Bio-Technology General Corp. Completes Enrollment in Study of Oxandrolone in Involuntary Weight Loss in Cancer Patients.

Business Editors & Health/Medical Writers

Preliminary Data Presented At the MASCC-ISOO 14th International

Symposium: Supportive Care in Cancer

Preliminary data from an ongoing open label study of the Bio-Technology General Corp. (NASDAQ: BTGC) product, oxandrolone, entitled "Oxandrolone increases weight, lean tissue, performance status and quality of life (QOL) in cancer-related weight loss (WL)," was presented in Boston on June 26, 2002 at the 14th International Symposium of The Multinational Association of Supportive Care in Cancer (MASCC) during a session on cachexia (disease-related weight loss) chaired by Charles Loprinzi, M.D., and Aminah Jatoi, M.D., both of the Mayo Clinic.

The study, underway at 17 sites nationally, is being led by investigator Jamie H. Von Roenn, MD, Professor of Medicine, Division of Hematology/Oncology at Northwestern University, Chicago and was closed for the last patient June 30. Final analysis of data on 139 patients who were losing weight at study entry will be completed in early fall 2002. The study design included an integrated approach of oxandrolone, 10 mg twice daily for four months, individualized nutritional recommendations and a resistance exercise program with elasticized bands. Data analysis presented at MASCC included preliminary data on 103 patients (60 men, 43 women).

The use of oxandrolone was associated with statistically significant increases in weight, body cell mass (BCM) which is largely muscle, increased scores for quality of life and improved performance status/activity scores. 78% of the 103 patients in the analysis were able to gain (55%) or stop losing weight (23%). Patients who gained weight had an average weight gain in 2 months of 8.7 lbs., with 46% of the gain as BCM. Weight stable patients also gained an average of 4.0 lbs. of BCM. By the month 2 timepoint, the rate of weight loss in the 22% who continued to lose weight after enrollment had significantly slowed compared to study entry and the majority of this group was subsequently able to stop losing weight or gained weight. Patients who lost weight in the first two months lost predominantly fat without significant decreases in BCM.

Oxandrolone was generally well tolerated in the study population. The side effects were similar to those seen in other studies of oxandrolone in disease-related weight loss. For example, (a) laboratory findings may include changes in blood lipids and transient mild elevations of specific liver tests (transaminases); (b) patients with a history of leg swelling or congestive heart disease may experience symptoms related to fluid retention. Full side effect profile for the study will be summarized during the final analysis in the fall. No oxandrolone-related serious adverse events were reported in this study population of cachectic cancer patients. One oxygen-dependent patient with advanced lung cancer died after one dose of study drug.

Patients with a majority of cancer types experience significant weight loss, either because of the disease itself or related to cancer treatment side effects. In disease-related weight loss (cachexia), there is a disproportionate loss of muscle in contrast to simple starvation or inadequate intake, where there is a balanced loss of fat and muscle. Cachexia in cancer patients is associated with progressive inability to carry out normal activities, increased fatigue, increased risk for treatment-related complications, compromised treatment outcomes, and decreased survival. Approaches currently used by oncologists generally include nutritional intervention, often with the aid of appetite stimulants.

As noted by several of the presenters at the MASCC meeting, there is a critical need for new options in reversing progressive weight loss in cancer cachexia, including nutrition and exercise with use of medications that can either slow the loss of BCM or increase BCM. According to Dr. Von Roenn who presented data from the study at the recent meeting of the American Society of Clinical Oncology (ASCO) in May, "Involuntary weight loss is a major challenge for oncologists and their patients. These study findings are highly encouraging because oxandrolone appears not simply to increase weight in patients who often have severe disease-related cachexia, but also increase BCM, which may result in improved function and quality of life."

Oxandrolone is a synthetic derivative of testosterone indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis.

Bio-Technology General Corp., a leading biopharmaceutical company, develops, manufactures and markets genetically engineered and other products for human health care. BTG's products are marketed worldwide. Products sold in the United States are Oxandrin(R) (oxandrolone, USP), marketed by BTG and by the Ross Products Division of Abbott Laboratories under a co-marketing agreement, Delatestryl(R) (testosterone enanthate), marketed by BTG, Mircette(R) (oral contraceptive), marketed by Organon, Inc., and BioLon(TM) (sodium hyaluronate), marketed by Akorn, Inc. Products sold internationally are Bio-Tropin(TM) (recombinant human growth hormone), BioLon(TM) (sodium hyaluronate), Bio-Hep-B(TM) (hepatitis B vaccine), Arthrease(TM) (sodium hyaluronate for osteoarthritis), and Silkis(R) (vitamin D derivative). BTG's news releases and other information are available on the Company's website at www.btgc.com.

Arthrease is a trademark of DePuy Orthopaedics, Mircette is a registered trademark of Organon, Inc., Silkis is a registered trademark of Galderma.

You should not rely on forward-looking statements contained in this press release including, but not limited to, statements regarding the safety and clinical activity of oxandrolone in adjunctive therapy of cancer-associated weight loss. Oxandrolone may prove safe and effective in only certain tumor types, if any.

Statements in this news release concerning the Company's business outlook or future economic performance, anticipated profitability, revenues, expenses or other financial items; and statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements" as that term is defined under the Federal Securities Laws. Forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to, changes and delays in product development plans and schedules, customer acceptance of new products, changes in pricing or other actions by competitors, patents owned by the Company and its competitors, and general economic conditions, as well as other risks detailed in the Company's filings with the Securities and Exchange Commission.

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    CONTACT: Wolfe Axelrod Weinberger Associates, New York
             Investor Relations:
             Don Weinberger, 212/370-4500
                         or
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             Leah Berkovits, 732/632-8800

    KEYWORD: NEW JERSEY
    INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICAL PHARMACEUTICAL
    SOURCE: Bio-Technology General Corp.