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".
Avantogen (formerly Australian Cancer Technology) is an international biotechnology company
developing a broad oncology-related product portfolio. Aside from RP101, Avantogen's PentrysŪ anticancer
vaccine is being evaluated in prostate cancer patients in Phase IIb clinical studies. Recently,
Avantogen merged its vaccine business, consisting of the Pentrys anti-cancer vaccine, and the GPI-0100 vaccine adjuvants, into Hawaii Biotech, Inc., a privately-held vaccine developer in Honolulu, Hawaii.
Hawaii Biotech develops state-of-the-art recombinant vaccines for common, deadly and incurable infectious diseases such as Influenza, West Nile encephalitis, and Dengue Fever. Avantogen is traded on the Australian Stock Exchange (ASX) under the symbol ACU. The company has established a Level 1 ADR stock program in the U.S. trading under the symbol AUCJY and also is listed on the Xetra exchange, the electronic trading system of the Frankfurt Stock Exchange, trading under the symbol CBS. For further information, visit www.Avantogen.com
Dr. Richard Opara, Executive Chairman
San Diego, CA, USA
Innovate is an international biotechnology company developing a focused oncology related product
candidate portfolio, including clinical evaluation of RP101 for patients for pancreatic cancer and preclinical evaluation two candidates, Capridine Beta in the setting of prostate cancer and an oral formulation of Paclitaxel. Innovate is traded on the OTC Bulletin Board under the symbol IOVO.OB. For
further information, visit www.Avantogen.com
Chris Nowers, CEO
Innovate Oncology, Inc.
San Diego, CA USA
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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