A BB&T

Health agencies from the U.S., Canada and Mexico agreed last month to strengthen cross-border coordination and cooperation in the surveillance, prevention and control of infectious diseases.

The memorandum of understanding, signed by U.S. Secretary of Health and Human Services Mike Leavitt, Canadian Minister of Health Tony Clement and Mexican Secretary of Health Jose Angel Cordova Villalobos, commits the three countries to assist one another during a public health emergency and describes the types of aid the countries may provide t one another during such an emergency.

"The health of our three nations relies upon our cooperation with and assistance to each other in times of need," Leavitt said. "As North American neighbors, we owe it to our citizens to work together whenever possible to minimize the spread and impact of an infectious disease outbreak or other public health emergency that may affect our nations."Clement said that threats to public health and safety "transcend borders, and this agreement represents a meaningful step forward in improving our nations' readiness."

Villalobos said that the memorandum "reflects a true cooperative intention from our nations to join forces during exceptional public health emergencies of international concern, and may be used as a model for other countries and regions of the world."

The three countries agree to cooperate to improve their public health emergency preparedness and response as to border health, laboratory testing, diagnosis and treatment, epidemiological investigation, and infectious disease control and to participate in trilateral or bilateral exercises to assess and strengthen public health emergency response.

Japanese study eyes breast augmentation via cell therapy

Cytori Therapeutics (San Diego) said a new study under way in Japan would examine the effect of adult stem and regenerative cells derived from adipose tissue in breast augmentation.

In this investigational procedure, a patient's breast is augmented with her own liposuctioned fat, which has been combined and enhanced with her own adipose-derived stem and regenerative cells. These cells are made available at the time of surgery using Cytori's Celution System.

This independent, investigator-initiated study is being sponsored by Tatsuro Kamakura, MD, chief medical officer of Cosmetic Surgery Seishin in Japan. The study will enroll 20 patients, all of whom will undergo a standardized cell-enhanced fat tissue transplantation procedure.

Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown pre-clinically to improve tissue retention compared to non-cell-enhanced tissue transfers.

The Celution System was evaluated in an 11-patient investigator-initiated safety and feasibility study, designated as RESTORE I, conducted in Japan. That study evaluated adipose-derived stem and regenerative cells extracted and processed with the Celution System to treat the complications of surgery and radiation damage following partial mastectomy.

Based on preliminary findings and other data, Cytori is sponsoring two post-marketing studies, designated as the RESTORE II and VENUS studies, which will further evaluate the use of adipose-derived stem and regenerative cells for reconstruction of breast tissue following a partial mastectomy.

RESTORE II will evaluate up to 70 patients at multiple European trial sites. VENUS will be a 20-patient single center adjunct to RESTORE II in patients with more severe damage and contour defects resulting from a partial mastectomy.

Hill-Rom to establish Innovation Center in Singapore

Hillenbrand Industries (Batesville, Indiana) said its Hill-Rom (also Batesville) medical-products subsidiary has selected Singapore as the site for its Asia-Pacific Innovation Center.

The center will become the home base for new Hill-Rom teams focused on research & development projects for global applications and will become a center of excellence for microelectronics and embedded software products.

"Innovation is one of the keys to success for global medical technology companies. That's why last April we announced our first Global Innovation Center and based it at our headquarters location in Batesville," said Peter Soderberg, president and CEO of both Hillenbrand and Hill-Rom.

He added, "The early success of that idea has led us to announce the creation of this second center in a part of the world that offers us diverse thinking and approaches as we become a more technology-intensive company. As we looked at potential sites, we found that Singapore has an increasingly knowledge-based economy, great technical talent, sophisticated healthcare institutions, and strong government support to grow its healthcare and technology sectors."

Lim Siong Guan, chairman of the Singapore Economic Development Board, hailed Hill-Rom's action. "The new center will add to the growing cluster of product development activities in Singapore and further solidifies our position as one of the leading locations in the region for medical technology product innovation."

Hill-Rom said the establishment of the Singapore Asia-Pacific Innovation Center calls for as many as 17 new positions to be created in the first year, with additional positions to be added over the course of five years. The company said it ultimately expects to have as many as 50 to 60 people based at the Singapore site.

The U.S. firm had previously reported plans for a significant increase in corporate spending on R&D, aimed at ensuring that its products meet both the current and unanticipated future needs of caregivers and the patients they serve.

That acceleration of R&D led to the formation of the Global Innovation Center in Batesville, announced in April, along with the creation of about 80 new Indiana-based jobs. In addition, Hill-Rom has R&D work ongoing at sites located in Montpellier and Pluvigner, France.

The company said the Singapore center is complementary to these world-wide efforts and also will serve as an extension for Hill-Rom's investments in its Suzhou, China, location.

While emphasizing that Hill-Rom is committed to its home base in Indiana, Soderberg said the company also recognizes the need to leverage opportunities in lower-cost regions as well as to tap into the talents and strengths of a global workforce.

Hill-Rom is working to finalize details on a site selection within Singapore. The company is targeting a site with up to 10,000 square feet of space to be used for offices, R&D labs, a customer experience center, and sales and marketing. The first phase of developing the Asia-Pacific Innovation Center is expected to be completed and operational by March 2008.

The company is a provider of a wide range of medical products and related services, including patient support systems, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, and workflow information technology solutions.

bioMérieux plans to open Algerian subsidiary in early '08

bioMérieux (Paris), a global in vitro diagnostics company, reported its plans to open a subsidiary in Algeria in early 2008. The new subsidiary, based in Algiers, will enhance bioMérieux's presence in Africa and illustrates the company's international expansion strategy.

The news was reported at an international biologists' congress in Paris, which was honoring Algeria this year. "Your country is making significant advances in its healthcare system. After over 30 years of collaboration, by creating this subsidiary in Algeria, we hope to play an integral role in its development," Alain Mérieux, president of bioMérieux, said to representatives of the Algerian Ministry of Health, Population and Hospital Reform.

As part of Algeria's 2005-2009 Healthcare Development Program, the country will create more than 100 healthcare facilities. bioMérieux said it will provide its expertise in the fight against infectious diseases and contribute to the scientific training of healthcare professionals.

In particular, bioMérieux said it intends to play a major part in protecting patients from healthcare-associated infections in Algeria, drawing on its unique offer in microbiology.

bioMérieux is represented in more than 150 countries through 35 subsidiaries and a large network of distributors. It provides diagnostic reagents, instruments and software.

Photocure sets de-merger of drug-delivery subsidiary

Photocure (Oslo, Norway), a developer of devices and pharmaceuticals for the photodynamic treatment and diagnosis of different types of cancer, said that its board has decided to de-merge PCI Biotech, its cancer-focused, drug-delivery subsidiary.

Following the completion of the de-merger process, PCI Biotech will seek a listing on the Oslo Stock Exchange.

Kjetil Hestdal, president/CEO of Photocure, said that the move is "an important step for both Photocure and PCI Biotech. By executing this planned de-merger, we will allow both companies to focus on their respective strengths in the treatment and diagnosis of cancer and in drug delivery."

Photocure currently owns 91.4% of the shares in PCI Biotech, with the remaining shares owned by Radium Hospital Research Foundation, 6.9%, and the employees of PCI Biotech, 1.7%. As a result of the de-merger, Photocure shareholders will receive one share in PCI Biotech for every share they own in Photocure.

Photocure said PCI Biotech has developed "a unique method for the light-directed drug delivery of therapeutic molecules directly into tumor cells." It said this internal delivery of drugs "has the potential to enhance the efficacy of current approaches to the treatment of cancer."

The technology, called photochemical internalization (PCI), can be used both for existing anti-cancer drugs and for emerging treatments, such as gene therapy using siRNA, and as such is of increasing interest in the pharmaceutical and biotech industry, Phoytocure said.

The board of Photocure said it made the de-merger decision for two primary reasons: PCI Biotech's focus on drug delivery is "clearly distinct" from Photocure's existing and future business opportunities; and Photocure believes that de-merging PCI Biotech will give PCI Biotech the best possible opportunity to develop its drug-delivery technology and "to release the value that this creates to shareholders."

Photocure said the de-merger will enable it to "focus entirely" on its commercial ambitions and the development of its R&D pipeline.

PCI Biotech has been a subsidiary of Photocure since 2000, and the company said that it has built "a solid technology platform, generated significant pre-clinical documentation and established a strong intellectual property position."

The soon-to-be separate company said it will launch the first clinical proof-of-concept study in 2008 to evaluate the ability of its technology to deliver an established anti-cancer agent into tumor cells.

Personal genomic service is launched by deCODE

deCODE genetics (Reykjavik, Iceland) reported the launch of deCODEme, which it characterized as "a pioneering service that enables individuals to get a detailed look at their own genome."

The company, a pioneer in applying human genetics to develop drugs and diagnostics for common diseases, said that through their subscriptions to deCODEme, individuals "can learn what your DNA says about your ancestry, your body — traits such as hair and eye color — as well as whether you may have genetic variants that have been associated with higher or lower-than-average risk of a range of common diseases." It said that the information will be "continually updated" as new discoveries are made.

deCODE said subscribers will create a secure, password-controlled personal account. Then, a few weeks after sending in a simple cheek swab, "customers will receive expert analysis of more than a million key variants across their genome, accessible through an easy-to-use and intuitive user interface."

The company said that, in more than a decade of research, it has analyzed the genomes of hundreds of thousands of people from around the world, "developing an unrivaled track record in gene discovery, in systems for genetic analysis, as well as data and privacy protection."

The introductory price of a subscription to deCODEme is under $1,000.

Canadian study cites accuracy of HPV testing with Capture 2

The first randomized, controlled study in North America of HPV testing as a stand-alone screen concluded that it is almost 40% more accurate than the traditional Pap smear in identifying women with advanced cervical disease, according to a report published in the New England Journal of Medicine.

The study, which involved more than 10,000 Canadian women ages 30 to 69, found that the HPV test's sensitivity — its ability to accurately identify women with pre-cancerous cervical cells or cancer — was 94.6%, compared to 55.4% for the Pap smear. HPV (humanpapilloma virus) is the primary cause of cervical cancer.

The study used Qiagen's (Amsterdam, the Netherlands) Hybrid Capture 2 High-Risk HPV DNA test — the only such test both CE-marked and FDA-approved. The molecular diagnostic test was developed by Digene (Gaithersburg, Maryland), now part of Qiagen. The company said the performance of the test has been validated in studies that included more than 300,000 women.

Participants in the Canadian Cervical Cancer Screening Trial (CCCaST) were randomly assigned to a "focus on Pap" or "focus on HPV" screening group; for ethical reasons, both groups received both tests. In the study, conventional cytology was used. All CCCaST participants who tested positive on either the Pap or HPV test were referred for a follow-up biopsy.

In addition to the HPV test's greater sensitivity, the study found that its specificity — the likelihood that women with positive results actually have disease — was slightly less than the Pap smear's (94.1% vs. 96.8%).

Qiagen said that HPV testing for routine cervical cancer prevention is most widely practiced in the U.S., where it is approved for use along with a Pap test in women age 30 and over. Under the currently recommended guidelines, screening that includes HPV testing may be performed at longer intervals than when the Pap is used alone.

However, the NEJM report authors concluded that co-testing "only marginally improved sensitivity compared with HPV testing alone. We believe that a shift from cellular to viral [screening] tests, coupled with education and vaccination, will contribute to more efficient control of cervical cancer."

Data cites Vermillion biomarkers used in cancer study

Vermillion (Fremont, California) and its collaborators presented data demonstrating that several of the company's ovarian cancer protein biomarkers could be used to detect early-stage ovarian cancer and to predict survival. These poster presentations were made at the 15th international meeting of the European Society of Gynecological Oncology in Berlin.

The ovarian cancer detection study showed that a panel of biomarkers in combination with CA125 could more accurately identify early stage ovarian cancer than could CA125 alone. CA125 is a commonly used tumor marker for ovarian cancer.

Vermillion said that for stage I disease, the combination correctly identified 80% of the cancers, while CA125 used alone predicted 68%. With stage II ovarian cancer, the Vermillion panel with CA125 identified 88% of the cancers compared to 71% for CA125 alone.

The study analyzed pre-operative serum samples from 231 patients.

In the survival study, researchers determined that Vermillion's seven biomarker panel could accurately and with statistical significance predict women with ovarian cancer who had good prognosis from those who did not. The study used Kaplan-Meier analysis to show that women with a low panel score were "significantly more likely to survive than women with high scores," independent of the stage of the disease.

Researchers analyzed pre-operative serum samples from 84 patients diagnosed with invasive epithelial ovarian cancer.

Hemopurifier trials begin in India

Aethlon Medical (San Diego), a developer of devices to treat infectious disease, reported initiating clinical testing of the Aethlon Hemopurifier in human studies at Fortis Hospital (Delhi, India) to evaluate safety of the Hemopurifier in up to 10 patients with end-stage renal disease.

The company said the Hemopurifier removes infectious viruses and immunosuppressive proteins from circulation, allowing the natural immune response to overcome viral infection.

Vijay Kher, MD, principal study investigator, is director of nephrology at Fortis. He previously acted as principal investigator of a Hemopurifier study conducted at the Apollo Hospital (Delhi). That study documented initial safety of the Hemopurifier and provided early efficacy observations during 24 treatments administered to dialysis patients co-infected with hepatitis-C.

The company said it also is discussing the treatment of HIV-infected patients with India's National AIDS Research Institute. It is estimated that India had 5.7 million HIV cases last year, the largest infected population of any other country.

Regulatory approvals

CVRx wins CE mark for Rheos hypertension therapy device system

CVRx (Minneapolis) received CE-mark approval for its Rheos Baroreflex Hypertension Therapy System, which it said is the only implantable device designed to control hypertension.

The company said the system was approved for marketing in Europe based on clinical studies conducted in both Europe and the U.S. It added that the system provides a "physiological rational" method to reduce blood pressure (BP), using the body's own natural BP regulation system, baroreflex, to control blood pressure.

The Rheos System includes a small pulse generator implanted under the collarbone; two thin lead wires that are implanted at the left and right carotid arteries and connecting to the pulse generator; and the Rheos Programmer System, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.

• Diamics (Novato, California) received the CE mark for its Pap-Map System for cervical cancer screening. Granted in the Netherlands, the registration will allow the system to be marketed in the European Union and other countries around the world that recognize CE-mark approval.
  Comprised of the Pap-Map Cervical Cancer Collector, the Pap-Map Handle and the Transfer Station, the system allows the capture of 360 degrees of cervical material and transfer the cells, with spatial orientation intact, to a slide to support localization of identified lesions in both initial diagnosis and follow-up treatments.
• InSightec (Haifa, Israel) said that the CE-marking for its ExAblate2000 for uterine fibroids has been changed to say that women planning future pregnancies should consult with their physicians before seeking treatment with the magnetic resonance-guided focused ultrasound surgery (MRgFUS) system. The CE mark had previously stated that only women who had completed their families should seek treatment with the non-invasive system.
• Covidien (North Haven, Connecticut) introduced the PleuraSeal Lung Sealant System to the European market. The system, CE-marked, is intended for use as a surgical sealant during elective pulmonary resection as an adjunct for standard closure techniques of visceral pleural air leaks.
  The PleuraSeal sealant system offers surgeons an advanced hydrogel technology that Covidien said provides "an immediate airtight seal that is effective intra-operatively and throughout the critical lung healing period."The following companies reported winning approval in Japan:
• Cytori Therapeutics (San Diego) won approval in Japan for its Celution System to be used in medical laboratories for stem cell collection and preservation procedures. Green Hospital Supply (Tokyo), Cytori's exclusive commercialization partner for the StemSource Cell Bank in Japan, expects to install the first hospital-based banks as early as 1Q08.
  The StemSource Cell Bank is a comprehensive onsite cell banking service, which includes the Celution System for automated cell processing plus all related equipment and software.
• Japan's Ministry of Health has approved Wright Medical Group's (Arlington, Tennessee) Conserve Plus Hip Resurfacing System.
  The system is available in Europe, Canada and Australia. It is not yet approved in the U.S., although it is in the FDA's regulatory approval pipeline.
  Wright said its system has many sizing options and a larger-diameter femoral head it said helps give patients more range of motion and a more natural gait after surgery.