Glioblastomas are the most frequent type of primary malignant brain tumours in adults. The medical rationale for Oligovax to focus on glioblastoma and start its first clinical trials in this indication are as follows:
• Glioblastoma represents an important medical condition for which there is no successful treatment. Median survival from first diagnosis is only 8 to 10 months with the combination of surgery and radiotherapy. Adjuvant chemotherapy prolongs survival by about 2 months. Under this triple treatment, the median survival is around 1 year and the mortality at 2 years is close to 85%
• Median survival after the first recurrence is approximately 6 months
• Human gliomas display a locally invasive pattern of growth and rarely metastasize, making local treatment clinically relevant
• The hemato-encephalic barrier is a great advantage in the context of local treatment: the injected drug remains longer in the targeted area, improving the chances of efficacy
• Glioblastoma, whose incidence rate is around 3/100,000, is an orphan disease. Oligovax has obtained Orphan Drug designation from the EMEA for its lead TLR9 agonist, Litenimod , for the treatment of glioblastoma, and expects to obtain such designation from the FDA.
A Phase I clinical trial of Litenimod which ended in June 2004 and enrolled twenty-four patients suffering from recurring glioblastoma demonstrated a good tolerance of the drug.
Efficacy was not the principal objective of this Phase I trial, which started with low doses. In addition, all patients had been previously heavily treated (surgical resection and radiotherapy in all of them; at least one line of chemotherapy in 22 of them). However, preliminary indications of efficacy were found, with a median survival of 7.2 months (compared to the usual 6 months after recurrence), a one-year survival of 30%, and 2 minor radiological responses.
Multi-centre randomized Phase II trial for newly diagnosed glioblastoma
Oligovax started a multi-centre, randomized, control group-controlled Phase IIb trial of Litenimod in patients with newly diagnosed glioblastoma in France in early 2006.
Patients will be treated - or not, in the control group - by several injections of Litenimod in the edges of the cavity formed by the surgical resection of the tumour.
This Phase II trial will include a total of eighty (80) patients, forty (40) in each group.
At present the Company plans an interim review of the data from this trial in 2008, and will use the data from this review to design and construct the expanded confirmatory studies leading to potential approval of Litenimod for this Orphan Disease.
Multi-centre Phase II trial for recurring glioblastoma
Oligovax started a multi-centre, open label, Phase IIa trial of Litenimod in patients with recurrent glioblastoma in France in September 2004.
As for the Phase I trial, patients will be treated with Litenimod within the tumour bed through implanted catheters, using the convection-enhanced delivery technique.
This Phase II trial will include forty (40) patients.
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