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Biotech / Medical : Indications -- Cancer -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (342)	3/11/2003 4:35:05 PM
From: tuck	Read Replies (1) \| Respond to of 1840

Erik, I don't think there's a connection. The protocol doesn't mention how many colonoscopies will be performed during the trial, but if it was, say, two per patient, it would be normal: >>Feb. 4, 2003 — Risk of perforation from colonoscopy is twice that from sigmoidoscopy, according to the results of a population-based study reported in the Feb. 5 issue of the Journal of the National Cancer Institute. However, rates of perforation during screening colonoscopy have declined over the eight years of the study. "Although the risk of bowel perforation is often cited as a major factor in the choice between colonoscopy and sigmoidoscopy for colorectal screening, good estimates of the absolute and relative risks of perforation are lacking," write Nicolle M. Gatto and colleagues from Columbia University and New York-Presbyterian Hospital in New York City. The authors used a database of Medicare beneficiaries aged 65 years and older to identify individuals who were cancer-free and who had undergone at least one colonoscopy or sigmoidoscopy between 1991 and 1998, and they then calculated the incidence and risk of perforation within seven days of the procedure. During 39,286 colonoscopies, there were 77 perforations, or 1.96 perforations per 1,000 procedures, compared with 31 perforations during 35,298 sigmoidoscopies, or 0.88 perforations per 1,000 procedures. After adjustment for clinical factors, the risk of perforation from colonoscopy was about twice that from sigmoidoscopy (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.2 - 2.8). Increasing age and the presence of two or more comorbidities increased the risk of perforation from either procedure. Approximately 5% of subjects who had a perforation died within 14 days of the procedure. Risk of death was significantly increased by perforation after colonoscopy (OR, 9.0; 95% CI, 3.0 - 27.3) or after sigmoidoscopy (OR, 8.8; 95% CI, 1.6 - 48.5). The difference in risk between the two procedures has been narrowing because the risk of perforation from colonoscopy has decreased over the years, presumably from improvements in technology and in training. "These observations should be useful to clinicians making screening and diagnostic decisions for individual patients and to policy officials setting guidelines for colorectal cancer screening programs," the authors write. J Natl Cancer Inst. 2003;95:230-236 Reviewed by Gary D. Vogin, MD<<

To: Icebrg who wrote (342)	4/25/2003 6:34:46 AM
From: Icebrg	Read Replies (1) \| Respond to of 1840

Active Biotech - Superantigens. Indications regarding prolonged survival with Active Biotech's TTS cancer drug Active Biotech's cancer product TTS CD2 (Tumour Targeted Superantigens) has shown positive survival results in non small-cell lung cancer (NSCLC). Lund, April 23, 2003. Sixty-seven (67) patients were included in a survival study performed as a follow-up on patients participating in Phase I clinical studies of the TTS product CD2. In these Phase I studies, which were conducted in the USA and Europe 1998-2000, NSCLC patients were treated with different doses of TTS to define the side effects and the maximum tolerable dose (MTD). The trials achieved their objectives and showed promising results (for further information, please visit www.activebiotech.com - press&news, June 26, 2001). It is these patients that now have now been followed up in a separate survival study. The median survival time in this study was 8.1 months, which is fully comparable to treatments currently on the market. Of the patients in the study, twenty-five per cent of the patients lived for 17.4 months or longer. The one-year survival rate was 43% and the two-year survival rate was 12%. The survival time for patients with NSCLC is highly dependent on the disease status. The patients in Active Biotech's studies belong to the groups designated advanced NSCLC stages III and IV. The evaluation includes all patients, independent of whether they have recieved the optimal dose or not. The TTS product has a unique, immune-mediated mode of action with fewer side effects than conventional treatments with cytotoxic drugs and radiation. A large proportion of the patients in these Phase I studies had undergone at least one course of a cytotoxic treatment to which they were no longer responding, and thus had a poor prognosis. Professor Steinar Aamdal of the Radium Hospital in Oslo, who was responsible for the European study, is enthusiastic about the results of the follow-up study: "This is a totally new method for treating lung cancer. Many patients were stabilised in their progressive disease and even though only a few patients responded with a tumour reduction, the results show a surprisingly long survival time for these patients, for whom the survival time is normally short." Today, non small-cell lung cancer is primarily treated using cytotoxic drugs and surgery. There is a high medical need for new treatment methods, since the available therapies do not produce satisfactory results.