Clinical Trial News and Research

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Oncolytics Biotech completes Phase I enrollment in Phase I/II trial of REOLYSIN for recurrent malignant gliomas

Oncolytics Biotech Inc. announced today that it has completed Phase I patient enrollment in its Phase I/II clinical trial to investigate the use of REOLYSIN(R) for patients with recurrent malignant gliomas (REO 007). The principal investigator is Dr. James Markert, Division Director of Neurosurgery, and Professor, Neurosurgery and Physiology, the University of Alabama at Birmingham.

23 Apr 2010

MMV supports Pfizer's AZCQ clinical trial for intermittent preventive treatment of malaria in pregnant women

Pfizer Inc. and Medicines for Malaria Venture (MMV) entered into an agreement for the development, access and delivery of a fixed-dose combination treatment consisting of azithromycin dihydrate (AZ) and chloroquine phosphate (CQ) for the Intermittent Preventive Treatment of P. falciparum malaria in pregnancy (IPTp). There is currently an unmet need for new treatment options and the World Health Organization (WHO) estimates that some 30 million pregnant women are at risk for malaria in endemic areas in Africa each year.

23 Apr 2010

New blood test to determine patients at low risk for rejection of transplanted hearts

After his heart transplant in 2005, Ramon Llenado underwent a biopsy every week, then every month, then every three months. Most heart transplant patients face a lifetime of these invasive tests, which involve snipping out tiny pieces of heart to check for possible organ rejection.

23 Apr 2010

Interesting heart rate dynamics in premature infants

A normal healthy heart beats at a variable rate with extraordinarily complex fluctuations across a wide range of time scales. Reduced complexity of heart rate has both clinical and dynamical significance - it may provide warning of impending illness, or clues about the dynamics of the heart's pacemaking system.

23 Apr 2010

New multi-faceted treatment program for young adults addicted to opioid drugs

A multi-faceted treatment program for young adults addicted to opioid drugs was unveiled today at the National Institute on Drug Abuse's Blending Conference in Albuquerque, N.M. This eighth meeting in the series brings together researchers and clinicians so their latest findings can be immediately applied to the needs of patients and their families dealing with addictive disorders.

23 Apr 2010

Geron scientists highlight importance of telomerase inhibitor, GRN163L at AACR 2010

Geron Corporation today announced five presentations by Geron scientists and collaborators on the company's telomerase inhibitor, imetelstat sodium, including the drug's activity against cancer stem cells, at the 101st American Association for Cancer Research annual meeting held in Washington D.C.

23 Apr 2010

Hospital for Special Care launches ALS Clinical Trials Unit at Neuromuscular Center

Hospital for Special Care announced today the launch of the region's first Amyotrophic Lateral Sclerosis (ALS) Clinical Trials Unit at its Neuromuscular Center. The new unit will be headed by Jinsy A. Andrews, M.D., a physician researcher recruited from Columbia University. Dr. Andrews, Director of Research & Clinical Trials Unit, Hospital for Special Care, specializes in neuromuscular research and will facilitate the hospital's first clinical trial for ALS upon her arrival.

23 Apr 2010

Nile Therapeutics prices underwritten public offering of common stock

Nile Therapeutics, Inc., a company focused on the development of novel therapeutics for heart failure patients, announced the pricing of its previously announced underwritten public offering of 6,500,000 units of its securities at a public offering price of $0.70 per unit. Each unit consists of one share of Nile common stock and 0.30 warrants to purchase common stock.

23 Apr 2010

Tryton Medical widens European availability of Side Branch Stent System

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced the launch of the TRYTON Side Branch Stent™ System in Austria, Belgium, Denmark, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, and the United Kingdom. The stent is used to treat bifurcation lesions, the largest unmet need confronting interventional cardiology.

23 Apr 2010

FDA grants conditional approval for first approved Total Spine Arthroplasty system clinical study

Flexuspine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted conditional approval to begin the initial phase of the Investigational Device Exemption (IDE) for a feasibility study of its FSU device. This is the first approved clinical study for a Total Spine Arthroplasty system in the U.S.

23 Apr 2010

Ampio Pharmaceuticals signs LOI to acquire DMI Biosciences

Ampio Pharmaceuticals, Inc., today announced that it has entered into a letter of intent to acquire DMI Biosciences, Inc.

23 Apr 2010

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).

23 Apr 2010

Valor Medical's European cerebral aneurysm clinical trial finalized with 30 patients treated

Valor Medical's CEO, H. Clark Adams, announced today that Valor's European clinical trial was finalized with 30 patients treated. Mr. Adams stated, "The trial took longer than expected because there are current approved therapies which were used as a first line of therapy. Patients who were enrolled to be treated with Valor's Neucrylate were not always acceptable candidates for these standard-of-care therapies.

22 Apr 2010

Alexion Pharmaceuticals reports total revenues of $117.6M from net product sales of Soliris

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter ended March 31, 2010.

22 Apr 2010

Cancers deficient in ASS enzyme allow ADI-PEG 20 to inhibit cancer cell growth

Polaris Group scientists and university collaborators reported at the American Association for Cancer Research (AACR), that a number of different cancers have a deficiency in a specific enzyme, argininosuccinate synthetase (ASS), which allows pegylated arginine deiminase (ADI-PEG 20) to inhibit cancer cell growth.

22 Apr 2010

Life sciences companies shifting away from traditional document management systems to emerging ECC solutions

Virtify, Inc., today announced the availability of a new IDC Health Insights study titled "Managing Paper at Its Roots: Extending Beyond Document Management to Enterprise Content Compliance." The new IDC Health Insights study, which was commissioned by Virtify, shows a growing trend in the life sciences industry away from traditional document management systems to emerging Enterprise Content Compliance (ECC) solutions.

22 Apr 2010

Alnylam Pharmaceuticals presents new data on ALN-TTR01 RNAi therapeutic at amyloidosis symposium

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, presented new pre-clinical data from its ALN-TTR program at the XII International Symposium on Amyloidosis in Rome on April 18 - 21, 2010. ALN-TTR01 is a systemically delivered RNAi therapeutic being developed for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR), including familial amyloidotic polyneuropathy (FAP) and familial amyloidotic cardiomyopathy (FAC).

22 Apr 2010

StemCells to initiate second clinical trial of HuCNS-SC human neural stem cells in NCL

StemCells, Inc. announced today that it has submitted a protocol to the FDA for initiation of a second clinical trial of its proprietary HuCNS-SC human neural stem cells in neuronal ceroid lipofuscinosis, which is also often referred to as Batten disease.

22 Apr 2010

ImmunoCellular Therapeutics, UPENN sign research agreement

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune based therapies for the treatment of various forms of cancer, announced today that the Company has entered into a sponsored research agreement and an option agreement with The University of Pennsylvania to support process development and manufacturing in a planned Phase II clinical trial of ICT-107, the Company's dendritic-cell based cancer vaccine product candidate for the treatment of glioblastoma multiforme.

22 Apr 2010

Infinity Pharmaceuticals initiates Phase 1b/2 trial of IPI-926 Hedgehog pathway inhibitor for pancreatic cancer

Infinity Pharmaceuticals, Inc., an innovative drug discovery and development company, today announced that it has initiated a randomized Phase 1b/2 clinical trial evaluating IPI-926, its novel, oral Hedgehog pathway inhibitor, in combination with gemcitabine in patients with pancreatic cancer.

22 Apr 2010

Clinical Trial News and Research

Oncolytics Biotech completes Phase I enrollment in Phase I/II trial of REOLYSIN for recurrent malignant gliomas

MMV supports Pfizer's AZCQ clinical trial for intermittent preventive treatment of malaria in pregnant women

New blood test to determine patients at low risk for rejection of transplanted hearts

Interesting heart rate dynamics in premature infants

New multi-faceted treatment program for young adults addicted to opioid drugs

Geron scientists highlight importance of telomerase inhibitor, GRN163L at AACR 2010

Hospital for Special Care launches ALS Clinical Trials Unit at Neuromuscular Center

Nile Therapeutics prices underwritten public offering of common stock

Tryton Medical widens European availability of Side Branch Stent System

FDA grants conditional approval for first approved Total Spine Arthroplasty system clinical study

Ampio Pharmaceuticals signs LOI to acquire DMI Biosciences

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Valor Medical's European cerebral aneurysm clinical trial finalized with 30 patients treated

Alexion Pharmaceuticals reports total revenues of $117.6M from net product sales of Soliris

Cancers deficient in ASS enzyme allow ADI-PEG 20 to inhibit cancer cell growth

Life sciences companies shifting away from traditional document management systems to emerging ECC solutions

Alnylam Pharmaceuticals presents new data on ALN-TTR01 RNAi therapeutic at amyloidosis symposium

StemCells to initiate second clinical trial of HuCNS-SC human neural stem cells in NCL

ImmunoCellular Therapeutics, UPENN sign research agreement

Infinity Pharmaceuticals initiates Phase 1b/2 trial of IPI-926 Hedgehog pathway inhibitor for pancreatic cancer

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