Pipeline
| Product candidate | Indication | Development status | Partner |
|---|---|---|---|
| NecLip-rFVIII (BAY 79-4980) | Hemophilia A | Multicenter phase II clinical trial initiated in 2008 by Bayer | Bayer Healthcare |
| NecLip-pdFVIII (LongAte) | Hemophilia A | Filing for marketing authorization in first territory | - |
| NecLip-rFVIIa (LongSeven) | Hemophilia patients with inhibitory antibodies | Phase I/II completed in Q1 2009 | - |
| NecLip-G-CSF | Peripheral blood stem cell transplantation | Preclinical stage | - |
| Liposomal glucocorticoid (REC-200) | Rheumatoid arthritis and autoimmune diseases | Preclinical stage | - |
NecLip-rFVIII (BAY 79-4980)
NecLip-rFVIII is a recombinant factor VIII (rFVIII) formulated with NecLip liposomes for the treatment of hemophilia A patients. The formulated rFVIII is marketed under the trade name Kogenate FS and is produced by Bayer Healthcare. Preclinical experiments and clinical trials indicate that NecLip-rFVIII improves hemostatic efficacy compared with standard rFVIII (publications). Results suggest that once-a-week prophylactic treatment with NecLip-rFVIII at a dose of 35 IU/kg/week may be as effective as conventional prophylactic treatment with rFVIII, which requires infusions at two- to three-day intervals at a total dose of 70-90 IU/kg/week.
In 2008, Bayer Healthcare initiated a multicenter phase II study in the United States, Europe and other locations. This non-inferiority phase II study compares the efficacy and safety of once-a-week prophylactic treatment with NecLip-rFVIII to standard three-times-a-week prophylactic treatment with rFVIII, in patients with severe hemophilia A. The phase II study will eventually include approximately 250 patients in the United States, Europe and Israel, and the duration of each patient’s treatment will be approximately one year. If successful, Bayer estimates to launch the product in the European Union in 2011, and in the United States in 2012.
Clinical studies preceding the current phase II study demonstrated a significant increase in the efficacy of NecLip-rFVIII in terms of bleed-free days compared with regular rFVIII.
NecLip-pdFVIII (LongAte)
Similar to its benefits with rFVIII, NecLip technology also increases the hemostatic efficacy of high-purity, plasma-derived FVIII (pdFVIII). Under its agreement with Bayer, Recoly retained commercialization rights of NecLip-pdFVIII in several territories, and we are currently filing for marketing authorization in one of these territories.
NecLip-rFVIIa (LongSeven)
Preclinical experiments indicate that NecLip technology increases the hemostatic efficacy of recombinant factor VIIa (rFVIIa) (publications). Combined results from a phase I/II clinical trial with NecLip-FVIIa suggest that for treatment of bleeding in hemophilia patients with inhibitors, one infusion of NecLip-rFVIIa at a dose of 90 µg/kg may roughly be equivalent to two infusions of standard rFVIIa given at 2-hour intervals at total dose of 180 IU/kg.
Recoly completed a phase I/II clinical trial with LongSeven. The open label, cross-over trial was conducted at the hemophilia center of the Russian Academy of Medical Sciences, Moscow, Russia. It included six hemophilia A patients with inhibitors to factor VIII. The trial evaluated the efficacy and safety of factor VIIa (FVIIa) formulated with PEGylated liposomes as compared to standard FVIIa (90µg FVIIa/kg in both treatment arms). The results indicate that formulation of FVIIa with PEGylated liposomes significantly enhances the hemostatic efficacy of FVIIa. Safety analysis indicated that the increased efficacy of liposomal FVIIa was not accompanied by increased thrombotic risk. The results suggest that in treatment of bleeding episodes in hemophilia patients with inhibitors, one dose of LongSeven is roughly equivalent to two doses of standard FVIIa given two hours apart.
NecLip-G-CSF
Pre-clinical studies in mice indicate that treatment with NecLip-G-CSF significantly increases stem cell mobilization into peripheral blood compared with treatment with a comparable amount of G CSF (publications). The increased mobilization observed in these studies is the basis of our expectation that NecLip-G-CSF can induce stronger mobilization of stem cells in human patients, leading to shorter and fewer cycles required to reach adequate stem cell levels in cancer patients and increasing the number of patients from whom stem cells can be harvested.
REC-200 - Liposomal glucocorticoid
Pre-clinical studies in rats indicate that encapsulated glucocorticoid has superior efficacy over standard glucocorticoid in the treatment of autoimmune arthritis in both early disease stage and disease peak (publications). The increased efficacy observed in these studies is the basis of our expectation that REC-200 can be an effective remitting agent at doses that minimize the side effects of glucocorticoid. We will therefore expect to be able to use REC-200 technology to convert an old and effective anti-inflammatory agent into a new, effective and safe disease-modifying drug for the treatment of rheumatoid arthritis and other autoimmune diseases.