ROCKVILLE, Md., Jan. 3 /PRNewswire/ -- CoGenesys, Inc. announced today the Company has submitted a Clinical Trial Application (CTA) to begin human studies in Europe of Neugranin(TM), a long-acting form of Granulocyte Colony Stimulating Factor (G-CSF), which is designed to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs. Neugranin is the second-most advanced clinical-stage compound in CoGenesys' broad pipeline of improved, long-acting biopharmaceuticals being developed to address unmet medical needs across a broad spectrum of therapeutic areas.
Pending CTA authorization, the Phase 1-2a clinical trial of Neugranin will be a randomized, multicenter, double-blind safety and tolerability trial in more than 60 patients with breast cancer. In the first phase of the study, subjects will receive a subcutaneous dose of Neugranin prior to receiving myelosuppressive chemotherapy (Doxorubicin/Docetaxel). In the second phase, patients will be given chemotherapy prior to dosing with Neugranin, while a positive control group will receive Neulasta(R), a pegylated form of G-CSF. Evaluations will include safety and tolerability, pharmacokinetic profiles, and, additionally, in the second phase, signals for effect.
Martha A. Reitman, M.D., CoGenesys' Senior Vice President, Medical Affairs, stated, "We are pleased to announce the regulatory submission for the company's second clinical trial program. Previously, findings from in vitro and in vivo tests have suggested that Neugranin may have a profile comparable to that of Neulasta(R), the current market leader for the treatment of patients who have reduced white blood cells (neutropenia). With a competitive cost of goods profile, Neugranin may represent an affordable treatment alternative to prevent and treat chemotherapy-induced febrile neutropenia in cancer patients. Further, there may be an opportunity to consider the regulatory pathway for Neugranin as a "bio-similar" drug."
Fighting Infections in Cancer Patients
Neutropenia is the most common side effect associated with the administration of chemotherapy in cancer patients. Neutropenia can lead to serious infections and hospitalization, and the presence of fever in these patients often necessitates the reduction of the dose of chemotherapy or causes a delay in the administration of the next cycle of chemotherapy. In certain cancers, such as breast cancer or non-Hodgkin's lymphoma, the importance of dose maintenance for treatment success has been well-established.
The worldwide market for colony stimulating factors is expected to reach $5 billion by 2010. Three products have been approved for marketing in the United States: Amgen's Neupogen(R) and Neulasta(R), and Schering AG's Leukine(R). Neulasta(R) is the only long-acting G-CSF product presently approved in the world. Neulasta alone generated $2.2 billion in sales in 2005. CoGenesys believes that Neugranin has the potential to be the second long-acting G-CSF product to enter this very large market.
About CoGenesys, Inc.
CoGenesys, Inc. was spun out of Human Genome Sciences, Inc. in June of 2006. The Company's strategy is to demonstrate safety and proof of concept in clinical trials followed by licensing or partnering of compounds to fund further development. CoGenesys has approximately 70 employees, including 20 PhD-level scientists, and a dedicated 48,000 sq. ft. facility with cGMP manufacturing capacity sufficient for early-stage clinical testing.
Development programs at CoGenesys are capitalizing on the depth of its pipeline and the breadth of its technology to develop lead drug candidates addressing a broad spectrum of diseases and applications, including cardiovascular disease, diabetes / metabolism, enzyme and protein replacement therapy and others. CoGenesys' state-of-the-art research and manufacturing facility is fully equipped, supporting both pre-clinical development and cGMP manufacture of biologics. The clinically validated albumin-fusion technology offers a number of advantages, including the ability to improve the bioavailability of existing biologicals, such as interferon alpha (being developed by Human Genome Sciences, Inc. (HGSI) and Novartis), and increased feasibility of developing pharmaceutically relevant peptides, such as GLP-1 (being developed by GlaxoSmithKline under license from HGSI).
In October 2006, the Company initiated Phase I/II testing of Cardeva(TM), a long-acting form of B-type natriuretic peptide (BNP) that is being developed for the treatment of patients with heart failure (HF). CoGenesys is also developing Neugranin(TM), a long-acting form of Granulocyte Colony Stimulating Factor (G-CSF), to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs, and Albulin-G, a long-acting form of insulin.
For more information about CoGenesys visit http://www.cogenesys.com/