Clinical Intelligence

Trillium launches phase I IC/BPS study

Thursday, December 15, 2011 08:31 AM

Trillium Therapeutics will begin a phase I clinical trial of its experimental drug, TTI-1612, in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). The company has recently received a No Objection Letter to its Clinical Trial Application from Health Canada's Biologics and Genetic Therapies Directorate. The single ascending dose trial, which will be conducted at multiple sites across southern Ontario, will evaluate the safety and tolerability of TTI-1612 in IC/BPS patients.

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Nektar initiates phase III BEACON trial in women with metastatic breast cancer

Wednesday, December 14, 2011 04:17 PM

Nektar Therapeutics has initiated a phase III global clinical trial evaluating NKTR-102 as a single agent in women with metastatic breast cancer. NKTR-102 is a next-generation topoisomerase I inhibitor designed using Nektar's proprietary polymer conjugate technology, and is being developed in multiple tumor settings. The BEACON study is designed to include approximately 840 metastatic breast cancer patients who have had prior treatment with anthracycline, taxane and capecitabine in either the adjuvant or metastatic setting.

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VAXIMM initiates oral therapeutic cancer vaccine trial

Tuesday, December 13, 2011 09:14 AM

VAXIMM has started the first clinical trial of its investigational oral therapeutic cancer vaccine VXM01. The placebo-controlled phase I dose escalation study intends to enroll up to 45 pancreatic cancer patients at the Heidelberg University Hospital (Heidelberg, Germany). The patients will receive several doses of VXM01, a therapeutic cancer vaccine that targets the tumor vasculature. The results of the initial double blind period of the study are expected in the first half of 2013.

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ChemoCentryx initiates phase II CCX140 trial

Monday, December 12, 2011 12:40 PM

ChemoCentryx has initiatied a phase II clinical trial for CCX140, an orally-administered small molecule for the treatment of diabetic kidney disease (diabetic nephropathy). CCX140 is a novel CCR2 inhibitor with a pharmacological profile unlike that of other CCR2 compounds that have been known to be tested by other sponsors. CCX140 works by blocking the infiltration and activation of certain populations of monocyte and macrophages and other cells bearing CCR2 that occurs during inflammation. This mechanism of action provides selective treatment of the disease without compromising other immune functions.

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Furiex's phase II PPD-10558 trial does not meet primary efficacy endpoint

Friday, December 9, 2011 12:49 PM

Furiex Pharmaceuticals has reported top-line results from the phase II trial of the investigational drug PPD-10558 in patients with statin-associated myalgia, or SAM. PPD-10558 did not meet its primary efficacy endpoint in this randomized, double-blind, proof-of-concept study. The study enrolled patients with high cholesterol and a prior history of SAM, and evaluated recurrence rates for SAM over a twelve-week treatment period across the following three different treatment regimens: placebo; PPD-10558; and atorvastatin (Lipitor). Patients did not report any significant differences in muscle symptoms, nor did they drop out due to SAM in significantly different percentages, among the three regimens. As expected, however, PPD-10558, a novel statin, did significantly lower LDL-cholesterol compared with placebo, and the compound also had a favorable safety profile.

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Pearl Therapeutics' COPD trial shows positive results

Friday, December 9, 2011 08:17 AM

Pearl Therapeutics has reported positive top-line results from a randomized, double-blind, phase IIb, dose-ranging study of glycopyrrolate, a long-acting muscarinic agonist delivered twice a day via metered-dose inhaler in patients with moderate-to-severe COPD. Four doses of GP MDI were compared to placebo and Atrovent HFA Inhalation Aerosol, a short-acting muscarinic antagonist given four times a day. All doses of GP MDI tested produced statistically significant improvements in lung function compared to placebo. Further, doses of PT001 were identified that were non-inferior to Atrovent HFA. PT001 was well tolerated and no safety concerns were identified.

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Zalicus initiates phase I Z160 trial

Wednesday, December 7, 2011 12:31 PM

Zalicus has initiated a phase I clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160 (formerly NMED-160), a novel oral N-type calcium channel blocker. Z160 has been reformulated with multiple state-of-the-art delivery techniques to address previous solubility and bioavailability issues. Zalicus plans to run phase I human pharmacokinetic and safety studies with these formulations during the remainder of 2011 and into early 2012. Based on this pharmacokinetic and safety data, Zalicus plans to select the best formulation to advance into phase II clinical development in 2012. A previous formulation of Z160 has been studied in clinical trials of over 200 subjects and was well tolerated.

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Curemark's phase III autism trial shows positive results

Wednesday, December 7, 2011 10:08 AM

Curemark has reported its phase III double blind randomized placebo controlled multicenter clinical trial of CM-AT for autism met its primary and secondary endpoints. The trial compared CM-AT to placebo in children with autism aged 3-8. Top line results demonstrate a statistically significant effect of CM-AT over placebo on both core and non-core symptoms of autism.

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Researchers use stem cells to determine new therapies for severe childhood epilepsy

Tuesday, December 6, 2011 01:52 PM

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Echo Therapeutics' diabetes monitoring trial shows positive results

Tuesday, December 6, 2011 09:18 AM

Echo Therapeutics has reported positive results from its clinical study of its Symphony tCGM System in patients with type 1 and type 2 diabetes. Data from the study confirm that Symphony successfully monitors the broad range of blood glucose values seen in people with diabetes.

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