Healthcare Industry News: Cytogen
News Release - June 21, 2006
New Survival Data on Evoltra(TM) (Clofarabine) in Elderly AML Reported at European Hematology Association CongressAMSTERDAM, Netherlands--(HSMN NewsFeed)--June 21, 2006--Bioenvision (Nasdaq:BIVN ) today announced new data from its BIOV-121 non-randomized phase II clinical study which based upon historical controls suggests that single agent Evoltra(TM) (clofarabine) is as effective as intensive chemotherapy in elderly patients with adverse Cytogenetics.
At the 11th Annual Congress of the European Hematology Association (EHA) in Amsterdam, Professor Alan Burnett, Chairman of the UK National Cancer Research Institute Hematological Study Group, compared Evoltra's(TM) efficacy and survival in elderly unfit patients with adverse Cytogenetics to that of elderly fit patients with adverse Cytogenetics treated with intensive chemotherapy. Professor Burnett presented data to show the survival outcome with single agent Evoltra(TM) was at least as good as the survival outcome in elderly fit patients treated with intensive chemotherapy.
Professor Burnett highlighted that, "clofarabine was able to, at least, match the treatment outcome in patients who are fit for intensive chemotherapy and, importantly does not cause alopecia and mucositis, side effects typically seen with intensive treatment."
The clofarabine data was from BIOV-121, Bioenvision's pivotal AML study in elderly patients unfit for intensive chemotherapy. All patients enrolled in the study were greater than 65 years of age and 62% were over 70 years. None of the patients had a favorable Cytogenetic profile, with all having either intermediate (70%) or adverse (30%) Cytogenetics. In patients over 70 years the overall response rate was 54% and the complete response rate (CR) was 49%. In those with an adverse Cytogenetic profile the overall response rate was 53% and the CR was 42%.
"The pivotal study database has only just been locked and we are still analyzing the data," said Hugh Griffith, Bioenvision's Chief Operating Officer, "but already we are seeing survival benefits in a group of patients with adverse Cytogenetics who have a particularly poor prognosis."
"These results show how Evoltra(TM) (clofarabine) could improve the lives of thousands of AML patients with adverse Cytogenetics who are in desperate need of safe and effective first-line treatment," said Dr. Andrew Saunders, Bioenvision's Medical Director. "These pivotal data will be an integral part of the Marketing Authorization Application we plan to file in Europe in the coming months so we can make Evoltra(TM) available to these critically ill patients."
About Evoltra(TM) (clofarabine)
The European Marketing Authorisation for Evoltra(TM) (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."
Evoltra(TM) (clofarabine) is not currently approved for adult AML. 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(TM) for the treatment of psoriasis and is planning further worldwide development of Evoltra(TM) in autoimmune diseases.
Evoltra(TM) (clofarabine) is a next generation purine nucleoside analog. Bioenvision holds an exclusive worldwide license for clofarabine (outside Japan and Southeast Asia) and an exclusive, irrevocable option to develop, market and distribute clofarabine for all human applications in Japan and Southeast Asia. Bioenvision granted an exclusive sublicense to Genzyme to develop and commercialize clofarabine for cancer indications in the US and Canada. Genzyme is commercializing clofarabine for certain cancer indications in the US and Canada under the brand name Clolar®. Bioenvision holds an exclusive license in the US and Canada for all non-cancer indications. 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.
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(TM), Modrenal® (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® technology, an advanced biomaterial that has been incorporated into various FDA approved medical devices and Suvus®, 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.
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.
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