Clinical Trial News and Research

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First human implants of the Conformable GORE TAG Thoracic Endoprosthesis performed

W. L. Gore & Associates (Gore) today announced the first human implants of the next generation Conformable GORE TAG® Thoracic Endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs). The first implants were performed by Joshua Rovin, MD and Eugene Murphy, MD, at Bayfront Medical Center and William McMillan, MD and Scott Schultz, MD, at North Memorial Medical Center.

21 Oct 2009

Targacept presents data from Phase 2b clinical trial of TC-5214

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics-, today announced the presentation of data from its recently completed Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment in subjects with major depressive disorder, or MDD, who did not respond adequately to first-line treatment with the representative SSRI citalopram hydrobromide.

20 Oct 2009

Novartis' Tasigna capsules meets primary endpoint in comparison trial with Gleevec

Novartis announced today that Tasigna (nilotinib) 200 mg capsules met its primary endpoint in the first head-to-head comparison with the company's groundbreaking drug Gleevec (imatinib mesylate) tablets*. Tasigna produced faster and deeper responses than Gleevec when given as first-line therapy for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna was well tolerated in the study.

20 Oct 2009

Repligen completes patient treatment in its Phase 3 RG1068 clinical trial

Repligen Corporation reported today that it has completed patient treatment in its Phase 3 clinical trial of RG1068, synthetic human secretin, in magnetic resonance imaging (MRI) of the pancreas. The study is designed to assess the sensitivity and specificity of RG1068 in conjunction with MRI for the detection of pancreatic duct abnormalities compared to MRI alone.

20 Oct 2009

Preliminary findings from EDC survey presented at DIA 3rd Annual Clinical Forum

Preliminary findings from a new survey on electronic data capture (EDC) use in clinical trials were presented today at the Drug Information Association's (DIA) 3rd Annual Clinical Forum in Nice, France. The survey, titled "Investigational Site Perspectives on Clinical Trial Information Systems," is the first update to a 2001 survey published on the topic.

20 Oct 2009

Novavax, Avimex and GE Healthcare initiate clinical study of H1N1 VLP influenza vaccine

Novavax, Inc. (Nasdaq: NVAX) announced today that it has initiated a two-stage clinical study of its virus-like-particle (VLP) H1N1 influenza vaccine in Mexico in collaboration with Avimex Laboratories (Avimex) and GE Healthcare.

20 Oct 2009

Trial collaborators present results from Prime-Boost HIV Vaccine Clinical Trial

Detailed results from the Prime-Boost HIV Vaccine Clinical Trial involving more than 16,000 adult volunteers in Thailand show that an investigational HIV vaccine regimen was safe and modestly effective at reducing the rate of HIV infection compared to placebo.

20 Oct 2009

Vitamin D and progesterone combination for treating traumatic brain injury

As doctors begin to test progesterone for traumatic brain injury at sites across the country, researchers are looking ahead to optimizing the hormone's effectiveness.

20 Oct 2009

Stemedica completes pre-IND meeting with the FDA concerning allogeneic mesenchymal bone marrow cells

Stemedica Cell Technologies, Inc., a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigative New Drug) to evaluate the safety and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.

20 Oct 2009

Rexahn Pharmaceuticals announces positive results from Phase IIa Serdaxin clinical study

Rexahn Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in CNS and oncology, today announced top-line results from a Phase IIa clinical study of Serdaxin™, its major depressive disorder (MDD) drug candidate.

20 Oct 2009

New technique to treat metabolic disorders in babies while still in the womb

Researchers say a new development in cord blood transplants for inherited metabolic disorders may be curative for some babies who are treated while still in the womb.

20 Oct 2009

Amylin Pharmaceuticals to present new data from its obesity program at Obesity 2009

Amylin Pharmaceuticals, Inc. today announced that new data from its obesity program will be presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society, to be held in Washington, D.C. October 24-28. Phase 2 data from the pramlintide/metreleptin combination treatment clinical program will be the subject of a late-breaking oral presentation.

20 Oct 2009

Positive results from Transave's Phase II ARIKACE clinical trials

Transave Inc., today reported additional positive clinical trial results on its lead investigational drug, ARIKACE(TM) (liposomal amikacin for inhalation), an antibiotic that aims to treat chronic lung infections.

20 Oct 2009

FDA approves Boehringer Ingelheim's MICARDIS for the reduction of risk of heart attack

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved a new indication for MICARDIS® (telmisartan) for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors. MICARDIS® is the first treatment in its class to be approved for this indication.

19 Oct 2009

Philippines and Malaysian regulatory agencies approve Celsion’s Phase III Thermodox trial

Celsion Corporation announced today that it has received approval from the regulatory agencis in the Philippines and Malaysia for its Pivotal Phase III primary liver cancer Clinical Trial Application.

19 Oct 2009

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.(1) MICARDIS is the most studied ARB in this high-risk patient population and has been commercially available to treat hypertension (high blood pressure) since its approval in 1998.

19 Oct 2009

PLC Systems' RenalGuard to be utilized in a live case transmission at the GISE 2009 conference

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today announced that its RenalGuard System(TM) will be utilized as part of a live case transmission from the Clinica Mediterranea, Naples, Italy, to the 30th Congresso Nazionale della Societa' Italiana di Cardiologia Invasiva (GISE) during the conference.

19 Oct 2009

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that it has initiated activities intended to complete the clinical development of the growth hormone secretagogue (GHS) / ghrelin agonist compound macimorelin (AEZS-130) which could be the first oral diagnostic test approved for growth hormone deficiency (GHD). Macimorelin is the International Non-proprietary Name (INN) designated for the compound by the World Health Organization (WHO).

19 Oct 2009

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

XenoPort, Inc. announced today that it has initiated a Phase 2b clinical trial of arbaclofen placarbil (AP), also known as XP19986, in patients with gastroesophageal reflux disease (GERD) who remain symptomatic despite treatment with a proton pump inhibitor (PPI). The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AP as adjunctive therapy to PPIs.

19 Oct 2009

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received the approval by Health Canada for its pivotal Phase III clinical trial SAPPHIRE in patients with recurrent or refractory anaplastic astrocytoma.

19 Oct 2009

Clinical Trial News and Research

First human implants of the Conformable GORE TAG Thoracic Endoprosthesis performed

Targacept presents data from Phase 2b clinical trial of TC-5214

Novartis' Tasigna capsules meets primary endpoint in comparison trial with Gleevec

Repligen completes patient treatment in its Phase 3 RG1068 clinical trial

Preliminary findings from EDC survey presented at DIA 3rd Annual Clinical Forum

Novavax, Avimex and GE Healthcare initiate clinical study of H1N1 VLP influenza vaccine

Trial collaborators present results from Prime-Boost HIV Vaccine Clinical Trial

Vitamin D and progesterone combination for treating traumatic brain injury

Stemedica completes pre-IND meeting with the FDA concerning allogeneic mesenchymal bone marrow cells

Rexahn Pharmaceuticals announces positive results from Phase IIa Serdaxin clinical study

New technique to treat metabolic disorders in babies while still in the womb

Amylin Pharmaceuticals to present new data from its obesity program at Obesity 2009

Positive results from Transave's Phase II ARIKACE clinical trials

FDA approves Boehringer Ingelheim's MICARDIS for the reduction of risk of heart attack

Philippines and Malaysian regulatory agencies approve Celsion’s Phase III Thermodox trial

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

PLC Systems' RenalGuard to be utilized in a live case transmission at the GISE 2009 conference

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

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