Novartis has started late-stage trials of the lung cancer compound ASA404, a move which sees the Swiss firm take on the responsibility for developing the drug from the UK’s Antisoma.

The novel mechanism of action of ASA404, a tumour-vascular disrupting agent “may represent a new approach to treating the most prevalent cause of cancer death”, Novartis said. The drug selectively causes the collapse of existing tumour blood supply leading to extensive tumour cell death, the firm added, making it distinct from angiogenesis inhibitors, which inhibit the formation of new tumour blood vessels.

The decision to move into Phase III comes on the back of a Phase II study where ASA404, in combination with chemotherapy, demonstrated a median overall survival advantage of more than five months in first-line treatment of advanced non-small cell lung cancer compared with chemotherapy alone. A similar survival advantage was observed in a subsequent extension of the Phase II study.

ASA404 is one of six oncology compounds Novartis is developing for potential registration over the next five years. The others are RAD001 (renal cell carcinoma and other cancers), SOM230 (Cushing's disease/refractory carcinoid tumors, acromegaly), LBH589 (cutaneous T-cell lymphoma and other cancers), EPO906 (ovarian cancer) and PKC412 (acute myelogenous leukaemia and aggressive systemic mastocytosis).

Antisoma is unsurprisingly pleased with the news about ASA404, especially as the move into the Phase III study, which will involve some 1,200 patients, triggers a $25 million payment to the firm. Chief executive Glyn Edwards said that the trial, which is called ATTRACT-1, puts ASA404 “on a clear path towards potential marketing applications”. He added that lung cancer is an indication with “substantial unmet clinical need and blockbuster sales potential, and Novartis’ trial is optimally designed to seek confirmation of the positive results seen in our two Phase II lung cancer studies”.

Aclasta beats Actonel in increasing bone mass
Staying with Novartis, the firm also announced results from a 833-patient study at the European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis in Istanbul which show that a once-yearly infusion of Aclasta/Reclast (zoledronic acid) was significantly better at increasing bone mass in patients with osteoporosis caused by glucocorticoids, compared with Sanofi-Aventis’ Actonel (risedronate).

The 833-patient study investigated both the prevention (288 patients) and treatment (545) of glucocorticoid-induced osteoporosis. In the first group, patients who received once-yearly Aclasta increased bone mineral density in the lumber spine by 2.6%, compared with 0.6% for those who received once-daily Actonel. In the treatment group, the Novartis drug increased BMD by 4.1% compared to a 2.7% rise for Actonel.

The Basel-based firm noted that it is already applying for an indication with the European Medicines Agency and the US Food and Drug Administration for the treatment and prevention of GIO.