Lyon, France, December 3, 2009 - Alizé Pharma, a group of companies developing innovative therapeutics for metabolic diseases and cancer, announces today that it has developed an improved L-asparaginase product with increased potency, reduced immunogenicity and longer duration of action. The product, Asparec(R), involves the use of a state-of-the-art PEGylation technology. Key preclinical data supporting the development of this product as second line therapy in ALL will be presented at the 51st ASH Annual Meeting to be held in New Orleans, LA on December 5-8, 2009.
Alizé’s Asparec(R) program focuses on a PEGylated r-crisantaspase product that has the potential to significantly impact the L-asparaginase market by becoming the reference product for second line therapy. L-asparaginases are widely used in the treatment of ALL. But although Escherichia coli -derived L-asparaginase products are used as first line therapy, there is a high incidence of allergic and immunogenicity reactions, requiring the use of second line products, such as Erwinia chrysanthemi-derived L-asparaginase (crisantaspase).
Key results to be presented at ASH indicate that the Asparec(R) product is ideally suited as second line therapy, as it is structurally similar to crisantaspase, but is both longer acting and less immunogenic thanks to its PEGylated nature. Results of pharmacokinetic and pharmacodynamic studies in mice revealed that the Asparec(R) product was at least 50 times more potent and was longer-acting than crisantaspase (Erwinase(R)) in depleting blood asparagine levels. In addition, PEGylation markedly reduced the immunogenicity vs Erwinase(R) as assessed by the antibody titers measured during eight weeks of chronic treatment in mice.
“The preclinical results for our Asparec(R) program are indicative of a therapeutic potential, fulfilling important medical needs for ALL patients,” says Alizé Pharma president and founder, Thierry Abribat. “They also show Alizé Pharma has a real business opportunity to take a leading position in the L-asparaginase market space. We will be actively seeking a commercial partner early in the development process according to our business strategy and to ensure timely take-up of the opportunity.”
Poster Presentations at ASH
Poster #2033
Title : Pharmacokinetics and Pharmacodynamics in Mice of a Pegylated Recombinant Erwinia chrysanthemi-Derived L-asparaginase
When: Sunday, December 6, 2009 at 6:00 pm Where: Hall E Poster Board II-10
Poster #2034
Title : Immunogenicity Profile in Mice of a Pegylated Recombinant Erwinia chrysanthemi-Derived L-asparaginase
When: Sunday, December 6, 2009 at 6:00 pm Where: Hall E Poster Board II-11
About Asparec(R)
Asparec(R) is a PEGylated recombinant L-asparaginase from Erwinia chrysanthemi (crisantaspase) and is being developed by Alizé Pharma in the treatment of Acute Lymphoblastic Leukemia (ALL) as second line therapy in children or adults when signs of hypersensitivity occur to the E. coli L-asparaginase products. In preclinical studies, the product has been shown to be more potent, longer acting and less immunogenic than Erwinase(R), the current second line reference product. Alizé Pharma is currently conducting the preclinical development of Asparec(R). The project has been accredited by the LyonBiopole competitive cluster; it is financially supported in part with a refundable grant from OSEO and with a FUI grant contributed both by the European Regional Development Fund (ERDF) and Grand Lyon.
About Alizé Pharma
The Alizé Pharma Group is composed of privately-held biopharmaceutical companies specialized in the development of innovative therapeutics for the treatment of metabolic diseases and cancer. The group acquires R&D programs from public or private laboratories, selecting them according to strict criteria, with particular reference to medical need and innovation. It then handles preclinical and clinical development and establishes partnerships with the pharmaceutical industry via co-development or out-licensing agreements. The first of the two entities of the Group, Alizé Pharma SAS, is dedicated to AZP-01, a program based on unacylated ghrelin agonists, a new therapeutic class for the treatment of Type II diabetes. AZP-01 and its analogs have the potential not only to control the disease but also to have a positive impact on other cardiovascular risk factors such as obesity, dyslipidemia and impaired vascular remodeling. The parent molecule and its analogs are protected by four patent families worldwide. The second entity is Alizé Pharma II SAS. It is focused on the development of Asparec(R) (AZP-02), a new, long-acting recombinant L-asparaginase with reduced immunogenicity for the treatment of acute lymphoblastic leukemia, and currently at the preclinical stage. Founded in April 2007, the Alizé Pharma group is based in Ecully, near Lyon, France. Its management is made up of a team of drug development experts and a board of directors offering wide international experience. Since its inception, the group has raised EUR 4.8 million with private and institutional investors.
