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CAMBRIDGE, Mass., Dec. 12 /PRNewswire-FirstCall/ -- Genzyme Corporation announced today that physicians have treated the first participants in a Phase 1 clinical trial to test the safety of Genz-29155, a small molecule developed by Genzyme for the treatment of multiple sclerosis.
The Phase 1 trial will initially involve up to 56 healthy volunteers, who will receive the drug in escalating doses. It will be followed in the second half of 2004 by a multiple dose Phase 1 study. If Phase 1 development is successful, the company anticipates launching a Phase 2 trial in patients with the relapsing-remitting form of multiple sclerosis in the second half of 2005.
Genz-29155, which was discovered through high throughput screening at Genzyme, has shown an ability in vitro to inhibit some, but not all, of the activities of tumor necrosis factor (TNF), a protein active in the regulation of certain immune responses. In vivo, Genz-29155 has shown potential to have an effect not only in models of multiple sclerosis, but of other immune- mediated diseases as well.
Genzyme's Immune-Related Portfolio
Genz-29155 is Genzyme's second product candidate now in clinical trials for an immune-mediated disease. Preliminary results are expected in early 2004 from a Phase 1/2 trial of CAT-192, a human monoclonal antibody against TGF beta1 that is being investigated with partner Cambridge Antibody Technology (CAT) for the treatment of diffuse systemic sclerosis. GC1008, a pan-specific human monoclonal antibody against TGF beta 1, 2 and 3, is expected to enter clinical trials next year for the treatment of idiopathic pulmonary fibrosis, also in partnership with CAT.
Among earlier-stage work, Genzyme announced recently that it has entered an early stage research and development collaboration with MacroGenics, Inc. of Rockville Maryland, to develop new treatments for a range of immune- mediated diseases.
Genzyme also has rights to a research program at San Francisco-based Therapeutic Human Polyclonals Inc. (THP) that is developing humanized polyclonal antibodies from transgenic sources. This collaborative program may ultimately have utility in transplantation, cancers of the blood, and immune- mediated diseases. Genzyme, through its wholly-owned subsidiary SangStat Medical Corporation, recently made a $3.2 million equity investment in THP following the successful completion of a milestone related to the development of its human antibody platform. The payment increased the company's equity stake in THP to approximately 19 percent.
Genzyme Corporation is a global biotechnology company dedicated to making a major positive impact on the lives of people with serious diseases. The company's broad product portfolio is focused on rare genetic disorders, renal disease, osteoarthritis and immune-mediated diseases, and includes an industry-leading array of diagnostic products and services. Genzyme's commitment to innovation continues today with research into novel approaches to cancer, heart disease, and other areas of unmet medical need. More than 5,300 Genzyme employees in offices around the globe serve patients in over 80 countries.
This press release contains forward-looking statements, including statements regarding: the potential efficacy of Genz-29155 in multiple sclerosis and other immune-mediated diseases; clinical trial plans, including the anticipated design and timing of trials for Genz-29155 and GC1008; the expected timing of preliminary results from a clinical trial of CAT-192; and the potential applications of the research being conducted at THP. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: enrollment rates in clinical trials; the ability to demonstrate the safety and efficacy of Genz-29155 in humans as a therapy for multiple sclerosis and other diseases; the actual timing and results of preclinical and clinical studies; the content and timing of decisions by regulatory authorities and institutional review boards related to clinical trials; the ability to supply sufficient product for development activities; and the factors discussed under the caption "Factors Affecting Future Operating Results" in Genzyme's Quarterly Report on Form 10-Q for the period ended September 30, 2003 and under the caption "Risk Factors" in SangStat Medical Corporation's Quarterly Report on Form 10-Q for the period ended June 30, 2003. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this document and we undertake no obligation to update or revise the statements.
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