It seems to me that all the targeted therapys (avastin included) will need defined biomarkers if we're ever going to consider them benefital to the patient. These drugs will be or 1st real step into personalized medicine.
[ASA404 is a “vascular disrupting agent” that NVS licensed from Antisoma for big money in 2007 (#msg-18920108). The NSCLC program was recently broadened from squamous NSCLC, where Avastin doesn’t compete, to both squamous and non-squamous NSCLC (#msg-24683088). ASA404 failed in ovarian cancer (#msg-21159441), but has shown phase-2 activity in HRPC (#msg-20145667).]
ZURICH -- Swiss drug maker Novartis AG said Friday it has started a late-stage trial on ASA404, to examine the experimental drug's potential in treating lung cancer after it succeeded in an intermediate test.
Novartis, based in Basel, Switzerland, also said it is assuming responsibility for the development of the drug from its United Kingdom biotech partner Antisoma PLC, which discovered the drug.
The study, called ATTRACT-1, is designed to support applications for marketing authorizations in the U.S., Europe and other territories. Its initiation triggers a $25 million milestone payment to Antisoma, the British company said.
"We're delighted that the phase III trial in lung cancer is underway, putting ASA404 on a clear path towards potential marketing applications," Glyn Edwards, chief executive at Antisoma, said in a statement. "Lung cancer is an indication with substantial unmet clinical need and blockbuster sales potential." Antisoma and Novartis had suffered a setback in July when ASA404 failed in human tests against ovarian cancer.
By contrast, an intermediate study in patients with advanced lung cancer showed that those who took ASA404 in combination with chemotherapy lived on average five months longer than those who took chemotherapy alone, Novartis said.
The drug belongs to a category of medicines known as targeted therapies. Targeted cancer drugs work by killing cancer cells specifically, or by hindering their proliferation, while traditional chemotherapy often kills deranged and healthy cells alike, leading to troublesome side effects.
ASA404 is part of a new class of drugs called tumor vascular disrupting agents, which selectively disrupt established blood vessels in solid tumors that rely on a network to survive and grow. The way the drug works is different from that of angiogenesis inhibitors, such as Roche Holding AG's Avastin, which inhibit the formation of new tumor blood vessels.
Novartis said in the past that its experimental drug could possibly also be used in combination with Avastin, however, such use would have to be confirmed in human tests.
Novartis had signed an exclusive licensing agreement with Antisoma for the world-wide rights to ASA404 in April 2007. Novartis in the past said it aims to file ASA404 by 2011 for regulatory approval in the U.S. and Europe.
Antisoma shares rose 9% to 27 pence, in a higher London market. The stock is down 45% year-on-year[due in part to the failure of ASA404 in ovarian cancer]. <<
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