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Senior research scientist to receive 2009 Astellas USA Foundation Award

Fredrick Khachik, Ph.D., a senior research scientist in the Department of Chemistry and Biochemistry at the University of Maryland, College Park, has been chosen to receive a 2009 Astellas USA Foundation Award.

11 Dec 2009

Tasigna demonstrates greater efficacy over Gleevec in chronic Ph+ CML patients

In a large Phase III clinical trial, Tasigna (nilotinib capsules) demonstrated greater efficacy over Gleevec (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The new clinical data were just presented as a late breaking abstract at the 51st annual meeting of the American Society of Hematology (ASH), in New Orleans, Louisiana.

11 Dec 2009

Cequent Pharmaceuticals' IND application for CEQ508 approved for clinical trial

Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, announced that the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) approved Cequent's first IND (investigational new drug) application yesterday.

10 Dec 2009

Merck commences Stimuvax Phase 3 trial in Asian patients with NSCLC

Oncothyreon Inc. today announced that Merck KGaA of Darmstadt, Germany, has initiated a Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine) in Asian patients with advanced non-small cell lung cancer (NSCLC). The trial, named INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response), is anticipated to enroll approximately 420 patients in China, Hong Kong, South Korea, Singapore and Taiwan.

10 Dec 2009

Schizophrenia: Once-monthly INVEGA SUSTENNA not inferior to bi-weekly RISPERDAL CONSTA

Treatment with once-monthly INVEGA® SUSTENNA(TM) is not inferior to treatment with bi-weekly RISPERDAL® CONSTA®, according to new data from a comparative study of both treatments in patients with schizophrenia. Results of the 13-week clinical trial were released this week.

10 Dec 2009

Convergence between EDC and RTSM solutions simplifies workflow management

Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (Nasdaq: PRXL), today introduced unique product convergence between its DataLabs® EDC solution and ClinPhone® Randomization and Trial Supply Management (RTSM) technologies.

From Parexel 10 Dec 2009

Fourth-quarter and full year fiscal 2009 results announced by Biodel

Biodel Inc. today reported financial results for the fourth quarter and fiscal year ended September 30, 2009.

10 Dec 2009

Promising trial on immunotherapy for preventing childhood cancer recurrence

CHILDREN in the UK with a high risk form of the childhood cancer neuroblastoma are set to benefit from a new international clinical trial - funded by Cancer Research UK - which uses immunotherapy to help prevent the disease from coming back.

10 Dec 2009

ACR Image Metrix presents computerized system validation for imaging clinical trials at the DIA forum

Brenda K. Young, BA, CCRA, senior director of clinical operations at ACR Image Metrix™, an imaging contract research organization (CRO) located in Philadelphia, Pennsylvania, has presented her experience in computerized system validation to the Drug Information Association (DIA) 3rd Annual Clinical Forum held in Nice, France, on October 19, 2009.

10 Dec 2009

Medifocus begins common stock trading on OTC Pink Sheets market

Medifocus, Inc., a biotechnology company focused on the commercialization of a proprietary and patented microwave focused heat system for the treatment of breast cancer is pleased to announce that the Company had begun trading its common stock on the OTC Pink Sheets market on Dec. 7, 2009.

10 Dec 2009

Results from Tulip PETAL Study of elagolix announced by Neurocrine Biosciences

Neurocrine Biosciences, Inc. today announced top-line efficacy and safety results from the Tulip PETAL Study (703 Study), its fifth Phase 2 clinical trial using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

10 Dec 2009

EC grants orphan drug designation for MP4CO for treating sickle cell disease

Sangart, Inc., a global biopharmaceutical company dedicated to developing life-saving medicines specifically designed to enhance the perfusion and oxygenation of ischemic (oxygen deprived) tissues through targeted oxygen and other gas delivery, today announced that the European Commission (EC) has granted orphan medicinal product designation for MP4CO for the treatment of sickle cell disease.

10 Dec 2009

Initiation of dose-finding study to evaluate safety and efficacy of MP4OX treatment

Sangart, Inc., a global biopharmaceutical company dedicated to developing life-saving medicines specifically designed to enhance the perfusion and oxygenation of ischemic (oxygen deprived) tissues through targeted oxygen delivery, today announced the initiation of a dose-finding study designed to evaluate the safety and efficacy of MP4OX treatment plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock.

10 Dec 2009

Second pivotal Phase 3 trial to evaluate investigational Lp-PLA2 inhibitor darapladib initiated

Attached is a press release issued earlier this morning by GlaxoSmithKline, announcing that GSK has initiated its second pivotal Phase 3 trial to evaluate the efficacy of long-term treatment with the investigational Lp-PLA2 inhibitor darapladib in men and women with acute coronary syndrome (ACS).

10 Dec 2009

Additional data from ALS patients enrolled in confirmatory Phase III STAR trial announced

AVANIR Pharmaceuticals, Inc. today announced additional data from the subset of patients with amyotrophic lateral sclerosis (ALS) enrolled in the confirmatory Phase III STAR trial.

9 Dec 2009

RegeneRx Biopharmaceuticals completes Phase I trial evaluating systemic administration of RGN-352

REGENERX BIOPHARMACEUTICALS, INC. announced today that it has completed and analyzed the safety data from its double-blind, placebo controlled Phase I clinical trial evaluating the systemic administration of RGN-352. The trial included testing of a single escalating intravenous dose of the drug candidate on forty healthy volunteers in Phase IA and, subsequently, over a fourteen-day treatment period on forty volunteers in Phase IB.

9 Dec 2009

Protalix Biotherapeutics completes NDA submission for taliglucerase alfa

Protalix Biotherapeutics, Inc. today announced the completion of its New Drug Application (NDA) submission with the U.S. Food and Drug Administration (FDA) for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for the potential treatment of Gaucher’s disease.

9 Dec 2009

Preliminary data from Phase 2 clinical trial of ZFP Therapeutic program presented

Sangamo BioSciences, Inc. announced today the presentation of preliminary data from the Phase 2 clinical trial of its ZFP Therapeutic(TM) program to develop SB-509 as a treatment for amyotrophic lateral sclerosis (ALS) at a Work in Progress session at the 20th International Symposium on ALS/MND held in Berlin, Germany.

9 Dec 2009

Clinical trial results demonstrate greater efficacy of nilotinib over imatinib for Ph+ CML

In a large clinical trial, nilotinib demonstrated greater efficacy over the current gold standard treatment, imatinib, in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase.

9 Dec 2009

VERTICAL Phase II trial results for NHL released

The Takeda Oncology Company today reported data from a clinical trial evaluating a VELCADE based combination for patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL).

9 Dec 2009

Clinical Trial News and Research

Senior research scientist to receive 2009 Astellas USA Foundation Award

Tasigna demonstrates greater efficacy over Gleevec in chronic Ph+ CML patients

Cequent Pharmaceuticals' IND application for CEQ508 approved for clinical trial

Merck commences Stimuvax Phase 3 trial in Asian patients with NSCLC

Schizophrenia: Once-monthly INVEGA SUSTENNA not inferior to bi-weekly RISPERDAL CONSTA

Convergence between EDC and RTSM solutions simplifies workflow management

Fourth-quarter and full year fiscal 2009 results announced by Biodel

Promising trial on immunotherapy for preventing childhood cancer recurrence

ACR Image Metrix presents computerized system validation for imaging clinical trials at the DIA forum

Medifocus begins common stock trading on OTC Pink Sheets market

Results from Tulip PETAL Study of elagolix announced by Neurocrine Biosciences

EC grants orphan drug designation for MP4CO for treating sickle cell disease

Initiation of dose-finding study to evaluate safety and efficacy of MP4OX treatment

Second pivotal Phase 3 trial to evaluate investigational Lp-PLA2 inhibitor darapladib initiated

Additional data from ALS patients enrolled in confirmatory Phase III STAR trial announced

RegeneRx Biopharmaceuticals completes Phase I trial evaluating systemic administration of RGN-352

Protalix Biotherapeutics completes NDA submission for taliglucerase alfa

Preliminary data from Phase 2 clinical trial of ZFP Therapeutic program presented

Clinical trial results demonstrate greater efficacy of nilotinib over imatinib for Ph+ CML

VERTICAL Phase II trial results for NHL released

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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