CoGenesys, Inc. Expands Clinical Programs with Initiation of Phase 1-2a Trial of Neugranin in Cancer Patients
- Category: Proteins and Peptides
- Published on Wednesday, 28 March 2007 03:00
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ROCKVILLE, MD, USA | Mar 27, 2007 | CoGenesys, Inc. announced today that the Company has initiated a Phase 1-2a study in Europe of Neugranin(TM), a long-acting form of Granulocyte Colony Stimulating Factor (G-CSF). Neugranin is designed to reduce infections associated with neutropenia, a reduction in the number of white blood cells which is the most common side effect associated with the administration of chemotherapy in cancer patients.
CoGenesys' Phase 1-2a study is a randomized, multicenter, double-blind, controlled safety, tolerability, and evaluation for effect 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 receive their chemotherapy prior to dosing, and 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, "The Phase 1-2a study builds on previous preclinical research demonstrating that our long-acting form of G-CSF will likely have a therapeutic profile comparable to that of Neulasta(R), the current market leader for the treatment of patients with neutropenia. In designing the trial, we have benefited from the fact that G-CSF is a well-characterized compound which has been studied in a number of patient populations, and we expect the program to advance rapidly through clinical development. We also believe that Neugranin will have a competitive cost-of-goods profile and therefore may represent an affordable treatment alternative to current therapy."
Steven C. Mayer, CoGenesys' Chief Executive Officer, commented, "We are pleased to announce the initiation of clinical trials for the second product candidate from our diverse pipeline of improved, long-acting biopharmaceuticals. The first study initiated in October 2006 with patient enrollment for our Phase 1-2 testing of Cardeva(TM), a long-acting form of B-type natriuretic peptide (BNP) which is being developed for the treatment of patients with heart failure. We also expect to initiate clinical trials of our third product candidate, a long-acting basal insulin, during summer 2007. In all of these trials, our strategy has been to identify important therapeutic areas and pursue strongly validated therapeutic modalities which can substantially benefit from our proprietary albumin-fusion technology."
Fighting Infections in Cancer Patients
Serious infections and hospitalization can result from neutropenia, and the presence of neutropenia-associated fever often necessitates the reduction of the dose of chemotherapy in patients or can cause a delay in the administration of the next cycle of chemotherapy. Treatment and prevention of neutropenia is a particular concern in a number of cancers, such as breast cancer or non-Hodgkin's lymphoma, in which 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 $2.7 billion in sales in 2006. 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 preclinical 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 1-2 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), now in clinical testing as a treatment to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs, and Albulin-G, a long-acting form of insulin.
SOURCE: CoGenesys, Inc.