Contract research news in brief
pharmafile | August 17, 2011 | News story | Research and Development |Â Â research and development newsÂ
Our round-up of news from the contract research sector includes the rejection of a cancer drug by the FDA because of procedural problems at a CRO-run study, plus updates from Criterium, Eurofins Optimed/Spaulding, Synexus and Covance.
US drugmaker Adventrx has had its lead drug for cancer – Exelbine (vinorelbine injectable emulsion) – rejected by the US FDA because of mistakes in a clinical trial carried out by an Argentinian contractor. The FDA believes the trial has been compromised because samples of the drugs under test were not retained for inspection by the agency. The agency sent the company a complete response letter saying that the trial would need to be repeated, something that will take two years and cost around $2 million, according to Adventrx chief executive Brian Culley.
Criterium has been hired to manage the operational aspects of a phase Ib/IIa clinical study of SNS01-T, Senesco Technologies’ lead therapeutic candidate for the treatment of multiple myeloma. The study’s design calls for twice-weekly dosing of patients for six weeks followed by a four-week safety data review period before escalating to a higher dose level in a new group of patients.
Eurofins Optimed and Spaulding have joined forces to offer a range of contract clinical research services to pharmaceutical companies, including study design, study execution/conduct, data management, statistical analysis and medical writing. The companies specialise in first-in-human, multiple rising dose, bioavailability/bioequivalence, drug interaction, food effect studies and proof-of-concept studies in patients. Eurofins said the alliance would allow to tap into Optimed’s systems-based approach to electronic data capture.
UK-based CRO Synexus has won its first contract to conduct a mild cognitive impairment (MCI) study. In November 2010, the company signed an agreement with dementia expert Dr Roger Bullock, for the development of more effective clinical trials for this field. Currently, Synexus is in discussions with a number of sponsors with a view to undertake further MCI trials. Synexus chief executive Christophe Berthoux said they have seen an increase in interest from sponsors who are investing significant sums of money into research for new treatments for MCI.
Covance has expanded its drug metabolism services to include drug-transporter interactions with eight human transporters. The company now offers assessment of drug-transporter interactions involving major human transporters key to drug disposition in a stably transfected, cell-based format. The eight cell lines in the drug-transporter interactions service include P-glycoprotein, breast cancer resistant protein, organic cation transporters 1& 2, organic anion transporter 3, organic anion transporting polypeptides 1B1 and 1B3 and multidrug resistance-associated protein 2.
Phil Taylor
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