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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

CEI releases new diabetes market forecast study

Since 2008, Cutting Edge Information has developed forecasting data for the diabetes treatment market. The new report -- "Diabetes Market Forecast to 2015" -- provides a deep analysis of the relevant clinical, commercial, and market trends affecting diabetes therapeutics today and their impact leading into the next decade. In addition to detailed drug, class, and company profiles, the study includes primary research findings generated from survey data and interviews with leading physicians and marketing executives.

7 Jan 2010

Cedars-Sinai Heart Institute selected as top 25 hospitals for cardiac bypass surgery

Worth magazine has selected Cedars-Sinai Heart Institute as one of the United States' top 25 hospitals for cardiac bypass surgery.

7 Jan 2010

ProFibrix B.V. receives loan up to $7.4 million to develop its new hemostat Fibrocaps

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that SenterNovem, an agency of the Dutch Ministry of Economic Affairs, has granted the company a loan under its new Innovation Credit scheme of potentially up to EUR 5 million to finance the further clinical development of its unique new hemostat Fibrocaps(TM).

7 Jan 2010

Nutrient mix shows potential to improve memory in Alzheimer's patients

In the early stages of Alzheimer's disease, patients typically suffer a major loss of the brain connections necessary for memory and information processing. Now, a combination of nutrients that was developed at MIT has shown the potential to improve memory in Alzheimer's patients by stimulating growth of new brain connections.

7 Jan 2010

Phase II clinical trial results of Liposome-Entrapped Paclitaxel announced

NeoPharm, Inc. today announced the results of a Phase II clinical trial of Liposome-Entrapped Paclitaxel (LEP) an active component of Taxol®. This multicenter, open-label trial of LEP was conducted at 5 centers in India.

7 Jan 2010

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.

7 Jan 2010

Study explains how H. pylori infection causes stomach cancer

Researchers report that Helicobacter pylori, the only bacterium known to survive in the harsh environment of the human stomach, directly activates an enzyme in host cells that has been associated with several types of cancer, including gastric cancer.

7 Jan 2010

Clinical Trial News and Research

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

CEI releases new diabetes market forecast study

Cedars-Sinai Heart Institute selected as top 25 hospitals for cardiac bypass surgery

ProFibrix B.V. receives loan up to $7.4 million to develop its new hemostat Fibrocaps

Nutrient mix shows potential to improve memory in Alzheimer's patients

Phase II clinical trial results of Liposome-Entrapped Paclitaxel announced

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Study explains how H. pylori infection causes stomach cancer

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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