And another....
CoGenesys Expands Clinical Programs with Initiation of Phase 1-2a Trial of Neugranin in Cancer Patients
Tuesday March 27, 7:30 am ET
Neugranin Designed to Reduce Infections Associated with Neutropenia
ROCKVILLE, Md., Mar. 27 /PRNewswire/ -- 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.
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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®, 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®, 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." |
