A Medical Device Daily

Global nanotechnology company pSivida (Perth, Australia) and Singapore General Hospital reported key findings from the final report on Phase IIa clinical trials with the company’s BrachySil product as a potential new brachytherapy treatment for inoperable primary liver cancer.

BrachySil is a micron-sized, nanostructured silicon particle in which radioactive 32-phosphorus (32-P) is immobilized. It is administered as a liquid suspension through a fine-gauge needle directly into tumors. The procedure takes place under local anesthesia and without the need for shielded rooms or robotic injectors, the company said, adding that patients can be discharged the next day.

The trial was conducted at the Singapore hospital on eight patients with advanced liver cancer who were evaluated at three and six months following treatment.

The report confirmed that the primary endpoint of the trial was achieved in its key indication that BrachySil (32-P BioSilicon) was found to be both safe and well tolerated.

Another key finding was that BrachySil also significantly reduced the size of tumors treated as determined by computed tomography (CT) scanning. No product-related adverse events were reported.

The company said the results pave the way for a multi-center Phase IIb dose-profiling study for BrachySil for the inoperable primary liver cancer indication. That trial, which is scheduled to begin later this year, is intended to provide data to support the registration of BrachySil as an approved treatment for liver cancer.

Dr. Pierce Chow, senior consultant in hepatobiliary and general surgery at Singapore General Hospital, said, “From the perspective of patients suffering with advanced cancer of this kind, BrachySil promises to offer the possibility of an effective, safe and relatively pain-free treatment, which can potentially improve both the duration and quality of life.”

Gavin Rezos, managing director of pSivida, said the report “confirms the excellent results for BrachySil that we previously announced at the 12-week interim study time point, and will provide not only a robust foundation for future clinical development and regulatory filing, but also a springboard for our ongoing licensing activities with partners looking to enhance their own portfolios of specialist cancer therapies.”

pSivida said BrachySil is being manufactured to regulatory guidelines by the company’s supply chain contract partners, including Atomising Systems and High Force in the UK and Auriga Medical in Germany. It said the manufacturing process has already been scaled up successfully to supply materials for clinical trial programs and early product launch.

Immucor in Japanese distribution j-v

Immucor (Norcross, Georgia), a provider of automated instrument-reagent systems to the blood transfusion industry, reported that it has agreed with Kainos Laboratories to restructure Kainos’ distribution of Immucor products in Japan. Immucor and Kainos will own 51% and 49%, respectively, of a newly formed joint-venture company that will become Immucor’s distributor in Japan.

The formation of the joint venture is subject to the approval of Kainos shareholders, expected to come on Thursday. Assuming approval, the j-v would be established on or about July 1.

Immucor has agreed to pay Kainos about $3.7 million for its initial 51% interest in the j-v and expects to buy the remaining 49% interest at a later date for about the same price. Immuncor said that Kainos has agreed to provide “certain services” to the j-v company.

Dr. Gioacchino De Chirico, president of Immucor, said, “We are pleased to take this key step toward direct distribution in Japan, the third-largest transfusion diagnostics market in the world after Europe and the U.S. We believe this joint venture will enable Immucor to accelerate its penetration of this important and attractive market.”

Hiroshi Hoketsu, who recently joined Immucor’s board following more than 20 years as president of Ortho Clinical Diagnostics in Japan, said, “The transfusion diagnostics market in Japan will benefit from Immucor’s expanded direct presence through this joint venture.”

Immucor manufactures reagents and systems used by hospitals, reference laboratories and donor centers to detect and identify certain properties of the cell and serum components of blood prior to transfusion. It also markets a family of automated instrumentation for various market segments.

Kainos develops diagnostic reagents, pharmaceuticals and medical instruments.

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