BioWorld International Correspondent
LONDON - New European Union rules on clinical trials that come into effect May 1 were a significant factor in Oxxon Pharmaccines Ltd.'s decision to open a U.S. facility in Boston.
"The requirements are significant for a small company, without me being able to identify any benefit," Deirdre Gillespie, CEO, told BioWorld International. "I don't want my timelines and data being dependent on the changes."
The Clinical Trials Directive is intended to harmonize the conduct of trials throughout Europe, including the 10 accession states that are joining the EU in May.
Critics, including the UK BioIndustry Association (BIA) and UK research charities, say the UK government's interpretation of the directive focuses on large-scale commercial trials carried out to gain marketing approvals and is too onerous for smaller-scale, early stage trials.
The BIA expressed concern that the legislation could undermine the UK's attractiveness as a location for carrying out clinical research.
Gillespie concurred, saying: "I haven't met a single biotech CEO with products in clinical trials who thinks this is a good idea. Most are saying: how did we let this creep up on us?'"
However, Gillespie stressed that Oxxon's No. 1 reason for opening the facility in Boston is to file an investigational new drug application with the FDA for its next therapeutic vaccine, a treatment for AIDS.
"In my experience growing Oxxon, it is advantageous if you have had your technology reviewed by the FDA, and that is the first reason [for setting up the Boston office]," she said. "But the Clinical Trials Directive has had an impact because it is complicated and bitty. I don't want to waste time translating everything into other languages."
The Boston facility also will put Oxxon in touch with experienced bioscience professionals and seasoned investors.
"I will be able to recruit top-notch executives and middle management that I wouldn't be able to persuade to relocate," Gillespie said.
The plan is to recruit eight to 10 staff over the next three years. Gillespie intends to divide her time evenly between Boston and Oxxon's recently opened research facility in Oxford, UK.
The company also announced that it is changing its name from Oxxon Pharmaccines to Oxxon Therapeutics. Although distinctive, Gillespie said she spent too much time explaining the pharmaccines tag. She said she'd rather "stand out for other reasons."
Oxxon raised £15 million (US$26.8 million) a year ago in its third funding round, enabling it to push its two lead products for hepatitis B and melanoma through to proof of efficacy.
"We are close to Phase II data now," Gillespie said. "We expect first results mid-year, with more results flowing in over the following six months."
The company has been offered terms for commercial rights to the two products, but Gillespie said: "We made a decision to wait. With a bit of data you can put a [zero] on the end [of a deal's value]."
Oxxon also has full rights to three further vaccines - for HIV infection, malaria and tuberculosis - which are being developed by academic collaborators. All have charitable funding.
The vaccines use sequential immunization with two different vectors carrying the gene for the same antigen. The "PrimeBoost" system primes the immune system to recognize the target and then boosts the immune response, generating cytotoxic T lymphocytes.
Gillespie said she will be looking for funding from the beginning of next year. "As the Phase II data come available in parallel with needing money, we will probably do another private round rather than try an [initial public offering]."