BIVN Bioenvision (MM)

Bioenvision (Nasdaq:BIVN) today announced that the first patients have been enrolled and commenced treatment in three separate, clinical studies of Modrenal(R) (trilostane). These studies are investigating the efficacy of Modrenal in three distinct settings: (1) a Phase IV trial in advanced, post-menopausal breast cancer, (2) a Phase II trial in pre-menopausal breast cancer; and (3) a Phase II trial utilizing Modrenal(R) as a neo-adjuvant (pre-operative) treatment in post-menopausal breast cancer. The Phase IV study will evaluate the efficacy of Modrenal(R) in post-menopausal women who have failed prior aromatase inhibitor therapy. The study is being conducted in nine leading UK centers and the first 18 patients have been recruited, with a target of 61 evaluable patients. The primary objective of the Phase IV study is to determine the clinical benefit rate associated with Modrenal(R) treatment, and the trial is expected to be completed Q4, calendar 2006. The study will add to the existing database for Modrenal(R) in over 700 patients with advanced post-menopausal breast cancer. The Phase II sponsored clinical study will focus on pre-menopausal women with advanced breast cancer who have relapsed or are refractory to first line treatment. The study is being conducted at eight leading UK centers and will recruit up to 41 evaluable patients. The primary objective of the Phase II study is to determine the clinical benefit rate associated with Modrenal(R) treatment and this trial is also expected to be completed Q4, calendar 2006. A Phase II, investigator sponsored study will examine the role of Modrenal(R) as first line treatment for post-menopausal patients with the objective of decreasing the breast cancer tumor mass prior to surgery. The first 12 patients have been recruited with a target of 30 evaluable patients in total. This study is expected to complete enrollment in Q2, calendar 2006. "These multi-center studies are an important step in the development of Modrenal(R)," commented Dr. Christopher Wood, CEO and Chairman of Bioenvision. "There is an enormous need for new drugs that offer alternative treatment options, especially for patients who have developed resistance to existing therapies," added Dr. Wood. Modrenal(R) is licensed and marketed in the UK to treat post-menopausal advanced breast cancer following relapse on initial hormone therapy and has demonstrated clinical benefit rates as high as 55%. Instigation of this new clinical trial program follows the discovery of new mechanisms of action for Modrenal(R), which is now known to be effective in cases of acquired endocrine resistance. About Modrenal(R) Modrenal(R) is approved in the UK to treat post-menopausal advanced breast cancer following relapse on initial hormone therapy. Over 800 patients with breast cancer have received Modrenal(R) (trilostane) in clinical trials, and its anti-tumor activity has been well documented; it is effective in a significant proportion of breast cancer patients, particularly those with hormone-sensitive tumors. New Mechanisms of Action Two novel mechanisms of action for Modrenal(R) have recently been discovered: The first unique mechanism of action, published in the International Journal of Cancer in 2002, explained how Modrenal(R) can uniquely effect the binding of the hormone estrogen to receptors on the surface of cancer cells, and in particular to estrogen receptor beta (ER-beta). ER-beta is now known to be important in controlling the proliferation of breast cancer and is an influential predictor of survival. Modrenal(R)'s effect on this receptor results in a reversal or reduction in the growth of the cancerous breast tissue. The second unique mechanism of action, presented at the American Society of Clinical Oncology 2004 Annual Meeting in New Orleans, outlined how Modrenal(R)'s ability to increase estrogen binding to ER-beta and also decrease binding to ER-alpha, brings about a newly discovered interaction at the binding site of a protein, AP1. AP1 is known to be an important component in cell proliferation pathways that become increasingly relevant as the cancer cells develop resistance to endocrine therapies, such as tamoxifen and aromatase inhibitors. Blocking the action of estrogen through the AP1 mechanism provides an additional means to reduce the rate of cancer cell proliferation. About Bioenvision Bioenvision's primary focus is the acquisition, development and distribution of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: Clofarabine (in co-development with Genzyme Corporation), Modrenal(R) (for which Bioenvision has obtained regulatory approval for marketing in the United Kingdom for the treatment of post-menopausal breast cancer following relapse to initial hormone therapy), and other products in clinical trials. Bioenvision is also developing anti-infective technologies, including Virostat for hepatitis-C and the OLIGON technology; an advanced biomaterial that has been incorporated into various FDA approved medical devices. For more information on Bioenvision please visit our web site at www.bioenvision.com. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Bioenvision's compounds under development in particular; the potential failure of Bioenvision's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioenvision's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioenvision's business, structure or projections; the development of competing products; uncertainties related to Bioenvision's dependence on third parties and partners; and those risks described in Bioenvision's filings with the SEC. Bioenvision disclaims any obligation to update these forward-looking statements.