Biotech company Lux Biosciences has partnered with PRA International, a global contract research organisation (CRO) headquartered in the US, to conduct the pivotal clinical trials of its new calcineurin inhibitor for the treatment of chronic inflammation of the eye.
The trial programme, which consists of three controlled, double masked studies, is investigating the use of the new drug, LX211, in different forms of active uveitis and to maintain control in patients with quiescent disease.
Lux, which specializes in the field of ophthalmic diseases, is conducting each of the three protocols in parallel with approximately 45 sites participating in the trials in North America, Europe and India. In addition, the firm expects to enrol more than 500 patients in total.
"Our development programme for LX211 continues according to plan, and we hope to complete enrolment in this trial programme by early 2008 and, if successful, seek regulatory approval for LX211 in late 2008," said Ulrich Grau, Lux Biosciences' CEO.
In addition to uveitis, Lux said it plans to develop the drug in other ophthalmic indications, including dry eye syndrome and age-related macular degeneration.
Uveitis is an under-diagnosed and under-recognised medical condition that causes vision impairment, ocular pain, and loss of vision. Experts estimate that 10 per cent of new US cases of blindness result from this disease.
Around 300,000 people suffer from uveitis in the US alone, and the only therapeutic class approved by the FDA for treatment of uveitis is corticosteroids, which are burdened with multiple side effects. Experts estimate that 10 per cent of new US cases of blindness result from this disease.
Last week, Amarin has announced the completion of two Phase III trials with Huntington's Disease (HD) treatment Miraxion.
The US trial was run by the Huntington's Study Group (HSG) and the European trial by Icon, in collaboration with European HD Network (EHDN).
In support of the European trial, Icon provided a range of development services including clinical research management, data management, statistics and CRF design services.
The trial was conducted in 33 sites in Europe and 240 patients with HD were enrolled in the trial over a 6-month period.
Meanwhile, Bentley has announced it has received approval from the Indian regulator to proceed with a Phase II clinical trial of its intranasal insulin product Nasulin.
Clinigene, a CRO owned by Biocon, will be in charge of managing the trials. Biocon is Bentley's licensing partner for the development and marketing of Nasulin in India and several other territories.
This 12 week study will start in March and is expected to be completed before the end of the year.
"Phase II clinical studies for this product will consist of 80 patients and will be conducted in six centers in India under the direction of top clinical investigators," said Dr. Arvind Atignal, Clinigene's chief operating officer.
In other clinical news this week, US firm Quintiles has announced it is expanding its capacity in the US.
The CRO has leased an extra 15,000 sq. ft. of offices at Imperial Centre business park, adding to the 200,000 sq. ft. it already leases at the site located in Durham, North Carolina.
Last week, the firm also opened its new data-processing center in Eastern North Carolina where it plans to create up to 60 jobs over the next three years.