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NEJM publishes positive clinical results from Phase 2 clinical study of volanesorsen

NEJM publishes positive clinical results from Phase 2 clinical study of volanesorsen

Isis Pharmaceuticals, Inc., the leader in RNA-targeted therapeutics, and Akcea Therapeutics, its wholly owned subsidiary, announced today that The New England Journal of Medicine (NEJM) has published positive clinical results from a Phase 2 clinical study evaluating volanesorsen (formerly ISIS-APOCIII Rx) in patients with very high to severely high triglycerides. [More]
Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections. [More]
LixiLan-O Phase III clinical trial meets primary endpoint in patients with type 2 diabetes

LixiLan-O Phase III clinical trial meets primary endpoint in patients with type 2 diabetes

Sanofi announced today that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin. The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, a GLP-1 RA, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with lixisenatide and compared with insulin glargine 100 units/mL. [More]
Consumption of B-GOS prebiotic has positive effect on gut microbiota, immune systems of elderly people

Consumption of B-GOS prebiotic has positive effect on gut microbiota, immune systems of elderly people

Clasado Biosciences Limited, the producers and suppliers of the second generation prebiotic Bimuno, a unique trans-galactooligosaccharide, and the Department of Food and Nutritional Sciences, The University of Reading, UK, today announce the results of human research demonstrating the positive effects of an advanced prebiotic on the immune system of the elderly. [More]

Moerae announces initiation of second MMI-0100 Phase 1 clinical trial for pulmonary disorders

Moerae Matrix Inc. announced today the initiation of its second Phase 1 clinical trial with MMI-0100, a first-in-class inhibitor of MAPKAP kinase 2 (MK2) that is being developed for pulmonary disorders characterized by inflammation and fibrosis. The study, conducted in the United Kingdom, is a double-blind, two-way cross-over design lipopolysaccharide (LPS) challenge study further evaluating the safety and tolerability of MMI-0100 when given via inhalation to healthy subjects who smoke. [More]
Researchers establish safety, dosing of new drug for treating blood cancers

Researchers establish safety, dosing of new drug for treating blood cancers

Researchers at University of California, San Diego School of Medicine have established the safety and dosing of a new drug for treating blood cancers. The findings are published online July 27 in The Lancet Haematology. [More]
Research brief provides clinical validation of LOXO-101 Phase 1 trial for treatment of TRK fusion cancer

Research brief provides clinical validation of LOXO-101 Phase 1 trial for treatment of TRK fusion cancer

The University of Colorado Cancer Center and Loxo Oncology, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development. [More]
Research brief describes enrollment of first patient with TRK fusion cancer in LOXO-101 Phase 1 trial

Research brief describes enrollment of first patient with TRK fusion cancer in LOXO-101 Phase 1 trial

The University of Colorado Cancer Center and Loxo Oncology, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase (TRK) fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development. [More]
Eddingpharm plans to begin Phase 1 study for BRINAVESS in China

Eddingpharm plans to begin Phase 1 study for BRINAVESS in China

Cardiome Pharma Corp. today announced that its Chinese development and commercialization partner, Eddingpharm, plans to initiate a Phase 1 study for BRINAVESSTM to support regulatory approval in China. The study will be conducted in healthy volunteers. [More]
Omeros' OMS721 granted FDA Fast Track designation for treatment of atypical hemolytic uremic syndrome

Omeros' OMS721 granted FDA Fast Track designation for treatment of atypical hemolytic uremic syndrome

Omeros Corporation today announced that the U.S. Food and Drug Administration granted Fast Track designation to OMS721 for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system. [More]
Phase 3 SUMIT study: Selumetinib fails to meet primary endpoint in patients with metastatic uveal melanoma

Phase 3 SUMIT study: Selumetinib fails to meet primary endpoint in patients with metastatic uveal melanoma

AstraZeneca today announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. [More]
New TCR therapy demonstrates encouraging clinical responses in patients with multiple myeloma

New TCR therapy demonstrates encouraging clinical responses in patients with multiple myeloma

Results from a clinical trial investigating a new T cell receptor (TCR) therapy that uses a person's own immune system to recognize and destroy cancer cells demonstrated a clinical response in 80 percent of multiple myeloma patients with advanced disease after undergoing autologous stem cell transplants (ASCT). [More]
GUMC physician leads new national clinical trial for melanoma treatment

GUMC physician leads new national clinical trial for melanoma treatment

A Georgetown University Medical Center physician renowned for his research in melanoma will lead a new national clinical trial involving novel treatments for the disease. The study compares the sequencing of two groups of drugs -- both effective in treating melanoma. [More]
New phase III cancer treatment trial opens for patient with advanced melanoma

New phase III cancer treatment trial opens for patient with advanced melanoma

A new phase III cancer treatment trial has opened for patient enrollment that examines two treatments that work in completely different ways yet have both been shown in previous clinical trials to be effective in treating patients with advanced melanoma, the ECOG-ACRIN Cancer Research Group announced today. [More]
InnaVirVax presents positive results of IVVAC-3S/P1 study at International AIDS Society Conference

InnaVirVax presents positive results of IVVAC-3S/P1 study at International AIDS Society Conference

InnaVirVax, a biopharmaceutical company specialized in research and development of therapeutic and diagnostic solutions for major infectious and chronic diseases, today announced the overall results of its Phase I/IIa clinical study of its VAC-3S immunotherapy, which is currently in development. [More]
Elderberry supplement can provide protection from cold, flu-like symptoms following long-haul flights

Elderberry supplement can provide protection from cold, flu-like symptoms following long-haul flights

The negative health effects of international air travel are well documented but now it seems that the common elderberry can provide some relief. [More]
Adaptimmune’s NY-ESO-1 TCR-engineered T-cell therapy mediates sustained antitumor effects in multiple myeloma patients

Adaptimmune’s NY-ESO-1 TCR-engineered T-cell therapy mediates sustained antitumor effects in multiple myeloma patients

Adaptimmune Therapeutics plc, a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that data from its Phase I/II study of its affinity enhanced T-cell receptor therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published in Nature Medicine. [More]
Early antiretroviral treatment prevents AIDS- and non-AIDS-related diseases in HIV-infected people

Early antiretroviral treatment prevents AIDS- and non-AIDS-related diseases in HIV-infected people

Starting antiretroviral therapy early not only prevents serious AIDS-related diseases, but also prevents the onset of cancer, cardiovascular disease, and other non-AIDS-related diseases in HIV-infected people, according to a new analysis of data from the Strategic Timing of AntiRetroviral Treatment (START) study, the first large-scale randomized clinical trial to establish that earlier antiretroviral treatment benefits all HIV-infected individuals. [More]
Tamsulosin works better on large kidney stones

Tamsulosin works better on large kidney stones

Tamsulosin works no better than placebo on small kidney stones, but does improve passage of more large kidney stones than placebo does. The results of this large clinical trial evaluating tamsulosin versus placebo were published online Friday in Annals of Emergency Medicine ("Distal Ureteric Stones and Tamsulosin: A Double-Blind, Placebo-Controlled, Randomized, Multi-Center Trial (The DUST Trial)"). [More]
Young, single South African women adhere well to daily PrEP regimen to prevent HIV infection

Young, single South African women adhere well to daily PrEP regimen to prevent HIV infection

A clinical study funded by the National Institutes of Health has found that young, single black women in South Africa adhered to a daily pill regimen to prevent HIV infection--an HIV prevention strategy known as pre-exposure prophylaxis, or PrEP. This finding is the first strong indication that this population at substantial HIV risk could accept and reliably adhere to daily PrEP dosing. [More]
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