Clinical contract news in brief
clinical contract research world last week.
Living Cell Technologies (LCT) has announced it has chosen Boston-based Geny Research Group to monitor clinical trials for its new Type 1 diabetes drug.
Geny will act as the project manager to ensure all elements of the Phase I and IIA trials conducted in Russia adhere to international and FDA standards.
The contract research organisation (CRO) will oversee the protocols and be responsible for all data analysis and management, and provide a trial report that may be submitted along with data from international studies for regulatory approval in any jurisdiction, said LCT.
The drug to be tested - DiabeCell - is a porcine pancreatic cell product for the treatment of insulin-dependent diabetes. The natural neo-natal pig islet cells are encased in capsules that allow insulin to be released but prevent the patient's immune system from attacking the cells. The islets are simply injected into the body and produce insulin as needed in response to the levels of glucose in the blood.
The new drug compound, which has just been approved for a Phase I/IIA trial might, benefit from a quicker route to commercialisation within Russia.
"Along with international biopharmaceutical firms, LCT is taking advantage of the growing interest and availability of funds for biotechnology in Russia," said Paul Tan LCT CEO.
"The pharmaceutical industry has noted Russia's centralised medical infrastructure and efficient recruitment of patients into clinical trials. The rapid regulatory process in Russia and the accepted use of animal cells in treating human disease may shorten the time to market."
LCT claims DiabeCell offers considerable advantages over other available treatments as there is no need for immuno-suppressive drugs and the supply of cells from LCT's natural biocertified pig herds are readily available, unlike human organ donors.
It is anticipated that the trial would start in the second quarter of 2007, with potential patients already identified, the company said.
Meanwhile, New Zealand-based Neuren Pharmaceuticals picked US firm Touchstone Research to conduct the clinical trials for its new drug - glipromate - after the US FDA approved the initiation of Phase III tests.
Touchstone will manage the global trial of 520 patients which will be carried out in the US, Australia and New Zealand. The Phase III trial is estimated to take 18 months and is budgeted to cost Neuren A$10m (€6m), which is substantially less than many other Phase III trials, the firm said.
"Currently there are no Australian or New Zealand CROs that have the experience to conduct clinical trials under US FDA regulations, which is why we had to engage an US-based company," Larry Glass, executive vice president of Neuren, told Outsourcing-Pharma.com
Maryland-headquartered Touchstone was recently acquired by Swiss CRO Hesperion.
Glypromate is a treatment aimed at preventing cognitive impairment following major cardiac surgery.
There are currently no treatments available to prevent cognitive impairment following cardiac surgery, which is experienced by up to 70 per cent of patients at discharge and more than one-third of patients at three months following surgery. It has been accepted as a condition requiring treatment by the FDA.
Neuren believes that conducting a Phase III trial under FDA authorisation moves glypromate towards a first in market position for a $1bn (€770m) market.
In the meantime, eclinical specialist ClinPhone has announced it is expanding its operations in the East coast of the US to meet growing demand and also to target the increasing number of pharma companies who set up base in the New England region.
Over the past 12 months, the company has opened offices in San Francisco and North Carolina, and has relocated its New Jersey US Headquarters to a larger facility. In addition, the company has recently announced the opening of its Australian office, serving the Asia-Pacific region.
The new office located in Boston will have both business development and operations capabilities and will allow ClinPhone to provide local project management support for its existing customers based in the area, the firm said.
"The six New England states comprise one of the largest biotechnology sector development areas in the US and are also home to laboratories of several major pharmaceutical companies making it an ideal location for this new ClinPhone office."
