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Latest Data Confirm Benefits of Clofarabine in Children With Relapsed/Refractory Acute Leukaemia Formal European launch of Evoltra® at International Pediatric Oncology Meeting in Geneva GENEVA, SWITZERLAND -- September 21, 2006 -- The latest results from the ongoing European study (BIOV-111)1 of Evoltra® (clofarabine) in paediatric acute lymphoblastic leukaemia (ALL) - presented for the first time this week - have confirmed Bioenvision's recently approved drug, Evoltra®, delivers a significant response rate in a difficult to treat patient population. In addition, updated results from the pivotal clinical study CLO-2122* 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 Paediatric 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 leukaemia is generally successful, patients with multiple relapsed or refractory leukaemia 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® in refractory and relapsed childhood acute lymphoblastic leukemia (ALL) – showed, in the evaluable patients, a complete response rate (CR + CRp) of 28%1. In addition, Evoltra® 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 patients1. 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 the pivotal clinical study CLO-2122* 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 of 66.6 weeks compared with just 7.6 weeks for the non responders2. "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, Department of Paediatric Haematology/Oncology, Tübingen, 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®. Dr. Handgretinger commented, "The majority of patients who received a transplant after responding to Evoltra® are still alive, one is alive three years post transplant". Evoltra® 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® 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® (clofarabine) The European Marketing Authorization for Evoltra® (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® for the treatment of psoriasis and is planning further worldwide development of Evoltra® in autoimmune diseases. Evoltra® (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®. 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. REFERENCE: Kearns et al. BIOV-111: A European phase II study of clofarabine (Evoltra®) in refractory and relapsed childhood acute lymphoblastic leukaemia (ALL). SIOP, 19 September 2006. Jeha et al. Clofarabine in paediatric patients with refractory or relapsed acute lymphoblastic leukaemia (ALL). SIOP, 18 September 2006. SOURCE: Bioenvision E-mail this page to a friend or colleague! To print, use this version