Cibus Pharmaceutical Inc. announced on Thursday that it hasfiled an investigational new drug application (IND) with FDAfor Phase II human clinical trials of its cholesterol-loweringdrug, CP408.

The privately held company, which re-incorporated with apharmaceutical focus last August, intends to have products onthe market before it integrates backward into a drug discoverycompany, its chief executive told BioWorld on Thursday.

"We're taking a reverse approach to building a pharmaceuticalcompany," said Jerome Arnold, Cibus' president and chiefexecutive officer.

The Redwood City, Calif., company is planning to developproducts from natural substances and living systems.

The company has a 2-year-old patent on a novel blend ofnatural plant fibers covering "virtually every major therapeuticclaim," Arnold said. The GELTRx system was developed toenhance bioavailability; the fibers inhibit pancreatic enzymaticactivity, reduce gastrointestinal side effects such as nausea andvomiting, and prolong time between doses.

In preclinical studies using the granular form of CP408, theproduct reduced "bad" cholesterol (LDL and VLDL), as well astriglycerides and other lipid fractions thought to contribute tocoronary heart disease. At the same time, it appeared toincrease the levels of "good" cholesterol (HDL).

CP408 has been reformulated into an oral tablet, and thecompany has applied for a patent on this potential product,Arnold said. He added that the IND demonstrates the value andviability of the delivery system, which the company hopes willreduce side effects.

Financed by Menlo Ventures, Cibus focuses on cardiovascularand gastrointestinal drugs and has licensed in products for nineprojects under agreements with two commercial researchlaboratories and two academic institutions.

Arnold said five of the nine products are already on themarket, and if CP408 is approved, the company will eithermarket it or license it out.

"We'll have products on the market well before our firstdiscovery project is in Phase I or II," he said.

Cibus plans to seek its second round of financing in the next sixmonths and would like to go public after its developmentprogram is in place, Arnold said.

Prior to its re-incorporation, Cibus did business as Bios, whichlicensed a high-fiber nutritional health care product, Arnoldsaid.

-- Nancy Garcia Associate Editor

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