Shares of the U.K.’s Antisoma suffered a meltdown Monday morning as investors reacted to the news that its lead program suffered a catastrophic Phase III failure. The developer decided to halt the late-stage study after an interim analysis concluded that ASA404–which is partnered with Novartis–had little chance of demonstrating a survival benefit for patients with untreated non-small cell lung cancer.

CEO Glyn Edwards frankly told Reuters that Novartis would probably do a quick assessment of where the program stands. And he didn’t sugarcoat the likely conclusion: “We have to say it’s quite unlikely that we will get any future cash flows from this program, although we weren’t expecting anything in the short term.”

Antisoma’s primary attention now will shift to its two leukemia programs. AS1413 is in Phase III and AS1411 is in a mid-stage study. Edwards says the company has plenty of cash to see its way through both of those trials over the course of the next year, but noted he would take a much more “pragmatic” approach to striking new licensing deals for 1413 and other unpartnered assets.

Investors, however, didn’t look ready to wait it out this morning. Antisoma’s shares dropped as much as 72 percent at one point. Antisoma says that it had about $67.41 million on hand at the end of February.

Source: FierceBiotech

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Antisoma sold sanofi-aventis U.S. rights to the FDA-approved chronic lymphocytic leukaemia (CLL) drug oral fludarabine for $65 million. The deal roughly doubles Antisoma’s cash resources and means the company will be able to fund its operations including clinical and preclinical pipeline development until at least mid-2011.

This, according to CEO, Glyn Edwards, “is well beyond when we expect key Phase III results for our leading products, ASA404 and AS1413.” Both compounds are designed to treat cancer. At December 2008, Antisoma reported  £52.7 million, or slightly over $79 million, in cash resources.

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Antisoma acquired U.S. rights to oral fludarabine as part of its $52.2 million share-based buy-out of Xanthus Pharmaceuticals in June 2008. The drug was approved by the FDA as second-line therapy for CLL in December 2008. Xanthus had itself acquired exclusive U.S. rights to the drug from Schering (now Bayer Schering Pharma) in June 2006.

The agreement with sanofi-aventis calls for a $60 million up front and additional, staged payments amounting to $5 million. The money will be used to complete Phase III trials with ASA404 and AS1413.

ASA404 is a small molecule tumor-vascular disrupting agent (VDA) which is being developed initially against lung cancer. ASA404 is being developed worldwide by Novartis, which negotiated exclusive, worldwide rights to the drug from Antisoma in 2007. The deal was worth a potential $890 million in total up-front, development, regulatory, and sales-related milestone payments.

Novartis has indicated it plans to pursue clinical development of ASA404 against breast cancer as its next priority indication, according to Antisoma’s vp marketing and communications, Daniel Elger.

AS1413, a DNA intercalator in development against secondary AML, is being developed in-house. Elger also confirmed the company plans to keep hold of the drug for the U.S. market but will partner at some stage for other territories. Results from the Phase III trial of AS14132 are expected in late 2010 or early 2011.

Source: GEN News

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Antisoma plc (LSE:ASM; USOTC:ATSMY) announces that its Tumour-Vascular Disrupting Agent, ASA404, will be evaluated by Novartis as a treatment for HER2-negative metastatic breast cancer. This indication is being prioritised ahead of prostate cancer, in which a phase II trial has been completed. Details of the plans for trials in breast cancer will be available later this year.

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Antisoma and Novartis have a worldwide development and commercialisation agreement for ASA404. Trials in breast cancer will be in addition to two ongoing pivotal phase III trials in patients with non-small cell lung cancer, one (ATTRACT-1) testing ASA404 as a first-line treatment and the other (ATTRACT-2) evaluating ASA404 as a second-line treatment. Because ASA404 acts by disrupting tumour blood vessels, it has potential application against a variety of solid tumours, all of which depend on tumour blood vessels to survive and grow.

Glyn Edwards, Antisoma’s CEO, said: “We are very pleased that Novartis is extending the development of ASA404 to metastatic breast cancer.  This represents a significant additional opportunity for ASA404. While there have been many advances in the treatment of breast cancer, there remains a great need for new and innovative approaches, especially for patients with metastatic cancer.”

About metastatic breast cancer
Worldwide, more than a million women are diagnosed with breast cancer and over 400,000 die from the disease each year. Metastatic breast cancer is the most advanced stage (stage IV). Over 100,000 patients present with stage IV disease each year in the US, Europe and Japan.

About ASA404
ASA404 (DMXAA) is a small-molecule Tumour-Vascular Disrupting Agent (Tumour-VDA) which selectively targets the blood vessels that nourish tumours. The drug was discovered by Professors Bruce Baguley and William Denny and their teams at the Auckland Cancer Society Research Centre, University of Auckland, New Zealand. It was in-licensed by Antisoma from Cancer Research Ventures Limited (now Cancer Research Technology), the development and commercialisation company of the Cancer Research Campaign (now Cancer Research UK), in August 2001. In a randomised phase II study in non-small cell lung cancer, addition of ASA404 to standard first-line chemotherapy was associated with a 5 month improvement in median survival. Worldwide rights to the drug were licensed to Novartis AG in April 2007.

About Antisoma
Antisoma is a London Stock Exchange-listed biopharmaceutical company that develops novel products for the treatment of cancer. The Company has operations in the UK and the US. Please visit www.antisoma.com for further information about Antisoma.

Source: Antisoma

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