Date: 2012-04-06
Type of information:
Product name: genetically modified human adenovirus encoding human PH20 hyaluronidase (VCN-01)
Compound: genetically modified human adenovirus encoding human PH20 hyaluronidase
Therapeutic area:
Action mechanism: VCN-01 is an oncolytic adenovirus. This tumor-selective replication-competent adenovirus expands selectively in tumors and provokes simultaneously the death of tumor cells and the amplification of the therapeutic effect to neighboring cells. In addition, VCN-01 expresses PH20 hyaluronidase that acts degrading hyaluronan, an important structural element of tumor extracellular matrix. Expression of hyaluronidase from VCN-01 facilitates penetration and decreases intratumoral fluid pressure, enhancing intratumoral virus spread.
Extensive preclinical studies with VCN-01 in animal models demonstrate a good toxicology.
Company: VCN Biosciences (Spain)
Disease: pancreatic cancer
Latest news: The product is currently at the preclinical phase, with the clinical phase due to start in 2013.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2011-06-15
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
