A Medical Device Daily

Pfizer (New York) has agreed to acquire PowderMed (Oxford, England), a privately held company that has developed a technology to deliver DNA directly to the cells of the body’s immune system and also developing a pipeline of vaccine candidates. Financial details were not disclosed.

PowderMed’s vaccine development program is based on its Particle Mediated Epidermal Delivery (PMED) technology, a needle-free delivery system that delivers DNA-coated microscopic gold particles into the skin using pressurized helium gas. The particles penetrate the epidermal layer of the skin activating cells that in turn trigger an immune response.

PowderMed said that vaccines based on the PMED technology “have been shown to elicit both antibody and cell-mediated immune responses, which could lead to improved efficacy compared to traditional vaccines.”

PowderMed says that it is at “the forefront of a scientific effort to overhaul a vaccine manufacturing system that has remained largely unchanged for the last 50 years.” This system produces flu vaccine inside chicken eggs, a process taking up to nine months and constrained by limited manufacturing capacity and a limited ability to quickly adapt vaccines to emerging strains of influenza.

PowderMed says that its DNA-based technology has the potential to leapfrog both egg-based vaccine technology and the cell-based vaccine technology currently being developed. Its vaccines are formulations stable at room temperature, potentially eliminating the need for cold storage. It says that its delivery device requires minimal medical training and may allow self-administration.

John LaMattina, MD, president of Pfizer Global Research and Development, said, “PowderMed’s technology may lead to new vaccines that are easier to use and store than current vaccines and may have the advantage of being more quickly adaptable to changing strains of influenza.”

“I am delighted that the potential of the PowderMed technology to revolutionize the prevention and treatment of infectious diseases is now in the hands of the world’s leading pharmaceutical company,” said Clive Dix, MD, founder and CEO of PowderMed.

PowderMed’s venture investors included Abingworth Management, Advent Venture Partners, Oxford Bioscience Partners and SV Life Sciences.

The acquisition, expected to close in the fourth quarter, is subject to various closing conditions.

Hologic tech positive in double-read study

Hologic (Bedford, Massachusetts), a developer of digital imaging systems for women’s health, reported on a study titled “Single reading with computer-aided detection and double reading of screening mammograms in the United Kingdom National Breast Screening Program.” The study, published in the October issue of Radiology, the performance of a radiologist using computer-aided detection (CAD) was superior to that of screening mammograms, which were double-read.

This study, by researchers from two UK breast centers, measured radiologists’ performance with the use of CAD. The study also showed a 15% increase in cancer detection rates when CAD was used. The CAD system used in the study, the ImageChecker 1000 version 5.0, was supplied by Hologic’s R2 Technology subsidiary.

The CAD program scans a mammogram for abnormalities and indicates the abnormality on a screen for the radiologist to check. The CAD system used R2 EmphaSize software providing variable size marks that correlate to lesion significance. A larger mark indicates that the CAD algorithm detects more mammographic features that are indicative of cancer.

The study included a sample of more than 10,000 mammograms obtained from women aged 50 years or older who underwent routine screening. Double-read mammograms initially were randomly allocated to be re-read by eight different radiologists using a single read and CAD. The researchers found that single reading with R2 CAD detected 6.5% more cancers — a 15% increase in the cancer detection rate — than that achieved with double reading (P=0.02)

Fiona Gilbert, of Aberdeen University (Aberdeen, UK), the study leader, said: “The mammograms studied were from a sample taken in 1996 so that all cancers that developed subsequently in this group of women could be included. We have now embarked on a new study to confirm that the CAD result is still as good when used in real day-to-day decision-making about breast cancer diagnosis.”

Sue Astley, MD, of Manchester University (Manchester, UK), who worked on the study, said the new research “will involve 30,000 women in three major screening centers, most of whom will have single reading with CAD in addition to their routine double reading. This is an opportunity for women in the UK to have their mammograms read using the latest CAD technology which is already available in America and other countries.”

The R2 ImageChecker was the first CAD system approved by the FDA for use with film-based mammography in 1998 and for digital mammography in 2001.

German hospital adopts Ablatherm-HIFU

EDAP TMS (Lyon, France), a developer of high intensity focused ultrasound (HIFU) treatment of prostate cancer, reported signing a revenue-per-procedure (RPP) services contract to provide Ablatherm-HIFU treatment of localized prostate cancer at Helios Klinikum Wuppertal (Wuppertal, Germany), the largest regional hospital in western Germany and a urology center specializing in minimally invasive treatment and nerve-sparing prostate procedures. The hospital will begin treating patients Oct. 23/24.

Judith Johannsen, general manager of EDAP, said, “Wuppertal made a complete evaluation of HIFU therapy in comparison to traditional treatments as well as the available HIFU devices. On both evaluations, EDAP provided clear and compelling clinical data based on long term studies using a consistent treatment protocol. Hence, EDAP demonstrated Ablatherm-HIFU offers patients a successful and compelling treatment choice, especially for nonsurgical patients or those concerned about maintaining a high quality of life after cancer treatment.

“We have decided to offer Ablatherm HIFU to our patients as an alternative treatment option because HIFU is a minimally invasive therapy, which, under the correct indication — patients who cannot pursue surgery, patients with local residual cancer, older patients with incidental carcinoma after TURP — should be integrated into our therapeutic spectrum of the management of prostate cancer,” said Stephan Roth, PhD, head of urology.

No Comments