• NeoPharm (Lake Forest, Illinois) reported that the independent data monitoring committee responsible for overseeing its Phase III PRECISE trial has reviewed the data for the trial’s first futility analysis and has recommended that the PRECISE trial continue as planned. The PRECISE trial has two futility analyses: the first at 50 deaths, and the second at 100 deaths. The primary endpoint of the PRECISE study is designed to determine whether there is an improvement of at least 50% in median survival of patients with glioblastoma multiforme resulting from treatment with the company’s cintredekin besudotox (IL13-PE38QQR) over treatment with Gliadel Wafer, the current primary treatment option from Guilford Pharmaceuticals (Baltimore). NeoPharm projects the study’s second futility analysis for 4Q05. The company also reported that enrollment in PRECISE is more than two-thirds complete, and that the PRECISE trial randomized its 200th patient in early June. If the company enrolls an average of 15 patients per month between June and December 2005, it will meet its goal to fully enrolling 300 patients in the PRECISE trial by year-end.

PEPID (Skokie, Illinois), a developer of medical information and support tools, reported the release of evidence-based Clinical Inquiries in its latest version of PEPID software for primary care professionals. The inclusion of evidence-based Clinical Inquiries into PEPID’s Primary Care Plus software – published for Palm OS, PocketPC, and available on PEPID Online – is a result of the PEPID Primary Care Plus Project, a collaboration between PEPID and the Family Physicians Inquiries Network (FPIN). Clinical Inquiries are initiated by real-world questions from family doctors, which are then thoroughly researched and published by the FPIN. With the inclusion of Clinical Inquiries in PEPID software, the company said physicians benefit from evidence-based answers to hundreds of practical, clinical real-world questions, and evidence summaries of the world literature identified through structured searches of multiple databases commentaries from noted primary care physicians.

• Thermage (Hayward, California) said research published in the June/July 2005 issue of Facial Plastic Surgery Journal further validates the mechanism of action produced deep within the skin by its ThermaCool System’s monopolar radio frequency (RF) energy. While the immediate tissue tightening and dermal collagen remodeling effects produced by the ThermaCool system have been well established since the device’s introduction in 2002, lead author Manoj Abraham, MD, of New York Medical College (Valhalla, New York) found that selective heating and tightening of the fibrous “threads” that run through the fat better explain visible contouring changes that are unique to the Thermage Procedure. Abraham said the research findings document the ability of monopolar RF to selectively heat and tighten the natural fibrous septae threads that give facial skin its structure and shape. Last year, the company introduced and trained its physician users on an enhanced treatment algorithm that supports the role of selectively heating fibrous septae. The ThermaCool device is cleared by the FDA for the treatment of facial wrinkles and rhytids and for treatment of the periorbital area.

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