Clinical Intelligence

Shire’s phase III VONVENDI study meets primary endpoint

Monday, December 5, 2016

Shire, a biotechnology company focused on serving individuals with rare diseases and other highly specialized conditions, has announced topline results from a phase III clinical trial of VONVENDI [von Willebrand factor (Recombinant)] to treat bleeds in elective surgical settings for adults with severe von Willebrand disease (VWD), the most common inherited bleeding disorder.

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First new HIV vaccine efficacy study in seven years has begun

Tuesday, November 29, 2016

The first HIV vaccine efficacy study to launch anywhere in seven years is now testing whether an experimental vaccine regimen safely prevents HIV infection among South African adults. The study, called HVTN 702, involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. HVTN 702 aims to enroll 5,400 men and women, making it the largest and most advanced HIV vaccine clinical trial to take place in South Africa, where more than 1,000 people become infected with HIV every day.

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Epizyme receives Fast Track for Tazemetostat in B-cell lymphoma

Tuesday, November 29, 2016

Epizyme, a clinical-stage biopharmaceutical company creating novel epigenetic therapies, has announced advancements in the company’s clinical programs evaluating tazemetostat, its first-in-class EZH2 inhibitor. The FDA has granted tazemetostat Fast Track designation in patients with diffuse large B-cell lymphoma (DLBCL) with EZH2 activating mutations. Additionally, Epizyme is focusing its phase II registration-enabling study in adult patients with genetically-defined solid tumors on those cancers marked by loss of INI1, and has expanded enrollment in the epithelioid sarcoma cohort of the study based on encouraging early activity in this patient population.

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Triphase announces full enrollment results for malignant glioma trial

Wednesday, November 23, 2016

Triphase Accelerator, a private drug development company dedicated to advancing novel compounds through clinical phase II proof-of-concept, has announced positive full enrollment results from its multicenter, open label, phase I study evaluating marizomib (MRZ) in combination with bevacizumab (BEV) in patients with WHO grade IV malignant glioma. Triphase separately announced on November 17, 2016 that Celgene acquired the assets relating to MRZ.

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BioSpecifics Technologies announces positive data from phase IIb cellulite study

Monday, November 21, 2016

BioSpecifics Technologies, a biopharmaceutical company that originated and continues to develop collagenase based-therapies with a first in class collagenase-based product collagenase clostridium histolyticum, or CCH, marketed as XIAFLEX in the U.S. and Xiapex in Europe today announced positive, highly statistically significant results from a phase IIb study of CCH for the treatment of cellulite, or edematous fibrosclerotic panniculopathy. Trial subjects receiving CCH showed statistically significant levels of improvement in the appearance of cellulite with treatment, as measured by the trial’s primary endpoint (p<0.001), compared to those subjects receiving placebo. CCH was well-tolerated in the actively treated subjects with most adverse events being mild to moderate in severity, and primarily limited to the local injection area.

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