South Texas Accelerated Research Therapeutics (START), a US-based group that claims to run the world’s largest co-ordinated network of Phase I clinical trials in oncology, has opened a Phase I research facility in China at Fudan University Shanghai Cancer Centre, the city’s largest cancer hospital.

A joint venture between START and Shanghai-based venture capital firm Cenova Ventures, START Shanghai will occupy some 7,000 sq ft of dedicated space on the fourth floor of Fudan Cancer Hospital, which manages an estimated 600,000 patient visits per year.

Cenova is investing US$6 million dollars in the Shanghai operation while START is providing unspecified cash and intellectual capital.

The new unit will have eight treatment beds, eight treatment chairs expandable to 12, and a facility for pharmacokinetic studies.

According to START, it is the first Phase I cancer research centre in China to meet all the applicable standards of three major national regulatory agencies: China’s State Food and Drug Administration, the US Food and Drug Administration and the European Medicines Agency.

Heading up START China as chief executive officer will be Carol Zhu, previously director of clinical development for GlaxoSmithKline China, while Dr Junning Cao will serve as clinical director. Chairman of the board is Dr Anthony Tolcher, president and co-founder of START.

Global ambition

The Fudan Centre has been conducting Phase III and late Phase II clinical trials for years, but only pharmacokinetic studies at the Phase I stage, Dr Cao noted.

Zhu said START Shanghai would give China the early clinical research data to compete in global drug development, help make homegrown anticancers available abroad and provide Chinese patients with access to the newest oncology drugs.

The expectation is that the new venture will run Phase I studies for US pharmaceutical companies and for some domestic Chinese biotechnology players.

“Some trials will be conducted exclusively in China while others will be take place in parallel in the United States and China,” Dr Tolcher commented, adding that studies run in China would have “distinct protocols with pharmacokinetic studies designed for an Asian population”.

Phase I network

START Shanghai is the third in START’s planned network of global satellite Phase I clinical research sites. The network already includes START Madrid, the organisation’s first non-US site opened in 2009, and the flagship START San Antonio site in the US, which opened in 2007.

According to the US-based group, this model of locating START Phase I centres in strategic locations around the world “allows for a profoundly different approach to oncology research that uses a round-the-clock system of integrated clinical trial research and makes the newest Phase I drugs available to end-stage cancer patients who live in places where there is limited access to these therapies”.