Medical Device Daily Contributing Writers

Plasticell Ltd. (London) has reported progress in the development of endogenous stem cell therapy, claiming its screens were able to pick out a small molecule which mimics granulocyte colony-stimulating factor (G-CSF), the growth factor that stimulates bone marrow cells to produce neutrophils.

The company's CEO, Yen Choo, said he believes it will be possible to screen for small molecules that induce endogenous stem cells to produce heart, brain and other tissues. "There's a lot of mixed-upness in the industry at present about how small molecules could be made to interact with stem cells," he told Medical Device Daily's sister publication BioWorld International. Choo presented the data at the World Stem Cells and Regenerative Medicines Conference in London earlier this week.

The finding is a significant endorsement of the use of embryonic stem cells in drug discovery. To date the emphasis here has been in using embryonic stem cells to generate specific cells, such as liver cells, or cells that are representative of particular diseases, for use in in vitro toxicity testing and drug screening.

Plasticell's CombiScreen assay takes this on to the next stage, using embryonic stem cells to generate blood progenitor cells, and using these to identify small molecules that will induce them to produce neutrophils. In this case Combiscreen was validated by its ability to pick out a known G-CSF mimic, provided by GlaxoSmithKline, which markets the first drug of this type, Promacta (Eltrombopag), an orally-available, once daily treatment developed by Ligand Pharmaceuticals, for treating low platelet count (thrombocytopenia).

Choo said that while it is well-known that Promacta is a G-CSF mimic, the stage is now set to use CombiScreen to discovery small molecules that prompt the differentiation of progenitor cells in tissues where the biology is not as well understood, as is the case in blood. "Furthermore, with CombiScreen you don't need to know the progenitor; it can be a blind screen."

CombiScreen builds on CombiCult, a bead-based high throughput system, which provides optimal culture conditions for growth and differentiation of stem cell lines. Colonies of cells are grown on the surface of the microscopic beads, which are then shuffled in up to 100,000 different combinations through a series of different cell culture media.

Choo said the work is very encouraging. "[It] heralds a new paradigm in the development of regenerative medicines, potentially paving the way for new synthetic drugs that regenerate damaged organs and tissues."

Plasticell believes that using small molecules to act on endogenous progenitor cells is far closer to the pharmaceutical industry's comfort zone than administering tissue therapies.

This was certainly given as the rationale behind the recent $45 million deal between epithelial stem cell specialist Epistem (Manchester, UK), and Novartis (Basel, Switzerland) to find small molecule inhibitors of the processes that induce epithelial stem cells to form cancer stem cells, or otherwise go awry in gastro-intestinal and dermatological diseases.

That agreement was significant in terms of pharma's engagement with stem cells in that rather than developing stem cells per se (of whatever variety) as therapies for injection or transplant, the aim is to develop biopharmaceuticals that modulate endogenous epithelial stem cells.

CE mark for Accent RF, Anthem RF

St. Jude Medical (St. Paul, Minnesota) reported European CE-mark approval of its Accent RF pacemaker and Anthem RF CRT-P (cardiac resynchronization therapy pacemaker).

The company says the Accent and Anthem product family features RF telemetry that enables secure, wireless communication between the implanted device and the programmer used by the clinician, making it the first integrated system of pacing devices with wireless telemetry from implant through follow-up.

Wireless communication is used when clinicians implant the device and during follow-up appointments, which can be performed in the office or via remote monitoring with the patient at home, allowing for more efficient and convenient care and device management.

Austrian/German distribution accord

SpectraScience (San Diego) said it has established a distribution partnership for the German and Austrian markets through Krainer Medtechnik (Vienna, Austria).

The WavSTAT Optical Biopsy System uses light to optically scan tissue and provides the physician with an immediate analysis. With FDA approval for sale in the U.S. and the CE mark for the European Union, the WavSTAT System is the first commercially available product that incorporates this technology for clinical use.

Michel Vaudry, SpectraScience's VP sales and marketing, said, "We are pleased to add another distribution partner in Europe. Krainer Medtechnik is a respected and well-established medical distribution company and its decision to add the WavSTAT Optical Biopsy System to their portfolio is a strong validation of the need for our technology."

Krainer was established in 1979 and distributes other leading gastroenterological diagnostics products.

Krainer Medtechnik's president/managing director, Guido Carniolan, said, "We are pleased to be SpectraScience's distribution partner and believe there is significant market potential for this innovative gastrointestinal cancer diagnostic system. With our strategy to be the leader in gastro-diagnostics, the WavSTAT Optical Biopsy System is an ideal fit into our program."

He added, "We see important benefits to our physicians, enabling them to quickly distinguish between normal and precancerous tissue in the GI tract and allowing for physical biopsy at exactly the same site and time that the optical biopsy is performed. More importantly, the WavSTAT objectively identifies the borders of tissue during surgery to determine if all cancerous tissue has been removed. This will prevent a second surgery."