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Anyone heard much about AS1404


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Just read small article in a weekly GP magazine about a new NSCLC drug (yet to be named but currently called AS1404) discovered in New Zealand which has had some positive Phase II tial data in stage III/IV NSLC in terms of survival. Anybody have any information on current trials in Australia or information on side-effects etc.?

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I read a bit about it in my own research. It looked good! The person to ask theses types of questions of is Randy W. Go on the link here that says something to effect of New Treatments or Clinical Trials and post your question there. He has such a gift of getting the info on the new stuff out to us!

Good luck!!

Kelly :D

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Lung cancer patients treated with an experimental new drug lived over a third longer than patients treated with standard chemotherapy, according to data released today.

The phase II study, carried out by UK biotech company Antisoma plc, looked at 70 patients with non-small cell lung cancer (NSCLC), the most common type of lung cancer.

Patients treated with AS1404 on top of standard chemotherapy lived over a third longer (14 months) than patients treated with chemotherapy alone (8.8 months). This is one of the largest increases in life expectancy ever seen in a trial adding a new drug to chemotherapy in NSCLC.

Looked at another way, patients getting AS1404 had a 27% lower risk of dying during the period of the trial than those who received chemotherapy alone.

Lung cancer has one of the lowest survival outcomes of any cancer. In England and Wales around 25% of patients are alive one year after diagnosis and this falls to 7% at five years. There are over 26,000 deaths a year in the UK from non-small cell lung cancer.

Safety data from the trial were also encouraging. The addition of AS1404 to chemotherapy was well tolerated.

These findings extend the positive data announced at a major US cancer conference in June 2006 (click here to get PDF file), which showed increased tumour response rates, longer time to disease progression and enhanced survival.

Antisoma plans to begin a phase III trial in lung cancer.

Dr Mark McKeage of the University of Auckland, New Zealand, one of the principal investigators in the AS1404 lung cancer study, said: “It is great to see this large survival benefit with AS1404 in lung cancer patients. This makes me feel very optimistic as we proceed into phase III testing.”

AS1404 is a world leader among a new class of drugs called Vascular Disrupting Agents (VDAs) These work by selectively destroying established tumour blood vessels, thus cutting off the tumour's blood supply. Solid tumours rely on a network of blood vessels to survive and grow.

AS1404 is able to distinguish between the tumour's blood supply and that of healthy organs (the capillary network is more permeable and less well organised than that of healthy tissue). It acts directly on the lining of the tumour's blood supply.

The lung cancer study is one of three phase II trials of AS1404. Positive response data were recently announced from a trial in prostate cancer and encouraging early data have been presented from an ovarian cancer study.

Antisoma is currently in talks with a number of companies with a view to licensing AS1404.

Commenting, Glyn Edwards, CEO of Antisoma, said: “Survival is the gold standard by which cancer drugs are judged and this news is therefore very exciting.”

Antisoma disclaimer

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.

Background on AS1404

AS1404 (DMXAA) 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. CRUK had supported two phase I studies in the UK and New Zealand.

Background on Antisoma

Based in London, UK, Antisoma is a biopharmaceutical company that develops novel products for the treatment of cancer. Antisoma fills its development pipeline by acquiring promising new product candidates from internationally recognised academic or cancer research institutions. Its core activity is the preclinical and clinical development of these drug candidates. Please visit www.antisoma.com for further information.

Background on the trial

The AS1404 phase II trial in lung cancer was a randomised controlled trial which enrolled patients receiving first-line chemotherapy treatment for stage IIIb or IV non-small cell lung cancer. Patients were randomly assigned to receive either AS1404 plus standard chemotherapy (carboplatin and paclitaxel) or standard chemotherapy alone. Seventy patients were evaluable for efficacy, 34 of whom received AS1404 plus chemotherapy while 36 received chemotherapy alone. The trial was conducted at hospitals in France, Germany, Australia and New Zealand.

Background on lung cancer

According to the latest figures available, there were 37,699 cases of lung cancer in the UK (Cancer Research UK incidence figures for 2002).

In the UK, 33,044 patients die every year of lung cancer (Cancer Research UK mortality figures 2004).

There are two main types of primary lung cancer which behave and respond to treatment quite differently. They are:

-- small cell lung cancer (SCLC)

-- non-small cell lung cancer (NSCLC).

Of all lung cancer patients, 80% will have non-small cell lung cancer.

Non-small cell cancer

There are three main types of non-small cell lung cancer. Sometimes it is not possible to tell which type someone has. This is because when the cells are looked at under a microscope they are not developed enough. The three types are:

Squamous cell carcinoma, which is the commonest type of lung cancer. It develops in the cells which line the airways. This type of lung cancer is often caused by smoking.

Adenocarcinoma, which develops from the cells which produce mucus (phlegm) in the lining of the airways.

Large cell carcinoma gets its name from the large, rounded cells that are seen when they are examined under the microscope. It is sometimes known as undifferentiated carcinoma. (CancerBACUP).

Phase 1, 2 , 3 and 4 trials

There are four phases of clinical trials.

Phase 1 (phase I)

These are the earliest trials in the life of a new drug or treatment. They are usually small trials, recruiting anything up to 30 patients (often a lot less).

Phase 1 trials test out new drugs or treatments in humans for the first time.

Phase 2 trials (phase II)

About 7 out of every 10 (70%) new treatments tested at phase 1 make it to phase 2 trials. Phase 2 trials are usually larger than phase 1 (around 50 people). If the results of phase 2 trials show that a new treatment may be as good as existing treatment, or better, it then moves to phase 3.

Phase 3 (phase III)

These trials compare new treatments with the best currently available treatment (the standard treatment). Phase 3 trials are usually much larger than phase 1 or 2. This is because differences in success rates may be small so that there is a need to have many patients in the trial to show a difference.

Often phase 3 trials involve many hundreds or even thousands of patients in different hospitals and countries.

Phase 4 (phase IV)

Phase 4 trials are done after a drug has been shown to work and has been granted a licence. The main reasons phase 4 trials are carried out is to find out: More about the side effects and safety of the drug; What the long term risks and benefits are; How well the drug works when it's used more widely than in clinical trials.


Article URL: http://www.medicalnewstoday.com/medical ... wsid=53052

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