BIVN Bioenvision (MM)

Bioenvision (Nasdaq NM: BIVN) today announced that the first seven patients had been enrolled in a Phase IV clinical study of Modrenal(R) (trilostane) in post-menopausal women with advanced breast cancer. The trial has been designed to evaluate the efficacy of Modrenal(R) in patients who have failed prior endocrine therapy with the new generation aromatase inhibitors. The study will be conducted in nine leading UK centers and will enroll up to an additional 54 patients. "We are delighted with the rapid recruitment we have seen in the first month of the study and we expect to complete enrollment within a year," said Hugh Griffith, Bioenvision's Chief Operating Officer. Modrenal is licensed in the UK to treat post-menopausal advanced breast cancer following relapse on prior therapy and has demonstrated clinical benefit rates as high as 55%. The first patients have also been enrolled in a Phase II trial, which evaluates the benefit of Modrenal(R) for women with pre-menopausal advanced breast cancer, who have relapsed or are refractory to prior therapies. "These new, multi-center studies are an important step in the commercial development of Modrenal(R), which has already demonstrated significant efficacy in patients whose prior treatments have failed," commented Dr. Christopher Wood, Chairman and CEO of Bioenvision. Initiation of the new clinical trial program follows the discovery of new mechanisms of action for Modrenal, 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 prior endocrine 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 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 in 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 an anti-viral agent (Virostat) 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.