CAMBRIDGE, Mass., Dec. 7 /PRNewswire/ -- TolerRx, Inc. announced today the initiation of three new clinical trials: a follow-on study of its lead product, TRX4, in subjects with Type 1 Diabetes; a Phase Ib study of TRX4 in subjects with moderate to severe psoriasis; and a Phase Ib study of TRX1, which is being developed in collaboration with Genentech, Inc., in subjects with refractory Cutaneous Lupus Erythematosus (CLE).
In a study of new-onset Type 1 diabetics published in the June 23, 2005, issue of the New England Journal of Medicine, TRX4 preserved the function of insulin-producing beta cells in the pancreas and reduced the amount of administered insulin needed to control blood glucose levels for at least 18 months after a single six day course of therapy. With clinical proof of concept established, TolerRx has initiated a follow-on study in the U.S. in subjects with new-onset Type 1 Diabetes utilizing multiple escalating doses in order to optimize and select a TRX4 regimen to be used in later phase trials.
TolerRx completed a Phase Ia clinical trial of TRX4 in subjects with moderate to severe psoriasis in which the safety and pharmacokinetic profile of TRX4 after escalating single intravenous infusions was established. No unpredictable adverse events were observed, and maximally tolerated doses were defined by cytokine release symptoms. Although the trial was not designed to assess efficacy, preliminary results demonstrated clinically meaningful improvements in several subjects’ skin as measured by psoriasis area and severity index scores (PASI; a composite measure of erythema, induration, desquamation and body surface area affected) after just single doses of TRX4. Based on these results, TolerRx has initiated a Phase Ib study of TRX4 that will evaluate the safety and efficacy of escalating multiple doses in subjects with moderate to severe psoriasis.
In addition, TolerRx announced the initiation of a Phase Ib trial of TRX1 in subjects with refractory CLE. In preclinical studies, TRX1 therapy has been shown to induce long-term, antigen-specific tolerance without compromising normal immune function. TolerRx has completed a Phase Ia single dose safety study in healthy volunteers, and the current trial will evaluate the safety and efficacy of multiple escalating doses of TRX1. TRX1 is a humanized antibody the company is developing in collaboration with Genentech, Inc.
“I am excited about the initiation of these clinical trials and the opportunity these products may represent for patients. We are evaluating the safety, efficacy, and immunoregulatory properties of TRX4 and TRX1 in disease indications in which there is either no approved therapy (beta cell preservation in diabetes mellitus) or there is a need for additional effective treatments (chronic plaque psoriasis and CLE), particularly for those patients who have failed standard treatment options. TRX4 and TRX1 may have the potential to provide a long-term benefit after only a short course of therapy, something that both physicians and patients would welcome,” stated Lou Vaickus, Chief Medical Officer at TolerRx.
“The initiation of these three clinical trials demonstrates our commitment and ability to rapidly execute our development strategy and provides promise to both our patients and shareholders,” added Douglas J. Ringler, President and CEO of TolerRx. “We are looking forward to completing enrollment in these trials and will strive to advance both TRX4 and TRX1 towards market approval.”
About TRX4
TRX4 is a monoclonal antibody that binds to a receptor found on all mature T cells called CD3, which is involved in normal T cell signaling. TRX4 is believed to inhibit the function of autoreactive T cells, which are important in propagating autoimmune diseases, such as Type 1 Diabetes and psoriasis, while inducing regulatory T cell pathways that promote immunological tolerance and inhibit autoreactive disease activity. TolerRx is currently enrolling subjects with Type 1 Diabetes to participate in a clinical study of TRX4 in the U.S. In addition, TolerRx is enrolling subjects with moderate to severe psoriasis to participate in a Phase Ib study of TRX4.
About TRX1
TRX1 is a humanized antibody that binds to the CD4 receptor found on a subset of T cells. In preclinical studies, TRX1 therapy has been shown to induce long-term, antigen-specific tolerance without compromising normal immune function. TRX1 is being developed for the potential treatment of autoimmune diseases in collaboration with Genentech, Inc. TolerRx has completed a Phase I trial of TRX1 and is currently enrolling subjects with refractory cutaneous lupus erythematosus to participate in a Phase Ib study.
About TolerRx
TolerRx is a biopharmaceutical company specializing in the discovery, development, and commercialization of novel therapies to treat patients with immune-mediated diseases. TolerRx’s has two antibodies in clinical development: TRX4 in Type 1 Diabetes and psoriasis, and TRX1 in cutaneous lupus erythematosus (CLE). TRX1 is a humanized anti-CD4 antibody, which is being developed in collaboration with Genentech, Inc. TRX4 is an anti-CD3 monoclonal antibody to which TolerRx owns exclusive rights. TolerRx is also developing new products to induce immunological tolerance for the treatment of autoimmune diseases and to remove tolerance for the treatment of cancer or chronic viral diseases. For more information, please visit http://www.tolerrx.com.
CONTACT: TolerRx, Inc. Douglas J. Ringler Chief Executive Officer 1-617-452-1300 dringler@tolerrx.com
TolerRx, Inc.
CONTACT: Douglas J. Ringler, Chief Executive Officer of TolerRx, Inc.,+1-617-452-1300, dringler@tolerrx.com
Web site: http://www.tolerrx.com//
