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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

Phase 3 clinical trial results of RG1068 to be discussed

Repligen Corporation announced today that the Company President and Chief Executive Officer, Walter C. Herlihy, Ph.D., will host a conference call and webcast on Wednesday, December 9th, 2009 at 8:30 a.m. EST, to discuss results of its Phase 3 clinical trial of RG1068 in MRI imaging of the pancreas.

9 Dec 2009

New drug designed to stop cancer from spreading by preventing mitosis

TGen Clinical Research Services at Scottsdale Healthcare (TCRS) is the world's first clinical trials site for a new drug designed to halt cancer cell division.

9 Dec 2009

Recruitment complete in Oxagen's OC000459 IIb clinical trial for asthma

Oxagen Limited, a drug discovery and development company specializing in inflammation, today announced that the recruitment for its double blind, randomised, placebo controlled Phase IIb clinical trial in asthma with OC000459, its lead oral CRTH2 (DP2) antagonist, has now been completed.

9 Dec 2009

CSC's stem cell-derived motor neuron product for SMA receives FDA orphan drug designation

California Stem Cell, Inc. (CSC) and Families of Spinal Muscular Atrophy (FSMA) announced today that the FDA has granted orphan drug designation to MOTORGRAFT™, a stem cell-derived motor neuron product, for the treatment of Spinal Muscular Atrophy (SMA).

9 Dec 2009

Smokers taking the Respiragene test try to quit smoking, reveals study

Smokers who see their own personal risk of developing lung cancer after genetic-based testing show stronger intention and take more action on quitting smoking, according to clinical trial results presented to an American Association of Cancer Research conference.

9 Dec 2009

TGen and Scottsdale Healthcare test PHA-848125ac drug for thymic cancer

The Translational Genomics Research Institute (TGen) and Scottsdale Healthcare are testing a new drug specifically for thymic cancer based on early promising results at Scottsdale Healthcare.

9 Dec 2009

University of Texas launches phase II clinical trial to test stem-cell-based therapy on injured heart muscle

The second phase of a clinical trial testing a new stem-cell-based therapy on injured heart muscle has been launched by researchers at The University of Texas Medical School at Houston. It is the only study site in the Texas Medical Center.

9 Dec 2009

First-quarter fiscal 2010 results announced by Helix BioPharma

Helix BioPharma Corp. today announced financial results for the first quarter ended October 31, 2009.

9 Dec 2009

NeuroPace announces clinical trial results demonstrating the RNS System

NeuroPace, Inc. today announced that results from its pivotal trial demonstrated the RNS- System, a novel investigational device that utilizes responsive brain neurostimulation, significantly reduced the frequency of seizures among people who have a common form of epilepsy that is difficult to treat with medication.

9 Dec 2009

Mozobil with chemotherapy may have a therapeutic impact on leukemic cells, reveals study

Genzyme Corporation announced today that a Phase 1/2 trial provided early clinical data suggesting that Mozobil (plerixafor injection) in combination with chemotherapy may offer a therapeutic impact on leukemic cells protected in bone marrow.

9 Dec 2009

Phase II clinical trial results of Doxorubicin Transdrug announced

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announces positive survival data in its phase II clinical trial with doxorubicin Transdrug® in patients with advanced hepatocellular carcinoma (primary liver cancer).

9 Dec 2009

Clinical Trial News and Research

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

Phase 3 clinical trial results of RG1068 to be discussed

New drug designed to stop cancer from spreading by preventing mitosis

Recruitment complete in Oxagen's OC000459 IIb clinical trial for asthma

CSC's stem cell-derived motor neuron product for SMA receives FDA orphan drug designation

Smokers taking the Respiragene test try to quit smoking, reveals study

TGen and Scottsdale Healthcare test PHA-848125ac drug for thymic cancer

University of Texas launches phase II clinical trial to test stem-cell-based therapy on injured heart muscle

First-quarter fiscal 2010 results announced by Helix BioPharma

NeuroPace announces clinical trial results demonstrating the RNS System

Mozobil with chemotherapy may have a therapeutic impact on leukemic cells, reveals study

Phase II clinical trial results of Doxorubicin Transdrug announced

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