Biotech Values

[DewDiligence]

NVS/Antisoma’s ASA404 Fails Futility Test in NSCLC

[ASA404 has at various times been called an anti-angiogenesis agent, a vascular targeting agent, and a vascular disrupting agent. Whatever it is, the drug has certainly had its share of problems. Antisoma’s original ASA404 development partner was Roche, who dumped the program in 2006 (#msg-11426863) after seeing phase-2 results in NSCLC (#msg-13604446) and ovarian cancer (#msg-21159441).

Nevertheless, in 2007 NVS stepped into the fray with a very lucrative deal for a tainted compound (#msg-18920108). In 2008, NVS started a phase-3 trial in NSCLC (the one that just failed: #msg-28401218) and broadened the trial from squamous NSCLC (where Avastin doesn’t compete) to both squamous and non-squamous NSCLC (#msg-24683088). A phase-2 trial of ASA404 in HRPC was nominally successful in 2007 (#msg-20145667), but the silence on HRPC in today’s PR implies that this program is no longer active.]

http://finance.yahoo.com/news/ATTRACT1-phase-III-trial-of-iw-1827607091.html?x=0&.v=1

›Monday March 29, 2010, 2:01 am

29 March 2010, London, UK, and Cambridge, MA: Antisoma plc (LSE: ASM; OTC: ATSMY) announces that the planned interim analysis of data from the ATTRACT-1 phase III trial of ASA404 in previously untreated non-small cell lung cancer (NSCLC) has shown that continuation of the trial would be futile, as there is little or no prospect of demonstrating a survival benefit with ASA404 in this setting. The ATTRACT-1 trial will therefore be halted.

No new or unexpected serious adverse effects of ASA404 have been identified by the trial's Data Monitoring Committee.

Glyn Edwards, CEO of Antisoma, said: "We are disappointed by the outcome of the ATTRACT-1 study, especially given the very encouraging phase II data reported in the same setting. We had hoped that this trial would show that use of ASA404 could improve treatment for patients with newly diagnosed lung cancer. We are now focused on delivering phase III results for our other late-stage product, AS1413."

Antisoma had unaudited cash and short-term investments of GBP 45.1 million at the end of February 2010.

A conference call will be held today at 9 am UK time. This will be available afterwards as a recording on the Antisoma website at www.antisoma.com. A further conference call will be held at 2 pm UK time/9 am Eastern time. Dial-in numbers for the calls are as follows: + 44 (0)20 3364 5947; UK Toll Free: 0808 238 7396; US Toll Free: 1866 793 4273; participant pin code: 468563#.‹