topper's finally got some new material, page-41

re:positive sirtex trials and profit jump up I called Sirtex and had good conversation with shareholder relations and some higher ups in the co. Company acknowledged that recent symposium and positive trial results are leading to vast increase in Sir Spheres with new chemo drugs by Pfizer and Aventis-Sanofi. I mentioned share price and they said good earnings and positve developments and all the positive progress and growing the co as they are will take good care of share price by itself and that Dr Gray has never sold even one of his 13 million shares and recently added 100,000 shares with his own money.
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Pharmacy News Article

6/14/05 - Abstracts show safety, efficacy of SIR-Spheres with new chemotherapy
Cancer Weekly via NewsEdge Corporation :

2005 JUN 14 - (NewsRx.com) -- Sirtex Medical Limited announced the publication of results of 2 separate phase 1/2 trials using SIR-Spheres in combination with chemotherapy for patients with advanced bowel cancer (colorectal cancer) that had spread to the liver.

Both abstracts were published this week at the Annual Meeting of the American Society of Clinical Oncology (ASCO) meeting in Orlando, Florida.

Sirtex has previously announced the results of past trials where SIR-Spheres has been combined with systemic chemotherapy and these have all produced positive outcomes. As improved regimens of chemotherapy have been introduced, it is essential that SIR-Spheres be evaluated in combination with the new chemotherapy. Modern chemotherapy for advanced bowel cancer (colorectal cancer) consists of using either Oxaliplatin or Irinotecan together with Fluorouracil/Leucovorin. Oxaliplatin and Irinotecan chemotherapy are approximately equally effective in treating patients with advanced bowel cancer.

The first abstract (No 3657) reported the results of a clinical trial undertaken conjointly at the Mount Medical Centre in Australia and the Leicester Royal Infirmary in the United Kingdom. The trial was sponsored by Sirtex Medical and supported by Sanofi-Synthelabo, the producers of Oxaliplatin and a pharmaceutical company.

This trial was designed to examine the safety and efficacy of adding an Oxaliplatin-based chemotherapy regimen to a single administration of SIR-Spheres in 17 patients who had secondary bowel cancer that had spread to the liver. As treatment with both oxaliplatinbased chemotherapy and SIR-Spheres can cause side effects, it was essential to evaluate what would happen when the 2 treatments were combined. The trial was designed to start with a low dose of chemotherapy and gradually escalate the dose if toxicity was not excessive. None of the 17 patients in this trial had previously received chemotherapy and all had advanced incurable disease that could not be surgically removed.

At the time of submitting the abstract to ASCO in December, 2004, 11 of the 17 patients had been followed long enough to determine the outcome of combination treatment. The results showed that toxicity was tolerable and within the acceptable range for this type of treatment. All 11 patients were evaluated by objective criteria and all 11 (100%) had their tumors regressed to the stage that was regarded as a 'response.' Furthermore, the median time that the cancer in the liver was held in remission has not yet been reached, but will exceed 11 months.

The second abstract (No 3701) reported the results of a clinical trial using SIR-Spheres in combination with Irinotecan chemotherapy that was undertaken in 4 Australian hospitals (Prince of Wales Hospital, Royal North Shore Hospital, Mount Medical Centre and Royal Adelaide Hospital). In contradistinction to the first trial that used Oxaliplatin-based chemotherapy, this trial was restricted to patients who had already received chemotherapy for their liver cancer, but the cancer had progressed despite the chemotherapy. Although all patients with advanced colorectal cancer are incurable and have a grave prognosis, the patients included in this second trial have a worse outlook with only a small percentage experiencing a positive result from treatment.

This second study was sponsored by Sirtex Medical and supported by Pharmacia-Upjohn (now Pfizer), the producers of Irinotecan. As all patients had already failed treatment with Fluorouracil/Leucovorin chemotherapy and in some cases Oxaliplatin as well, this study was designed to evaluate the effect of combining SIR-spheres with Irinotecan alone.

Twenty-five patients were included in the study, but at the time of submitting the abstract to ASCO in December, 2004, only 17 of the 25 patients had been followed long enough to determine the outcome of treatment. As with the previous trial, the toxicity profile was acceptable. In 9 of the 17 patients (53%) objective responses were observed. In a further 5 patients (29%) the disease was stabilised. In all patients, the median time before the liver cancer started to progress again was 7.5 months and the median survival was 12 months.

This means that more than 80% of this poor prognosis group of patients benefited from treatment with SIR-Spheres. The results are far better than could be expected using chemotherapy alone.

It is of note that because these trials were both 'dose-escalation' studies, the amount of chemotherapy drug that was used in many of the patients was below the maximum that can be given. Therefore, as the efficacy of chemotherapy is dose-dependent, it is reasonable to expect that using higher drug doses will result in an even better outcome when used in combination with SIR-Spheres.

Sirtex Medical Limited has previously announced the results of clinical trials using SIR-Spheres, either alone or in combination with chemotherapy drugs for the treatment of a variety of cancers that have spread to the liver. In the last announcement on April 19, Sirtex reported the results of an American study in 34 patients with breast cancer that had spread to the liver and that also resulted in 100% of patients showing a positive response to treatment.

This article was prepared by Cancer Weekly editors from staff and other reports. Copyright 2005, Cancer Weekly via NewsRx.com.

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