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MultiCell Technologies Inc.(OTCBB:MCET), with guidance by exceptional management & brilliant scientists, is poised to grow with the exploding human cell-based in-vitro testing industry. With the cost of development for the average drug now estimated at over $800,000,000, pharmaceutical companies desperately need to improve their efficiency when it comes to weeding out new molecular entities that could pose problems in later stage development.
To this end, most are investing in more early stage high-throughput in-vitro testing with human cells (where possible).
Since the majority of drugs now on the market are metabolized in the liver - over half of them by one hepatic enzyme alone - hepatocytes are among the most prized cells for early toxicological screening, drug development, and drug-to-drug interaction studies.
The following is a list of companies who have signed or are preparing to sign licenses to evaluate MultiCell's unique line of readily available, fully functional, immortalized hepatocytes:
Astra Zeneca, Aventis, Amgen, Bristol Myers Squibb, Eisai, Lilly, Novartis, Abbott, Bayer, Boehringer Ingleheim, Biogen, Genzyme, Glaxo Smith Kline, Johnson & Johnson, Hoffman LaRoche, Lexicon, Merck, Millenium, Neurogen, Shering Plough, Pfizer, Hoffman La Roche, Wyeth, Daiichi, Takeda (Japan’s largest pharma), Fujisawa, Ono, Mitsubishi, Shinogi, Sumitomo, Japan Tobacco
MultiCell has developed a unique line of liver cells that reproduce endlessly in culture. This cell line, designated as Fa2N-4, could replace primary human liver cells (from cadavers) for use in several types of high throughput early tox screening, enzyme induction, and drug/drug interaction studies.
Primary liver cells are difficult to obtain, not available on any predicable schedule, expensive and labor intensive to prepare, and of inconsistent quality. Also, primaries lose their functionality rapidly when thawed following cryopreservation. MultiCell's immortalized hepatocytes do not have any of these limitations.
Previous attempts to create immortalized liver cell lines employed tumorigenic cells which were incapable of generating the necessary P450 enzymes. MultiCell's lines are immortalized using the large SV40 T-antigen in a process that ultimately results in the expression of hTERT, allowing the cells to reproduce indefinitely, yet maintain the enzyme expression profiles of a fully differentiated liver cell.
From a recent study done by Hoffman La Roche, which expanded on similar findings made by Pfizer:
“Conclusion: Fa2N-4 cells performed much like fresh human hepatocytes. Using a panel of inducers, both mRNAs and P450 enzymatic activities were induced. These immortalized cells have potential for use as an alternative to primary human liver tissue for In Vitro Induction Studies.”
MultiCell has signed a seven-year, $18,000,000 exclusive distribution deal with XenoTech LLC, a leading cell product provider, and one of the United States' most successful CRO's.
In addition, MultiCell's hepatocytes produce fully human, therapeutic proteins including albumin, and factors VIII and IX. And chief scientist Dr. Ronald Faris has generated a unique protein, dubbed the "Magic-X Protein," from the cells for which a patent application will soon be made. This protein may treat a currently untreatable acute disease with an estimated $1,000,000,000 annual market. Details will not be released until the patent application has been submitted.
MultiCell's hepatocytes also generate adult liver stem cells, for which Dr. Faris own's the patent. Both the hepatocytes themselves and the stem cells could be used in allogeneic transplants to treat various types of liver disease.
Adult liver stem cells also make ideal vectors for gene therapy directed at the human liver.
Finally, immortalized hepatocytes represent the only commercially practical method of supplying cells for a bioartificial liver, and several of these are in or near clinical trials. However, MultiCell's subsidiary, Xenogenics, owns the PREMIER bioartificial liver technology in the industry. Patented under the name "SYBIOL," which stands for Synthetic Bioartificial Liver, the continuing R&D of this medical device is currently on hold, allowing the parent, MultiCell, to focus on the manufacturing, promotion & marketing of it's liver cell lines to "BigPharma." As the FDA approval process is a long & expensive one, CEO Jerry Newmin has chosen to defer the SYBIOL project at the present time, in favor of redirecting The Company's focus & resources towards cell-based products to attempt to bring about immediate revenue & profits. To this end, it is The Company's hope of increasing shareholder value in the near term.
MultiCell was formally Exten Industries - a holding company. The company underwent a radical restructuring, purchased and then merged with MultiCell, and is now on its way to becoming a profitable biotech in the field of cell-based products and cell-based therapy.
(Special thanks to "ThalioMiles" of Raging Bull for composing much of this MultiCell Synopsis)
Wishing "Profound Prosperity" to all present & future MultiCell investors!
Long & Strong...I Remain,
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