Kuros, Synthes to Co-Develop Bioactive Materials for Specified Applications

Swiss biomaterials firm Kuros Biosurgery and Synthes inked a license and development agreement under which they will work together commercialize Kuros’ synthetic matrix technology in specified fields. Kuros is focused on the development of biomaterials and bioactive-biomaterial combination products for trauma, wound, and spinal applications.

The firm’s candidates are based on a platform that allows the combination of either natural (fibrin) or synthetic matrices that enable the controlled release of active molecules. The active biologics are chemically linked into the biomaterials and can be further engineered to contain an enzymatically-sensitive degradation site between the active domain of the biologic and the linking site. In the case of the fibrin-based matrices, the degradation site is sensitive to enzymes activated by a patient’s own cells as they invade and degrade the matrix during the tissue repair process. The active domain of the biologic is then effectively released on cellular demand.

Similarly, for synthetic matrix-based products, the active biologic is attached using either entrapment or non-enzymatic chemical cross-linking to the matrix as it forms. As with the fibrin-bound bioactives, enzymatically sensitive degradation sites can also be engineered between the active domain and the linking site to enable release upon cellular demand.

Kuros has nine candidates in various stages of clinical development. Lead orthopedic trauma candidates KUR-111 and KUR-113 have met their primary endpoints in large Phase IIb clinical trials. Preparations for Phase III studies are ongoing. KUR-111 is an autograft replacement candidate comprising a fibrin matrix, variant parathyroid hormone (vPTH), and hydroxyapatite/calcium phosphate (HA/TCP) granules. KUR-113 is a fracture product in development for promoting bone repair in tibial shaft fractures, and comprises a fibrin matrix and a variant PTH, which is prepolymerized by the surgeon into a gel-like paste and then applied to the sites of fracture.

Kuros wound healing and sealant pipeline includes lead candidate KUR-023, a synthetic dural sealant that has successfully completed a European clinical study intended for CE Marking. Additional bone regenerating, wound, and burn healing products are also in development.

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Australasian alert for tainted blood

CSL contaminated batches of Albumin recalled after lengthy delays to notify.
Yesterday the Therapeutic Goods Administration (TGA) in Australia quarantined CSL Human Albumin solutions from further use while an assessment is carried out into the safety of the products.
That followed notification from CSL Biotherapies that some batches of the solutions manufactured before January 25 had been contaminated with coolant ethylene glycol, due to equipment failure.
As a result the TGA issued a recall to all hospitals throughout Australia, New Zealand, Hong Kong and Singapore for the albumin, the main protein in plasma, manufactured before January 25.
CSL had advised the TGA that levels of contamination were "very low" and adverse clinical effects appeared unlikely. So far, CSL had not found evidence of anyone who received the albumin suffering ill effects. Toxicity due to ethylene glycol would occur acutely and delayed effects beyond 72 hours would not be expected.
CSL was continuing further tests ''to quantify the levels of contamination and the extent of the batches affected''.
Today a New Zealand Ministry of Health spokesman said CSL had not yet identified any batches of albumin in the country that were affected, but testing was continuing.
Hospitals had been advised and were working with the New Zealand Blood Service to manage use of the existing stock.
The ministry was also "promptly" sourcing stock it could be sure of.
In Australia, the TGA said that as a result of the action to quarantine stocks, supplies of albumin may be limited in the immediate future.
Stocks in Australia were being quarantined from further use until safety implications had been fully assessed.
Advice released by the TGA last night on the effect of ethylene glycol said ingestion of the coolant could lead to acute renal failure and trigger symptoms consistent with alcohol intoxication.
The highest risk would be anticipated among those patients requiring the largest volumes of albumin.