Clinical Trial News and Research

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Auxilium Pharmaceuticals' XIAFLEX gets FDA approval for treatment of Peyronie's disease

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has approved XIAFLEX (collagenase clostridium histolyticum, or CCH), an in-office, biologic for the treatment of Peyronie's disease. XIAFLEX is the first and only FDA-approved treatment proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy.

6 Dec 2013

Eisai reports new data analyses on FYCOMPA (Perampanel) at AES meeting

Today, Eisai Inc. announced that 16 abstracts highlighting new data analyses on FYCOMPA (perampanel) will be presented at the 67th annual American Epilepsy Society (AES) meeting, taking place in Washington, D.C. from December 6 – 10.

6 Dec 2013

Telomerase inhibiting drug induces morphologic, molecular, clinical remissions in myelofibrosis patients

metelstat, a novel telomerase inhibiting drug, has been found to induce morphologic, molecular and clinical remissions in some patients with myelofibrosis a Mayo Clinic study has found. The results were presented today at the 2013 American Society of Hematology Annual Meeting in New Orleans.

6 Dec 2013

Genocea commences GEN-004 Phase 1 study to prevent pneumococcus infections

Genocea Biosciences, Inc., a clinical-stage company pioneering novel T cell vaccines, announced today that it has initiated a Phase 1 study of GEN-004, an investigational vaccine candidate for pneumococcus (Streptococcus pneumoniae), a major cause of infectious disease-related death globally. GEN-004 is the first vaccine candidate designed to prevent infections caused by all strains of pneumococcus through a novel T cell-mediated mechanism of action.

5 Dec 2013

CEL-SCI gets approval to start enrollment for Multikine Phase III study for head and neck cancer

Further advancing one of the largest Phase III trials for head and neck cancer in the world, CEL-SCI Corporation announced today that it has received approval from the Agency for Medicaments and Medical Devices of the government of Bosnia and Herzegovina to begin enrollment of subjects into the Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection).

5 Dec 2013

AtheroNova completes active treatment portion of Phase 1 clinical trial with AHRO-001

AtheroNova Inc., a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announces achievement of a major milestone with the completion of the active treatment portion of its Phase 1 clinical trial with its lead compound, AHRO-001. The Phase 1 study objective is to evaluate the safety, tolerability and pharmacokinetics of AHRO-001 in healthy volunteers. The clinical study is being conducted in Russia with AtheroNova's licensing partner, OOO CardioNova.

5 Dec 2013

B2G2 component of grape seed extract induces apoptosis in prostate cancer cells

A University of Colorado Cancer Center study published online ahead of print in the journal Nutrition and Cancer describes the laboratory synthesis of the most active component of grape seed extract, B2G2, and shows this synthesized compound induces the cell death known as apoptosis in prostate cancer cells while leaving healthy cells unharmed.

5 Dec 2013

Archimedes Model simulation suggests genetic screening for breast cancer risk can reduce deaths

Archimedes Inc., a healthcare modeling and analytics company, today announced results of a simulated clinical trial which found that the seven single-nucleotide polymorphisms (7SNP) genetic test for breast cancer was most cost effective when used to guide MRI screenings for patients found to have an intermediate lifetime risk of developing the disease.

5 Dec 2013

Senesco completes cohort 3 of SNS01-T Phase 1b/2a trial for multiple myeloma and lymphoma treatment

Senesco Technologies, Inc. reported today the completion of cohort 3 of its Phase 1b/2a clinical trial for its drug, SNS01-T, for the treatment of multiple myeloma and lymphoma. The Company has also received approval from its Data Review Committee to proceed to cohort 4, which is expected to require six evaluable patients.

5 Dec 2013

Enrollment opens for IMO-8400 Phase 1/2 trial in patients with Waldenström's macroglobulinemia

Idera Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing a novel therapeutic approach for the treatment of autoimmune diseases and genetically defined forms of B-cell lymphoma, today announced that enrollment is open for a Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström's macroglobulinemia, following acceptance of its Investigational New Drug application by the U.S. Food and Drug Administration.

5 Dec 2013

MassBiologics gets FDA orphan drug designation for MBL-HCV1 antibody

MassBiologics of the University of Massachusetts Medical School has received an orphan drug designation from the U.S. Food and Drug Administration for MBL-HCV1, a monoclonal antibody developed to prevent hepatitis C virus recurrence in patients receiving a liver transplant.

5 Dec 2013

FDA accepts ARCA biopharma's Gencaro IND application for atrial fibrillation

ARCA biopharma, Inc., a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the Company's Gencaro Investigational New Drug application for atrial fibrillation has been accepted by the U.S. Food and Drug Administration and is now active.

4 Dec 2013

Top cancer research centers to establish new biotechnology company focused on cancer immunotherapy

The Fred Hutchinson Cancer Research Center (Fred Hutch) and Memorial Sloan-Kettering Cancer Center (MSKCC), along with pediatric partner Seattle Children's Research Institute, have joined forces to launch Juno Therapeutics Inc., a new biotechnology company focused on bringing forward novel immunotherapies for cancer.

4 Dec 2013

Presence of ERG protein in biopsied prostate tissue increases likelihood of cancer development

Researchers from Weill Cornell Medical College have shown that the presence of a particular protein in biopsied prostate tissue substantially increases the likelihood that cancer will develop in that organ. The discovery will likely help physicians decide how closely to monitor men potentially at risk for the cancer -- among the most confusing and controversial dilemmas in health care.

4 Dec 2013

Dye reduction in diagnostic heart procedures: an interview with Mike McCormick, CEO Osprey Medical

Iodine based contrast media (dye) is radiopaque and is commonly used for diagnostic and interventional heart procedures. It allows physicians to see real time images of the heart vessels and treat any blockages.

3 Dec 2013

Soligenix initiates orBec Phase 2 study for GI manifestations of chronic GVHD

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it has initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating orBec (oral beclomethasone 17,21-dipropionate or BDP) as a treatment for the gastrointestinal manifestations of chronic Graft-versus-Host disease.

2 Dec 2013

Stroke patients report improvements in their motor function using novel rehabilitation device

Using a novel stroke rehabilitation device that converts an individual's thoughts to electrical impulses to move upper extremities, stroke patients reported improvements in their motor function and ability to perform activities of daily living. Results of the study were presented today at the annual meeting of the Radiological Society of North America.

2 Dec 2013

InnaVirVax starts VAC-3S Phase 2 clinical trial for treatment of HIV-1 infection

InnaVirVax SA today announced the initiation of a Phase 2 clinical trial assessing the therapeutic properties of the VAC-3S vaccine when combined with standard antiretroviral therapy in the course of HIV-1 infection.

1 Dec 2013

Patrys to present data from PAT-SM6 Phase I/IIa trial in multiple myeloma at ASH conference

Patrys Limited (ASX: PAB), a clinical stage biotechnology company has announced that updated results from its PAT-SM6 Phase I/IIa clinical trial in multiple myeloma will be presented at the 55th American Society of Hematology Annual Meeting in New Orleans, LA on 7- 10 December 2013.

29 Nov 2013

Study finds way to regulate sleep patterns of children with brain disorders

For parents of children with brain disorders or visual impairment, nights can be long and frustrating, leading to even more difficult days as exhaustion takes hold.

29 Nov 2013

Clinical Trial News and Research

Auxilium Pharmaceuticals' XIAFLEX gets FDA approval for treatment of Peyronie's disease

Eisai reports new data analyses on FYCOMPA (Perampanel) at AES meeting

Telomerase inhibiting drug induces morphologic, molecular, clinical remissions in myelofibrosis patients

Genocea commences GEN-004 Phase 1 study to prevent pneumococcus infections

CEL-SCI gets approval to start enrollment for Multikine Phase III study for head and neck cancer

AtheroNova completes active treatment portion of Phase 1 clinical trial with AHRO-001

B2G2 component of grape seed extract induces apoptosis in prostate cancer cells

Archimedes Model simulation suggests genetic screening for breast cancer risk can reduce deaths

Senesco completes cohort 3 of SNS01-T Phase 1b/2a trial for multiple myeloma and lymphoma treatment

Enrollment opens for IMO-8400 Phase 1/2 trial in patients with Waldenström's macroglobulinemia

MassBiologics gets FDA orphan drug designation for MBL-HCV1 antibody

FDA accepts ARCA biopharma's Gencaro IND application for atrial fibrillation

Top cancer research centers to establish new biotechnology company focused on cancer immunotherapy

Presence of ERG protein in biopsied prostate tissue increases likelihood of cancer development

Dye reduction in diagnostic heart procedures: an interview with Mike McCormick, CEO Osprey Medical

Soligenix initiates orBec Phase 2 study for GI manifestations of chronic GVHD

Stroke patients report improvements in their motor function using novel rehabilitation device

InnaVirVax starts VAC-3S Phase 2 clinical trial for treatment of HIV-1 infection

Patrys to present data from PAT-SM6 Phase I/IIa trial in multiple myeloma at ASH conference

Study finds way to regulate sleep patterns of children with brain disorders

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