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Clofarabine European Study Confirms Efficacy in Pediatric Patients With Acute Lymphoblastic Leukemia; Study Update at American Society of Hematology

Posted on: Tuesday, 13 December 2005, 09:00 CST

Bioenvision (Nasdaq:BIVN) today provided preliminary data from the Company's Phase II sponsored study of clofarabine in pediatric patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL). The update was given to a meeting of study investigators and European and Japanese hematologists.

Bioenvision reported that a total of 37 patients have been enrolled to date in study BIOV-111, which is being conducted in 40 European centers (11 UK; 11 France; 9 Germany; 6 The Netherlands; 2 Italy; 1 Austria). Of the 20 evaluable patients, 5 (25%) have achieved, according to investigator assessment, a complete response (CR + CRp). "This is similar to the 20% complete response rate seen in the U.S. pivotal study upon which clofarabine was approved by FDA in December 2004 and confirms the clinical benefit of clofarabine in this highly relapsed and refractory group of patients" said Dr. Andrew Saunders, Bioenvision's medical director.

Bioenvision continues to expand the number of sites and the geographical reach of this important study which remains open to patient enrollment.

About clofarabine

Clofarabine is a next generation of the drug class, purine nucleoside analogs that inhibit DNA production necessary for cancer cell growth. Bioenvision and Genzyme (Nasdaq: GENZ) are co-developing clofarabine. Bioenvision holds an exclusive worldwide license to clofarabine (outside Japan and Southeast Asia). Bioenvision granted an exclusive sublicense to Genzyme to develop and commercialize clofarabine for cancer indications in the United States and Canada. Bioenvision holds an exclusive license in the US and Canada to all non-cancer indications and an exclusive, irrevocable option to develop and market clofarabine for all human applications in Japan and Southeast Asia.

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 adult and pediatric ALL and AML in the U.S. and Europe. In the U.S., orphan drug status extends market exclusivity for seven years. The FDA also recently granted an additional six months market exclusivity to clofarabine under the Best Pharmaceuticals for Children Act. In Europe, the designation provides marketing exclusivity for 10 years. In December 2004, FDA approved the use of clofarabine for treatment of pediatric patients 1 to 21 years old with relapsed or refractory ALL after at least two prior regimens.

In Europe, Bioenvision filed a marketing authorization application (MAA) with EMeA in July 2004 for approval of clofarabine for use in pediatric patients with ALL who are relapsed or refractory to at least two prior regimens of treatment. Bioenvision has received and responded to the CHMP's Day 120 List of Questions and in October 2005, Bioenvision received the CHMP's Day 180 List of Questions. Bioenvision currently are compiling data sufficient to make a complete response to the EMeA.

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: 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 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.

Source: Business Wire

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