Medical Device Daily Contributing Writer
and Staff Reports

Agendia (Amsterdam, the Netherlands) has closed a third funding round to advance development and marketing of its microarray-based cancer diagnostics. Total investment was not disclosed, but company CEO Bernhard Sixt said it was more than $10 million.

The company had raised a smaller, second round in October, but has taken on more financing now to exploit progress in clinical validation of its lead product, MammaPrint, a prognostic tool that predicts on the basis of an expression profile comprising 70 genes whether a woman newly diagnosed with breast cancer is likely to experience a recurrence. It stratifies patients more accurately than current criteria and spares about 20% from undergoing unnecessary chemotherapy.

“MammaPrint is significantly out-performing the Saint Gallen criteria, as well as other standards,” Sixt said. Agendia's founders performed much of the underlying scientific work at the Netherlands Cancer Institute (NKI) in Amsterdam.

A preliminary validation of the test, performed at five European cancer centers by an independent research consortium, has been accepted for publication in the Journal of the National Cancer Institute, Sixt said. The positive data also will enable a wider study, involving 6,000 patients, to begin in multiple centers. Some 250 were picked, he said, from around 800 applicants.

“There was a huge interest internationally, but the centers had to pass significant quality hurdles,” Sixt said. The study is being conducted by the TransBIG consortium, which is partially funded by the European Commission's Sixth Framework Program. The trial sponsor is the European Organization for the Treatment and Research of Cancer (Brussels, Belgium).

The product already has achieved registration under the CE marking program, which governs the sale of medical devices in the European Union, although sales remain modest at present. Five cancer centers in the U.S. also have access to the technology under an FDA investigational device exemption, which permits its use in clinical trials. “We are now talking about how to commercialize this on a broader basis,” Sixt said.

Agendia currently performs all of the procedures required by the test. Its facility, Sixt said, is one of the few laboratories with ISO 17025 quality accreditation. “We have this overkill of quality because we want to concentrate on talking about clinical utility rather than test quality issues,” he said. Eventually, the company aims to capture the test in a kit that can be used in clinical settings.

The company also is commercializing a second product, CupPrint, which identifies the primary tumor in cancers of unknown primary (CUP) – between 2% and 7% of all cancer cases, Sixt said, depending on the sophistication of the pathology employed. CUP has a poor prognosis, but about 15% of patients can have improved survival if the primary tumor is recognized sufficiently quickly.

“The distal metastases react to the same treatment as the primary tumor,” he said. It can identify 39 clinically defined tumor types at present, based on a readout of 800 genes.

Agendia will launch three more products over the next six months, Sixt said, two of which will provide further diagnostic information in breast cancer. The third will address a different form of cancer.

New lab for BioHeart's MyoCell

Bioheart (Sunrise, Florida) and PharmaCell (Maastricht, the Netherlands) reported the opening of a lab facility in Maastricht. The new lab is an advanced research facility that also has Good Manufacturing Practices (GMP) cell production capabilities to support research related to Bioheart's adult muscle stem cell technology.

Bioheart has developed MyoCell, a cell therapy that involves extracting and culturing cells from a patient's own thigh muscle. Those cells are inserted back into the patient's damaged heart region via the MyoCath, a minimally invasive injection-catheter system. Bioheart is enrolling patients in its European Phase II clinical trial, SEISMIC, to test its MyoCell and MyoCath product candidates.

The research at the lab could lead to new intellectual property development and more job creation for the Maastricht region.

Howard Leonhardt, chairman and CEO of Bioheart, hailed the opening of the new facility. “We chose the Maastricht region due to its highly educated work force and its ideal location with close proximity to top research institutes such as the University of Maastricht,” he said.

PharmaCell is an enterprise that grows cells and conducts research for third parties. Its facility contains three small cell-cultivation units and a GMP production unit in the Biopartner Center in Maastricht.

Bracco/VisualSonics development accord

VisualSonics (Toronto), a developer of high-resolution, ultrasound-based, in vivo micro-imaging systems, and the Bracco Group, a maker of ultrasound-based contrast agents, have signed an agreement for the joint development and manufacture of MicroMarker contrast agents optimized for preclinical molecular imaging on VisualSonics' Vevo 770 micro-ultrasound platform.

Bracco will develop and manufacture a complete line of contrast agent kits for VisualSonics' rapidly growing customer base using the Vevo 770 micro-ultrasound platform, specifically designed for the preclinical research market. Bracco will manufacture the agents based on its technology atBracco Research (Geneva, Switzerland). The two companies will collaborate to develop a complete line of kits and protocols for a variety of biomarkers and research applications including cancer, cardio and vascular applications.

“With the addition of contrast-enhanced molecular imaging capabilities to its micro-ultrasound technology, VisualSonics/Bracco offer the only platform with high spatial and temporal resolution that simultaneously provides anatomical, functional and molecular data,” said Dr. Michel Schneider, director of Bracco Research.

VisualSonics CEO Tom Little said, “VisualSonics and Bracco are in an ideal position to penetrate the $500 million incremental annual market potential in preclinical contrast agent revenues. By partnering with Bracco, we are able to leverage their world-class expertise in manufacturing contrast agent kits and quickly provide a variety of application-specific kits and protocols optimized for our customers' specific research and drug discovery and development needs.”

The companies said micro-ultrasound is the fastest-growing preclinical imaging modality. This enabling technology is facilitating research in cardiac and vascular disease, cancer, stem cell research and developmental biology.

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