BIVN Bioenvision (MM)

Bioenvision, Inc. (NasdaqGM:BIVN) announced today it has filed a clinical trial authorization (CTA) to begin two Phase I studies of clofarabine gel for the treatment of psoriasis, a disease that affects an estimated 125-million people worldwide. Bioenvision filed the CTA with the Federal Institute for Drugs and Medical Devices (BfARM) in Germany. Filing a CTA is the German equivalent of filing an investigational new drug (IND) application with the FDA. Enrollment in the first trial is expected to begin in December 2006, upon receiving ethics board approval of the clinical trial protocol. BIOV-141 will test clofarabine gel in 20 healthy individuals. BIOV-142 is a controlled proof of concept study which will determine the gel�s activity in 15 patients with psoriasis. The trials will be conducted on the Company�s behalf by Bioskin Institute for Dermatological Research and Development GmbH in Hamburg, a German clinical research organization that specializes in testing dermatology products. Bioenvision developed the gel formulation in the USA. �This is the next step in expanding the Evoltra� (clofarabine) franchise as planned,� said David P. Luci, CFO and General Counsel of Bioenvision. �Bioenvision has worldwide rights to clofarabine in autoimmune disease and testing in psoriasis marks the start of a new phase of product development for Bioenvision.� In the United States alone the psoriasis market is estimated to be between $2 - $3 billion each year according to the National Psoriasis Foundation. �There is no known cure and there is no one, single treatment that works for everyone, so new treatment options are constantly needed to fight this disease,� said Dr. Christopher B. Wood, Chairman and Chief Executive Officer of Bioenvision. �Psoriasis is not only a cosmetic problem, it is a chronic condition which frequently interferes with a person�s quality of life.� �Nucleoside analogs have previously demonstrated activity in autoimmune disease. Clofarabine is a nucleoside analog, and our studies have shown clofarabine is one of the most powerful agents in this class,� said Hugh Giffith, Chief Operating Officer of Bioenvision. �Detailed preclinical studies have already been completed. We are conducting these clinical studies with clofarabine gel to further explore its potential for treating patients with psoriasis.� About 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. About Psoriasis Psoriasis is a chronic, non-contagious, inflammatory skin disease. It is caused by the patient�s lymphocytes initiating an autoimmune reaction in the skin. This is followed by a monocyte-initiated inflammatory response. The disease most often appears as inflamed patches of skin or lesions covered by a silvery-white scale. Psoriasis most often appears in young adulthood and usually recurs throughout an individual�s life. It can occur on any part of the body and can cause itching and discomfort ranging from mild to severe. There is no known cause for psoriasis. According to the National Institutes of Health (NIH) between 5.8 and 7.5 million Americans have psoriasis. The rationale for using clofarabine as a topical application is that clofarabine is known to effectively destroy lymphocytes, which are the causative agents in psoriasis. 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�, 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. Bioenvision, Inc. (NasdaqGM:BIVN) announced today it has filed a clinical trial authorization (CTA) to begin two Phase I studies of clofarabine gel for the treatment of psoriasis, a disease that affects an estimated 125-million people worldwide. Bioenvision filed the CTA with the Federal Institute for Drugs and Medical Devices (BfARM) in Germany. Filing a CTA is the German equivalent of filing an investigational new drug (IND) application with the FDA. Enrollment in the first trial is expected to begin in December 2006, upon receiving ethics board approval of the clinical trial protocol. BIOV-141 will test clofarabine gel in 20 healthy individuals. BIOV-142 is a controlled proof of concept study which will determine the gel's activity in 15 patients with psoriasis. The trials will be conducted on the Company's behalf by Bioskin Institute for Dermatological Research and Development GmbH in Hamburg, a German clinical research organization that specializes in testing dermatology products. Bioenvision developed the gel formulation in the USA. "This is the next step in expanding the Evoltra(R) (clofarabine) franchise as planned," said David P. Luci, CFO and General Counsel of Bioenvision. "Bioenvision has worldwide rights to clofarabine in autoimmune disease and testing in psoriasis marks the start of a new phase of product development for Bioenvision." In the United States alone the psoriasis market is estimated to be between $2 - $3 billion each year according to the National Psoriasis Foundation. "There is no known cure and there is no one, single treatment that works for everyone, so new treatment options are constantly needed to fight this disease," said Dr. Christopher B. Wood, Chairman and Chief Executive Officer of Bioenvision. "Psoriasis is not only a cosmetic problem, it is a chronic condition which frequently interferes with a person's quality of life." "Nucleoside analogs have previously demonstrated activity in autoimmune disease. Clofarabine is a nucleoside analog, and our studies have shown clofarabine is one of the most powerful agents in this class," said Hugh Giffith, Chief Operating Officer of Bioenvision. "Detailed preclinical studies have already been completed. We are conducting these clinical studies with clofarabine gel to further explore its potential for treating patients with psoriasis." About 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 Psoriasis Psoriasis is a chronic, non-contagious, inflammatory skin disease. It is caused by the patient's lymphocytes initiating an autoimmune reaction in the skin. This is followed by a monocyte-initiated inflammatory response. The disease most often appears as inflamed patches of skin or lesions covered by a silvery-white scale. Psoriasis most often appears in young adulthood and usually recurs throughout an individual's life. It can occur on any part of the body and can cause itching and discomfort ranging from mild to severe. There is no known cause for psoriasis. According to the National Institutes of Health (NIH) between 5.8 and 7.5 million Americans have psoriasis. The rationale for using clofarabine as a topical application is that clofarabine is known to effectively destroy lymphocytes, which are the causative agents in psoriasis. 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. 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.