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Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that its affiliate VGX International Inc. has received approval in Korea to begin a Phase I clinical trial in healthy volunteers for Inovio’s SynCon™ preventive DNA vaccine (VGX-3400) targeting H5N1 avian influenza.

2 Mar 2010

Archimedes Pharma raises GBP65 million in new funding

Archimedes Pharma, the leading specialty pharma company, today announced that it has raised GBP65 million (approx US$100 million) in new funding. The round was led by new investor Novo Growth Equity, the growth equity fund of Novo A/S, and included participation by major current investor, Warburg Pincus, a global private equity firm. Archimedes also announced the appointment of a new President and Chief Executive Officer, Jeffrey H. Buchalter, formerly President and Chief Executive Officer of US-based Enzon.

2 Mar 2010

IgPro20 protects PI patients against infection

Data presented today suggest that 20 percent liquid formulation, Immune Globulin Subcutaneous (Human) (SCIg), or IgPro20 effectively protects patients with primary immunodeficiencies (PI) against infection. The 20 percent formulation, the highest Ig concentration currently available, was also shown to sustain serum IgG levels without causing unexpected rates of adverse events. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, US.

2 Mar 2010

PTSD drug: Cannabis Science to file first application for FDA clinical trials

Cannabis Science Inc., a pharmaceutical cannabis company in the US, is pleased to announce that it now has the results of its survey of more than 1,300 individuals with PTSD, including a large cohort of veterans. The survey was conducted by Cannabis Science Advisory Board member Dr. Mitch Earleywine PhD. of the State University of New York (Albany).

2 Mar 2010

Celsion to commence Phase II Study of ThermoDox and RFA for CRLM

Celsion Corporation today announced that it will initiate a Randomized Phase II Study of Lyso-Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Radiofrequency Ablation (RFA) for Colorectal Liver Metastases (CRLM). Dr. Steven K. Libutti, Professor and Vice Chairman, Department of Surgery and Director of the Montefiore-Einstein Center for Cancer Care and Albert Einstein College of Medicine in New York City, will serve as Principal Investigator for the study.

2 Mar 2010

Quark Pharmaceuticals commences dosing in clinical study of QPI-1007 for NAION

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, announced today the dosing of the first patient in a Phase I study of the investigational neuroprotective agent, QPI-1007.

2 Mar 2010

Peer-reviewed articles elucidate role of clusterin in promoting tumor resistance to cancer treatment

OncoGenex Pharmaceuticals, Inc., announced today that two peer-reviewed articles have been published that further elucidate the biological function of clusterin, its role in promoting tumor resistance to cancer treatment, and the role of an inhibitor of clusterin such as custirsen (OGX-011) that is designed to knock down treatment resistance in the cells and enhance the effectiveness of cancer therapies.

1 Mar 2010

Synexus recruits 87% of agreed number of patients in major osteoporosis study within deadline

Following the recent announcement from Manchester-based Synexus that they had randomised 2,700 patients in just ten months for an osteoporosis study, the company has once again demonstrated that it is possible to recruit the agreed number of patients within the study deadline by recruiting 87% of patients to another study for the same therapeutic area.

From AES - Accelerated Enrollment Solutions 1 Mar 2010

[11C]PiB PET neuroimaging exhibits potential for monitoring therapeutics on amyloid beta load during Alzheimer’s disease treatment

Elan Corporation, plc today announced that findings from a Phase II study which suggested bapineuzumab reduced amyloid-beta deposits in the brains of Alzheimer’s disease patients as measured using a neuroimaging technique known as [11C]PiB PET, were published in the February 28, 2010 online edition of Lancet Neurology. Bapineuzumab is a compound under development by Pfizer and Janssen Alzheimer Immunotherapy, a Johnson & Johnson subsidiary in which Elan holds a minority equity interest.

1 Mar 2010

ADMET tester Absorption Systems joins Society of Toxicology as Affiliate

Absorption Systems, a leader in testing drugs for ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity), has joined the Society of Toxicology, the premier global professional association of toxicologists, as an SOT Affiliate. The firm, a contract research organization, has more than a decade of experience assisting pharmaceutical and biotechnology companies in determining which compounds in development should be advanced into clinical testing.

27 Feb 2010

Single submission of orphan drug designation annual report for both FDA and EMA

In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. Both agencies have agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic products designated by both the United States and the European Union.

27 Feb 2010

Synta Pharmaceuticals presents preclinical and clinical data of Hsp90 inhibitor STA-9090

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that Dr. Geoffrey I. Shapiro of Dana-Farber Cancer Institute, presented preclinical and clinical data on STA-9090, a potent second-generation Hsp90 inhibitor, at IASLC (International Association for the Study of Lung Cancer) 10th Annual Targeted Therapies of the Treatment of Lung Cancer Meeting in Santa Monica, CA.

27 Feb 2010

Teva Pharmaceutical announces clinical study results of Copaxone in RRMS patients

Teva Pharmaceutical Industries Ltd. today announced the publication of data from the 15-year clinical study with Copaxone® (glatiramer acetate injection), which is the longest prospective and continuous evaluation ever conducted in relapsing-remitting multiple sclerosis (RRMS) patients. The data were published in the February issue of the journal Multiple Sclerosis.

26 Feb 2010

Antiretroviral therapy reduces mortality rates in patients co-infected with HIV and TB

Initiating antiretroviral therapy (ART) during tuberculosis therapy significantly reduced mortality rates by 56 percent in a randomized clinical trial of 642 patients co-infected with HIV and tuberculosis. The study, which provides further impetus for the integration of TB and HIV services, lays to rest the controversy on whether co-infected patients should initiate ART during or after TB treatment.

26 Feb 2010

Study confirms efficacy and tolerability of lacosamide for uncontrolled POS

A recent multi-center study has confirmed earlier study results that 400 mg/day of lacosamide provides a good balance of efficacy and tolerability for patients with uncontrolled partial-onset seizures (POS), and doses of 600mg/day may provide additional benefit for some patients.

26 Feb 2010

Resverlogix commences enrollment in RVX-208 Phase 2 clinical trial for atherosclerosis in ACS patients

Resverlogix Corp. announced today that it has officially activated the first site for the ASSURE 1 trial and commenced enrollment of patients for dosing of RVX-208. ASSURE 1 is the second Resverlogix Phase 2 clinical trial, led by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with acute coronary syndrome (ACS). This preparatory acute coronary syndrome study will ensure that 50 percent of the enrolled patients receive the IVUS (intravascular ultrasound) assessment.

26 Feb 2010

Genta initiates new dose-ranging study of tesetaxel drug

Genta Incorporated announced that the Company has initiated a new dose-ranging study of tesetaxel, the Company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

26 Feb 2010

Kinex Pharmaceuticals announces KX2-391 Phase 2 safety and efficacy clinical trial in men with CRPC

Kinex Pharmaceuticals opened a Phase 2 clinical trial to evaluate the safety and efficacy of KX2-391 in patients with bone-metastatic, castrate-resistant prostate cancer (CRPC) who have not had prior chemotherapy.

25 Feb 2010

Cannabis Science completes selection of initial cannabis-based pharmaceutical for FDA clinical trials

Cannabis Science Inc., a pharmaceutical cannabis company, is pleased to report to their shareholders that the choice of our initial cannabis-based pharmaceutical for FDA clinical trials has been made. The Company has reported several possible drugs for FDA clinical trials. Based on extensive studies, the Company has decided to contract with a group based in Colorado to handle the Company’s FDA filings.

25 Feb 2010

OncoGenex Pharmaceuticals receives CHMP advice on OGX-011 development plan in treatment of mCRPC

OncoGenex Pharmaceuticals announced today that it has received written, scientific advice from the European Medicines Agency (EMA) on the company's development plan for OGX-011 (also known as custirsen) for the treatment of men with metastatic castrate-resistant prostate cancer (mCRPC). The input received from the Committee for Medicinal Products for Human Use (CHMP) at the EMA was in overall agreement with OncoGenex's development plan regarding the proposed preclinical studies and both the study designs and analyses for the Phase III trials.

25 Feb 2010

Drug Trial News

Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Archimedes Pharma raises GBP65 million in new funding

IgPro20 protects PI patients against infection

PTSD drug: Cannabis Science to file first application for FDA clinical trials

Celsion to commence Phase II Study of ThermoDox and RFA for CRLM

Quark Pharmaceuticals commences dosing in clinical study of QPI-1007 for NAION

Peer-reviewed articles elucidate role of clusterin in promoting tumor resistance to cancer treatment

Synexus recruits 87% of agreed number of patients in major osteoporosis study within deadline

[11C]PiB PET neuroimaging exhibits potential for monitoring therapeutics on amyloid beta load during Alzheimer’s disease treatment

ADMET tester Absorption Systems joins Society of Toxicology as Affiliate

Single submission of orphan drug designation annual report for both FDA and EMA

Synta Pharmaceuticals presents preclinical and clinical data of Hsp90 inhibitor STA-9090

Teva Pharmaceutical announces clinical study results of Copaxone in RRMS patients

Antiretroviral therapy reduces mortality rates in patients co-infected with HIV and TB

Study confirms efficacy and tolerability of lacosamide for uncontrolled POS

Resverlogix commences enrollment in RVX-208 Phase 2 clinical trial for atherosclerosis in ACS patients

Genta initiates new dose-ranging study of tesetaxel drug

Kinex Pharmaceuticals announces KX2-391 Phase 2 safety and efficacy clinical trial in men with CRPC

Cannabis Science completes selection of initial cannabis-based pharmaceutical for FDA clinical trials

OncoGenex Pharmaceuticals receives CHMP advice on OGX-011 development plan in treatment of mCRPC

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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