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Nascent Cell Analysis Shop Cell Kinetics May Name First CEO, Mulls Financing Options Beyond Parent


This article has been updated from a previous version, which omitted Gideon Berke's full name and title.

In its quest to become an independent company and bring its cellular analysis platform to market, nascent biotech Cell Kinetics hopes to name its first CEO within the next few weeks, Cell Kinetics' parent company Medis Technologies said this week.

In addition, Cell Kinetics is currently considering financing options that could help it operate independently of publicly traded Medis Tech, and is contemplating securing venture capital or selling shares to current Medis Tech shareholders.

A successful spin-off would allow Medis Technologies to fully concentrate on its fuel cell technology business, and enable Cell Kinetics to commercialize its flagship CellScan platform for personalized chemotherapy, infectious disease diagnosis, and eventually, drug discovery.

Medis Tech has been seeking a CEO for Cell Kinetics since the beginning of this year when the subsidiary established itself as an independent entity, and seems to have finally identified a strong candidate, Robert Lifton, Medis Tech's chairman and CEO, told CBA News this week.

"Both parties are interested," Lifton said, although he declined to provide any more details about the candidate's identity for confidentiality reasons.

"We got to the point where breast cancer was such a focus, and then we said, 'What are we going to do now?' We had put a huge amount of money into the company, and knew we had to do something to create value."

The new CEO's background will undoubtedly help elucidate exactly in which markets Cell Kinetics intends to initially play. According to Medis Tech, the CellScan instrument platform has potential in several markets, including diagnostics and drug discovery.

The CellScan platform consists of a "cell carrier," which is a slide containing 10,000 individual wells, each large enough to accommodate one or a few cells at the most; a scanning instrument; and software.

Cells that are either engineered to express a fluorescent protein or labeled with a fluorescent indicator are "plated" on the cell carrier, which is then inserted into the CellScan reader.

The fluorescence reader excites labeled cells with a laser, and is capable of measuring two main parameters: fluorescence intensity, which can be used to derive information about apoptosis, cell health, and cellular metabolism; and fluorescence polarization, which can give information about where a probe is located in a cell — for instance, whether it is membrane bound or floating in the cytoplasm. In addition, changes in fluorescence polarization measurements have been shown to indicate cellular changes in response to antigen or hormone stimulation.

CellScan is not an imaging platform; rather, it uses photomultiplier tubes to measure fluorescence emission. In addition, only one drug or other stimulating molecule can be applied to the cells per experiment, although the drug can be washed out and replaced with another substance.

Most importantly, researchers will be able to evaluate a drug's effect on a variety of cells over time, and can go back and isolate individual cells of interest using the computer program. Medis Tech is currently developing a single-cell retrieval unit to enable this process.

According to Lifton, CellScan's capabilities make it conducive to any application in which researchers want to follow the response of a large number of single cells over time to a specific substance. However, it appears for the time being that Cell Kinetics will target the clinical market space with these capabilities, which harkens back to Medis Technologies' roots, according to Lifton.

"We started the original company with this technology, which is where the name Medis came from," Lifton said. "Our focus at the beginning was on breast cancer, and on using lymphocyte cells stimulated by antigens for breast cancer to make diagnoses."

Lifton said that initial results of such tests were "spectacular," and much better than mammography, with an approximately 18-percent false-negative and false-positive rate.

"However, the cost of a false positive, using this kind of screening method, would have been prohibitive," he added.

As a result, Medis Tech's progress in this area slowed considerably. Luckily, Lifton said, the company was able to exploit in-house engineering expertise to move in a completely different direction: the development of liquid fuel cell technology, which became a relatively successful venture.

"We got to the point where breast cancer was such a focus, and then we said, 'What are we going to do now?'" Lifton said. "We had put a huge amount of money into the company, and knew we had to do something to create value. When the other stuff came along, we did it, but we never stopped work with the CellScan, and these new applications were slowly developed."

Many of these applications have been developed at a research center devoted to CellScan at Bar-Ilan University in Israel, where the underlying cell carrier technology was originally developed. Most of Medis Tech's operations are also based in Israel, although Lifton and the company's investor relations team are located in New York.

The most promising applications for CellScan, according to Gideon Berke, scientific advisor for Medis Tech and professor of immunology at the Weizmann Institute, can be found anywhere that flow cytometric-like analysis of cells is desired, but the fluorescence signal is too low or the number of cells is too small for a traditional flow cytometer.

"In flow cytometry, a cell gets measured in the space of a few microseconds," Berke said. "With CellScan, the cells fit in the wells, and can be monitored in either time mode or photon-counting mode, so very weak signals can be evaluated. You can instruct the machine to stay on a cell for five, 15, or 50 seconds, or you can tell it to collect so many thousands of photons in a number of seconds."

In addition, Berke said, CellScan users can revisit a cell any number of times during the course of an experiment, and the cells can be reevaluated for as long as they are kept alive on the cell carrier. This allows real-time kinetic monitoring of a cell's response to, for instance, chemotherapy drugs, something that a flow cytometer cannot do.

"Where I see great promise is in small biopsies, for breast, prostate, or other cancers, where the tissue mass is very small, and the number of cells would also be small," Berke said. "This is all you get. You have to do the analysis on a very limited number of cells — maybe dozens or a few hundred, and a flow cytometer cannot handle that small a number."

Consequently, Medis Tech sees individualized chemotherapy as a very promising area, as well as drug discovery using stem cells, which are typically in short supply.

Lifton said that one of Cell Kinetics' first priorities will be establishing partnerships with hospitals and affiliated research centers, particularly in the US, to conduct feasibility studies using CellScan. The company already has established relationships with researchers from Memorial Sloan Kettering Cancer Center in New York; several Israeli hospitals and research centers; the Oncological Center in Cluj, Romania; and multiple sites in Tashkent, Uzbekistan, in collaboration with the Uzbekistan Health Ministry.

In fact, improvements to CellScan came from the laboratory of Eric Holland, a neurologist and cancer researcher at MSKCC. Lifton said Holland suggested that Medis Tech find a way to keep cells alive for longer on the cell carrier, which would in turn allow researchers to kinetically monitor cellular response to treatments over the course of several days. These suggestions in turn led to the development of a new surface for the CellScan carriers that allow cells to remain happy, and even proliferate, for as long as a week, Lifton said.

This development could allow Cell Kinetics to extend CellScan into a high-content analysis type of platform for applications such as stem cell research and drug discovery, Lifton and Berke said.

In addition, Medis Tech has developed a method by which it can coat the cell carriers with different biological molecules, such as antibodies, cytokines, and hormones, all of which could enable the platform to eventually be used as a device for disease diagnoses. Lifton said that the company has already published work in the areas of tuberculosis, lupus, and drug allergies.

— Ben Butkus ([email protected])

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