15 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Singapore-based Austrianova presented additional safety and efficacy data from a second phase II pancreatic cancer clinical trial at the International Society for Cell and Gene Therapy (ISCGT) meeting held in Singapore on October 5 and 6.
The trial data presented by Dr John Dangerfield, COO, Austrianova, reported phase II safety and efficacy data that confirmed and extended the data obtained from a previous phase I/II trial.
Both pancreatic cancer trials employed cellulose sulphate encapsulated, living cells expressing cytochrome P450 CYP 2B1 followed by low dose chemotherapy. These cells are able to convert the inactive chemotherapy drug ifosfamide to a highly tumour toxic form at the site where they are placed in the body. As a result, the encapsulated cells create a high level of drug in the area of the pancreatic tumour where the treatment can provide for the greatest anti-tumour effect, coupled with a significant reduction in side-effects since much lower doses of the chemotherapeutic drug need to be used.
The results reported at the ISCGT meeting revealed that safety and efficacy data from a total of 27 patients is now available. None of the patients treated showed any immunological, capsule, or cell-related adverse events from the live cell encapsulated treatment approach. Moreover and most importantly, the data presented confirmed the approximate doubling of median survival when compared to the data available for the current standard treatment, Gemzar. In addition, there was a doubling of the number of patients surviving for over one year treated with encapsulated cells plus chemotherapy compared to the standard Gemzar treatment. A further significant finding reported at the ISCGT meeting was that the treatment procedure was successfully performed at 4 different cancer treatment centres in Europe by three different interventional radiologists.
Austrianova CEO Dr Brian Salmons said, "We are pleased to announce the additional clinical trial data presented at the ISCGT meeting. The data confirms the safety of the capsule instillation and the long term safety of the capsule material in the body. Moreover, the median survival and one year survival was also confirmed and, therefore, the importance of the treatment was verified," said Prof Walter H Gunzburg, chairman of Austrianova Singapore. "This brings the total number of patients treated to 27 and provides the impetus for the next steps in the development of this product for the treatment of pancreatic cancer in the first line but also for use against other solid tumours."