Clinical Intelligence

ImmunoGen doses first patient in phase III ovarian cancer study

Friday, January 27, 2017

ImmunoGen, a provider of antibody-drug conjugates (ADCs) for the treatment of cancer, has announced that the first patient has been dosed in FORWARD I, the company’s phase III clinical trial evaluating mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer. Mirvetuximab soravtansine is a first-in-class, folate receptor alpha (FRα)-targeting ADC.

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Pfizer posts positive phase II C. difficile vaccine results

Friday, January 27, 2017

Pfizer announced that the phase II study evaluating the company’s Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis. The randomized study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer’s vaccine candidate is designed to help prevent C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis, by inducing a functional antibody response capable of neutralizing the two main disease-causing toxins produced by C. difficile (toxins A and B).

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Synergy’s Trulance FDA approved for chronic idiopathic constipation

Monday, January 23, 2017

The FDA has approved Synergy Pharmaceuticals’ Trulance (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.

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Concert’s CTP-656 receives FDA Orphan designation for cystic fibrosis

Monday, January 23, 2017

Concert Pharmaceuticals has announced that the FDA has granted Orphan Drug designation for CTP-656, Concert’s next generation CFTR potentiator being developed for the treatment of cystic fibrosis. In December 2016, Concert initiated a phase II trial in the U.S. evaluating CTP-656 in cystic fibrosis patients with gating mutations. Topline results from the phase II trial are expected by year-end 2017.

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Panacea Pharmaceuticals initiates phase I cancer vaccine study

Thursday, January 19, 2017

Panacea Pharmaceuticals, a clinical stage biopharmaceutical company developing novel biologically targeted cancer therapies and diagnostics for unmet medical needs, has announced that the first patient has been enrolled and dosed in the open-label, parallel designed, multicenter phase I clinical trial of PAN-301-1 for the treatment of persistent prostate cancer to assess safety and immunogenicity. Clinical sites for the PAN-301-1 trial are located in Alabama, California, Nebraska and South Carolina and the trial is managed by Accelovance.

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