Clinical Intelligence

Auxilium releases CORDLESS results

Friday, July 1, 2011 10:24 AM

Auxilium Pharmaceuticals has announced three-year recurrence data from the Collagenase Optimal Reduction of Dupuytren's—Long-term Evaluation of Success Study (CORDLESS) for XIAFLEXR (collagenase clostridium histolyticum) in the treatment of adult Dupuytren's contracture patients with a palpable cord.

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VIVUS Submits NDA for Treatment of Erectile Dysfunction

Friday, July 1, 2011 10:20 AM

VIVUS has submitted a New Drug Application (NDA) to the FDA seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The NDA submission follows the successful completion of an extensive phase III program for avanafil, which included over 1,350 patients, where avanafil was shown to be well tolerated and effective in treating men with ED.

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ACORN reports positive research results

Friday, July 1, 2011 10:17 AM

Accelerated Community Oncology Research Network (ACORN) reported positive results of a large, double-blind, randomized phase IIb trial in patients with breast cancer. The study evaluated a drug regimen for the treatment of locally advanced or metastatic breast cancer. The regimen, NexavarR (sorafenib) tablets in combination with either Gemcitabine (GemzarR) or Capecitabine (XelodaR), found statistically significant improvement in progression-free survival.  Forty investigative sites enrolled 160 patients over a three-year period.

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ChemoCentryx reports CCX140 meets primary endpoint

Wednesday, June 29, 2011 12:53 PM

ChemoCentryx said CCX140, an orally active CCR2 antagonist, successfully met its primary endpoint of safety and tolerability and demonstrated clinical efficacy in a phase II study in patients with type 2 diabetes on stable doses of metformin.  

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Omeros unlocks orphan GPCRs linked to leukemia and sleep disorders

Wednesday, June 29, 2011 12:51 PM

Omeros said it has identified compounds that interact with orphan G protein-coupled receptors (GPCRs) P2Y8 and OPN4. P2Y8 (also known as P2RY8) is associated with acute lymphoblastic leukemia (ALL), an aggressive cancer of the white blood cells and the most common type of malignancy diagnosed in children.

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Micell Technologies reduces study sample size

Wednesday, June 29, 2011 12:20 PM

Micell Technologies announced that it has completed its review of the scheduled four-month follow-up on the first 10 patients from the DESSOLVE I first-in-human trial of the MiStent Drug-Eluting Coronary Stent System ("MiStent DES"), an ultra-thin drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation. Based on results observed in the DESSOLVE I trial, Micell has reduced the sample size in its DESSOLVE II CE Mark study from 270 to 171 planned subjects.

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Halozyme's ultrafast insulin demonstrates reduced variability of insulin absorption

Sunday, June 26, 2011 08:46 PM

Halozyme Therapeutics has announced final results from a study in type 1 diabetes patients who receive their insulin treatment with a pump demonstrating that Aspart-PH20, a formulation of Halozyme's rHuPH20 (recombinant human hyaluronidase) with the active ingredient in NovoLog, reduces the variability of insulin absorption and reduces post-meal glycemic excursions compared to NovoLog alone.

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Reata and Abbott initiate global phase III study of Bardoxolone Methyl

Friday, June 17, 2011 03:08 PM

Reata Pharmaceuticals and Abbott have initiated a pivotal phase III clinical trial to evaluate the safety and efficacy of bardoxolone methyl in patients with chronic kidney disease (eGFR of 15-29 mL/min/1.73 m2) and Type 2 diabetes.

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Sunshine Biopharma to conduct trial for Jewish General Hospital

Friday, June 17, 2011 02:57 PM

Sunshine Biopharma, a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, has executed an agreement with The Jewish General Hospital, one of McGill University's Hospital Centers, to conduct the necessary R&D to advance Sunshine's lead compound, Adva-27a, through the various stages of pre-clinical studies and phase I clinical trials.

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QE3 clinical trial stopped

Friday, June 10, 2011 12:04 PM

According to the National Parkinson Foundation, the National Institute for Neurological Disease and Stroke (NINDS) has stopped the clinical trial of Coenzyme Q10, referred to as the QE3 study.

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