PsiOxus Therapeutics, Ltd. (PsiOxus) has announced that two of its on-going phase I studies of the oncolytic vaccine enadenotucirev (previously known as ColoAd1) will be presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting to be held 30 May to 3 June, 2014 in Chicago, Illinois.
The EVOLVE (EValuating OncoLytic Vaccine Efficacy) trial is a phase I/II trial of intravenous administration of enadenotucirev to patients with epithelial cancers and the MoA (Mechanism of Action) trial is a phase I “window of opportunity” trial evaluating intravenous and intra-tumoural administration of enadenotucirev to patients with colon cancer.
Enadenotucirev is an oncolytic Ad11/Ad3 chimeric group B adenovirus that has previously been shown to selectively destroy metastatic solid tumours at low concentrations in pre-clinical models.
To date, a combined total of 46 cancer patients have been dosed with up to four cycles (12 doses) of enadenotucirev. An independent Data Safety Monitoring Committee has approved the proposed dose to be taken into phase 2 clinical trials for both single cycle and repeat cycle administration. This safety data will be presented at the ASCO meeting.
Intra-tumoural delivery of oncolytic viruses to superficial tumour sites has been shown to be clinically successful in phase III clinical trials, but systemic delivery of viruses to metastatic tumour sites via intravenous delivery has been more elusive.
In the two PsiOxus studies, the ability to selectively deliver the live replicating virus to tumour cells has been examined by a number of techniques including positron emission tomography scans, immunohistochemistry, quantitative polymerase chain reaction assays, and viral plaque assays.
• Dr Emiliano Calvo will present A First in Human Phase I study of enadenotucirev, an oncolytic Ad11/Ad3 chimeric group B adenovirus, administered intravenously in patients with metastatic epithelial tumours (poster board 170) at ASCO on Sunday, June 1 in S Hall A2 from 8:00 a.m. to 11:45 a.m.
• Dr Rocio Garcia Carbonero will present Phase 1 Mechanism of Action Study of Intra-tumoral or Intravenous Administration of enadenotucirev, an Oncolytic Ad11/Ad3 Chimeric group B Adenovirus in Colon Cancer Patients Undergoing Resection of Primary Tumour (poster board 178B) at ASCO on Sunday, June 1 in S Hall A2 from 8:00 a.m. to 11:45 a.m.
Dr John Beadle, CEO of PsiOxus, commented: “We are looking forward to the presentation of these clinical study results as we assess the safety profile of enadenotucirev as well as intravenous delivery of this oncolytic vaccine to cancer cells in patients. We remain on track to initiate phase II study later this year.”