Biotech Values

[randychub]

Antisoma reports survival advantage for AS1404 in lung cancer and regains product rights
4 June 2006

These result look good. Anyone know why Roche would give all rights back?

http://www.antisoma.com/admin/data/datFiles/4_june_2006_2.asp


Atlanta, Georgia, and London, UK: 4 June 2006 Antisoma announces the presentation at ASCO of positive data from a phase II lung cancer study of its vascular disrupting agent AS1404 (DMXAA). Patients receiving AS1404 in addition to standard chemotherapy showed increased tumour response rates, longer time to disease progression and enhanced survival compared with patients receiving standard chemotherapy alone.

Antisoma also announces that it has regained all rights to AS1404 from Roche, and plans to take the drug forward promptly into a phase III trial in lung cancer. Extensive preparations have already been made to allow seamless progression to the next stage of development.

Dr Mark McKeage of the University of Auckland, New Zealand, one of the Principal Investigators in the AS1404 lung cancer study and the presenter of the findings at ASCO, said: “These are undoubtedly some of the most interesting data to emerge in lung cancer in recent years, and I look forward to seeing the drug proceed rapidly into phase III trials.”

Antisoma’s CEO Glyn Edwards said: “This is a great moment for Antisoma and a credit to all those who have backed or collaborated with us to achieve this success. AS1404 has shown proof of concept in a robust study in lung cancer, which represents one of the largest market opportunities in oncology, and is now firmly established as the leading drug in the class of vascular disrupting agents. We are excited by the potential of AS1404 to bring benefits to patients with a variety of cancers and look forward to seeing further data from trials in lung cancer and other tumour types. We are also delighted to have regained full rights to the drug, and will endeavour to maximise shareholder value by advancing AS1404 ourselves while also considering the merits of any offers from new potential partners.”

Details of the phase II results in lung cancer

The phase II data presented at ASCO are from a randomised controlled four-nation trial which enrolled patients receiving first-line chemotherapy treatment for stage IIIb or IV non-small cell lung cancer. Seventy patients were evaluable for efficacy, 34 of whom received AS1404 plus standard chemotherapy while 36 received standard chemotherapy alone. Projected six-month survival rates are 82.0% for patients receiving AS1404 and 54.8% for patients receiving standard chemotherapy. Projected median survival is currently 12.0 months with AS1404 and 7.6 months in the standard chemotherapy group. Data on time to tumour progression and tumour responses also show an advantage with AS1404, with median time to progression longer by 17 days (132 vs 115 days for the standard chemotherapy group) and a higher tumour response rate (31.2% with AS1404 vs 22.2% with standard chemotherapy).

Safety findings from the study show that addition of AS1404 to chemotherapy was well tolerated and that there was no requirement to lower doses of the chemotherapy agents. The study included patients with both squamous and non-squamous tumour histolog ies ; no differences in safety were observed between these groups.

In parallel with preparations for phase III, Antisoma is conducting an extension study in which additional lung cancer patients are being treated with 1800 mg/m 2 AS1404 (a higher dose than the 1200 mg/m 2 dose that was standard in the phase II trial). Data from this study will be presented at future scientific meetings, as will findings from a phase II trial in prostate cancer and further data from a phase II trial in ovarian cancer, from which initial findings have also been presented at ASCO 2006 (see separate announcement).

According to the World Health Organisation, there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately 1.1 million deaths. The American Cancer Society (ACS) estimates that around 173,000 people will be diagnosed with lung cancer in the United States in 2006. The US National Cancer Institute reports that lung cancer is the single largest cause of deaths from cancer in the US, responsible for nearly 30% of all cancer deaths. Non-small cell lung cancer is the most common form of the disease and accounts for more than 80% of all lung cancers.

The ASCO poster in which the lung cancer data were presented is reproduced on the Antisoma website at www.antisoma.co.uk, along with a webcast about the company’s ASCO presentations.

Enquiries: Glyn Edwards, CEO [phone]
Daniel Elger, Director of Communications
Antisoma plc

Mark Court/Lisa Baderoon/
Rebecca Skye Dietrich [phone]
Buchanan Communications



Antisoma disclaimer

Except for the historical information presented, certain matters discussed in this statement are forward looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements. These risks and uncertainties may be associated with product discovery and development, including statements regarding the company's clinical development programmes, the expected timing of clinical trials and regulatory filings. Such statements are based on management's current expectations, but actual results may differ materially.


Further details of the AS1404 phase II trial in lung cancer

The AS1404 lung cancer trial has been conducted at hospitals in France, Germany, Australia and New Zealand. Half of the patients in the study have received AS1404 plus chemotherapy (carboplatin and paclitaxel) while the other half have received chemotherapy alone.

Promising preliminary response findings from the study were reported in October 2005, while the ASCO presentation includes more mature data covering multiple endpoints.

Endpoints in the study include:

response rate, assessed using RECIST (Response Evaluation Criteria In Solid Tumours ). Possible outcomes include complete response (disappearance of all tumours), partial response (more than 30% but less than 100% reduction in the sum of the longest diameters of ‘target’ tumour lesions), stable disease (between a 30% reduction and a 20% increase in the sum of lesion measurements) and progressive disease (greater than 20% increase in the sum of lesion sizes or appearance of new lesions); response rates quoted in this release are derived from independent assessment of patient scans by a reader blinded to the treatment received; 2 patients in the AS1404 group and 9 patients in the standard chemotherapy group could not be evaluated in the independent assessment of response.

time to tumour progression, assessed as the time from the start of treatment until the first recording of progressive disease according to RECIST; the values quoted in this release are based on independent assessment of scans and derive from an uncensored analysis of time to progression data

survival, defined as the time from the start of treatment until death from any cause; follow up of patients is ongoing and present survival projections have been made after a total of 21 deaths.
Background on AS1404

AS1404 (DMXAA) is a small-molecule vascular disrupting agent (VDA). It is the first member of this class of drugs to report positive efficacy data from a controlled study. AS1404 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 Technologies) in August 2001.