Clinical Intelligence

Keryx completes patient enrollment for phase III Zerenex trial

Monday, September 19, 2011 12:28 PM

Keryx Biopharmaceuticals has completed patient enrollment in the long-term study component of its phase III registration program of Zerenex, the company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The Zerenex phase III registration program, which is being conducted pursuant to a Special Protocol Assessment (SPA) with the FDA, is comprised of an already successfully-completed phase III short-term study, and this ongoing phase III long-term study.

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VIVUS to re-submit QNEXA NDA

Thursday, September 15, 2011 12:21 PM

VIVUS has reached agreement with officials of the Endocrine and Metabolic Division of the FDA on a plan that allows for an early resubmission of the QNEXA New Drug Application for the treatment of obesity. The resubmission plan allows VIVUS to seek approval for an initial indication that includes obese men and women of non-child bearing potential.  Based on this agreement, VIVUS intends to resubmit the QNEXA NDA by the end of October 2011, prior to completion of the FORTRESS study.

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ChemoCentrx’s diabetes trial meets primary endpoint

Thursday, September 15, 2011 12:10 PM

ChemoCentryx has reported that its novel, orally active CCR2 antagonist, CCX140-B, demonstrated an excellent safety profile and exhibited clear signs of biological and clinical effect in a phase II study in patients with type 2 diabetes on stable doses of metformin. 

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Lexicon’s LX4211 trial shows positive results

Tuesday, September 13, 2011 11:30 AM

Lexicon Pharmaceuticals reported positive data from a recently completed clinical trial and mechanistic study of LX4211, a dual inhibitor of the sodium glucose transporters 1 and 2 (SGLT1 and SGLT2).  The favorable safety profile and effects on multiple parameters of glycemic control and cardiovascular health in healthy normal subjects support the broad potential of LX4211 in the treatment of diabetes and associated metabolic conditions.

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Pharmasset initiates phase IIb QUANTUM trial

Tuesday, September 13, 2011 10:57 AM

Pharmasset has begun screening in a phase IIb, international study of PSI-7977 and PSI-938, two nucleotide analog polymerase inhibitors for the treatment of chronic hepatitis C (HCV). The QUANTUM trial will evaluate interferon-free regimens of PSI-7977 400mg QD and PSI-938 300mg QD with and without ribavirin over 12 or 24 weeks in patients with HCV who have not been treated previously. The trial will also evaluate the use of PSI-938 monotherapy.

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Omeros identifies four orphan GPCRs

Tuesday, September 13, 2011 10:49 AM

Omeros has identified compounds that interact selectively with each of four additional orphan G protein-coupled receptors (GPCRs) - GPR15, GPR39, GPR78 and GPR161. Omeros has now announced that it has unlocked 14 of the 80 Class A orphan GPCRs. GPCRs represent the premier family of drug targets, with more than 30% of currently marketed drugs targeting only 46 GPCRs. There are approximately 120 orphan GPCRs. Omeros is initially targeting Class A orphan GPCRs.

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Marshall Edwards initiates phase I ME-143 trial

Friday, September 9, 2011 12:48 PM

Marshall Edwards, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, has initiated a phase I clinical trial of its lead drug candidate ME-143 in patients with refractory solid tumors. The trial is being conducted in collaboration with the Sarah Cannon Research Institute in Nashville, Tennessee, following the approval of an Investigational New Drug (IND) application by the FDA last month.

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The CenterWatch Monthly, September 2011

Thursday, September 1, 2011 02:35 PM

Integrated CRO alliances growing but poorly executed

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Aterena Zentaris’ AGHD study shows favorable results

Tuesday, August 30, 2011 12:03 PM

Aeterna Zentaris has reported favorable top-line results of its completed phase III study with AEZS-130 as the first oral diagnostic test for Adult Growth Hormone Deficiency (AGHD). The results show that AEZS-130 reached its primary endpoint demonstrating >90% area-under-the-curve (AUC) of the Receiver Operating Characteristic curve, which determines the level of specificity and sensitivity of the product. The company is currently proceeding with further detailed analyses of the data and preparing for a pre-New Drug Application (NDA) meeting with the FDA in the upcoming months, which would be followed by the filing of a NDA for the registration of AEZS-130 in the United States.

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AiCuris’ Letermovir receives Fast Track designation

Monday, August 29, 2011 12:58 PM

AiCuris announced today that the FDA has granted Fast Track designation for one of its lead drugs, AIC246, an inhibitor of the human cytomegalovirus (HCMV).

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