Clinical Trial News and Research

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Additional data from Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease presented

Protalix BioTherapeutics, Inc., announced today that additional data from the Company's pivotal Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease was presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010 in Miami, Florida, during an oral session titled, "Novel Enzyme Replacement Therapy for Gaucher Disease: Phase III Pivotal Clinical Trial with Plant Cell Expressed Recombinant Glucocerebrosidase (prGCD) - taliglucerase alfa."

12 Feb 2010

First FDA-approved umbilical cord blood stem cells infusion trial in children with cerebral palsy

Medical College of Georgia researchers are conducting the first FDA-approved clinical trial to determine whether an infusion of stem cells from umbilical cord blood can improve the quality of life for children with cerebral palsy.

12 Feb 2010

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

PARI Pharma has enrolled the first patient in its Phase 2b clinical trial studying inhaled liposomal cyclosporine A (L-CsA) delivered via a customized Investigational eFlow Nebulizer System. The multinational study is investigating the safety and efficacy of PARI's L-CsA formulation. In previous clinical trials, reactions from physicians and lung transplant recipients to PARI's drug-device combination were encouraging.

11 Feb 2010

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a Phase I clinical trial for NuPIAO to the Chinese State Food and Drug Administration (SFDA).

11 Feb 2010

YM Biosciences to present JAK1/2 inhibiting small molecule and vascular disrupting agent data at Cancer Conference

YM BioSciences Inc., is presenting posters on its JAK1/2 inhibiting small molecule (CYT387) and on its novel vascular disrupting agent (CYT997) at the Lorne Cancer Conference in Lorne, Victoria, Australia. CYT387 is an oral JAK1/2 inhibitor, originating from the seminal discovery of JAK1 and JAK2 kinases by Dr. Andrew Wilks, the founder of Cytopia Limited, now YM Australia. CYT997 is an orally-available agent with dual mechanisms of vascular disruption and cytotoxicity and has the potential to be broadly active against a range of tumor types.

11 Feb 2010

Alexion Pharmaceuticals announces financial results for quarter and year ended December 31, 2009

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter and year ended December 31, 2009. For the three months ended December 31, 2009, Alexion Pharmaceuticals, Inc. ("Alexion" or, the "Company") reported net product sales of Soliris® (eculizumab) of $110.6 million, reflecting strong additions of new patients, compared to $77.4 million for the same period in 2008.

11 Feb 2010

Biomagnetics Diagnostics to accelerate development of assay test cartridge for malaria, HIV/AIDS, hepatitis and TB

Biomagnetics Diagnostics Corp., a developer of revolutionary diagnostic systems and technology for malaria, HIV/AIDS, hepatitis, tuberculosis and detection, announced today the implementation of a program to accelerate the availability of the world's first Integrated Optical BioSensor (IOBS) platform. The Company is currently reviewing research and manufacturing partnerships to develop simple to replicate bench top versions of the IOBS platform on which single pathogen or multiple pathogen testing assay cartridges can be developed.

11 Feb 2010

MUHC commences clinical trial of Exsulin for type 1 diabetes

A clinical trial of Exsulin, an innovative new treatment that targets the underlying cause of type 1 diabetes, has begun at the McGill University Health Centre (MUHC). Under the direction of Dr. George Tsoukas of the MUHC and the McGill University Faculty of Medicine, the study will assess the effectiveness of Exsulin.

11 Feb 2010

41st Annual Meeting on Women's Cancer to be hosted in San Francisco, California

The Society of Gynecologic Oncologists (SGO) will host its 41st Annual Meeting on Women's Cancer March 14-17, 2010 at the Moscone West Convention Center in San Francisco, California. This year's meeting will feature more than 434 scientific presentations in addition to lectures, workshops, symposia and postgraduate courses that focus on emerging science, clinical trials and treatment advances for physicians and health care professionals in the field of gynecologic oncology.

11 Feb 2010

DMC recommends Gamida-Teva JV to continue enrollment in StemEx Phase III trial for leukemia and lymphoma

Elbit Imaging Ltd. announces that its associated company (approximately 28% holding on a fully diluted basis), Gamida Cell Ltd. ("Gamida Cell") through the Gamida-Teva Joint Venture (JV), announced today that the Data Monitoring Committee ("DMC") has independently reviewed preliminary data from the pivotal registration, Phase III clinical trial of StemEx (called ExCell) and has recommended that the JV continue to enroll patients in this study.

11 Feb 2010

CINJ researchers develop new vaccine strategy for pancreatic cancer

More than 42,500 people in the United States were diagnosed with pancreatic cancer last year and nearly 35,200 died from the disease, according to The American Cancer Society.

11 Feb 2010

Trimel BioPharma Holdings updates business developments

Trimel BioPharma Holdings Inc. is today providing an update on a number of operational items that have contributed significantly to advancing the Company and achieving its initial objectives.

10 Feb 2010

Raptor Pharmaceutical to present DR Cysteamine trial data at Lysosomal Disease Network Symposium

Raptor Pharmaceutical Corp., today announced the presentation of cystinosis data at the Annual Lysosomal Disease Network WORLD Symposium 2010, being held February 10-12 in Miami, Florida. Biomarker data from a Phase IIb pilot study of Raptor's proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") will be the subject of a poster titled, "Correlation of Plasma Cysteamine and WBC Cystine Levels at Steady State in Patients Treated with Cysteamine Bitartrate." The results will also be published in an upcoming issue of the journal Molecular Genetics and Metabolism.

10 Feb 2010

Medicinal chemistry paper related to the discovery of CUDC-101 published

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that a medicinal chemistry paper related to the discovery of CUDC-101, Curis’s HDAC, EGFR and Her2 inhibitor, was published online in the Journal of Medicinal Chemistry and also will be published in an upcoming print version of the journal.

10 Feb 2010

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

Celsion Corporation announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox® clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

10 Feb 2010

MDS to divest remaining MDS Pharma Services Early Stage business for $45M

MDS Inc., a leading provider of products and services to the global life sciences markets, today announced that it has signed agreements to divest its remaining MDS Pharma Services Early Stage business, which provides Discovery through Phase IIa clinical trial services to biotechnology and pharmaceutical companies, for $45 million and certain minority equity interests.

10 Feb 2010

Positive results from Naurex's Phase I clinical trial of GLYX-13 reported

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel glycine site functional partial agonist (GFPA) NMDA receptor modulators, today reported positive top-line results from its Phase I clinical trial of lead compound GLYX-13.

10 Feb 2010

DMC recommends JV to continue enrolling patients in Phase III clinical trial of StemEx

The Gamida Cell-Teva Joint Venture (JV) announced today that the Data Monitoring Committee (DMC) has independently reviewed preliminary data from the pivotal registration, Phase III clinical trial of StemEx (called ExCell) and has recommended that the JV continue to enroll patients in this study.

10 Feb 2010

BioClinica reports financial results for quarter and year ended December 31, 2009

BioClinica™, Inc., a global provider of clinical trial services, today announced its financial results for the quarter and year ended December 31, 2009. The operating results of Phoenix Data Systems (“PDS”) are included in the financial results following the acquisition of PDS that was completed March 24, 2008.

From Clario 10 Feb 2010

Provectus Pharmaceuticals publishes article on novel treatment for metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announces the publication of an article, entitled “A novel treatment for metastatic melanoma with intralesional rose bengal and radiotherapy: a case series," authored by Dr. Matthew C. Foote, Dr. Bryan H. Burmeister, Janine Thomas, and Dr. B. Mark Smithers, in the current issue of the peer-reviewed journal, Melanoma Research (20(1):48-51, February 2010).

10 Feb 2010

Clinical Trial News and Research

Additional data from Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease presented

First FDA-approved umbilical cord blood stem cells infusion trial in children with cerebral palsy

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

YM Biosciences to present JAK1/2 inhibiting small molecule and vascular disrupting agent data at Cancer Conference

Alexion Pharmaceuticals announces financial results for quarter and year ended December 31, 2009

Biomagnetics Diagnostics to accelerate development of assay test cartridge for malaria, HIV/AIDS, hepatitis and TB

MUHC commences clinical trial of Exsulin for type 1 diabetes

41st Annual Meeting on Women's Cancer to be hosted in San Francisco, California

DMC recommends Gamida-Teva JV to continue enrollment in StemEx Phase III trial for leukemia and lymphoma

CINJ researchers develop new vaccine strategy for pancreatic cancer

Trimel BioPharma Holdings updates business developments

Raptor Pharmaceutical to present DR Cysteamine trial data at Lysosomal Disease Network Symposium

Medicinal chemistry paper related to the discovery of CUDC-101 published

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

MDS to divest remaining MDS Pharma Services Early Stage business for $45M

Positive results from Naurex's Phase I clinical trial of GLYX-13 reported

DMC recommends JV to continue enrolling patients in Phase III clinical trial of StemEx

BioClinica reports financial results for quarter and year ended December 31, 2009

Provectus Pharmaceuticals publishes article on novel treatment for metastatic melanoma

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