Future

Phase III efficacy trial in patients with recurrent glioblastoma multiforme

• Crusade Laboratories has been granted orphan drug status in Europe for “the use of Herpes simplex virus lacking infected cell protein 34.5 in the treatment of glioma.”
• Regulatory approvals have been granted for a Phase III trial.
• The trial will recruit patients on first recurrence post resection and radiotherapy.
• Patients will be randomised into one of two treatment arms : HSV1716 or conventional chemotherapy.
• The European Medicines Agency (EMEA) has stated that satisfactory results in this trial could lead to a license and marketing authorisation in glioma.

Phase I/II trial in patients with advanced metastatic ovarian carcinoma

• This trial will be carried out in patients with epithelial ovarian carcinoma that has metastasised throughout the abdomen and who are scheduled to undergo cryoreduction surgery.
• Patients will receive intraperitoneal infusion of HSV1716.
• Evaluation criteria will be safety and biological activity.

Phase I/II trial in patients with unresectable hepatocellular carcinoma

• This trial will be carried out in patients with unresectable carcinoma and measurable disease.
• Patients will receive HSV1716 at doses by intra-arterial injection into a branch of the main hepatic artery supplying the tumor.
• Evaluation criteria will be safety and biological activity.