Clinical Intelligence

Palatin, AstraZenca collaborate in AZD2820 obesity trial

Tuesday, August 16, 2011 10:09 AM

Palatin Technologies and AstraZeneca have initiated the phase I clinical trial of AZD2820, a subcutaneously-administered peptide melanocortin receptor partial agonist, under development as a single-agent therapy for the treatment of obesity.

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FDA reviews BYDUREON, type 2 diabetes medication

Friday, August 12, 2011 02:48 PM

Amylin Pharmaceuticals, Eli Lilly, and Alkermes have reported that the FDA has acknowledged the companies’ BYDUREON (exenatide extended-release for injectable suspension) resubmission. The FDA has categorized it as a class II resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012. BYDUREON is an investigational medication for type 2 diabetes.

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Antares’ VIBEX MTX trial meets primary endpoints

Friday, August 5, 2011 10:58 AM

Antares Pharma has reported positive results of a clinical study evaluating VIBEX MTX, a proprietary auto injector product designed to give a rapid subcutaneous injection of methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). The clinical pharmacokinetic study evaluated several dose strengths of MTX delivered by a healthcare professional to RA patients with VIBEX MTX versus subcutaneous or intramuscular injection using a conventional needle and syringe. The primary end points were met with all three methods of administration providing equivalent performance in the patients studied, together with comparable safety.

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FDA approves Anascorp, first specific treatment for scorpion stings

Thursday, August 4, 2011 12:52 PM

The FDA has approved Anascorp, the first specific treatment for a scorpion sting by Centruroides scorpions in the United States.

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NWBT expands clinical sites in ongoing brain cancer trial

Thursday, August 4, 2011 11:36 AM

Northwest Biotherapeutics has expanded its number of clinical trial sites, and now has 12 sites across the U.S. open and active, where patients can enroll in the ongoing clinical trial of DCVax immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. The company also reported that a substantial number of additional sites are in progress. With the 12 sites already open and active, and others in progress, the company is on track to fulfill its prior projection that it will have 15 sites open and active in Q3 of this year.

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Cara Therapeutics initiates phase II CR845 trial

Wednesday, August 3, 2011 11:43 AM

Cara Therapeutics has begun the dosing of the first patient in a phase II clinical trial of its peripherally-selective, kappa opioid agonist, CR845, for the treatment of acute post-operative pain. The double-blind, placebo-controlled trial is expected to enroll a minimum of 200 patients at multiple clinical sites in the United States, and will evaluate the efficacy and safety of intravenous CR845 administered both pre- and post-operatively in women undergoing laparoscopic hysterectomy. This trial follows the successful completion of a 46 patient, multi-center, double-blind phase II study of CR845, in the same surgical population, where both analgesic and opioid-sparing effects of CR845 were demonstrated and the drug was found to be safe and well tolerated after a single post-operative dose.

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The CenterWatch Monthly, August 2011

Monday, August 1, 2011 08:26 AM

Sponsors target new areas to speed cycle times

Biopharmaceutical company executives struggle to find ways of shortening drug development cycle time. Sponsors place a high priority on accelerating cycle time to help improve R&D productivity, yet median cycle times, according to analysis of FDA and industry data, increased by nearly 15% between 1994 and 2009, from 77.3 to 81.9 months. Executives say the greatest challenge to reducing cycle time is the large, phase III clinical trial, which has become more complex. Yet overall, these executives say the most promising areas for improving cycle times are...

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Lexicon successfully completes phase I LX1033 trial

Friday, July 29, 2011 11:16 AM

Lexicon Pharmaceuticals has successfully completed a phase I clinical trial of LX1033, an orally-delivered small-molecule drug candidate for diarrhea-predominant irritable bowel syndrome (IBS-d).  Lexicon plans to move LX1033 forward into a phase II study in patients with IBS-d.

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Polaris doses first patient in phase III ADI-PEG 20 trial

Friday, July 29, 2011 11:13 AM

Polaris Group has dosed the first patient in a phase III clinical trial evaluating its lead cancer therapeutic, pegylated arginine deiminase (ADI-PEG 20), in hepatocellular carcinoma (HCC) patients.

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Micell completes enrollment for DESSOLVE II study

Friday, July 29, 2011 11:11 AM

Micell Technologies has completed patient enrollment in its DESSOLVE II CE Mark clinical study of the MiStentR drug-eluting coronary stent system. The MiStent DES is an ultra-thin drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation. Enrollment of 183 patients across 26 study centers throughout Europe and New Zealand was accomplished ahead of schedule.

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