Forbes Reports Additional Exciting Data On FM-VP4, a Novel Cardiovascular Pharmaceutical Compound.

Health/Medical Writers

VANCOUVER, B.C.--(BW Healthwire)--Oct. 31, 2000

Forbes Medi-Tec (NASDAQ:FMTI)(TSE:FMI.) today announced details of successful laboratory results of studies on its novel cardiovascular pharmaceutical compound, FM-VP4.

Significant advances are reported in investigations of the mechanism of action, effectiveness in additional animal and cell culture models, manufacturing upscaling and toxicology studies. This reaffirms the Company's strategy of continued fast tracking towards filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for approval to initiate Phase I clinical trials. These latest research results follow earlier pre-clinical trials in mice which demonstrated that FM-VP4 reduced cholesterol levels by 75 per cent, decreased triglyceride (blood fat) levels by 44 per cent, and reduced the formation of atherosclerotic lesions by 75 per cent in eight weeks. The key finding from the newly completed studies indicates that FM-VP4 has 15 times higher efficacy than unmodified sterols in the inhibition of cholesterol absorption.

Recent advances have been made in the following key areas:

Mechanism of action

FM-VP4 is a proprietary, novel chemical entity synthesized at Forbes' research laboratories. The compound has been shown to inhibit cholesterol absorption and turnover in the blood stream in experimental rats. Rats were fed a test meal of fat containing radiolabelled cholesterol. Over a period of 48 hours, the rate of appearance of the radiolabelled cholesterol in the blood stream was determined. The studies demonstrate that FM-VP4 has not only 15 times higher activity than free sterols but also the new compound is a potent inhibitor of cholesterol absorption and transporter into the blood. The methods describing this assessment of cholesterol absorption will be published in the January 2001 Issue of Journal of Pharmaceutical Sciences.

The above was further confirmed in additional studies using a cultured cell model of nutrient absorption from the gut. These studies also reaffirm that FM-VP4 inhibits cellular uptake of cholesterol and that the new compound is highly potent compared to the free sterols.

Taken together, these data confirm that the likely mechanism of action for this novel drug is the inhibition of cholesterol uptake and its secretion into the blood stream.

Effectiveness in experimental animals

The Company previously reported the remarkable lipid lowering and anti-atherosclerotic properties of FM-VP4 in apo E knockout mice. Recent studies have now confirmed the effectiveness of FM-VP4 in a second animal species, the cholesterol-fed gerbil. In this study, the FM-VP4 consumption decreased the blood cholesterol level by 50 per cent. By contrast, blood triglyceride levels were unaffected in this animal model. "A remarkable observation from this study was that LDL cholesterol was selectively targeted and the pool of this lipoprotein in plasma was virtually abolished with no change in the level of HDL cholesterol," noted Dr. Haydn Pritchard, Vice-President, Pharmaceutical Research and Development at Forbes Medi-Tech Inc. "This resulted in a significant decrease in the LDL:HDL ratio, a key indicator of atherosclerotic risk in humans. This is a highly significant observation for a novel lipid modifying drug," he added.

Toxicology studies

Key toxicology studies are now underway at well-recognized contract research organizations in North America and Europe, data from which will form part of the IND filling to the FDA.

Upscale manufacture to pilot scale

To provide sufficient material for the studies described above and for the anticipated Phase I and Phase II human studies, Forbes has entered into an agreement with a major chemical company for the synthesis of FM-VP4 at pilot scale. Technology for this has already been transferred from the Forbes research laboratories to the pilot plant and the first batches of FM-VP4 have now been released for R&D use.

"We are absolutely delighted with the results coming in for FM-VP4," said Dr. Pritchard. "The strength of evidence clearly establishes that this is a very promising novel, effective lipid modifying agent. FM-VP4 will clearly have value in the reduction of risk factors for atherosclerosis and related cardiovascular disease. We can confidently move ahead towards our IND filing and human studies which are planned for early next year."

Cardiovascular disease is the leading cause of death and disability in the western world resulting in more than one million deaths each year in Canada and the US and costing the health care system in excess of US $190 billion annually in direct costs. The annual worldwide market for prescription pharmaceuticals aimed at reducing cholesterol reached $10.3 billion (U.S.) in 1998 and is growing by approximately 7.5 per cent annually.

Forbes Medi-Tech Inc. is a diversified health sciences company dedicated to the research, development and commercialization of innovative nutraceutical and pharmaceutical products derived from nature. By extracting plant sterols from pulping by-products, Forbes is developing cholesterol-lowering agents to be used both as functional food ingredients and pharmaceutical therapeutics in the battle against heart disease. Forbes is also developing innovative fermentation technology that converts plant sterols into pharmaceutical fine chemicals, essential in the production of various pharmaceutical steroids such as contraceptive agents and anti-inflammatories. Phytrol(tm) and CardioRex(tm) are trademarks of Forbes Medi-Tech Inc.

The NASDAQ National Market and the Toronto Stock Exchange have not reviewed and do not accept responsibility for the adequacy or accuracy of the content of this News Release. This press release contains certain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934, which statements can be identified by the use of forward looking terminology, such as "may", "will", "expect", "anticipate", "estimate", "predict", "plans" or "continue" or the negative thereof or any other variations thereon or comparable terminology referring to future events or results. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including the risk of technical obsolescence, intellectual property risks, marketing/manufacturing and partnership/strategic alliance risks, any of which could cause actual results to vary materially from current results or the Company's anticipated future results. See the Company's reports filed with the Toronto Stock Exchange and the U.S. Securities and Exchange Commission from time to time for cautionary statements identifying important factors with respect to such forward-looking statements, including certain risks and uncertainties, that could cause actual results to differ materially from results referred to in forward-looking statements. The Company assumes no obligation to update the information contained in this press release.