January 16, 2010.

9 Jan 2010

Jiangsu Government grants $1.8M for research and development of hUC-MSC technologies

The Jiangsu Government's Science and Technology Department has announced a $1.8 million grant - the Jiangsu Technological Achievements Transformational Grant - to support the research and development of human umbilical cord mesenchymal stem cell (hUC-MSC) technologies. The grant recipient and administrator, Shenzhen Beike Biotechnology Co., Ltd. (http://www.beikebiotech.com ), is working with Jiangsu University and Nanjing University's Drum Tower Hospital to fulfill the grant's requirements.

9 Jan 2010

Svelte Medical Systems initiates European clinical trial for SOAW delivery system

Svelte Medical Systems, Inc. is pleased to announce that it has initiated its European clinical trial at the Thoraxcenter Research Center in Rotterdam, the Netherlands for its “Stent-on-a-Wire” (SOAW) cobalt–chromium Bare Metal Stent.

9 Jan 2010

FDA grants unconditional approval for World Heart's Levacor VAD BTT study

World Heart Corporation, a developer of mechanical circulatory systems, announced today that it has received unconditional approval from the U.S. Food and Drug Administration ("FDA") for the bridge-to-transplant ("BTT") study of the Levacor Ventricular Assist Device ("VAD"). Study enrollment will encompass 160 subjects, a reduction from the approximately 200 subjects of the original statistical plan. As previously announced, the BTT study will begin initially at ten clinical sites.

8 Jan 2010

TetraLogic Pharmaceuticals commences its TL32711 SMAC mimetic Phase 1 clinical trial

TetraLogic Pharmaceuticals announced today that the Company has completed dosing of the first cohort in a Phase 1 clinical trial of its selective SMAC mimetic, TL32711. The Phase 1 trial is an open-label, dose-escalation study evaluating the safety and tolerability of TL32711 in adults with solid tumors or lymphoma refractory to standard therapies. The study will also assess the pharmacokinetics, pharmacodynamics and anti-tumor activity of TL32711.

8 Jan 2010

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

Chinese researchers have become the world's fifth most prolific contributors to peer-reviewed scientific literature on clock-reversing regenerative medicine even as a skeptical international research community condemns the practice of Chinese clinics administering unproven stem cell therapies to domestic and foreign patients.

8 Jan 2010

3Sbio submits registrational clinical trial application for Feraheme injection

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.

8 Jan 2010

Cell Medica signs R&D agreement with the Center for Cell and Gene Therapy

Cell Medica, a clinical cellular therapeutics company developing proven cell therapies which address important unmet clinical needs in oncology and infectious diseases, announced today the signing of an R&D agreement with the Center for Cell and Gene Therapy, a joint program of Baylor College of Medicine, Texas Children’s Hospital and The Methodist Hospital, Houston, Texas.

8 Jan 2010

Patient enrollment in Tolerx's Phase 3 clinical study DEFEND-1 completed

Tolerx, Inc., today announced the completion of patient enrollment in its Phase 3 clinical study DEFEND-1, which is evaluating the safety and efficacy of otelixizumab, a targeted T cell immunomodulator, in patients with new-onset autoimmune type 1 diabetes.

8 Jan 2010

University Hospitals Case Medical Center conducts Phase 2 clinical trial of gene therapy for AD

University Hospitals Case Medical Center is one of 12 sites conducting the first Phase 2 clinical trial of a gene therapy for Alzheimer's disease (AD). The study uses a viral-based gene transfer system called CERE-110, which is designed to deliver nerve growth factor (NGF) into the brain.

8 Jan 2010

Phase 1 clinical trial of SIRT1 inhibitor for the treatment of Huntington’s Disease commenced

Elixir Pharmaceuticals, Inc. announced today that its partner, Siena Biotech S.p.A., has commenced Phase 1 clinical testing of Elixir’s potent, first-in-class SIRT1 (sirtuin-1) inhibitor for the treatment of Huntington’s Disease.

8 Jan 2010

Gore's next generation Conformable GORE TAG Thoracic Endoprosthesis enters clinical trial

W. L. Gore & Associates (Gore) announced the first human implants of the next generation Conformable GORE TAG® Thoracic Endoprosthesis in the United States for the treatment of traumatic transection of the thoracic aorta.

8 Jan 2010

Pfizer and Debiopharm Group enter into co-development agreement to conduct Phase 3 trial of tremelimumab

Pfizer Inc. (Pfizer) and Debiopharm Group™ (Debiopharm) announced today that they have entered into a co-development agreement to conduct a Phase 3 trial of tremelimumab (CP675,206), a fully human anti-CTLA4 monoclonal antibody for the treatment of patients with unresectable, Stage IV melanoma.

8 Jan 2010

Muscular Dystrophy Association announces milestone grant to develop new treatments for ALS

Buoyed by the extraordinary progress being made by the ALS Therapy Development Institute, the Muscular Dystrophy Association today announced a new milestone-driven grant of $2.5 million, adding to the $18 million MDA already has invested with ALS TDI -- the world's only non-profit research center focused exclusively on developing treatments for amyotrophic lateral sclerosis (ALS).

7 Jan 2010

Rituximab treatment reduces patients' response to pneumonia vaccine

Researchers from Johns Hopkins University determined that immune responses to the tetanus vaccine were not changed when rituximab in combination with methotrexate (MTX) was compared with MTX alone in patients with rheumatoid arthritis (RA).

7 Jan 2010

Penn researchers study benefits of bariatric surgery for treating Type 2 diabetes

A multi-disciplinary team of Penn researchers, including diabetes, weight loss and bariatric surgery experts, are conducting a study funded by the National Institutes of Health (NIH) to determine if bariatric surgery, either gastric bypass or adjustable gastric banding surgery, is more effective than lifestyle modification to reduce weight and ultimately treat Type 2 diabetes.

7 Jan 2010

Clinical Trial News and Research

Results from Phase 2a clinical trial of Raptor Pharmaceutical's cysteamine bitartrate published

Vertex Pharmaceuticals plans proof-of-concept clinical trials in RA and epilepsy

Autism spectrum disorders result from miswiring of connections in developing brain

LFB completes conversion of all acquired preferred stock

FDA yet to review MannKind’s NDA for insulin therapy

Jiangsu Government grants $1.8M for research and development of hUC-MSC technologies

Svelte Medical Systems initiates European clinical trial for SOAW delivery system

FDA grants unconditional approval for World Heart's Levacor VAD BTT study

TetraLogic Pharmaceuticals commences its TL32711 SMAC mimetic Phase 1 clinical trial

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

3Sbio submits registrational clinical trial application for Feraheme injection

Cell Medica signs R&D agreement with the Center for Cell and Gene Therapy

Patient enrollment in Tolerx's Phase 3 clinical study DEFEND-1 completed

University Hospitals Case Medical Center conducts Phase 2 clinical trial of gene therapy for AD

Phase 1 clinical trial of SIRT1 inhibitor for the treatment of Huntington’s Disease commenced

Gore's next generation Conformable GORE TAG Thoracic Endoprosthesis enters clinical trial

Pfizer and Debiopharm Group enter into co-development agreement to conduct Phase 3 trial of tremelimumab

Muscular Dystrophy Association announces milestone grant to develop new treatments for ALS

Rituximab treatment reduces patients' response to pneumonia vaccine

Penn researchers study benefits of bariatric surgery for treating Type 2 diabetes

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