Clinical Trial News and Research

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Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

18 Feb 2010

Quintiles launches QTEA solution to speed patient recruitment

Quintiles today launched innovative, web-based technology to enable world-class marketing for clinical trial enrolment at an individual site-level. Named Quintiles Trial Enrolment Accelerator (QTEA), this new solution will speed patient recruitment by helping customers better manage the quality, consistency and effectiveness of messaging and media outreach.

18 Feb 2010

World's smallest ultrasound device could offer a new level of home therapy for painful ailments

It looks more like an iPod than a medical tool. But the latest miniature ultrasound device created by Cornell biomedical engineering graduate student George K. Lewis could one day introduce a whole new level of home therapy for arthritis, injury and other painful ailments.

18 Feb 2010

Athersys completes enrollment in phase I MultiStem allogeneic stem cell therapy clinical trial

Athersys, Inc. and Angiotech Pharmaceuticals, Inc. announced that Athersys has completed patient enrollment for its phase I clinical trial of MultiStem(R), its allogeneic stem cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. Top line results of the trial are expected to be announced midyear, upon completion of the four-month patient follow-up visits and analysis of results.

17 Feb 2010

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

Tioga Pharmaceuticals, Inc. today announced the closing of an $18 million equity financing. Current investors Forward Ventures, New Leaf Venture Partners and BB Biotech Ventures were joined by new investor Genesys Capital Partners.

17 Feb 2010

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Otonomy, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of OTO-104 in patients with Meniere's disease, a debilitating disorder of the inner ear affecting balance and hearing.

17 Feb 2010

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Marcadia Biotech Inc. today announced that it has initiated a Phase 1 clinical trial of MAR701, a novel dual agonist of the incretin hormone receptors for glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP). Marcadia plans to initially develop this compound as a treatment for type 2 diabetes with once-weekly dosing. The Phase 1 trial will evaluate MAR701 in healthy volunteers at escalating dose levels.

17 Feb 2010

Fourth-quarter and full-year 2009 results announced by Celsion

Celsion Corporation, a leading oncology drug development company, today announced financial results for the fourth quarter and year ended December 31, 2009. Management also highlighted the progress made in clinical trials of ThermoDox®, Celsion's heat activated liposomal encapsulation of doxorubicin, including the Company's pivotal Phase III trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, and recurrent chest wall breast cancer.

17 Feb 2010

Phase II clinical trial result of abiraterone drug shows promise for advanced prostate cancer

New results from a phase II clinical trial of the prostate cancer drug abiraterone suggest that it may help men with advanced disease who have tried standard treatments.

17 Feb 2010

Obecure enters into licensing and clinical supply agreement with Grunenthal's subsidiary for XR betahistine

Obecure Ltd (http://www.obecure.com)., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., announced today the execution of a licensing and clinical supply agreement with Farmaceutici Formenti SPA, the Italian Subsidiary of the Grunenthal Group.

17 Feb 2010

Postmenopausal women undergoing combination hormone therapy at increased risk of heart disease: WHI confirms

New analyses from the Women's Health Initiative (WHI) confirm that combination hormone therapy increases the risk of heart disease in healthy postmenopausal women. Researchers report a trend toward an increased risk of heart disease during the first two years of hormone therapy among women who began therapy within 10 years of menopause, and a more marked elevation of risk among women who began hormone therapy more than 10 years after menopause. Analyses indicate that overall a woman's risk of heart disease more than doubles within the first two years of taking combination HT.

17 Feb 2010

Quintiles' anatomic pathology services now available in China to help develop effective cancer treatments

Quintiles today announced the availability of anatomic pathology services through its central laboratory in Beijing, China, to help biopharmaceutical companies develop more effective cancer treatments. These services complement assay development, digital pathology and core lab offerings available through the facility to help customers comply with China’s restrictions on tissue import/export.

17 Feb 2010

Special issue reviews current state of science in fetal therapy

Repairing birth defects in the womb. Inserting a tiny laser into the mother's uterus to seal off an abnormal blood flow and save fetal twins. Advancing the science that may allow doctors to deliver cells or DNA to treat sickle cell anemia and other genetic diseases before birth.

17 Feb 2010

Cancer Research UK, immatics Biotechnologies sign collaboration agreement to trial IMA950 vaccine for GMB

CANCER RESEARCH UK and Cancer Research Technology - the charity's development and commercialisation arm - have reached a collaboration agreement with immatics Biotechnologies to trial their new treatment vaccine, IMA950, for glioblastoma multiforme (GMB), one of the most common forms of brain cancer.

16 Feb 2010

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Alkermes, Inc. today announced positive topline data from a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC).

16 Feb 2010

Fourth-quarter and full-year 2009 results announced by Vanda Pharmaceuticals

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders, today announced financial and operational results for the fourth quarter and full year ended December 31, 2009.

16 Feb 2010

Palatin Technologies announces net income of $4.5M for second-quarter fiscal 2010

Palatin Technologies, Inc. today announced results for its second quarter ended December 31, 2009. Palatin reported net income of $4.5 million, or $0.04 per basic and diluted share, for the quarter ended December 31, 2009, compared to a net loss of $0.4 million, or $0.00 per basic and diluted share, for the same period in 2008. Total revenues in the quarter ended December 31, 2009 were $7.3 million, compared to $1.2 million for the same period in 2008.

16 Feb 2010

Sinovac Beijing expands production capacity with acquisition of buildings and land use rights in Changping

Sinovac Biotech Ltd. (SVA), a leading China-based vaccine manufacturer, today announced the completion by its subsidiary, Sinovac Beijing, of the acquisition of buildings and land use rights. The total consideration for the purchase is approximately RMB120 million ($17.6 million), which will be financed from working capital. The initial payment of RMB56.5 million ($8.3 million) will be paid before February 20, 2010 and the balance of the purchase price will be paid in three installments within three years.

16 Feb 2010

TVM Capital MENA receives DFSA approval to start regional healthcare growth capital fund

TVM Capital MENA today announced that it has received the approval of the Dubai Financial Services Authority (DFSA) to start operation of its first regional healthcare growth capital fund with US$40 million of subscriptions from founding investors, Saudi Health Investment Company (SHIC), the International Finance Corporation (IFC), and GE Healthcare. TVM Capital MENA Ltd., the fund’s operator, is based in the Dubai International Financial Centre (DIFC) and is licensed and regulated by the DFSA.

15 Feb 2010

Synexus takes just ten months to carry out 52,000 DEXA scans

It took clinical trial experts Synexus, just ten months to carry out 52,000 DEXA scans and randomise over 2,700 patients across twelve of their UK, European and African dedicated research centres.

From AES - Accelerated Enrollment Solutions 15 Feb 2010

Clinical Trial News and Research

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Quintiles launches QTEA solution to speed patient recruitment

World's smallest ultrasound device could offer a new level of home therapy for painful ailments

Athersys completes enrollment in phase I MultiStem allogeneic stem cell therapy clinical trial

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Fourth-quarter and full-year 2009 results announced by Celsion

Phase II clinical trial result of abiraterone drug shows promise for advanced prostate cancer

Obecure enters into licensing and clinical supply agreement with Grunenthal's subsidiary for XR betahistine

Postmenopausal women undergoing combination hormone therapy at increased risk of heart disease: WHI confirms

Quintiles' anatomic pathology services now available in China to help develop effective cancer treatments

Special issue reviews current state of science in fetal therapy

Cancer Research UK, immatics Biotechnologies sign collaboration agreement to trial IMA950 vaccine for GMB

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Fourth-quarter and full-year 2009 results announced by Vanda Pharmaceuticals

Palatin Technologies announces net income of $4.5M for second-quarter fiscal 2010

Sinovac Beijing expands production capacity with acquisition of buildings and land use rights in Changping

TVM Capital MENA receives DFSA approval to start regional healthcare growth capital fund

Synexus takes just ten months to carry out 52,000 DEXA scans

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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