Date: 2012-09-26
Type of information:
phase: 1-2
Announcement: treatment of the first patient
Company: PsiOxus Therapeutics (UK)
Product: ColoAd1
Action
mechanism: ColoAd1 is a systemically available oncolytic vaccine under development by PsiOxus. The vaccine is injected into the bloodstream, and is then delivered to the cancer sites, where it replicates inside of cancer cells and kills them. Each infected cell produces thousands of new copies of ColoAd1, which spread to nearby cancer cells and kills them, as well, while ignoring normal cells. The approach represents a new generation of so-called “self-amplifying” cancer therapy that has the effect of killing tumors and acting as a cancer vaccine.
Disease: metastatic solid tumors
Therapeutic area: Cancer - Oncology
Country: Europe (UK, Spain, Belgium)
Trial
details: The Evolve (EValuating OncoLytic Vaccine Efficacy) study is a multinational Phase I/II study. It will be conducted at up to 20 sites in Europe. The Principal Investigator and Independent Oncologist of the Evolve Study is Professor Josep Tabernero from the Vall d\'Hebron University Hospital in Barcelona.
The safety, biological activity and efficacy of ColoAd1 will be evaluated in 126 patients, with initial results expected by the end of 2013.
The initial phase aims to establish a safe dose schedule for ColoAd1 in cancer patients. The Phase II component will then recruit patients with metastatic colorectal cancer and who have already received standard firstline therapy. The primary endpoint of the Phase II component is Progression Free Survival (PFS) when compared to patients receiving standard therapy alone. Secondary endpoints include response rates and overall survival.
Latest
news: PsiOxus Therapeutics has treated the first patient in its phase I/II clinical trial of ColoAd1 for the treatment of metastatic solid tumors. The Evolve (EValuating OncoLytic Vaccine Efficacy) study is the first clinical trial of the systemically available oncolytic vaccine ColoAd1, a highly potent, broad-spectrum, anticancer therapeutic capable of destroying tumour cells at minute concentrations. Initial results are expected by the end of 2013 and the first patient was dosed this week at a site in Belgium.
The trial is funded from the recent £22 million (US$34 million) investment made by Imperial Innovations, SROne, Lundbeckfond Ventures and Invesco Perpetual, as well as £1.8 million of support from the Wellcome Trust.
The Phase I component is currently recruiting patients with solid tumours and who have no further conventional treatment options open to them. The initial target indications for ColoAd1 are metastatic colorectal cancer and primary hepatic cellular carcinoma.
