A Medical Device Daily

Inovio Biomedical (formerly Genetronics Biomedical; San Diego) reported that is has launched, in collaboration with the University of Southampton (Southampton, UK), a UK Medicines and Healthcare Products Regulatory Agency-approved Phase I/II clinical trial employing its MedPulser electroporation system. Inovio's MedPulser will be used to deliver a therapeutic plasmid-based DNA vaccine to skeletal muscles to treat recurrent prostate cancer.

The trial, sponsored and led by the University of Southampton, will investigate whether the DNA vaccine, developed in the laboratory of Professor Freda Stevenson, will stimulate immune responses against prostate cancer and whether use of the electroporation system enhances this response.

In this Phase I/II open-label study, plasmid DNA encoding a prostate tumor antigen is delivered directly to skeletal muscles in patients with recurrent prostate cancer either by injection or using Inovio's DNA system that uses electroporation to enable the entry and uptake of plasmid DNA into the muscle cells. It has been shown in preclinical studies to induce antigen production and generation of an immune response against the tumor antigen.

"Available treatments for recurrent prostate cancer are intended primarily to only slow disease progression," stated Avtar Dhillon, MD, president and CEO of Inovio. "We are excited to partner with these pioneering scientists at the University of Southampton in what we believe is the first use of electroporation to deliver DNA vaccines in human skeletal muscle with the goal of achieving therapeutic benefits. Using this system, we hope to improve the quality of life of these prostate cancer patients."

"Preclinical models with electroporation-enabled delivery of a plasmid-based DNA vaccine showed significant induction of specific immune responses," said Christian Ottensmeier, MD, Cancer Research UK senior research fellow and chief investigator at the University of Southampton.

Decisions about treatments for prostate cancer are difficult. About 80% of men diagnosed with prostate cancer have early stage disease, but it is difficult to predict whether a tumor will grow slowly with no health consequences, or will grow quickly and become life-threatening. A physician can choose among watchful waiting, or treating with radiation therapy, radical prostatectomy (surgical removal of the entire prostate gland along with nearby tissues), or hormonal therapies. These treatments can have detrimental effects on urinary, bowel and sexual functions, compromising quality of life.

Inovio's MedPulser Electroporation Therapy System was developed to enhance local cellular uptake of biopharmaceuticals, including DNA. Animal experiments have shown that this technology can be used to enhance the effect of plasmid-based DNA vaccines.

Inovio is commercializing a cancer therapy using its MedPulser tumor ablation system in conjunction with bleomycin, an approved anti-cancer drug, with the goal, it says, of improving quality of life while reducing costs compared to existing treatment methods.

The MedPulser has received the CE mark, and Inovio is conducting multi-center, premarketing observational studies treating newly diagnosed and recurrent head and neck cancers as well as skin cancers in preparation for a European product launch.

The University of Southampton has around 20,000 students and nearly 5,000 staff. Its annual turnover is in the region of GBP 270 million.

Sigma-Aldrich completes Proligo buy

Sigma-Aldrich (St. Louis) reported that it has completed the acquisition, from Degussa (Frankfurt) of the Proligo Group (Boulder, Colorado), a supplier of genomics research tools, including custom DNA, custom RNA and phosphoramidite raw materials used for DNA and RNA synthesis. Terms of the purchase were not disclosed.

While its headquarters operation is in Colorado, Proligo also has manufacturing facilities in Paris; Hamburg, Germany; Helios, Singapore; Kyoto, Japan; and Lismore, Australia. The company employs about 300 staff worldwide.

"As we noted when we announced our intent to make this acquisition, the Proligo Group is another key step in our strategy to provide revolutionary technology tools that fully meet the research needs of scientists in the rapidly growing field of genomics," said David Harvey, Sigma-Aldrich's CEO and chairman. "Proligo provides us with one of only four exclusive licenses to a key Massachusetts Institute of Technology [Cambridge, Massachusetts] patent application that covers the use of RNA in gene silencing, the new frontier in genomics research."

He continued: "It builds on our previously-announced partnership with Ingex to develop and market their revolutionary new gene disruption technology [TargeTron]; our exclusive licensing arrangement with Rubicon [Salt Lake City] in whole genome amplification [GenomePlex]; our recently announced agreement to serve as a scientific collaborator and distribution partner with The RNAi Consortium, comprised of The Broad Institute, seven world-class research institutions and four commercial partners; and our own internal R&D activities." He said this would support Sigma Aldrich's effort to become "a global leader" in the area of genomics and gene silencing research tools.

Proligo had 2004 sales of about $40 million. Nine months of Proligo's operating results will be added to Sigma-Aldrich's 2005 performance, increasing, it said, overall sales growth by roughly 2%.

Sigma-Aldrich said that, including funding for the purchase, it expects to remain within its targeted debt-to-capital ratio of 30% to 35% during 2005.

Sigma-Aldrich manufactures biochemical and organic chemical products and kits used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as components in pharmaceutical and other high-tech manufacturing.

Cegedim acquires Target Software

Cegedim (Paris), which calls itself the European leader in customer relationship management (CRM) solutions for healthcare, reported acquiring Target Software (Allentown, Pennsylvania). Terms were not disclosed.

Target Software licenses its suite of CRM, sales force automation, and drug sample management applications, known as Target SFA, to U.S. pharmaceutical companies.

The Target SFA suite leverages Microsoft architectures and development tools, including .NET and Windows Mobile. Target Mobile, the company's mobile sales software, is designed for mobile platforms, including pocket PC's, tablets and wireless PDA phones. In addition to its pharmaceutical company licensees, Target Software is used by contract sales organizations in the U.S. The combination of Cegedim and Target Software "is a decisive new milestone in the realization of Cegedim's ambition to become a global player in the field of CRM software and services dedicated to the worldwide healthcare industry," the company said.

Cegedim has a 36-year history of supplying CRM and IT services to healthcare professionals and pharmaceutical companies. Its offerings consist, it says, "of recurring services enhanced by proprietary databases."

Cegedim employs 4,200 people, operates in 58 countries and generated EUR 428 million in 2004.