A Medical Device Daily, and Nuala Moran, Contributing Writer

EDAP TMS (Lyon, France) reported the recent publication of articles confirming the company’s position, it said, as “the preeminent provider of HIFU [High Intensity Focused Ultrasound] therapy for localized prostate cancer.”

The articles detail the repeatability of outcomes at new centers from the start of service, lower side effects, including a 69% preservation of potency using Ablatherm-HIFU and the safety of repeating HIFU therapy in patients who may require follow-up care.

Raphael Varona, medical director for EDAP, said that the studies “further demonstrate Ablatherm-HIFU specifically offers patients the ability to secure effective treatment for localized prostate cancer with a low risk of side effects as compared to other therapies, and do so without precluding other therapies if they should require more aggressive intervention strategies at a later time ... . [T]hese studies provide even greater clarity that Ablatherm offers a highly predictable outcome across centers around the world through the careful refinement and parameters built to ensure the most appropriate application of HIFU to the patient case.”

European Urology, the journal of the European Association of Urology (Arnhem, the Netherlands), in its April issue published a study of 227 patients treated with the Ablatherm-HIFU unit at Edouard Herriot Hospital (Lyon, France) from April 1994 to July 2003 with the Ablatherm-HIFU unit. It showed a progression of success as the unit parameters were refined, with most patients having low-risk cancers.

Post-HIFU biopsies were negative in 86% of the patients across the entire study spectrum, and 84% of patients reached a nadir PSA of less than 0.5 ng/ml. The study also demonstrates that the elective combination of a transurethral resection of the prostate procedure prior to HIFU greatly reduced catheter time.

The study notes that a similar study population in Germany achieved a 93.4% success rate and median nadir PSA of 0.07 ng/ml by treating 146% of the prostate volume by overlapping treated areas without observing higher side effects than those reported in the Lyon study. The study notes that the high success rate identifies HIFU as a competitive therapy against mainline choices, based on HIFU’s rapid results obtained post-treatment and no therapeutic impasse.

“These studies ... confirm our position as a new but important part of the prostate cancer treatment choices for patients in Europe today,” said Hugues de Bantel, EDAP CEO. “EDAP continues to add to its marketing and education programs in key markets to help develop more centers offering Ablatherm-HIFU care and increase the number of patients seeking HIFU treatment. We are seeing early signs for success in these programs, which have just begun.”

Advisory group bemoans biotech inadequacies

A group of senior European businessmen and academics have delivered a condemnation of the inadequacies of Europe’s political commitment to biotechnology. The Competitiveness in Biotechnology Advisory Group , appointed by the European Union in 2003, said that public and politicians are failing to understand what is at stake in discussions of biotechnology. They cite “a negative spiral of excessive precaution that is undermining entrepreneurship and therefore the competitiveness of the sector in Europe.” And they blame Europe’s confusions over GM crops for the continued negative environment for biotech.

Europe has not resolved underlying questions about the merits of biotechnology, according to the report, submitted to EU officials as input to the early 2007 review of European policy on life sciences and biotechnology.

“Europe is still handicapped by the biotechnology debate being so focused on genetically modified plants, influenced by the thought of potential but unproven risk in the absence of obvious benefits,” it said.

The group fears that polarized debate will continue as long as GM crops are not widely grown in Europe. “It is easy to claim risks and dangers in the absence of familiarity and positive experience,” it said. “Politicians are still hesitating and wondering about whether to deal with the new challenges, instead of putting appropriate policies in place.”

The report expresses regret that the development of a set of EU rules and regulations “has not convinced decision-makers that GMOs are fully acceptable for food or feed” and says this hesitancy blocks other biotechnology initiatives, such as growing optimized crops for non-food use, such as biofuels.

The group calls for extension of patent protection to compensate for regulatory delays and for efforts to demonstrate biotech’s merits to a skeptical public.

“One of the major challenges is the difficulty in seeing ‘biotechnology’ in the product on the market,” the group said, since consumers see a biomedicine only as a medicine, a bioplastic as just a plastic, and biofuel as just fuel. This invisibility translates to a lack of recognition of biotech’s benefits, it says.

The report says that the risks of new technology are often overestimated, leading to excessive safeguards, “inhibiting the development of new technology in young and fragile industries.”

EuropaBio backs biorefineries initiative

The European biotech industry association EuropaBio has come out strongly in support of an EU initiative promoting the development of biorefineries in Europe. The European Conference on Biorefinery Research, in Helsinki Oct. 20-21, focused on industrial opportunities of current and future biorefineries and provided a technical review of the state of the art for biomass fractionation and conversion technologies.

EuropaBio insists that biorefineries are a key element of a bio-based economy to reduce dependence on fossil fuels for energy and industrial raw materials.

“Biorefineries use renewable raw materials to produce energy and a wide range of everyday products in an economically viable manner,” said Jack Huttner, chairman of the Industrial Biotechnology Council of EuropaBio.