Historic

1. GBM (glioma)

• Accounts for 44% of all primary brain tumors with an incidence of 5 - 8 per 100,000 per year in Europe and North America.
• Median survival is ~1 year from diagnosis of primary disease and ~4 months from recurrence.
• Conventional therapies of surgery, radiation and chemotherapy make little impact.
  Clinical Trials using HSV1716
• Since October 1997, 43 patients with either primary or recurrent glioma have received HSV1716 in three separate clinical trials (published in peer reviewed journals). These trials involved either direct intratumoral injection or injection of HSV1716 into brain surrounding tumor immediately post resection.
• No toxicity related to treatment with HSV1716 experienced by any patient.

2. Melanoma

• Malignant melanoma is a serious form of skin cancer associated with high mortality and the management of the disease is unsatisfactory.
• Once melanoma nodules are no longer completely removable surgically, there is no proven method of increasing overall survival.
  Clinical trial using HSV1716 in patients with advanced stage melanoma
  The study involved injection of HSV1716 into nodules easily accessible under the skin in five patients.
• No toxicity due to treatment with HSV1716 was experienced by any patient and flattening of melanoma modules was observed.

3. Squamous cell carcinoma of the head and neck (SCCHN)

• SCCHN afflicts an estimated 125,000 patients annually in Europe, North America and the Far East.
• Primary therapy is surgery with adjuvant radiotherapy but tumors recur in 30% of patients and on recurrence the patient is considered incurable.
• Combination chemotherapy induces responses in 30-50% of patients but there is no clear impact on survival.
  Clinical trial in patients with SCCHN
• Twenty patients with operable SCCHN were given direct injections of various doses of HSV1716 into tumor.
• Tumors were resected at various times post virus administration.
• No toxicity was experienced by any patient virus replication in tumors was identified.