BIVN Bioenvision (MM)

Bioenvision, Inc. (NasdaqGM:BIVN) today announced the latest results from the ongoing European study (BIOV-111) of Evoltra(R) (clofarabine) in pediatric acute lymphoblastic leukemia (ALL) - presented for the first time this week - have confirmed Bioenvision's recently approved drug, Evoltra(R), delivers a significant response rate in a difficult to treat patient population. In addition, updated results from the pivotal clinical study CLO-212* showed that response to clofarabine provides the opportunity for patients to proceed to stem cell transplant, which offers them the best chance for long term survival. The data was presented this week at the 38th Congress of the International Society of Pediatric Oncology (SIOP) in Geneva, Switzerland, which is one of the largest gatherings of pediatric cancer specialists in the world and this year has attracted over 1700 delegates. Although the first-line treatment of children with leukemia is generally successful, patients with multiple relapsed or refractory leukemia have a low response rate to existing treatment options and a very poor prognosis, with a median survival of approximately 9-10 weeks. Study BIOV-111 - response rate and survival benefits Interim results from Study BIOV-111 - the ongoing European phase II study of Evoltra(R) in refractory and relapsed childhood acute lymphoblastic leukemia (ALL) - showed, in the evaluable patients, a complete response rate (CR + CRp) of 28%. In addition, Evoltra(R) achieved a notable survival advantage, with a current median survival of 37.4 weeks in responding patients compared to 9.4 weeks in non-responding patients. Dr Pamela Kearns, Senior Lecturer in Pediatric Oncology, Bristol University and Bristol Royal Hospital for Children, who presented the data commented, "The overall remission rate seen in this study is exceptional in such a difficult to treat group of patients who have failed other currently available treatments. Evoltra achieves durable responses with a notable survival advantage for the responders". Study CLO-212* - latest update Updated results from pivotal clincial study CLO-212* were presented at SIOP. Dr Sima Jeha, St. Jude Children's Hospital, Memphis, reported that a 30% response rate was achieved in heavily pre-treated patients with multiple relapsed/refractory ALL with a median survival at the latest data cut-off is 66.6 weeks compared with just 7.6 weeks for the non responders. "Although the original aim of this phase II study was not to follow patients indefinitely, due to the very favorable results and the number of patients proceeding to transplant, the protocol was amended and we continued to follow them," said Dr. Jeha. Dr Rupert Handgretinger, Tubingen, Germany one of the transplant specialists in the study also presented updated information on those children who received a stem cell transplant following response to Evoltra(R). Dr Handgretinger commented, "The majority of patients who received a transplant after responding to Evoltra(R) are still alive, one is alive three years post transplant". Evoltra(R) was granted European Marketing Authorization by the European Commission on 29th May 2006 and is available in all 25 member states of the European Union. Bioenvision chose the SIOP 2006 meeting as the ideal forum to officially launch Evoltra(R) in Europe. The formal launch meeting was attended by approximately 200 of the worlds leading pediatric hematologists and oncologists. In addition study results were presented at the plenary sessions of SIOP and at a dedicated Evoltra satellite symposium. *clinical study CLO-212 was conducted by Genzyme Corporation in the U.S. About Evoltra(R) (clofarabine) The European Marketing Authorization for Evoltra(R) (clofarabine) is for "the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients less than or equal to 21 years old at initial diagnosis." Clofarabine is in clinical development for the treatment of other hematological cancers and solid tumors. Bioenvision is also conducting late-stage preclinical development of Evoltra(R) for the treatment of psoriasis and is planning further worldwide development of Evoltra(R) in autoimmune diseases. Evoltra(R) (clofarabine) is a next generation purine nucleoside analog. Bioenvision holds an exclusive worldwide license (excluding U.S. and Canada) for the cancer applications of clofarabine and an exclusive worldwide license for all non-cancer indications. Bioenvision granted an exclusive sublicense to Genzyme Corporation to develop and commercialize clofarabine for certain cancer indications in the U.S. and Canada, which Genzyme markets under the name of Clolar(R). Bioenvision originally obtained clofarabine development and commercialization rights under patents held by Southern Research Institute. Clofarabine has been granted orphan drug designation for the treatment of both ALL and AML in the U.S. and Europe. In Europe, the designation provides marketing exclusivity for 10 years following Marketing Authorization. About Bioenvision Bioenvision's primary focus is the acquisition, development, distribution and marketing of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: Evoltra(R), 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. Bioenvision is also developing anti-infective technologies, including the OLIGON(R) technology, an advanced biomaterial that has been incorporated into various FDA approved medical devices and Suvus(R), an antimicrobial agent currently in clinical development for refractory chronic hepatitis C infection. For more information on Bioenvision please visit our Web site at www.bioenvision.com: http://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.