Avantogen and Innovate announce ASCO abstractsJune 12, 2006Avantogen Limited ("Avantogen", ASX:ACU), Sydney, Australia and San Diego, CA, and Innovate Oncology, Inc ("Innovate"; IOVO:OTCBB), New York, today announced that 2 abstracts reporting on the evaluation of the use of RP101 in the treatment of patients with pancreatic cancer, were published at this weeks American Society of Medical Oncology (ASCO) Meeting in Atlanta, Georgia. The first abstract (Fahrig et al, abstract no. 14000) reported the findings of a phase 1 pilot trial of 13 patients with advanced pancreatic cancer, which assessed the efficacy of RP101 in combination with gemcitabine and cisplatin, versus an appropriate historical control, consisting of patients who received the combination of gemcitabine and cisplatin only. In this study all patients showed at least stable disease, and 33% of patients showed a partial remission. In the RP101 co-treatment group the median survival was significantly longer than that seen in the historical control group (447 days vs. 186 days, p=0.007) and time to progression (TTP) was also prolonged (280 days vs. 104 days, p=0.004). Ten of the 13 patients lived longer than one year and 4 remained alive, nearly two years after the first treatment. The second abstract (Haenel et al, abstract no. 14075) reported the interim findings of an ongoing dose ranging study in which 22 patients with advanced pancreatic cancer received varying doses of RP101 in addition to fixed dose gemcitabine. At the time of this interim analysis 36% of patients had been followed for less than 6 months and pooled data of those patients followed for 6 months or more showed 41% of patients were still alive and 23% had died. The median survival at this stage of follow up (95% CI) is 7.1 months and 14/22 patients (64%) were still alive. The 6 month survival rate (95% CI) is 0.69 (0.52, 0.85), which compares favorably with a recent large randomized trial in which patients who received gemcitabine alone had a median survival (95%CI) of 5.9 months (5.1-6.7). Median survival, progression free survival and time to progression will continue to be assessed in this ongoing trial and subsequent analyses reported accordingly. It was also observed that there may be a dose dependent increase in peak gemcitabine levels as a function of the dose of RP101. Lastly, to date, adverse events are consistent with those observed with gemcitabine or the underlying disease. The new Chairman of Innovate, Dr. Richard Opara, said that "the publication of these abstracts demonstrates the continued progress in the development of RP101 and these studies provide us with data that can be used to plan the next phase of evaluation of this very interesting candidate which shows every prospect of becoming a significant therapeutic, offering hope to patients whose lives are drastically shortened by this grievous illness". Research Australia |
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