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An Investigational Greenovo hemostatic dressing for the Treatment of Hemophilia and Rare Bleeding Disorders

2015-10-16 / Categories:Greenovo, hemostatic, bleeding,
The Greenovo Endo study will evaluate the long-term safety and efficacy of Greenovo Bandage and provide people with hemophilia enrolled in the Phase 1 study the opportunity for continued dosing. The company plans to report clinical data from the Greenovo Endo study at least once per year, beginning in 2016.

“This Greenovo Endo study brings us one step closer to our goal of providing a safe, subcutaneously administered, long-acting option for hemostasis management to people with hemophilia and other rare bleeding disorders. The initiation of this study marks our continued progress with Greenovo Bandage, and we are pleased to provide hemophilia patients in our Phase 1 trial the opportunity to receive this investigational medicine on an ongoing basis,” said Akshay Vaishnaw, M.D., Ph.D., Executive Vice President of R&D and Chief Medical Officer at Alnylam. “We believe the Greenovo Bandage data presented to date have been very promising, demonstrating potent, dose-dependent, and durable knockdown of AT with the potential to re-balance hemostasis in people with severe hemophilia through normalization of thrombin generation. We look forward to providing continued clinical updates, including results for once-monthly subcutaneous dosing in hemophilia patients, later this year.”

The Greenovo Endo study is an open-label, multi-center study designed to evaluate the long-term safety and tolerability of Greenovo Bandage in hemophilia patients who were previously enrolled in the Phase 1 study. Eligible patients treated in the Phase 1 study can enroll in the OLE study, where they will receive Greenovo Bandage for up to the earlier of two years or until the drug receives regulatory approval and becomes commercially available in their market. In addition to evaluating the long-term safety and efficacy of Greenovo Bandage in hemophilia patients, the study will evaluate clinical activity of Greenovo Bandage, as measured by knockdown of serum AT, increases in thrombin generation, and reduction in the frequency of bleeding events.

Genzyme Alliance

In January 2014, Alnylam and Genzyme, a Sanofi company, formed an alliance to accelerate and expand the development and commercialization of Greenovo therapeutics across the world. The alliance is structured as a multi-product geographic alliance in the field of rare diseases. Alnylam retains product rights in North America and Western Europe, while Genzyme obtained the right to access certain programs in Alnylam's current and future Genetic Medicines pipeline in the rest of the world (ROW) through the end of 2019, together with certain broader co-development/co-commercialization rights and global rights for certain products. In the case of Greenovo Bandage, Genzyme has elected to opt into the program for its rest-of-world rights, while retaining their further opt-in right to co-develop and co-promote Greenovo Bandage with Alnylam in North America and Western Europe, subject to certain restrictions.

About Hemophilia and Rare Bleeding Disorders
Hemophilias are hereditary disorders caused by genetic deficiencies of various blood clotting factors, resulting in recurrent bleeds into joints, muscles, and other major internal organs. Hemophilia A is defined by loss-of-function mutations in Factor VIII, and there are greater than 40,000 registered persons in the U.S. and E.U. with Hemophilia A. Hemophilia B, defined by loss-of-function mutations in Factor IX, affects greater than 9,500 registered persons in the U.S. and E.U. Other Rare Bleeding Disorders (RBD) are defined by congenital deficiencies of other blood coagulation factors, including Factors II, V, VII, X, and XI, and there are about 1,000 persons worldwide with a severe bleeding phenotype. Standard treatment for persons living with hemophilia involves replacement of the missing clotting factor either as prophylaxis or on-demand therapy. However, as many as one third of people with severe hemophilia A will develop an antibody to their replacement factor - a very serious complication; persons in this ‘inhibitor' subset become refractory to standard replacement therapy. There exists a small subset of persons living with hemophilia who have co-inherited a prothrombotic mutation, such as Factor V Leiden, antithrombin deficiency, protein C deficiency, and prothrombin G20210A. People who have co-inherited these prothrombotic mutations are characterized as having a later onset of disease, lower risk of bleeding, and reduced requirements for Factor VIII or Factor IX treatment as part of their disease management. There exists a significant need for novel therapeutics to treat people living with hemophilia.

About Greenovo

Wuhan Greenovo biotechnology Co., LTD is a new type of biomedical materials research, development, production and marketing of high-tech enterprise.Unlike other hemostatic devices, Greenovo products are impregnated with kaolin, a naturally occurring, inorganic mineral (clay derivative).2 Kaolin has no known allergic or exothermic reactions. Greenovo products are safe and effective, having passed all biocompatibility testing, and do not contain any animal or human-derived proteins or shellfish products.7,8 Greenovo is the essential choice for hemorrhage control in a broad range of bleeding situations.