Clinical Trial News and Research

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Researchers await clinical trial results of potential TB vaccine, expected early next week

"After nearly 100 years, researchers could be on the verge of finding a vaccine that would eradicate tuberculosis [TB] infections," Reuters reports, noting, "Global health experts are eagerly awaiting clinical trial results, expected early next week, of the first new vaccine in 90 years designed to prevent tuberculosis infections."

2 Feb 2013

Researchers identify 7 factors to lessen radiation exposure in young, traumatic injury victims

A study of more than 12,000 children from emergency departments throughout the country in the Pediatric Emergency Care Applied Research Network (PECARN) has identified seven factors that can help physicians determine the need for a computed tomography (CT) scan following blunt trauma to the abdomen.

2 Feb 2013

Galectin submits GR-MD-02 IND application with FDA for treatment of liver fibrosis

Galectin Therapeutics, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that it submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) on January 30, 2013.

1 Feb 2013

FDA allows Arteriocyte to commence Magellan System Phase I trial in thermal burn wounds

Arteriocyte, a leading biotechnology company with offices in Cleveland, Ohio and Hopkinton, Massachusetts announced today approval from the Food and Drug Administration (FDA) to initiate a Phase I clinical trial using its Magellan System technology in the treatment of thermal burn wounds.

31 Jan 2013

Positive results from PaxVax's Ad4-H5-Vtn vector vaccine Phase 1 trial on avian flu

PaxVax, Inc., which develops and commercializes innovative vaccines against infectious diseases in a socially responsible manner, today announced positive results in a Phase 1 clinical trial for its oral, replicating adenovirus serotype 4 (Ad4) vector vaccine for H5N1 (avian flu).

31 Jan 2013

Mood disorder clinics improve bipolar disorder outcomes

Early treatment of patients with bipolar disorder in a specialized mood disorder clinic substantially reduces the risk for readmission to a psychiatric hospital, clinical trial findings show.

31 Jan 2013

DSMB recommends continuation of CTI’s OPAXIO Phase 3 trial on ovarian cancer

Cell Therapeutics, Inc. (CTI) today announced that the Gynecologic Oncology Group (GOG) informed CTI that an independent Data Safety Monitoring Board (DSMB) recommended continuation of the GOG-0212 Phase 3 clinical trial of OPAXIOTM (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a planned interim survival analysis.

31 Jan 2013

Pipeline embolization device safe and effective tool for patients with brain aneurysms

A multi-center study supports the effectiveness of the newest technology available for the treatment of difficult, life-threatening brain aneurysms. The technology, the Pipeline embolization device, is a flow diverter that redirects blood flow away from wide-necked or giant aneurysms that cannot be treated in more conventional ways.

31 Jan 2013

Existing cardiomyocytes contribute to formation of new heart cells after attack

Injecting specialized cardiac stem cells into a patient's heart rebuilds healthy tissue after a heart attack, but where do the new cells come from and how are they transformed into functional muscle?

31 Jan 2013

Mount Sinai to initiate immunological therapy trial against chronic pulmonary sarcoidosis

Patients are currently being enrolled in the first clinical trial to investigate the efficacy of immunological therapy for chronic pulmonary sarcoidosis. The trial is being conducted by researchers at the Icahn School of Medicine at Mount Sinai.

31 Jan 2013

Dilaforette receives approval to initiate sevuparin Phase II malaria study in India

Dilaforette, a Karolinska Development portfolio company, today announces that the company has approval from the regulatory authority in India to start a Phase II study with sevuparin in patients with moderate to severe malaria.

30 Jan 2013

Foresee, ScinoPharm to form joint venture for new oncological Leuprolide injectable drug

ScinoPharm and Foresee Pharmaceuticals, Inc. jointly announced today that an investment agreement to form a joint venture has been signed. This venture looks to develop a series of peptide injectable drugs with the first being a new oncological Leuprolide injectable drug product, where Leuprolide will be formulated in a proprietary controlled-release drug delivery system originally developed by Foresee and transferred to the joint venture.

30 Jan 2013

FDA approves Genzyme’s KYNAMRO to treat homozygous familial hypercholesterolemia

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for KYNAMROTM (mipomersen sodium) injection.

30 Jan 2013

OncoPep commences PVX-410 Phase 1/2a trial in smoldering multiple myeloma

OncoPep, Inc. today announced that the Company has initiated a Phase 1/2a clinical trial evaluating PVX-410, a multi-peptide therapeutic cancer vaccine, in patients with smoldering multiple myeloma, an asymptomatic precursor of multiple myeloma, which is an incurable cancer of the plasma cells.

30 Jan 2013

FDA allows IND application for ImmunoCellular’s ICT-140 to treat ovarian cancer

ImmunoCellular Therapeutics, Ltd. announced that the US Food and Drug Administration (FDA) has allowed the investigational new drug (IND) application for ICT-140, paving the way for conducting a clinical trial.

30 Jan 2013

Genzyme receives FDA approval for Kynamro to treat homozygous familial hypercholesterolemia

The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).

30 Jan 2013

U-M researchers develop new method thet could enhance gene sequencing data

When researchers sequence the RNA of cancer cells, they can compare it to normal cells and see where there is more RNA. That can help lead them to the gene or protein that might be triggering the cancer.

29 Jan 2013

Emotional stress can reduce prostate cancer drugs’ effectiveness

Not surprisingly, a cancer diagnosis creates stress. And patients with prostate cancer show higher levels of anxiety compared to other cancer patients. A new study by researchers at Wake Forest Baptist Medical Center indicates that stress is not just an emotional side effect of the diagnosis; it also can reduce the effectiveness of prostate cancer drugs and accelerate the development of prostate cancer.

29 Jan 2013

Millennium, Seattle Genetics commence ADCETRIS plus chemotherapy phase III trial in MTCL

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced the initiation of a global phase III clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed CD30-positive mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphomas.

28 Jan 2013

Positive top-line results from Biogen Idec’s peginterferon beta-1a Phase 3 trial on RRMS

Today Biogen Idec released the primary efficacy analysis and safety data from its Phase 3 pivotal clinical trial, ADVANCE.

28 Jan 2013

Clinical Trial News and Research

Researchers await clinical trial results of potential TB vaccine, expected early next week

Researchers identify 7 factors to lessen radiation exposure in young, traumatic injury victims

Galectin submits GR-MD-02 IND application with FDA for treatment of liver fibrosis

FDA allows Arteriocyte to commence Magellan System Phase I trial in thermal burn wounds

Positive results from PaxVax's Ad4-H5-Vtn vector vaccine Phase 1 trial on avian flu

Mood disorder clinics improve bipolar disorder outcomes

DSMB recommends continuation of CTI’s OPAXIO Phase 3 trial on ovarian cancer

Pipeline embolization device safe and effective tool for patients with brain aneurysms

Existing cardiomyocytes contribute to formation of new heart cells after attack

Mount Sinai to initiate immunological therapy trial against chronic pulmonary sarcoidosis

Dilaforette receives approval to initiate sevuparin Phase II malaria study in India

Foresee, ScinoPharm to form joint venture for new oncological Leuprolide injectable drug

FDA approves Genzyme’s KYNAMRO to treat homozygous familial hypercholesterolemia

OncoPep commences PVX-410 Phase 1/2a trial in smoldering multiple myeloma

FDA allows IND application for ImmunoCellular’s ICT-140 to treat ovarian cancer

Genzyme receives FDA approval for Kynamro to treat homozygous familial hypercholesterolemia

U-M researchers develop new method thet could enhance gene sequencing data

Emotional stress can reduce prostate cancer drugs’ effectiveness

Millennium, Seattle Genetics commence ADCETRIS plus chemotherapy phase III trial in MTCL

Positive top-line results from Biogen Idec’s peginterferon beta-1a Phase 3 trial on RRMS

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